{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 10, "total": 56191 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10006141", "primarysourcecountry": "KP", "occurcountry": "KP", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "1", "companynumb": "KP-ROXANE LABORATORIES, INC.-2014-RO-00371RO", "duplicate": "1", "reportduplicate": { "duplicatesource": "ROXANE", "duplicatenumb": "KP-ROXANE LABORATORIES, INC.-2014-RO-00371RO" }, "primarysource": { "reportercountry": "COUNTRY NOT SPECIFIED", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "62", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pneumonia aspiration", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "BK virus infection", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Encephalitis viral", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "MYCOPHENOLATE MOFETIL", "drugauthorizationnumb": "065410", "drugadministrationroute": "065", "drugindication": "PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE", "openfda": { "application_number": [ "ANDA203575", "ANDA216390", "ANDA214283", "ANDA210370", "ANDA214525", "ANDA214871", "ANDA214079", "NDA216482", "ANDA218227", "ANDA210181", "ANDA212087", "ANDA203859", "ANDA090456", "ANDA090055", "ANDA065416", "ANDA090253", "ANDA207022", "ANDA065491", "ANDA217828", "ANDA208119", "ANDA091249", "ANDA200197", "ANDA203005", "ANDA065413", "NDA050722", "NDA050723", "NDA050759", "ANDA212130", "ANDA212634", "ANDA217937", "ANDA065379", "ANDA065451" ], "brand_name": [ "MYCOPHENOLATE MOFETIL", "MYHIBBIN", "CELLCEPT" ], "generic_name": [ "MYCOPHENOLATE MOFETIL", "MYCOPHENOLATE MOFETIL HYDROCHLORIDE" ], "manufacturer_name": [ "Par Health USA, LLC", "ONESOURCE SPECIALTY PHARMA LIMITED", "BPI Labs LLC", "VistaPharm, LLC", "Lannett Company, Inc.", "Amneal Pharmaceuticals NY LLC", "Wuxi Fortune Pharmaceutical Co.,Ltd.", "Azurity Pharmaceuticals, Inc.", "ARMAS PHARMACEUTICALS INC", "Aurobindo Pharma Limited", "CONCORD BIOTECH LIMITED", "Mylan Institutional LLC", "Strides Pharma Science Limited", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Accord Healthcare Inc.", "Camber Pharmaceuticals, Inc.", "Teva Pharmaceuticals USA, Inc.", "Ascend Laboratories, LLC", "Advagen Pharma Limited", "Hikma Pharmaceuticals USA Inc.", "Genentech, Inc.", "Meitheal Pharmaceuticals Inc.", "Sandoz Inc", "NorthStar Rx LLC" ], "product_ndc": [ "42023-172", "83270-000", "54288-141", "66689-307", "0527-5160", "69238-1595", "65050-2073", "24338-018", "72485-415", "59651-646", "68254-5000", "68254-5003", "67457-386", "64380-725", "64380-726", "23155-830", "23155-836", "16729-019", "16729-094", "31722-878", "0093-7334", "59651-624", "31722-879", "67877-225", "67877-266", "67877-230", "72888-185", "72888-192", "0054-0166", "0054-0163", "0004-0259", "0004-0260", "0004-0298", "0004-0261", "60219-1595", "71288-803", "23155-848", "59651-638", "0781-2067", "0781-5175", "72603-751" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "ORAL" ], "substance_name": [ "MYCOPHENOLATE MOFETIL", "MYCOPHENOLATE MOFETIL HYDROCHLORIDE" ], "rxcui": [ "311881", "311880", "199058", "2684851", "200060", "213394", "616435", "616444", "616447" ], "spl_id": [ "1df5a45a-835a-454f-b9b1-5265b801cdca", "42ed2be4-bc3d-281a-e063-6394a90aeb7f", "1a8abd3a-6834-4468-a443-ca95e795b17d", "ae50c781-e225-4275-a23a-03b4b2a1e507", "6cb7ed46-e457-4e92-8a15-e771e3dca2d5", "62350c79-05dc-4568-bd51-489f8221136a", "42d339f9-3fb1-6882-e063-6294a90a3012", "d90d3f5a-98a2-4e50-8bb1-db76875c9b8c", "42edff88-f01d-0908-e063-6294a90a3b0f", "83531645-459d-4746-bc46-2d32928e9417", "6eb2ddd0-ab23-44ae-a1ce-acc44e4f7e29", "4c643876-2577-4197-ac9b-81bab65d1362", "51752987-c49c-40b6-8fe2-1d1c99554312", "4c6ca7cd-80b3-4703-904c-6d6d78965f4b", "50ae55f7-2f85-5d74-e063-6394a90acdb1", "3b604c8c-672d-7b1e-e063-6394a90a255f", "d924ecfe-fba4-41ad-a1c1-e8ee06d76e67", "19947991-db65-4143-a57c-dc180d695426", "48432e06-b34c-4277-e063-6394a90a6ba0", "f8b5a092-55fd-4e91-aa56-98fe69f1c091", "967b53be-dfe4-4767-878c-d6a16cd3d391", "f2ff4283-6a46-451e-9a9e-e7090ecf2b3a", "96ad05fd-dd3d-4c3c-9bc2-cafbfed2cb65", "ad799779-cc87-4d12-9836-74375149b84b", "545a5c62-f746-4667-91ec-68673bfa787f", "8c49656c-3408-41e6-be90-e003e057d2fc", "b5316b1d-ed7b-426d-9b86-dd17018c97a5", "abdd39b5-dac9-4e5c-9722-17473947909d", "8d255117-cfa8-4893-8e2e-945eee7b12c4", "b080be2a-5a17-45d5-bffd-4ce8cb13e8b1", "127eabe2-8386-452a-ad6b-d879e1f2c099" ], "spl_set_id": [ "35ba0428-e267-49a5-99a9-c58853f7989d", "461a252f-ff81-4e08-b256-a497b14835fa", "32001417-130d-4c08-8e63-94ba3627ce5f", "175d8b87-e06a-4c9e-b3de-378114b52274", "24c0b94a-c141-44b6-a6f0-ade1669b254c", "27fd9381-8d82-4187-897f-98f41f94e90f", "ca633c6a-1e58-4faa-8e5d-71f89cefaa01", "d9af72d6-7b3e-4c08-94b9-1d8b499cb7f9", "ffcc237c-f31b-77b8-e053-6294a90a603e", "20fa7709-a203-481f-aaf4-e98fab1acd0d", "64ac00ee-298c-49cf-a91c-78019a0d014d", "da02b428-42a4-4007-b0b7-695f2db010f2", "32dd890a-cfe3-4129-bce6-1d3dbe38e4f3", "3ac54299-15cc-4c7a-8831-60c15a859b85", "741e079a-646b-47ec-84ac-8e12574c2aaf", "118e9bc8-c1a9-41d0-89e6-251f3be0b99c", "b414303f-e6f3-4e22-a537-96be352b59a4", "3eb584dc-f72d-4545-96fa-ab3d47be41ce", "c3ded171-89da-4644-9ee8-dbcf6258036f", "9f84ea84-2d8b-4d91-a33f-7dfb5df937dc", "21ff53b0-b4ba-4473-91e4-76ef41681064", "a15c26d8-5a27-48ba-a669-8546803d901f", "e94895d9-f040-4a75-9f04-9814238b8f3c", "37241e87-4af4-4dc3-a1aa-ea6f20d8dc40", "5d7f7b88-79e3-4a56-a9f3-796c28049a60", "9650af9b-d36f-4a2f-9647-d0f798933402", "df3ba2e9-00bb-40af-8658-2c5fd2e398ef", "8faf357b-99a1-440b-8eac-8545cb19a69c", "99b2eb58-8d14-48fc-bbe1-aacb711a783e", "b41cca9f-0922-4171-8d1b-8e0d32ae1cc1", "127eabe2-8386-452a-ad6b-d879e1f2c099" ], "package_ndc": [ "42023-172-04", "83270-000-04", "54288-141-04", "66689-307-08", "0527-5160-82", "69238-1595-2", "65050-2073-0", "24338-018-01", "72485-415-04", "59651-646-26", "68254-5000-2", "68254-5000-1", "68254-5003-1", "68254-5003-2", "68254-5003-3", "67457-386-00", "67457-386-81", "64380-725-06", "64380-725-07", "64380-726-06", "64380-726-07", "64380-726-11", "23155-836-01", "23155-836-05", "23155-830-01", "23155-830-05", "16729-094-01", "16729-094-29", "16729-094-16", "16729-019-01", "16729-019-16", "31722-878-01", "31722-878-05", "0093-7334-01", "0093-7334-05", "59651-624-01", "59651-624-05", "31722-879-01", "31722-879-05", "67877-225-01", "67877-225-05", "67877-225-84", "67877-225-38", "67877-266-01", "67877-266-05", "67877-266-84", "67877-266-38", "67877-230-22", "72888-192-01", "72888-192-05", "72888-185-01", "72888-185-05", "0054-0163-29", "0054-0163-25", "0054-0166-25", "0054-0166-29", "0004-0260-01", "0004-0260-43", "0004-0259-01", "0004-0259-43", "0004-0298-09", "0004-0261-29", "60219-1595-2", "71288-803-20", "71288-803-21", "23155-848-51", "59651-638-01", "59651-638-05", "0781-2067-89", "0781-2067-01", "0781-2067-05", "0781-2067-72", "0781-5175-01", "0781-5175-05", "0781-5175-10", "71288-803-91", "71288-803-92", "72603-751-01" ], "unii": [ "9242ECW6R0", "UXH81S8ZVB" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE", "drugadministrationroute": "042", "drugindication": "PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "1", "medicinalproduct": "METHOTREXATE", "drugadministrationroute": "042", "drugindication": "PROPHYLAXIS AGAINST GRAFT VERSUS HOST DISEASE", "openfda": { "application_number": [ "ANDA210454", "NDA011719", "NDA212479", "ANDA040385", "ANDA040263", "ANDA220225", "ANDA040632", "ANDA201529", "ANDA201749", "ANDA081235", "NDA205776", "NDA208400", "ANDA040266", "ANDA040843", "ANDA207812", "ANDA081099", "ANDA040716", "ANDA089343", "ANDA089342", "ANDA089341", "ANDA089340", "ANDA213343", "ANDA217552", "NDA204824" ], "brand_name": [ "METHOTREXATE", "JYLAMVO", "TREXALL", "RASUVO", "XATMEP", "OTREXUP" ], "generic_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Chartwell RX, LLC", "Hospira, Inc.", "SHORLA ONCOLOGY INC.", "Teva Women's Health LLC", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Alembic Pharmaceuticals Limited", "Eugia US LLC", "Sun Pharmaceutical Industries, Inc.", "Mylan Pharmaceuticals Inc.", "Medexus Pharma Inc.", "Aurobindo Pharma Limited", "Azurity Pharmaceuticals, Inc.", "Teva Parenteral Medicines, Inc.", "Zydus Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc.", "Accord Healthcare, Inc.", "Zydus Lifesciences Limited", "Accord Healthcare Inc.", "Antares Pharma, Inc." ], "product_ndc": [ "62135-772", "61703-350", "61703-408", "81927-204", "51285-366", "51285-367", "51285-368", "51285-369", "63323-123", "62332-711", "62332-712", "0143-9830", "46708-711", "46708-712", "55150-510", "55150-511", "55150-512", "55150-513", "47335-235", "61703-124", "61703-161", "0378-0014", "0143-9367", "59137-505", "59137-510", "59137-515", "59137-520", "59137-525", "59137-530", "59137-535", "59137-540", "59137-550", "59651-182", "52652-2001", "63323-122", "0703-3671", "0703-3675", "0703-3678", "68382-775", "0555-0572", "16729-277", "0143-9516", "0143-9519", "0143-9518", "0143-9517", "70771-1058", "16729-486", "62332-730", "54436-010", "54436-075", "54436-012", "54436-015", "54436-017", "54436-020", "54436-022", "54436-025", "46708-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "INTRATHECAL", "INTRA-ARTERIAL" ], "substance_name": [ "METHOTREXATE SODIUM", "METHOTREXATE" ], "rxcui": [ "105585", "1655956", "1946772", "2671456", "2671462", "105586", "283510", "283511", "283671", "284592", "284593", "284594", "284595", "311625", "1655959", "1655960", "1655967", "1655968", "1441416", "1544378", "1544383", "1544385", "1544386", "1544387", "1544388", "1544389", "1544390", "1544394", "1544395", "1544396", "1544397", "1544398", "1544401", "1544402", "1544403", "1544404", "1921592", "1921598", "1441402", "1441407", "1441411", "1441413", "1441418", "1441422", "1441424", "1594757", "1594759", "1747179", "1747181", "1747185", "1747187", "1747192", "1747194" ], "spl_id": [ "462a5023-e5a1-692a-e063-6294a90a7236", "95b8b8da-da4e-4bba-9038-3cf65f3d5c1a", "37b3e76b-ac3d-4f93-adf1-91f52f676b8a", "53bd9776-70ec-46f9-e063-6294a90a7011", "d1e7432e-253d-49f0-ab0a-bb859210ccd6", "880c2caa-1b11-45ce-a54e-a3733da367f0", "91ce9c78-370f-49a1-ae22-428bdddb389f", "49eb25b2-c59c-4374-a216-076767fe1126", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "524f657e-d138-9c87-e063-6294a90a93ad", "6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "01ad6cb9-5879-4c06-801b-0de84eebaae7", "7950579c-084b-472b-a7ce-f342691aff97", "29d04017-dd64-4dea-a064-7b3b0805f423", "9fe03573-fff3-4051-8598-8542eee1273f", "4e3b0925-2cdc-4743-91cf-860d98dd4661", "3d21237a-ef53-4592-bf06-0c739696203d", "e81074cc-12b4-4ac9-a5bb-749188989b2c", "5d9b7269-19d4-4d2c-b252-f3ff759dffa5", "9c7cf5a6-e720-4e83-bb08-f371e9bb9c9e", "2bae3cfe-7aa0-c14c-e063-6294a90a19f4", "3046ff78-3565-46d1-a88b-283e5ff6e7c3", "ae399908-cfb6-44dc-83da-8981f5dabbb8", "52d366f6-f339-ff1a-e063-6294a90a1577", "9dd138d6-6889-400e-a994-9931af68244a", "2d07eb50-d314-a6a0-e063-6394a90ac970", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "spl_set_id": [ "2609da8f-80dc-448e-8eba-35d11488ce7f", "0d63ba29-b692-41b4-87e8-351265c8273f", "0e30eaef-5a09-4104-8a11-c32933eadeab", "96e931f5-51ae-4bdf-a441-bb0dd26d4c0e", "e942f8db-510f-44d6-acb5-b822196f5e8c", "b585f621-f6c9-4735-ab61-bd1b401f3df0", "a63364d5-4dfa-49d7-8a5e-c8959ae1d37a", "b080eb92-fc72-4ce6-a7ab-3f9ce2415526", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "63bb6fbf-dd59-4edc-af8f-d0c397ca1262", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "bd287e89-32f9-4396-95fa-4b562869f476", "70c09984-2b36-424f-8b27-3fd0cd4e833d", "8593f7fc-eabe-44ae-bb05-b3d7d408e4f7", "d0075461-0e7e-4967-9c9b-d6440e912c0e", "09931d44-a3f8-49dc-a3f2-b527ee4214bf", "aec9984e-34c5-481b-b6bf-9bb5caf1daf8", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "346ec9ce-dc98-4a55-b55e-d3af11f2d703", "948e0bab-6524-4b87-9853-1799d4415558", "9b34b1d8-d125-41a2-9f6f-3fab67b573bd", "dd035a9f-cd40-4314-b9d8-2294b8a924e2", "3989d30d-56e5-4e8d-9379-c30fecc894f2", "59ea7b32-2b6d-4197-92c3-015936f04ebe", "874c7f43-a3be-4236-89cc-24c44e3c5813", "04a95db9-a124-4b97-bd71-1c37a6b3b0c8", "9ab8ce16-f7de-41d4-a4c8-1c742621b6d5", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "package_ndc": [ "62135-772-35", "61703-350-37", "61703-350-38", "61703-408-41", "61703-350-09", "61703-350-10", "61703-408-25", "81927-204-01", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "63323-123-10", "62332-711-01", "62332-711-05", "62332-712-01", "0143-9830-01", "46708-711-01", "46708-711-05", "46708-712-01", "55150-510-01", "55150-510-05", "55150-511-01", "55150-511-10", "55150-512-01", "55150-512-10", "55150-513-01", "47335-235-96", "47335-235-83", "61703-124-40", "61703-161-02", "61703-161-05", "0378-0014-01", "0143-9367-01", "59137-505-00", "59137-505-01", "59137-505-04", "59137-510-00", "59137-510-01", "59137-510-04", "59137-515-00", "59137-515-01", "59137-515-04", "59137-520-00", "59137-520-01", "59137-520-04", "59137-525-00", "59137-525-01", "59137-525-04", "59137-530-00", "59137-530-01", "59137-530-04", "59137-535-00", "59137-535-01", "59137-535-04", "59137-540-00", "59137-540-01", "59137-540-04", "59137-550-00", "59137-550-01", "59137-550-04", "59651-182-36", "59651-182-01", "52652-2001-1", "52652-2001-6", "63323-122-50", "0703-3671-01", "0703-3675-01", "0703-3678-01", "68382-775-60", "68382-775-16", "68382-775-01", "68382-775-05", "68382-775-10", "68382-775-77", "0555-0572-35", "0555-0572-02", "16729-277-30", "16729-277-03", "16729-277-35", "0143-9519-10", "0143-9518-01", "0143-9517-01", "0143-9516-01", "70771-1058-3", "70771-1058-9", "70771-1058-1", "70771-1058-5", "70771-1058-0", "70771-1058-2", "70771-1058-7", "16729-486-36", "16729-486-01", "62332-730-36", "62332-730-31", "54436-075-01", "54436-075-02", "54436-075-04", "54436-010-01", "54436-010-03", "54436-010-02", "54436-010-04", "54436-012-01", "54436-012-03", "54436-012-02", "54436-012-04", "54436-015-01", "54436-015-03", "54436-015-02", "54436-015-04", "54436-017-01", "54436-017-03", "54436-017-02", "54436-017-04", "54436-020-01", "54436-020-03", "54436-020-02", "54436-020-04", "54436-022-01", "54436-022-03", "54436-022-02", "54436-022-04", "54436-025-01", "54436-025-03", "54436-025-02", "54436-025-04", "46708-730-36", "46708-730-31" ], "unii": [ "3IG1E710ZN", "YL5FZ2Y5U1" ], "nui": [ "N0000175584", "N0000000111" ], "pharm_class_epc": [ "Folate Analog Metabolic Inhibitor [EPC]" ], "pharm_class_moa": [ "Folic Acid Metabolism Inhibitors [MoA]" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10006196", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "1", "companynumb": "JP-ASTELLAS-2014JP002185", "duplicate": "1", "reportduplicate": { "duplicatesource": "ASTELLAS", "duplicatenumb": "JP-ASTELLAS-2014JP002185" }, "primarysource": { "reportercountry": "JP", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "57", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Chronic graft versus host disease", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "PROGRAF", "drugauthorizationnumb": "050708", "drugdosageform": "Formulation Unknown", "drugadministrationroute": "065", "drugindication": "CHRONIC GRAFT VERSUS HOST DISEASE", "actiondrug": "5", "openfda": { "application_number": [ "NDA050708", "NDA210115", "NDA050709" ], "brand_name": [ "PROGRAF" ], "generic_name": [ "TACROLIMUS" ], "manufacturer_name": [ "Astellas Pharma US, Inc." ], "product_ndc": [ "0469-0607", "0469-0617", "0469-0657", "0469-3016", "0469-1230", "0469-1330" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "TACROLIMUS" ], "rxcui": [ "108513", "108514", "108515", "198377", "198378", "198379", "261134", "313190", "2052605", "2052609", "2052703", "2052704" ], "spl_id": [ "e9157663-1515-4ba3-83b5-1622cf6f0f99" ], "spl_set_id": [ "7f667de1-9dfa-4bd6-8ba0-15ee2d78873b" ], "package_ndc": [ "0469-0607-73", "0469-0617-73", "0469-0617-11", "0469-0657-73", "0469-0657-11", "0469-3016-01", "0469-1230-50", "0469-1330-50" ], "unii": [ "WM0HAQ4WNM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISOLONE", "drugdosageform": "Formulation Unknown", "drugadministrationroute": "065", "drugindication": "ACUTE GRAFT VERSUS HOST DISEASE", "openfda": { "application_number": [ "ANDA080531", "ANDA040571", "ANDA215673", "ANDA040323", "ANDA219509", "ANDA218083", "ANDA040775" ], "brand_name": [ "PREDNISOLONE" ], "generic_name": [ "PREDNISOLONE", "PREDNISOLONE ORAL", "PREDNISOLONE ORAL SOLUTION" ], "manufacturer_name": [ "Chartwell RX, LLC", "PAI Holdings, LLC dba PAI Pharma", "Aurobindo Pharma Limited", "Tulex Pharmaceuticals Inc", "Zhejiang Xianju Pharmaceutical Co., Ltd.", "Hisun Pharmaceuticals USA, Inc.", "Lannett Company, Inc.", "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "Chartwell Governmental & Specialty RX, LLC." ], "product_ndc": [ "62135-437", "0121-0885", "59651-491", "62135-250", "70404-077", "60722-5011", "42658-160", "0527-5406", "23155-927", "68999-250" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISOLONE" ], "rxcui": [ "198142", "283077" ], "spl_id": [ "1b180b1a-f4e2-e1ee-e063-6294a90adc05", "1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "c535b93f-b31f-411f-848c-b5e6782f321f", "19febba3-956f-d1a9-e063-6394a90afda5", "561d8c9c-b67f-7fb2-e063-6394a90a0316", "da9dfcf4-1631-4923-9536-72c27fc0b307", "9f93400d-a8c0-435a-ad65-48717cc455cf", "5122ba73-5783-49f0-9b9c-a03d59d8899c", "d2e4ebab-8c9d-44cb-b665-293007f7e058", "43e3bba6-a836-f5e7-e063-6294a90a10e4" ], "spl_set_id": [ "2e965355-f7f2-4dd3-9c5c-1524c6f39c91", "cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3", "070f1937-50a5-457f-bef5-4e597014e26d", "aa40f582-cced-4e6e-90f0-10ab310ab2a7", "757b41c4-a0fe-4a09-8816-a4cdb7558f41", "52e6e21d-94b8-41a0-8d13-371c0e66bcee", "16d4e064-66d3-4497-8c7d-3aa355f91e1d", "86652e2d-664a-4388-a611-c2a9aa4a4bc8", "b079834f-9aa3-4db9-bd53-de28e8f81c04", "2dac9898-6492-4f34-ad86-83a902e0fe0b" ], "package_ndc": [ "62135-437-30", "0121-0885-08", "0121-0885-16", "59651-491-50", "59651-491-01", "62135-250-37", "62135-250-47", "62135-250-45", "62135-250-24", "70404-077-14", "70404-077-16", "60722-5011-0", "60722-5011-1", "42658-160-05", "0527-5406-68", "0527-5406-70", "23155-927-51", "23155-927-52", "68999-250-45", "68999-250-24" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "9PHQ9Y1OLM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISOLONE", "drugdosageform": "Formulation Unknown", "drugadministrationroute": "065", "drugindication": "CHRONIC GRAFT VERSUS HOST DISEASE", "openfda": { "application_number": [ "ANDA080531", "ANDA040571", "ANDA215673", "ANDA040323", "ANDA219509", "ANDA218083", "ANDA040775" ], "brand_name": [ "PREDNISOLONE" ], "generic_name": [ "PREDNISOLONE", "PREDNISOLONE ORAL", "PREDNISOLONE ORAL SOLUTION" ], "manufacturer_name": [ "Chartwell RX, LLC", "PAI Holdings, LLC dba PAI Pharma", "Aurobindo Pharma Limited", "Tulex Pharmaceuticals Inc", "Zhejiang Xianju Pharmaceutical Co., Ltd.", "Hisun Pharmaceuticals USA, Inc.", "Lannett Company, Inc.", "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "Chartwell Governmental & Specialty RX, LLC." ], "product_ndc": [ "62135-437", "0121-0885", "59651-491", "62135-250", "70404-077", "60722-5011", "42658-160", "0527-5406", "23155-927", "68999-250" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISOLONE" ], "rxcui": [ "198142", "283077" ], "spl_id": [ "1b180b1a-f4e2-e1ee-e063-6294a90adc05", "1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "c535b93f-b31f-411f-848c-b5e6782f321f", "19febba3-956f-d1a9-e063-6394a90afda5", "561d8c9c-b67f-7fb2-e063-6394a90a0316", "da9dfcf4-1631-4923-9536-72c27fc0b307", "9f93400d-a8c0-435a-ad65-48717cc455cf", "5122ba73-5783-49f0-9b9c-a03d59d8899c", "d2e4ebab-8c9d-44cb-b665-293007f7e058", "43e3bba6-a836-f5e7-e063-6294a90a10e4" ], "spl_set_id": [ "2e965355-f7f2-4dd3-9c5c-1524c6f39c91", "cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3", "070f1937-50a5-457f-bef5-4e597014e26d", "aa40f582-cced-4e6e-90f0-10ab310ab2a7", "757b41c4-a0fe-4a09-8816-a4cdb7558f41", "52e6e21d-94b8-41a0-8d13-371c0e66bcee", "16d4e064-66d3-4497-8c7d-3aa355f91e1d", "86652e2d-664a-4388-a611-c2a9aa4a4bc8", "b079834f-9aa3-4db9-bd53-de28e8f81c04", "2dac9898-6492-4f34-ad86-83a902e0fe0b" ], "package_ndc": [ "62135-437-30", "0121-0885-08", "0121-0885-16", "59651-491-50", "59651-491-01", "62135-250-37", "62135-250-47", "62135-250-45", "62135-250-24", "70404-077-14", "70404-077-16", "60722-5011-0", "60722-5011-1", "42658-160-05", "0527-5406-68", "0527-5406-70", "23155-927-51", "23155-927-52", "68999-250-45", "68999-250-24" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "9PHQ9Y1OLM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISOLONE", "drugdosageform": "Formulation Unknown", "drugadministrationroute": "065", "openfda": { "application_number": [ "ANDA080531", "ANDA040571", "ANDA215673", "ANDA040323", "ANDA219509", "ANDA218083", "ANDA040775" ], "brand_name": [ "PREDNISOLONE" ], "generic_name": [ "PREDNISOLONE", "PREDNISOLONE ORAL", "PREDNISOLONE ORAL SOLUTION" ], "manufacturer_name": [ "Chartwell RX, LLC", "PAI Holdings, LLC dba PAI Pharma", "Aurobindo Pharma Limited", "Tulex Pharmaceuticals Inc", "Zhejiang Xianju Pharmaceutical Co., Ltd.", "Hisun Pharmaceuticals USA, Inc.", "Lannett Company, Inc.", "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "Chartwell Governmental & Specialty RX, LLC." ], "product_ndc": [ "62135-437", "0121-0885", "59651-491", "62135-250", "70404-077", "60722-5011", "42658-160", "0527-5406", "23155-927", "68999-250" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISOLONE" ], "rxcui": [ "198142", "283077" ], "spl_id": [ "1b180b1a-f4e2-e1ee-e063-6294a90adc05", "1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "c535b93f-b31f-411f-848c-b5e6782f321f", "19febba3-956f-d1a9-e063-6394a90afda5", "561d8c9c-b67f-7fb2-e063-6394a90a0316", "da9dfcf4-1631-4923-9536-72c27fc0b307", "9f93400d-a8c0-435a-ad65-48717cc455cf", "5122ba73-5783-49f0-9b9c-a03d59d8899c", "d2e4ebab-8c9d-44cb-b665-293007f7e058", "43e3bba6-a836-f5e7-e063-6294a90a10e4" ], "spl_set_id": [ "2e965355-f7f2-4dd3-9c5c-1524c6f39c91", "cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3", "070f1937-50a5-457f-bef5-4e597014e26d", "aa40f582-cced-4e6e-90f0-10ab310ab2a7", "757b41c4-a0fe-4a09-8816-a4cdb7558f41", "52e6e21d-94b8-41a0-8d13-371c0e66bcee", "16d4e064-66d3-4497-8c7d-3aa355f91e1d", "86652e2d-664a-4388-a611-c2a9aa4a4bc8", "b079834f-9aa3-4db9-bd53-de28e8f81c04", "2dac9898-6492-4f34-ad86-83a902e0fe0b" ], "package_ndc": [ "62135-437-30", "0121-0885-08", "0121-0885-16", "59651-491-50", "59651-491-01", "62135-250-37", "62135-250-47", "62135-250-45", "62135-250-24", "70404-077-14", "70404-077-16", "60722-5011-0", "60722-5011-1", "42658-160-05", "0527-5406-68", "0527-5406-70", "23155-927-51", "23155-927-52", "68999-250-45", "68999-250-24" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "9PHQ9Y1OLM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CYCLOSPORINE", "drugdosageform": "Formulation Unknown", "drugadministrationroute": "065", "drugindication": "ACUTE GRAFT VERSUS HOST DISEASE", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CYCLOSPORINE", "drugdosageform": "Formulation Unknown", "drugadministrationroute": "065", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "2", "medicinalproduct": "INFLIXIMAB", "drugdosageform": "Formulation Unknown", "drugadministrationroute": "065", "drugindication": "CHRONIC GRAFT VERSUS HOST DISEASE", "openfda": { "application_number": [ "BLA103772" ], "brand_name": [ "INFLIXIMAB", "REMICADE" ], "generic_name": [ "INFLIXIMAB" ], "manufacturer_name": [ "Janssen Biotech, Inc." ], "product_ndc": [ "57894-160", "57894-030" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "INFLIXIMAB" ], "rxcui": [ "310994", "213361" ], "spl_id": [ "3bfeaa57-8d95-4bc9-8bb5-274271688470", "36afec96-dd29-9328-e063-6294a90af8e4" ], "spl_set_id": [ "b05c174f-832c-4321-b34f-2c4ad3742269", "a0a046c1-056d-45a9-bfd9-13b47c24f257" ], "package_ndc": [ "57894-160-01", "57894-030-01" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "B72HH48FLU" ] } } ] } }, { "safetyreportversion": "3", "safetyreportid": "10007198", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "2", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140407", "fulfillexpeditecriteria": "2", "companynumb": "US-JNJFOC-20140302120", "duplicate": "1", "reportduplicate": { "duplicatesource": "JANSSEN", "duplicatenumb": "US-JNJFOC-20140302120" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "41", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Atrial fibrillation", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Oropharyngeal pain", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "STELARA", "drugauthorizationnumb": "125261", "drugstructuredosagenumb": "45", "drugstructuredosageunit": "003", "drugdosageform": "Liquid", "drugadministrationroute": "058", "drugindication": "PSORIASIS", "drugstartdateformat": "102", "drugstartdate": "20091221", "actiondrug": "4", "drugrecurreadministration": "2", "openfda": { "application_number": [ "BLA761044", "BLA125261" ], "brand_name": [ "STELARA" ], "generic_name": [ "USTEKINUMAB" ], "manufacturer_name": [ "Janssen Biotech, Inc." ], "product_ndc": [ "57894-054", "57894-061", "57894-060" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "USTEKINUMAB" ], "rxcui": [ "853350", "853354", "853355", "853356", "1654077", "1654079", "1811255", "1811257" ], "spl_id": [ "f5c559d4-8f2c-4eed-8bc3-ed7a92bbd5c1" ], "spl_set_id": [ "c77a9664-e3bb-4023-b400-127aa53bca2b" ], "package_ndc": [ "57894-061-02", "57894-061-03", "57894-061-04", "57894-054-27", "57894-054-16", "57894-060-02", "57894-060-03", "57894-060-04" ], "nui": [ "N0000192797", "N0000192796", "N0000192799", "N0000192798" ], "pharm_class_epc": [ "Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]" ], "pharm_class_moa": [ "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]" ], "unii": [ "FU77B4U5Z0" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE", "drugdosageform": "Unspecified", "drugadministrationroute": "065", "drugindication": "PSORIASIS", "actiondrug": "4", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } } ] } }, { "safetyreportversion": "7", "safetyreportid": "10010024", "primarysourcecountry": "DE", "occurcountry": "DE", "transmissiondateformat": "102", "transmissiondate": "20250114", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20241109", "fulfillexpeditecriteria": "1", "companynumb": "IT-ABBOTT-11P-083-0855315-00", "duplicate": "1", "reportduplicate": [ { "duplicatesource": "Pfizer", "duplicatenumb": "2017531981" }, { "duplicatesource": "EMA", "duplicatenumb": "DE-EMA-DD-20171215-nimmievhp-122556" }, { "duplicatesource": "EVHUMAN", "duplicatenumb": "DE-SZ09-PHHY2015DE068443" }, { "duplicatesource": "EVHUMAN", "duplicatenumb": "DE-DEXPHARM-20150532" }, { "duplicatesource": "AMGUSA", "duplicatenumb": "9465160" }, { "duplicatesource": "EVHUMAN", "duplicatenumb": "803125821" }, { "duplicatesource": "BFARM", "duplicatenumb": "DE-BFARM-13370223" }, { "duplicatesource": "EVHUMAN", "duplicatenumb": "DE-MEDAC-20140347" }, { "duplicatesource": "EVHUMAN", "duplicatenumb": "NZ-Adis-3125821-53933" }, { "duplicatesource": "EVHUMAN", "duplicatenumb": "DE-PFIZER INC-2017531981" }, { "duplicatesource": "EVHUMAN", "duplicatenumb": "DE-STADA-098313" }, { "duplicatesource": "AMGUSA", "duplicatenumb": "10000115839" }, { "duplicatesource": "EVDUP#MYLANLABS", "duplicatenumb": "DE-MYLANLABS-2015M1019414" }, { "duplicatesource": "EVDUP#Orion Corporation ORION PHARMA", "duplicatenumb": "DE-Orion Corporation ORION PHARMA-TREX2015-0301" }, { "duplicatesource": "EVDUP#BIOGEN", "duplicatenumb": "DE-BIOGEN-2017BI00459930" }, { "duplicatesource": "Pfizer", "duplicatenumb": "DE-PFIZER INC-2017552191" }, { "duplicatesource": "EVDUP#TEVA", "duplicatenumb": "DE-TEVA-572153GER" }, { "duplicatesource": "EVDUP#BFARM", "duplicatenumb": "DE-BIOGENIDEC-2013BI112995" }, { "duplicatesource": "EVDUP#1038339180", "duplicatenumb": "DE-BIOGEN-2013BI112995" }, { "duplicatesource": "AMGEN", "duplicatenumb": "DE-AMGEN-DEUSP2017188204" }, { "duplicatesource": "EMA", "duplicatenumb": "DE-PFIZER INC-2017531981" }, { "duplicatesource": "EMA", "duplicatenumb": "DE-EMA-DD-20180307-mshettyp-175524" }, { "duplicatesource": "European Medicines Agency", "duplicatenumb": "DE-EMA-DD-20180904-hjainp-114717" } ], "primarysource": { "reportercountry": "DE", "qualification": "1", "literaturereference": "Kowalzick L, Eickenscheidt L, Komar M, Schaarschmidt E. Long term treatment of psoriasis with TNF-alpha antagonists. Occurence of malignant melanoma. Hautarzt. 2009;60:655-657.; Kowalzick L, Eickenscheidt L. Occurrence of keratoacanthoma five years after development of malignant melanoma during long term treatment of psoriasis with TNF-alpha-antagonists. Tumordiagn-Ther 2015; 36(3):162-164." }, "sender": { "sendertype": "1", "senderorganization": "ABBVIE" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "56", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Malignant melanoma stage I", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Keratoacanthoma", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Hyperkeratosis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Therapy non-responder", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Keratoacanthoma", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ADALIMUMAB", "drugbatchnumb": "Not Available", "drugauthorizationnumb": "125057", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "2", "drugintervaldosagedefinition": "803", "drugadministrationroute": "058", "drugindication": "Psoriasis", "drugstartdateformat": "602", "drugstartdate": "2007", "drugtreatmentduration": "6", "drugtreatmentdurationunit": "801", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ADALIMUMAB" }, "openfda": { "application_number": [ "BLA125057", "BLA761219", "BLA761071", "BLA761154" ], "brand_name": [ "HUMIRA", "ADALIMUMAB" ], "generic_name": [ "ADALIMUMAB", "ADALIMUMAB-AATY", "ADALIMUMAB-ADAZ", "ADALIMUMAB-FKJP" ], "manufacturer_name": [ "Cordavis Limited", "CELLTRION USA, Inc.", "AbbVie Inc.", "Sandoz Inc", "Biocon Biologics Inc" ], "product_ndc": [ "83457-124", "83457-554", "83457-243", "83457-616", "83457-817", "72606-022", "72606-040", "72606-041", "0074-0124", "0074-3799", "0074-4339", "0074-9374", "0074-0243", "0074-0554", "0074-0067", "0074-2540", "0074-1539", "0074-0616", "0074-0817", "61314-325", "61314-327", "61314-332", "61314-391", "83257-020", "83257-021", "83257-022" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "797544", "1726844", "1726846", "1872979", "1872980", "1921009", "1921010", "1921016", "1921017", "1921238", "1921240", "2639651", "2639659", "2668483", "2668485", "2668487", "2668489", "727703", "727705", "763564", "763565", "825169", "825170", "1594352", "1594357", "1594358", "1655726", "1655728", "1656703", "1801277", "1801278", "1855523", "1855524", "1855526", "1855527", "1872983", "1872984", "1872985", "1872986", "1873086", "1873087", "1921244", "1921245", "1921467", "1921468", "2531133", "2531134", "2641644", "2641653", "2641655", "2641660", "2641662", "2640404", "2640412", "2640417" ], "spl_id": [ "5fe81b1a-cc31-444e-a0f1-1ea4f7334b89", "4ba7057b-2495-42ba-9c35-95d87449259c", "8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a", "ae54abc4-e9c5-4c5a-8fa7-968e5ad72050", "39c67c8f-7fbd-a17a-1535-5d41ece68818" ], "spl_set_id": [ "4977567e-3525-44ac-9ff5-f1e74b053950", "c44365e9-d470-4e35-978d-8565a9e3471e", "608d4f0d-b19f-46d3-749a-7159aa5f933d", "3468792f-63ef-4916-8ed1-8214f327d9dd", "5cde907d-6747-0e62-db25-1718ee717fe7" ], "package_ndc": [ "83457-554-02", "83457-553-01", "83457-927-01", "83457-124-02", "83457-123-01", "83457-243-02", "83457-242-01", "83457-616-02", "83457-615-01", "83457-817-02", "83457-816-01", "72606-022-01", "72606-022-02", "72606-022-03", "72606-022-04", "72606-022-05", "72606-022-06", "72606-022-07", "72606-022-08", "72606-022-09", "72606-022-10", "72606-022-11", "72606-022-12", "72606-040-01", "72606-040-02", "72606-040-03", "72606-040-04", "72606-040-05", "72606-040-06", "72606-041-01", "0074-3799-02", "0074-3799-71", "0074-3799-06", "0074-3799-03", "0074-4339-02", "0074-4339-07", "0074-4339-71", "0074-4339-73", "0074-4339-01", "0074-4339-74", "0074-9374-71", "0074-0243-02", "0074-0243-71", "0074-0554-01", "0074-0554-02", "0074-0554-04", "0074-0554-06", "0074-0554-71", "0074-0554-74", "0074-0554-73", "0074-0067-02", "0074-2540-01", "0074-2540-03", "0074-0124-74", "0074-0124-73", "0074-0124-01", "0074-0124-03", "0074-0124-02", "0074-0124-04", "0074-1539-03", "0074-0616-71", "0074-0616-02", "0074-0817-02", "61314-327-64", "61314-327-20", "61314-332-64", "61314-325-20", "61314-391-64", "83257-020-42", "83257-021-42", "83257-022-32" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ADALIMUMAB" ], "nui": [ "N0000175610", "N0000175451", "M0001357" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "pharm_class_cs": [ "Antibodies, Monoclonal [CS]" ], "unii": [ "FYS6T7F842" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ADALIMUMAB", "drugauthorizationnumb": "125057", "drugindication": "Psoriasis", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ADALIMUMAB" }, "openfda": { "application_number": [ "BLA125057", "BLA761219", "BLA761071", "BLA761154" ], "brand_name": [ "HUMIRA", "ADALIMUMAB" ], "generic_name": [ "ADALIMUMAB", "ADALIMUMAB-AATY", "ADALIMUMAB-ADAZ", "ADALIMUMAB-FKJP" ], "manufacturer_name": [ "Cordavis Limited", "CELLTRION USA, Inc.", "AbbVie Inc.", "Sandoz Inc", "Biocon Biologics Inc" ], "product_ndc": [ "83457-124", "83457-554", "83457-243", "83457-616", "83457-817", "72606-022", "72606-040", "72606-041", "0074-0124", "0074-3799", "0074-4339", "0074-9374", "0074-0243", "0074-0554", "0074-0067", "0074-2540", "0074-1539", "0074-0616", "0074-0817", "61314-325", "61314-327", "61314-332", "61314-391", "83257-020", "83257-021", "83257-022" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "797544", "1726844", "1726846", "1872979", "1872980", "1921009", "1921010", "1921016", "1921017", "1921238", "1921240", "2639651", "2639659", "2668483", "2668485", "2668487", "2668489", "727703", "727705", "763564", "763565", "825169", "825170", "1594352", "1594357", "1594358", "1655726", "1655728", "1656703", "1801277", "1801278", "1855523", "1855524", "1855526", "1855527", "1872983", "1872984", "1872985", "1872986", "1873086", "1873087", "1921244", "1921245", "1921467", "1921468", "2531133", "2531134", "2641644", "2641653", "2641655", "2641660", "2641662", "2640404", "2640412", "2640417" ], "spl_id": [ "5fe81b1a-cc31-444e-a0f1-1ea4f7334b89", "4ba7057b-2495-42ba-9c35-95d87449259c", "8bf84b15-6763-41cf-bfa4-bcee9ad4ef9a", "ae54abc4-e9c5-4c5a-8fa7-968e5ad72050", "39c67c8f-7fbd-a17a-1535-5d41ece68818" ], "spl_set_id": [ "4977567e-3525-44ac-9ff5-f1e74b053950", "c44365e9-d470-4e35-978d-8565a9e3471e", "608d4f0d-b19f-46d3-749a-7159aa5f933d", "3468792f-63ef-4916-8ed1-8214f327d9dd", "5cde907d-6747-0e62-db25-1718ee717fe7" ], "package_ndc": [ "83457-554-02", "83457-553-01", "83457-927-01", "83457-124-02", "83457-123-01", "83457-243-02", "83457-242-01", "83457-616-02", "83457-615-01", "83457-817-02", "83457-816-01", "72606-022-01", "72606-022-02", "72606-022-03", "72606-022-04", "72606-022-05", "72606-022-06", "72606-022-07", "72606-022-08", "72606-022-09", "72606-022-10", "72606-022-11", "72606-022-12", "72606-040-01", "72606-040-02", "72606-040-03", "72606-040-04", "72606-040-05", "72606-040-06", "72606-041-01", "0074-3799-02", "0074-3799-71", "0074-3799-06", "0074-3799-03", "0074-4339-02", "0074-4339-07", "0074-4339-71", "0074-4339-73", "0074-4339-01", "0074-4339-74", "0074-9374-71", "0074-0243-02", "0074-0243-71", "0074-0554-01", "0074-0554-02", "0074-0554-04", "0074-0554-06", "0074-0554-71", "0074-0554-74", "0074-0554-73", "0074-0067-02", "0074-2540-01", "0074-2540-03", "0074-0124-74", "0074-0124-73", "0074-0124-01", "0074-0124-03", "0074-0124-02", "0074-0124-04", "0074-1539-03", "0074-0616-71", "0074-0616-02", "0074-0817-02", "61314-327-64", "61314-327-20", "61314-332-64", "61314-325-20", "61314-391-64", "83257-020-42", "83257-021-42", "83257-022-32" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ADALIMUMAB" ], "nui": [ "N0000175610", "N0000175451", "M0001357" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "pharm_class_cs": [ "Antibodies, Monoclonal [CS]" ], "unii": [ "FYS6T7F842" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE", "drugbatchnumb": "Not Available", "drugauthorizationnumb": "065003", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Psoriasis", "drugtreatmentduration": "2", "drugtreatmentdurationunit": "802", "actiondrug": "6", "drugadditional": "4", "activesubstance": { "activesubstancename": "CYCLOSPORINE" }, "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "1", "medicinalproduct": "REMICADE", "drugbatchnumb": "Not Available", "drugseparatedosagenumb": "1", "drugdosagetext": "6 INFUSIONS AT 8 WEEKS INTERVAL", "drugadministrationroute": "042", "drugindication": "Psoriasis", "drugtreatmentduration": "5", "drugtreatmentdurationunit": "803", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "openfda": { "application_number": [ "BLA103772" ], "brand_name": [ "REMICADE" ], "generic_name": [ "INFLIXIMAB" ], "manufacturer_name": [ "Janssen Biotech, Inc." ], "product_ndc": [ "57894-030" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "INFLIXIMAB" ], "rxcui": [ "213361", "310994" ], "spl_id": [ "36afec96-dd29-9328-e063-6294a90af8e4" ], "spl_set_id": [ "a0a046c1-056d-45a9-bfd9-13b47c24f257" ], "package_ndc": [ "57894-030-01" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "B72HH48FLU" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ETANERCEPT", "drugbatchnumb": "Not Available", "drugstructuredosagenumb": "100", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugadministrationroute": "058", "drugindication": "Psoriasis", "drugstartdateformat": "610", "drugstartdate": "200706", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ETANERCEPT" }, "openfda": { "application_number": [ "BLA103795" ], "brand_name": [ "ENBREL" ], "generic_name": [ "ETANERCEPT" ], "manufacturer_name": [ "Immunex Corporation" ], "product_ndc": [ "58406-010", "58406-425", "58406-021", "58406-032", "58406-044", "58406-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ETANERCEPT" ], "rxcui": [ "253014", "261105", "727757", "802652", "809158", "809159", "1653223", "1653225", "2182338", "2182340", "2392140", "2392142" ], "spl_id": [ "de3ee3bd-0047-4365-a4c7-5786521a1649" ], "spl_set_id": [ "a002b40c-097d-47a5-957f-7a7b1807af7f" ], "package_ndc": [ "58406-425-41", "58406-425-34", "58406-424-01", "58406-910-01", "58406-021-01", "58406-021-04", "58406-021-96", "58406-032-01", "58406-032-04", "58406-032-96", "58406-032-90", "58406-010-01", "58406-010-04", "58406-010-96", "58406-044-01", "58406-044-04", "58406-044-96", "58406-044-24", "58406-044-90", "58406-055-01", "58406-055-04", "58406-055-96", "58406-055-90" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "OP401G7OJC" ] } }, { "drugcharacterization": "1", "medicinalproduct": "METHOTREXATE", "drugbatchnumb": "Not Available", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Psoriasis", "drugtreatmentduration": "5", "drugtreatmentdurationunit": "803", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "METHOTREXATE" }, "openfda": { "application_number": [ "ANDA210454", "NDA011719", "NDA212479", "ANDA040385", "ANDA040263", "ANDA220225", "ANDA040632", "ANDA201529", "ANDA201749", "ANDA081235", "NDA205776", "NDA208400", "ANDA040266", "ANDA040843", "ANDA207812", "ANDA081099", "ANDA040716", "ANDA089343", "ANDA089342", "ANDA089341", "ANDA089340", "ANDA213343", "ANDA217552", "NDA204824" ], "brand_name": [ "METHOTREXATE", "JYLAMVO", "TREXALL", "RASUVO", "XATMEP", "OTREXUP" ], "generic_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Chartwell RX, LLC", "Hospira, Inc.", "SHORLA ONCOLOGY INC.", "Teva Women's Health LLC", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Alembic Pharmaceuticals Limited", "Eugia US LLC", "Sun Pharmaceutical Industries, Inc.", "Mylan Pharmaceuticals Inc.", "Medexus Pharma Inc.", "Aurobindo Pharma Limited", "Azurity Pharmaceuticals, Inc.", "Teva Parenteral Medicines, Inc.", "Zydus Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc.", "Accord Healthcare, Inc.", "Zydus Lifesciences Limited", "Accord Healthcare Inc.", "Antares Pharma, Inc." ], "product_ndc": [ "62135-772", "61703-350", "61703-408", "81927-204", "51285-366", "51285-367", "51285-368", "51285-369", "63323-123", "62332-711", "62332-712", "0143-9830", "46708-711", "46708-712", "55150-510", "55150-511", "55150-512", "55150-513", "47335-235", "61703-124", "61703-161", "0378-0014", "0143-9367", "59137-505", "59137-510", "59137-515", "59137-520", "59137-525", "59137-530", "59137-535", "59137-540", "59137-550", "59651-182", "52652-2001", "63323-122", "0703-3671", "0703-3675", "0703-3678", "68382-775", "0555-0572", "16729-277", "0143-9516", "0143-9519", "0143-9518", "0143-9517", "70771-1058", "16729-486", "62332-730", "54436-010", "54436-075", "54436-012", "54436-015", "54436-017", "54436-020", "54436-022", "54436-025", "46708-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "INTRATHECAL", "INTRA-ARTERIAL" ], "substance_name": [ "METHOTREXATE SODIUM", "METHOTREXATE" ], "rxcui": [ "105585", "1655956", "1946772", "2671456", "2671462", "105586", "283510", "283511", "283671", "284592", "284593", "284594", "284595", "311625", "1655959", "1655960", "1655967", "1655968", "1441416", "1544378", "1544383", "1544385", "1544386", "1544387", "1544388", "1544389", "1544390", "1544394", "1544395", "1544396", "1544397", "1544398", "1544401", "1544402", "1544403", "1544404", "1921592", "1921598", "1441402", "1441407", "1441411", "1441413", "1441418", "1441422", "1441424", "1594757", "1594759", "1747179", "1747181", "1747185", "1747187", "1747192", "1747194" ], "spl_id": [ "462a5023-e5a1-692a-e063-6294a90a7236", "95b8b8da-da4e-4bba-9038-3cf65f3d5c1a", "37b3e76b-ac3d-4f93-adf1-91f52f676b8a", "53bd9776-70ec-46f9-e063-6294a90a7011", "d1e7432e-253d-49f0-ab0a-bb859210ccd6", "880c2caa-1b11-45ce-a54e-a3733da367f0", "91ce9c78-370f-49a1-ae22-428bdddb389f", "49eb25b2-c59c-4374-a216-076767fe1126", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "524f657e-d138-9c87-e063-6294a90a93ad", "6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "01ad6cb9-5879-4c06-801b-0de84eebaae7", "7950579c-084b-472b-a7ce-f342691aff97", "29d04017-dd64-4dea-a064-7b3b0805f423", "9fe03573-fff3-4051-8598-8542eee1273f", "4e3b0925-2cdc-4743-91cf-860d98dd4661", "3d21237a-ef53-4592-bf06-0c739696203d", "e81074cc-12b4-4ac9-a5bb-749188989b2c", "5d9b7269-19d4-4d2c-b252-f3ff759dffa5", "9c7cf5a6-e720-4e83-bb08-f371e9bb9c9e", "2bae3cfe-7aa0-c14c-e063-6294a90a19f4", "3046ff78-3565-46d1-a88b-283e5ff6e7c3", "ae399908-cfb6-44dc-83da-8981f5dabbb8", "52d366f6-f339-ff1a-e063-6294a90a1577", "9dd138d6-6889-400e-a994-9931af68244a", "2d07eb50-d314-a6a0-e063-6394a90ac970", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "spl_set_id": [ "2609da8f-80dc-448e-8eba-35d11488ce7f", "0d63ba29-b692-41b4-87e8-351265c8273f", "0e30eaef-5a09-4104-8a11-c32933eadeab", "96e931f5-51ae-4bdf-a441-bb0dd26d4c0e", "e942f8db-510f-44d6-acb5-b822196f5e8c", "b585f621-f6c9-4735-ab61-bd1b401f3df0", "a63364d5-4dfa-49d7-8a5e-c8959ae1d37a", "b080eb92-fc72-4ce6-a7ab-3f9ce2415526", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "63bb6fbf-dd59-4edc-af8f-d0c397ca1262", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "bd287e89-32f9-4396-95fa-4b562869f476", "70c09984-2b36-424f-8b27-3fd0cd4e833d", "8593f7fc-eabe-44ae-bb05-b3d7d408e4f7", "d0075461-0e7e-4967-9c9b-d6440e912c0e", "09931d44-a3f8-49dc-a3f2-b527ee4214bf", "aec9984e-34c5-481b-b6bf-9bb5caf1daf8", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "346ec9ce-dc98-4a55-b55e-d3af11f2d703", "948e0bab-6524-4b87-9853-1799d4415558", "9b34b1d8-d125-41a2-9f6f-3fab67b573bd", "dd035a9f-cd40-4314-b9d8-2294b8a924e2", "3989d30d-56e5-4e8d-9379-c30fecc894f2", "59ea7b32-2b6d-4197-92c3-015936f04ebe", "874c7f43-a3be-4236-89cc-24c44e3c5813", "04a95db9-a124-4b97-bd71-1c37a6b3b0c8", "9ab8ce16-f7de-41d4-a4c8-1c742621b6d5", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "package_ndc": [ "62135-772-35", "61703-350-37", "61703-350-38", "61703-408-41", "61703-350-09", "61703-350-10", "61703-408-25", "81927-204-01", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "63323-123-10", "62332-711-01", "62332-711-05", "62332-712-01", "0143-9830-01", "46708-711-01", "46708-711-05", "46708-712-01", "55150-510-01", "55150-510-05", "55150-511-01", "55150-511-10", "55150-512-01", "55150-512-10", "55150-513-01", "47335-235-96", "47335-235-83", "61703-124-40", "61703-161-02", "61703-161-05", "0378-0014-01", "0143-9367-01", "59137-505-00", "59137-505-01", "59137-505-04", "59137-510-00", "59137-510-01", "59137-510-04", "59137-515-00", "59137-515-01", "59137-515-04", "59137-520-00", "59137-520-01", "59137-520-04", "59137-525-00", "59137-525-01", "59137-525-04", "59137-530-00", "59137-530-01", "59137-530-04", "59137-535-00", "59137-535-01", "59137-535-04", "59137-540-00", "59137-540-01", "59137-540-04", "59137-550-00", "59137-550-01", "59137-550-04", "59651-182-36", "59651-182-01", "52652-2001-1", "52652-2001-6", "63323-122-50", "0703-3671-01", "0703-3675-01", "0703-3678-01", "68382-775-60", "68382-775-16", "68382-775-01", "68382-775-05", "68382-775-10", "68382-775-77", "0555-0572-35", "0555-0572-02", "16729-277-30", "16729-277-03", "16729-277-35", "0143-9519-10", "0143-9518-01", "0143-9517-01", "0143-9516-01", "70771-1058-3", "70771-1058-9", "70771-1058-1", "70771-1058-5", "70771-1058-0", "70771-1058-2", "70771-1058-7", "16729-486-36", "16729-486-01", "62332-730-36", "62332-730-31", "54436-075-01", "54436-075-02", "54436-075-04", "54436-010-01", "54436-010-03", "54436-010-02", "54436-010-04", "54436-012-01", "54436-012-03", "54436-012-02", "54436-012-04", "54436-015-01", "54436-015-03", "54436-015-02", "54436-015-04", "54436-017-01", "54436-017-03", "54436-017-02", "54436-017-04", "54436-020-01", "54436-020-03", "54436-020-02", "54436-020-04", "54436-022-01", "54436-022-03", "54436-022-02", "54436-022-04", "54436-025-01", "54436-025-03", "54436-025-02", "54436-025-04", "46708-730-36", "46708-730-31" ], "unii": [ "3IG1E710ZN", "YL5FZ2Y5U1" ], "nui": [ "N0000175584", "N0000000111" ], "pharm_class_epc": [ "Folate Analog Metabolic Inhibitor [EPC]" ], "pharm_class_moa": [ "Folic Acid Metabolism Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CALCIUM MONOETHYLFUMARATE\\DIMETHYL FUMARATE\\MAGNESIUM MONOETHYLFUMARAT", "drugbatchnumb": "Not Available", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Psoriasis", "drugenddateformat": "602", "drugenddate": "2005", "drugtreatmentduration": "4", "drugtreatmentdurationunit": "801", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "CALCIUM MONOETHYLFUMARATE\\DIMETHYL FUMARATE\\MAGNESIUM MONOETHYLFUMARATE\\ZINC MONOETHYLFUMARATE" } }, { "drugcharacterization": "1", "medicinalproduct": "NEOTIGASON", "drugbatchnumb": "Not Available", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Psoriasis", "drugtreatmentduration": "2", "drugtreatmentdurationunit": "802", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ACITRETIN" } }, { "drugcharacterization": "2", "medicinalproduct": "CALCIPOTRIENE", "drugseparatedosagenumb": "1", "drugadministrationroute": "061", "drugindication": "Psoriasis", "drugstartdateformat": "602", "drugstartdate": "1993", "activesubstance": { "activesubstancename": "CALCIPOTRIENE" }, "openfda": { "application_number": [ "ANDA090633", "ANDA078468", "ANDA205772", "NDA022563", "NDA020273", "NDA020554" ], "brand_name": [ "CALCIPOTRIENE", "PELLIX", "SORILUX", "CALCITRENE" ], "generic_name": [ "CALCIPOTRIENE" ], "manufacturer_name": [ "Glenmark Pharmaceuticals Inc., USA", "Sun Pharmaceutical Industries, Inc.", "Perfero Pharma, Inc.", "Cosette Pharmaceuticals, Inc.", "Glenmark Pharmaceuticals Inc.,USA", "Mayne Pharma", "Prasco Laboratories", "Northstar Rx LLC" ], "product_ndc": [ "68462-310", "51672-4154", "87143-300", "0713-0318", "68462-501", "51862-512", "51862-376", "66993-878", "66993-877", "16714-763", "51672-5278" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "CALCIPOTRIENE" ], "rxcui": [ "198373", "308865", "2742555", "313921", "1020035", "1020039", "1013636" ], "spl_id": [ "a281edd2-1ec3-440c-9823-1c7541ff8c83", "5698a2a4-f8fb-0b4b-e063-6394a90ab60c", "ba4b6a09-9cc9-4617-8c81-b09ecca5fb9e", "ed81406a-8c10-5c33-e053-2a95a90a941f", "d0707037-c9cd-4c52-a1f5-4c8f72f62010", "8200e8ca-3486-4e51-8a3c-6efee8913d50", "cf0e1842-298b-47e7-9d51-f0789ae086ca", "701245ab-fce0-4a80-90c7-9e3cfa79a9f5", "3682f2c5-9bce-4b4a-a4d6-9af29f08ad63", "ee33f5da-8d1a-429e-aa0c-15d19353fc44", "5698b4f1-b04f-1b1f-e063-6394a90ae022" ], "spl_set_id": [ "1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc", "277d843a-0ea9-429d-813d-49ed72dafb64", "492ea9cf-0117-4d84-a964-9c0121706ed3", "21378c25-5622-8bf7-1a8c-b05940a846a0", "7ec750f6-26ea-46bc-aa7b-174fd25253a2", "26756ac7-a80c-49db-97bb-351f76ad8a71", "51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe", "fe7cd92a-f066-4c4a-80c8-e3f929ad4181", "377eafda-737c-4ba2-9ec5-61209b8814ed", "a882ef4f-603e-4421-97ae-2c78822c767a", "94d4f46a-f254-4fe2-b4bd-7a533d6324fe" ], "package_ndc": [ "68462-310-65", "68462-310-66", "51672-4154-5", "51672-4154-3", "51672-4154-4", "87143-300-60", "0713-0318-53", "68462-501-65", "68462-501-66", "51862-512-60", "51862-376-60", "51862-376-12", "66993-878-61", "66993-878-78", "66993-877-61", "66993-877-78", "16714-763-01", "16714-763-02", "51672-5278-5", "51672-5278-3", "51672-5278-4" ], "nui": [ "M0022797", "N0000175849" ], "pharm_class_cs": [ "Vitamin D [CS]" ], "pharm_class_epc": [ "Vitamin D Analog [EPC]" ], "unii": [ "143NQ3779B" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CLOBETASOL", "drugseparatedosagenumb": "1", "drugadministrationroute": "065", "drugindication": "Psoriasis", "activesubstance": { "activesubstancename": "CLOBETASOL" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20080501" } } }, { "safetyreportversion": "2", "safetyreportid": "10010229", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20150529", "fulfillexpeditecriteria": "1", "companynumb": "GB-009507513-1403GBR003074", "duplicate": "1", "reportduplicate": { "duplicatesource": "MERCK", "duplicatenumb": "GB-009507513-1403GBR003074" }, "primarysource": { "reportercountry": "GB", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Chronic spontaneous urticaria", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Insomnia", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Angioedema", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Pruritus", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CETIRIZINE HYDROCHLORIDE.", "drugdosagetext": "10 MG DAILY", "drugadministrationroute": "065", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "CETIRIZINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA078336", "ANDA207235", "ANDA209274", "NDA019835", "ANDA091327", "ANDA090750", "ANDA090182", "ANDA077829", "ANDA210622", "ANDA218895", "ANDA090760", "ANDA076601", "ANDA090142", "ANDA078933", "ANDA209107", "ANDA090765", "ANDA213105", "ANDA078780", "NDA211415", "ANDA078876", "ANDA213557", "ANDA201546", "NDA021621", "ANDA204226", "NDA022578", "NDA022155", "ANDA077498", "ANDA078343", "ANDA078692", "ANDA090191", "ANDA090766", "ANDA212266", "ANDA078398", "ANDA076047", "ANDA078862", "ANDA090254", "ANDA077946", "ANDA220335", "ANDA090474", "ANDA078488", "ANDA076677", "ANDA078412" ], "brand_name": [ "BETR REMEDIES ALL DAY ALLERGY RELIEF", "CAREONE ALLERGY RELIEF", "CURIST ALLERGY RELIEF", "DG HEALTH ALL DAY ALLERGY", "ZYRTEC HIVES", "CETIRIZINE HYDROCHLORIDE", "CHILDRENS ALLERGY RELIEF", "CHILDRENS CETIRIZINE HYDROCHLORIDE", "ALLERGY RELIEF", "ZYRTEC ALLERGY", "CETIRIZINE HYDROCHLORIDE (ALLERGY)", "CVS CETIRIZINE HYDROCHLORIDE", "BASIC CARE ALL DAY ALLERGY", "ALL DAY ALLERGY RELIEF", "TOPCARE ALL DAY ALLERGY", "SIMPLY RIGHT CHILDRENS CETIRIZINE", "QUZYTTIR", "BERKLEY AND JENSEN ALL DAY ALLERGY", "ALL DAY ALLERGY", "CHILDRENS ALLERGY", "EQUATE ALLERGY RELIEF", "WELBY ALLERGY RELIEF", "CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF", "PENTREXCILINA DAY TIME", "ZYRTEC", "24 HOUR ALLERGY", "UP AND UP CHILDRENS ALLERGY", "WAL-ZYR ALL DAY ALLERGY", "CETIRIZINE HYDROCHLORIDE - HIVES", "PREMIER VALUE CHILDRENS CETIRIZINE", "REXALL ALL DAY ALLERGY RELIEF", "EXCHANGE SELECT ALL DAY ALLERGY", "CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG (OVAL SHAPE)", "CETIRIZINE HYDROCHLORIDE TABLETS, 5 MG", "CETIRIZINE HYDROCHLORIDE TABLETS, 10 MG", "CHILDRENS ZYRTEC", "AMAZON BASIC CARE ALL DAY ALLERGY RELIEF", "TOP CARE ALL DAY ALLERGY", "MEMBERS MARK CHILDRENS CETIRIZINE", "KIRKLAND SIGNATURE ALLER TEC ALLERGY", "CABINET ALLERGY RELIEF", "CETIRIZINE", "LEADER ALL DAY ALLERGY", "SIGNATURE CARE ALLERGY RELIEF", "EQUATE CHILDRENS ALLERGY RELIEF", "CETIRIZINE HYDROCHLORIDE HIVES RELIEF", "ALLERGY", "CHILDRENS CETIRZINE", "CETIRIZINE HYDROCHLORIDE TABLETS,10 MG", "VALUMEDS ALL DAY ALLERGY CETIRIZINE HYDROCHLORIDE", "CETIRIZINE HYDROCHLORIDE 10 MG", "QUALITY CHOICE CETIRIZINE HYDROCHLORIDE", "HEB ALLERGY RELIEF", "CABINET ALL DAY ALLERGY RELIEF", "CETIRIZINE HYDROCHLORIDE (HIVES RELIEF)", "GOOD SENSE ALL DAY ALLERGY", "VALUMEDS 24-HOUR ALLERGY RELIEF", "ALLERGY RELIEF INDOOR AND OUTDOOR ALLERGIES", "CHILDRENS ZYRTEC ALLERGY", "MEMBERS MARK ALLERGY RELIEF", "CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE", "WELBY CHILDRENS ALLERGY RELIEF", "UP AND UP ALLERGY RELIEF", "GOODNOW ALLERGY RELIEF", "CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY", "RIGHT REMEDIES ALL-DAY ALLERGY RELIEF", "CETRIZINE HYDROCHLORIDE", "RITE AID CHILDRENS ALLERGY RELIEF", "CABINET ALLERGY RELIEF REFILL CETIRIZINE HCI", "EQUALINE ALL DAY ALLERGY", "GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY", "CRCLE CETIRIZINE HYDROCHLORIDE", "GOODMEDS ALL DAY ALLERGY RELIEF CETIRIZINE HCL" ], "generic_name": [ "CETIRIZINE HYDROCHLORIDE", "CETIRIZINE", "CETIRIZINE HYDROCHLORIDE ALLERGY", "CETIRIZINE HYDROCHLORIDE TABLETS" ], "manufacturer_name": [ "Live Betr LLC", "American Sales Company", "Little Pharma, Inc.", "Dolgencorp Inc", "Kenvue Brands LLC", "BAJAJ MEDICAL, LLC", "C.D.M.A., Inc.", "Sun Pharmaceutical Industries, Inc.", "Prodose, Inc", "Strategic Sourcing Services", "Indoco Remedies Limited", "Aurohealth LLC", "CVS Pharmacy", "OHM LABORATORIES INC.", "WALGREENS", "Amazon.com Services LLC", "RITE AID CORPORATION", "Amneal Pharmaceuticals LLC", "DOLGENCORP, INC.", "Topco Associates LLC", "Sam's West Inc", "ESTEVE PHARMACEUTICALS, S.A.", "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "BJWC", "Safeway", "LIDL US LLC", "HyVee Inc", "Publix Super Markets Inc", "Wal-Mart Stores Inc", "CVS Pharmacy, Inc.", "KROGER COMPANY", "Aldi Inc", "OPMX LLC", "H E B", "Meijer Distribution Inc", "RETAIL BUSINESS SERVICES , LLC.", "Umasuto, LLC", "BluePoint Laboratories", "WALGREEN CO.", "Target Corporation", "WALGREEN COMPANY", "Granules Pharmaceuticals Inc.", "Pharmacy Value Alliance LLC", "TIME CAP LABORATORIES, INC.", "Dolgencorp, LLC", "Army & Air Force Exchange Service", "MARKSANS PHARMA LIMITED", "Magno-Humphries, Inc.", "Ohm Laboratories Inc.", "Fred's, Inc.", "Walgreen Company", "Costco Wholesale Company", "Dr.Reddy's Laboratories Limited", "Spirit Pharmaceutical LLC", "LEADER/ CARDINAL HEALTH 110, INC.", "Major Pharmaceuticals", "Cardinal Health 110, LLC. dba Leader", "BETTER LIVING BRANDS, LLC", "Marlex Pharmaceuticals, Inc", "Strategic Sourcing Services LLC", "Dr. Reddy's Laboratories Inc.", "Rising Pharma Holdings, Inc.", "INNOVUS PHARMACEUTICALS, INC.", "Padagis Israel Pharmaceuticals Ltd", "Kroger Company", "NorthStar Rx LLC", "Grocery Outlet, Inc", "WALMART INC.", "Sandoz Inc", "MARC GLASSMAN, INC.", "TerSera Therapeutics LLC", "Cabinet Health P.B.C.", "STRATEGIC SOURCING SERVICES LLC", "Camber Consumer Care Inc", "Amerifoods Trading Company", "Better Living Brands, LLC", "YYBA CORP", "Chain Drug Marketing Association Inc.", "Granules India Ltd", "Chain Drug Consortium, LLC", "RETAIL BUSINESS SERVICES,LLC.", "FAMILY DOLLAR SERVICES, INC", "CHAIN DRUG MARKETING ASSOCIATION INC.", "L. Perrigo Company", "DISCOUNT DRUG MART", "SAFEWAY", "SDA Laboratories, Inc.", "HARRIS TEETER", "FSA STORE INC.", "QUAGEN PHARMACEUTICALS LLC", "Amerisource Bergen", "First Nation Group, LLC", "Bionpharma Inc.", "United Natural Foods, Inc. dba UNFI", "Advanced Rx LLC", "Valu Merchandisers Company", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Gobrands, Inc", "LIDL US, LLC", "Rite Aid Corporation", "TWIN MED, LLC", "Advagen Pharma Ltd.,", "AAA PHARMACEUTICAL, INC.", "Aventura Pharmaceuticals, LLC", "WINCO FOODS, LLC", "Strive Pharmaceuticals Inc.", "APOZEAL PHARMACEUTICALS INC", "Strive Pharmaceuticals Inc", "Granules USA, Inc.", "VALU MERCHANDISERS COMPANY", "Marc Glassman, Inc.", "TOPCO ASSOCIATES LLC", "PD-Rx Pharmaceuticals, Inc.", "Mylan Pharmaceuticals Inc.", "Innovus Pharmaceuticals, Inc.", "PAI Holdings, LLC dba PAI Pharma", "Chain Drug Consortium, LLC (Premier Value)", "Retail Business Services, LLC", "Bi-Mar" ], "product_ndc": [ "80267-409", "41520-715", "72559-003", "55910-458", "50580-116", "61037-480", "63868-865", "51672-2147", "68210-4159", "70677-0149", "14445-152", "50580-754", "58602-444", "58602-445", "58602-812", "51316-182", "51672-4070", "51660-066", "0363-1794", "72288-007", "11822-4228", "65162-005", "55910-269", "36800-448", "65162-046", "68196-102", "68118-100", "23155-929", "68391-400", "58602-860", "21130-425", "71141-294", "55910-934", "42507-458", "56062-106", "49035-458", "69842-234", "30142-058", "64024-499", "58602-030", "69729-137", "50580-753", "37808-106", "58602-863", "41250-458", "72476-194", "85293-001", "68001-436", "0363-0068", "82442-475", "0363-2106", "70010-293", "68016-165", "58602-861", "49483-682", "55910-699", "50580-778", "55301-076", "25000-160", "25000-219", "25000-220", "50580-730", "54257-270", "72288-691", "51660-939", "36800-180", "55315-354", "0363-4101", "68196-475", "56062-102", "58602-036", "63981-458", "55111-351", "55111-699", "68210-0119", "72288-980", "58602-806", "70000-0047", "50580-786", "0363-0471", "0904-6717", "70000-0380", "21130-090", "49035-276", "49035-106", "68210-4219", "58602-422", "21130-712", "10135-762", "50580-790", "58602-838", "70677-1007", "70677-1241", "37808-583", "65162-145", "0363-9602", "43598-811", "16571-402", "0363-3393", "57483-190", "45802-919", "41226-692", "16714-799", "85828-194", "79903-406", "68016-106", "0781-5283", "68998-194", "49483-692", "70720-100", "82725-1103", "70677-1236", "69230-316", "0781-5284", "70010-163", "61504-194", "21130-098", "73581-202", "63868-132", "16571-401", "62207-764", "37808-102", "68016-939", "72476-764", "55319-939", "21130-653", "58602-716", "82725-3103", "57237-357", "58602-446", "58602-447", "58602-813", "50580-128", "63868-665", "41520-781", "0113-0981", "53943-194", "69842-961", "21130-640", "16571-134", "82725-1003", "50580-791", "66424-564", "65162-684", "72288-411", "72036-194", "81522-194", "56062-111", "0113-9458", "51672-2106", "70752-103", "70752-104", "59779-458", "50580-782", "55910-710", "45802-626", "68196-413", "51672-2102", "46122-101", "64024-475", "21130-099", "65162-045", "61037-479", "81469-353", "21130-465", "69452-465", "56062-939", "41163-197", "58602-856", "11673-502", "57237-358", "0363-3311", "80513-731", "58602-823", "30142-172", "45802-974", "68210-4230", "58602-862", "63941-939", "83324-091", "0781-1684", "82501-0422", "71141-133", "11822-1002", "55681-302", "72888-480", "65162-003", "57344-194", "69206-990", "69729-139", "50580-721", "36800-458", "67091-494", "58602-028", "70692-180", "83745-188", "70692-139", "50580-726", "11822-2106", "82725-3003", "69452-426", "41163-458", "24385-998", "69848-006", "63941-194", "58602-808", "68998-939", "76162-009", "72789-458", "82442-617", "0378-3635", "0378-3637", "57483-250", "0121-0874", "68016-023", "41250-618", "72476-623", "0363-4025", "69842-237", "50580-752", "37835-611", "55681-073", "82725-4103" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE" ], "rxcui": [ "1014678", "1014675", "1020026", "1014673", "1014676", "1014677", "1014674", "2261746", "2261754", "1011482", "1020022", "1482533", "1011485", "1020021", "1991946", "1020023", "2558501", "2558503", "1014643" ], "spl_id": [ "4a017852-db01-4085-8947-d92a19ec4e5c", "ee2f07ef-66a7-476e-b4e5-ed887992bf9e", "2748ceef-df18-d866-e063-6294a90a7ff8", "54199e31-e4b5-407e-97eb-dc35ed4de5a1", "37b38291-50c9-00c9-e063-6394a90a83ef", "3ba40b0a-2360-0431-e063-6394a90a285e", "434f1b5b-1e26-406a-a5e2-df310b74e993", "53b5fbb1-4c70-0f2c-e063-6394a90a4f7b", "4949097a-aedb-eb3c-e063-6294a90a1192", "e4c85780-7cb5-b55c-e053-2995a90a0314", "c1a05a6d-3db7-446f-927b-787a062ad1ae", "3a6e2ec1-eab8-beec-e063-6394a90aa39c", "146cd9eb-d2c1-4424-9e37-350004f18507", "3f168e67-2692-2005-e063-6394a90a747e", "3b528d29-2957-8382-e063-6294a90aa8a7", "53580728-757e-08a5-e063-6394a90acb2e", "08332210-6c16-be1e-e063-6394a90a0bbe", "3ba3f1a6-e1ea-f193-e063-6394a90ad645", "c3e987c5-7ca1-4514-aa0a-6668ff2937c5", "e3c8a262-ed07-4ae0-be85-be55d3459695", "ecec220d-7f42-4778-987a-887566b20783", "0c774d83-58dd-d9b3-e063-6394a90a6f7a", "eb748140-aec8-4fcf-9597-20610d87635a", "b1326566-e6ae-44c3-a1c5-3b0f5be3fc1f", "1ba5f59e-81b7-c660-e063-6394a90af7fd", "57e97eb8-9e05-8888-e063-6394a90a68de", "ef266d70-f451-4938-b720-2103625cd384", "09c3300a-a96f-4967-aa1d-85b6e9fd5798", "99f8f81a-d083-48c1-a923-4ed0dfcd989f", "8b6eebd5-99d8-4acf-aec4-2b1c8d32ed4b", "ea23a5a6-3f35-41bb-e053-2a95a90a1f5c", "6baa66e7-93df-43d9-a301-5d9c14274c99", "a9ba17ab-f223-4850-a8c4-96ae247ed081", "29a2f347-2061-7d9a-e063-6294a90a98e9", "8478b5cf-8c1f-40f6-9d98-ffdce498cbe1", "36c631f4-2590-4c5e-b64a-39e3b1b9b268", "013f034c-15f9-4da2-b74c-ac999b276053", "2324487c-1a2c-42b1-a018-22f7ee9d5bcd", "95f01d24-5f39-41e2-b6d9-90c4f3fbdffe", "26f56cb7-be59-a0c2-e063-6294a90a15fa", "506ace58-15cc-77b4-e063-6394a90a0813", "3e05caf8-84cf-478f-9401-762f51c9e796", "0b6e8c63-a76c-4184-a9cc-9691378c3ee5", "18b74fff-8596-4050-93ee-4f15e6811de4", "c6f31728-fdb8-f78d-e053-2a95a90a253e", "2fb2f0c8-a45a-5c2a-e063-6394a90a1587", "4262085e-1de6-302e-e063-6394a90a0026", "5d00aeb2-1ed9-4d51-a939-e137af4608f2", "b718635b-61ea-45ff-951a-8df776d4ebd1", "236ed4fb-cea6-468a-9a9c-10e346533690", "569120e7-e21e-c7a2-e063-6394a90a2346", "39ad746e-1dd7-f3fb-e063-6394a90a767d", "20dddc76-5ac2-498d-bff3-2d722a58891e", "dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6", "eba98b0b-bc85-4d05-8875-86b85bd462b4", "3254957b-3bb2-98a9-e063-6394a90a9358", "e61a6e00-ceae-4a3b-bbf8-ead4edc14d59", "172d56b9-ba90-4e1b-934a-f75307564ea3", "40cb0507-49ef-8320-e063-6294a90ae39f", "cf6d242a-ce61-23b7-e053-2a95a90a856c", "4c474cbd-276d-42ed-8082-33fc8e7eb683", "2a87ee90-da59-4e35-9cda-27759ba080d4", "6fe07c0a-a5f6-45dd-b67e-ea214d3870e3", "17d2db07-4de0-4e02-8e2e-0082c275faab", "28f9d48e-60ee-4d58-af55-0b6206044e31", "c1765b31-cc97-4f6e-bb57-d90f16b73a15", "39fcf979-486a-5810-e063-6394a90aaeac", "bd489217-bf7c-429b-a58c-426104f7e779", "11b36474-0f5b-4454-8e5e-023c36ddad54", "000d3a47-3836-b678-9487-2bbc518cd57f", "2a804c42-e22a-703e-e063-6394a90a3b1b", "fafa0608-3d6e-41a9-8c62-53b728a39d82", "a74bd49f-8718-4483-9019-b761138669c9", "5c5725c9-4879-424d-829c-44017284977a", "41a5a9a1-61a6-f771-e063-6294a90aed87", "b8e38b9c-29f4-4f19-b1e9-e14c3926b7a9", "cdf7d985-c5aa-4002-a152-58fe4d6ba6e2", "f547a78c-52a9-40c8-b48c-7e76681b9c5d", "4a207903-34f2-4db3-a813-e02bd7f93053", "54158ca6-c0d8-c8b2-e063-6394a90a385d", "26f1efff-e30b-4c6b-b1d1-51be507fbef1", "2a838f53-0e3c-3892-e063-6394a90a23d6", "91498d0f-2f98-4820-9db1-5b1815594ed6", "38a06b8a-bd81-4696-e063-6294a90a1f38", "3f7dc523-2934-780a-e063-6294a90a837f", "322eb217-089d-e92d-e063-6394a90a6566", "ef1f5185-9a05-4092-9bdc-954102616ccb", "b13a3e2a-c087-727c-8d9e-90faa85292e6", "498adc5b-0e60-f64c-e063-6394a90a62ea", "e2ba6632-3350-4d5f-a03e-5e68dce98576", "2231625e-ba4f-4106-81ed-12137d0464a6", "7f752fde-e10a-4cbc-84bb-cd42849484c7", "adfee3f6-660a-305c-2cf4-bd509acfad36", "538948d8-34aa-4460-8d66-ee8fcf4c60ab", "58393fad-a47a-4948-90c5-7fc175d85a61", "89db2c96-62f6-4e75-8f0d-321b44094c60", "431bdf74-dfe3-4e4f-91e9-2b638ada6d47", "3e7fad54-62e1-6d0a-e063-6394a90a5785", "31542c85-db9e-4225-bd25-d231710595b0", "5256dd4a-ca7c-1585-e063-6394a90a0926", "97ddae8d-b4cb-462d-8a9a-950ee6a658c6", "51b02412-ebbd-4045-8af4-4b8b8e90daf4", "73150a55-d6f0-4ae0-847a-f9679694bf80", "ea60a2f4-2e8f-c1f1-e053-2a95a90a286a", "12f9d89b-5334-1339-e063-6394a90ad0e8", "32f69271-f228-41a9-8133-61cb47d73045", "41d8205a-6010-c622-e063-6394a90abdb2", "3996d9c8-9a1e-e9ca-e063-6294a90a4e8c", "14a303ce-ffb0-acd3-e063-6294a90a9327", "4b5cb5f2-f046-4a6f-abfc-da4280fce674", "451b5247-4660-9ebe-e063-6294a90a13c2", "092d4666-dc93-1c0f-e063-6294a90a7aaf", "4471f8dd-d97b-4a3e-a238-cbf8cd606f11", "0e13664c-b422-d2fa-e063-6394a90a2d33", "2f9f8dc0-8034-445c-b7b0-bf680a6be979", "37fb3dd8-d5bf-46e4-8331-0c8c1eac540d", "5691298e-b03a-ccb8-e063-6394a90ae113", "53296254-e9a0-3be3-e063-6394a90a742c", "62e359b6-7269-4672-9db1-0e9abc63afb3", "46518a5f-819b-3a94-e063-6294a90a4533", "65ed577d-07a6-40e5-bff5-26b9ec806f04", "14ab13cb-7eca-40cd-8eb1-4933676e091b", "1bbefda2-d3c5-4d31-b3ec-7da077e41157", "3231f007-8ce6-a79f-e063-6394a90a4af4", "36fee17d-2444-41d2-aca7-2f22d3f87cc0", "5ebdf17c-288b-4fed-89c8-7d1f42a128d0", "37b3c47a-f31a-20f4-e063-6294a90ab07a", "24358839-3c09-2895-e063-6294a90ad893", "11e72e08-b407-4a84-a79e-1f14b987b1ec", "5b1203c7-9678-4cee-9d7b-6510da295561", "af0d3f87-af0b-23a5-e053-2995a90a338a", "c4c715b2-8239-4b57-bfd9-c3c4ddea19c1", "463f17c8-bcef-ecdb-e063-6294a90a3404", "8ed398ca-3d43-43b4-9597-4457d6943357", "2cb6ac08-d6b2-21fa-e063-6394a90a269f", "500a1503-02c8-cc05-e063-6394a90a24fb", "0eb0b074-9f48-a3ad-e063-6394a90a9ded", "9cc0ee28-2f21-4c0a-90fe-b22b3fe321c9", "36de155a-75d8-471a-be42-56bf64a7b39a", "08f15d4b-b676-acec-e063-6394a90aa778", "2fc20c71-6615-68d4-e063-6294a90a736e", "ade9acd2-126f-4612-b761-3f9c83fcc773", "c93a5e52-e438-4421-bdca-1fcfdcdb9b98", "5698bba4-d090-a558-e063-6294a90a600a", "eb119bad-6e21-4378-a556-41b1b790d84c", "131dd209-e1fe-4dd4-9523-8c0da50b78f4", "327f7ae1-8b12-ef7a-e063-6294a90abd4a", "ba7d3995-c992-457c-a628-f036d77cc638", "2263eac3-aa51-4b35-8535-db7e21cf5660", "f8834e23-1240-4098-95f2-c8e31d6c2c64", "38f727a4-1153-9087-e063-6294a90ae97b", "659426e2-438c-40c1-8bb6-bb036168f8b6", "a8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a", "b3b261a6-e56a-458a-a5a4-92bd95f4e2fc", "79a66101-ea46-4515-bb20-ce790b750d70", "3b5908fd-b2c0-ba45-e063-6294a90a6fb0", "5359e5b7-5279-c7fc-e063-6394a90a378b", "81d6b4b4-2c46-4727-82fe-f7cedce89cc5", "45745bf3-a132-b51a-e063-6394a90a712e", "acd5c107-c9fc-42fd-baf2-714888f59bd4", "fbe573b2-eb20-af53-e053-6394a90a2dc9", "bc89802b-be9c-489d-b006-7dd0bb7e2ceb", "8f32f92c-9043-439d-a318-8f4ae6b1ad39", "836319e1-8b7b-46a4-8303-5d241c6dcb98", "1d57d104-36ee-4210-ac65-4828d19ccab9", "35019a5a-fbea-124b-e063-6394a90a5ec4", "bd9c2a41-9024-46a4-87c6-7d6f5f1fafbf", "05203ede-e178-4663-aaf9-c0b155a38707", "71411b7e-4fb8-4c33-b260-287128711d0a", "0bde5cd4-6043-3d42-e063-6394a90ac001", "c6f65c7b-e626-4ef3-910d-03702cac03bf", "2d78941a-3bfd-4c92-aa00-2a4f99db44c8", "1fd10ca6-5ab4-50d2-e063-6294a90a3a09", "2ca4b053-0031-4a34-a1b1-8eaadb0879c6", "5d8e3ec6-14de-463d-bea1-d40f50266304", "4cf9e5b8-0be6-4a8b-9ee3-7e7272864279", "6c4b2dd2-0897-4bcb-a570-6bc6f5332828", "0e12b3c6-357a-b0dc-e063-6394a90a8ea4", "4c56197b-744a-fe94-e063-6394a90ac0e7", "f9d002fa-9c05-4275-a783-053bf1993ca0", "52e3fa47-d8fe-183e-e063-6294a90a5a75", "3e808491-ec96-4f20-bb5e-3a9e5c72550e", "18ab8b3c-80f1-72ea-e063-6394a90ac0d1", "48bb7dd3-c2b8-ecfb-e063-6294a90af77d", "dc4e4803-536c-4a2b-9faa-e307a66eb91a", "f91594ff-8c0c-0385-e053-6394a90a04e7", "e407f522-6f4f-4049-a2df-23cb18c1eb1f", "98197653-9fb8-41a6-8bc2-00bf418ed39f", "6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499", "b451c631-6bdc-d42e-e053-2995a90af099", "40cb0300-d3f3-4a66-e063-6394a90a41dc", "29a12559-c0c3-2b55-e063-6394a90a9255", "414fa38e-f7c6-459c-e063-6294a90a5a54", "390da0b9-8970-1b38-e063-6394a90ac470", "41d79fc7-75b2-120e-e063-6294a90a2f0c", "6e7bab3d-af1a-4b74-921d-99aca2aa0fd3", "49064fc4-3c0c-4d8f-9576-f57ad03f9cfe", "468e40c3-a669-29bd-e063-6394a90a8812", "45b23ce1-1611-b7a9-e063-6394a90a50eb", "30494d65-a846-4f13-a076-242f193e4651", "1e5b54b1-a7d9-44ae-b2e5-0a77793ad13a", "7baa79c5-be46-4b09-8cae-c306edb7f97a", "44086625-2cfd-7204-e063-6294a90a5b52", "b0ae7da4-e25b-4ff3-995a-ce3add69c6c2", "5670c6c3-a4ab-4268-917a-99e0579f3079", "b1644d9c-353b-44bf-b3f9-9bd8b83976f2", "31dc1106-c6ed-4dcd-81e3-206cbd47017b", "c067a0f7-cadb-42cb-9bd4-6b901aec98c4", "6511653d-8712-4cd5-86bf-307042127dc7", "4f85d968-dae7-479c-869e-6e79021de97c", "ed5abf26-6de5-46f8-924a-744e4fc5a04e", "621f3d87-d69e-41e6-8ece-22099cb87c01", "40a49b40-f7f1-74c3-e063-6294a90a55ed", "36d0b7f3-2156-873a-e063-6294a90ac015", "4e69476d-dee2-dac7-e063-6294a90a06d4", "4ef9092c-6914-a7d3-e063-6394a90ac985" ], "spl_set_id": [ "4a017852-db01-4085-8947-d92a19ec4e5c", "833e8904-d37d-4478-af7c-8287f2d079a7", "8c429732-5cf3-f41b-e053-2995a90a302a", "b9ac489a-80ed-4077-b68e-d03df1b892a6", "31136e3a-94fa-0860-e063-6394a90a008d", "36b24a3c-6284-5a6d-e063-6394a90a7743", "b4feed95-86ca-411c-99b5-773e485e752f", "30cbaa91-2216-efd2-e063-6294a90aaaed", "e0e5f482-0282-410c-8c40-0a33ca4ea23a", "1dd63ede-37ca-4b5a-bfed-1aca5dd15424", "2942e093-5077-44d3-b080-8d945d03c55f", "2c1ecee3-c2c1-25a2-e063-6294a90aad54", "3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25", "3d711302-dc4e-0a69-e063-6394a90ade10", "6d81446e-f713-4ca4-af38-3d31cf618873", "97802669-b4bd-4807-b3c1-6c6f5a2b0c67", "f3c66f47-016a-799a-e053-2995a90ad424", "36b6d0e4-8da5-9df5-e063-6294a90af326", "c3e987c5-7ca1-4514-aa0a-6668ff2937c5", "de169567-5cde-5c4a-e053-2a95a90a1215", "e01f0db4-1b49-4b6e-b2fc-61834897bdd3", "0643ea78-9709-8526-e063-6394a90a227b", "10c512a1-bb96-4d2a-9e41-a422efb57e28", "273172b2-9aaf-46fb-a1ce-2961650eacd3", "48b47541-cf0c-48a7-9a65-2158fd1284f1", "573770f6-b76e-f6ba-e063-6294a90aa54d", "a9b21d71-106e-4bd5-aaab-9254c8a44e0d", "b38c0068-5b06-4976-b68d-617bcc14f051", "c111f6f3-e190-447f-b4a4-e277af641483", "c5e74b2c-7871-4f28-a77d-0d674b9b8c5e", "e5fd935d-5b60-7270-e053-2995a90a7141", "6baa66e7-93df-43d9-a301-5d9c14274c99", "8889af37-8345-4358-994d-7d8b847f4874", "9a8b5af0-72bb-48d5-bb5e-0dc6808bf466", "b33eb97f-5ac3-4eb7-b23a-cf550ce46287", "b45c95f2-91c9-55b5-e053-2995a90a75b7", "b8b2af96-af48-5f63-e053-2995a90a7d7c", "cf6b3017-c8b6-4862-aa33-19ed02a43c28", "e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d", "26f56cb7-be58-a0c2-e063-6294a90a15fa", "dc613bd5-70fd-1d9b-e053-2995a90a41cd", "fdd3f9a0-b4be-498a-b8e0-1a9740399736", "0b6e8c63-a76c-4184-a9cc-9691378c3ee5", "2b03c026-3e8a-4283-981f-965bc084c03d", "95bf367c-eea8-73f9-e053-2a95a90a3dea", "9af4ab23-d6d3-43f9-a026-76fd9771963f", "a86fbe45-08db-bddf-e053-2a95a90aa792", "3d2eac7f-db44-4771-8c7e-a38e68a7f24b", "4b1ee9b1-d22e-4fb2-8dcd-912374da12d7", "4ce79791-748a-49d0-af34-73f589670d3f", "562b5e6c-6103-df3d-e063-6394a90a897d", "a4931f0b-86f2-42c5-b2df-b359bb46f44a", "c1ae7bb1-e154-4745-b01e-bc91d50d35c8", "dfbddafb-9455-5805-e053-2a95a90ad0d9", "4d79fb74-1895-4efe-8016-c0dd5ed10f7a", "6a962a1c-c197-492b-bfa6-e0c28eda1533", "e7220494-3640-4b33-b577-ed3ca7c483e8", "652b0c65-a3f2-4454-9cf2-51a3389282cc", "9d8e78ea-af98-4f7c-8db5-044b49582f80", "f0a3e654-5fec-4f98-84da-4c30500633b4", "113e66f1-b922-8533-e063-6294a90ab30e", "161c4122-2c89-46e6-a6ae-db088087330d", "1a217b8a-621a-4b6d-a7ed-37b04f829d66", "55e799b2-e325-4286-aa9a-b88e99ab1146", "678dcc09-55da-4d9d-a39a-c450c61c387b", "9c6e7a8b-f8ad-4f6b-abb1-5cde86b75c7d", "ae216d0b-8ccc-4cc4-82f4-4d0f3a256822", "bd489217-bf7c-429b-a58c-426104f7e779", "d4a688aa-02d4-4af6-9a91-ed31679cfaf8", "de152651-bfcd-856a-8329-a2ac93a376bc", "e49c3c91-aab8-478e-97fa-04ed06180021", "e71e259a-494e-4a9a-b0e4-25bd25dd0e07", "ffbca2a4-8df0-4c85-adf9-9414cd706fb2", "0cab7aa8-ded3-46f1-b801-2663cc9b0173", "0face45c-af24-3559-e063-6294a90abde5", "9e728bf2-0cb9-ecf5-e053-2a95a90a408a", "a5be7921-c1cb-4b9f-9f4a-1c4b68b2b8a3", "ce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf", "24099cbf-61ee-4ec8-a4ec-95a66ceaa0c0", "b73950f4-af6f-4dc7-bce2-9ec43c45eee5", "0d026538-5708-4030-b65d-18790e72059a", "507df969-804c-4e95-bb42-c1224fce2b28", "52dc28ac-4059-4b6c-8bbc-22aa479a549a", "eb60ae7d-87db-7413-e053-2a95a90afd76", "eb917099-fecf-6b55-e053-2995a90aaafa", "013ce40e-37c9-4b84-b530-ed895f60ce0e", "17e93c22-1ff7-4af9-bd5a-448836aec65f", "52b70885-f623-b1c8-29c6-584bff46ed45", "54509525-ad99-4165-a571-47ece058e292", "8649fc1e-ad56-4660-bbbb-8f1ed795697b", "aad39214-5bf1-427b-a00e-410224c51c95", "c0165b0e-d5e9-a028-e053-2a95a90ab431", "e4eca4df-9ad8-b7c4-b512-bfaed5673789", "5481ccb3-b311-4b25-b923-4fe8522ea92b", "5cdd59a0-4d23-4f51-9aca-d66a639f8472", "89db2c96-62f6-4e75-8f0d-321b44094c60", "91fe3ab8-c155-4482-9f06-f029d3563aad", "bc020340-ef39-e49a-e053-2a95a90af810", "c9d1e26f-c95a-4991-95fa-9ed6ed484fe2", "441d049c-8844-955e-e063-6294a90a666d", "473ad691-2499-a706-e063-6394a90a9781", "6b22f568-7ebd-4479-b764-6e5481d8c15a", "817d07cf-5e31-421f-9e95-943bae01f5b0", "951b6f19-15fe-45d7-e053-2995a90aa254", "d78223ba-80d5-47f8-e053-2a95a90aebdb", "f33e859d-ebc9-4d4f-a57d-204c48760d20", "3071238a-6b35-4da8-8305-eced56c513ce", "601c2846-30e7-40f1-96b4-64fbed719c0b", "941e4aa9-6388-424c-87ad-3ea2ec5aafea", "a814a06b-96ed-4403-bbd7-fc1142988b50", "d55dfce1-acef-3342-e053-2a95a90a4b83", "f6ce3cdf-2e6d-61e8-e053-6294a90af7d3", "f7e16d96-4f23-cbca-e053-6394a90aef4e", "0502f197-21e1-44f2-b621-c8df1ccd956e", "2e8cc4e3-8386-42de-801f-fef37f612849", "6493d4f6-dead-45ec-ade1-28ce624af33d", "6efd5a60-e281-43f9-a52c-a95f46fbcbfc", "9abdae64-4c3d-47f3-8224-fc81f7bfe557", "9d7d2342-a594-4851-810b-b7bce1bd07dc", "9f04520e-161d-3f7b-e053-2a95a90a678d", "b326dacc-6123-47a7-9fde-6909db1d780b", "cfc3daa5-7248-4105-95ee-4e19199655ce", "1bbefda2-d3c5-4d31-b3ec-7da077e41157", "889316bc-5f98-426a-9750-2fdb0c427408", "c6f08e78-10fc-48d0-a3e1-e227081548eb", "2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a", "31400cb2-fe85-ef74-e063-6294a90a11fb", "4f2d0a71-fda5-435a-a220-3292cd74a42a", "533abfc1-226e-4a68-bfcc-ec046a4d5751", "5b1203c7-9678-4cee-9d7b-6510da295561", "844e0e60-f293-4588-9f34-c866bdad6f53", "b955c7ed-29da-959f-e053-2a95a90a03d4", "ed0eecfb-85bf-63bf-e053-2995a90a0e03", "efabbad5-a162-45c8-a896-5af58e5d2d39", "fcb87d13-3385-4f4c-8d5e-6ba58e952e4e", "0fe77356-d945-46a0-882e-b3bbab784556", "222a7e77-33a6-44ca-9ab1-0bc4fc431aa3", "365cbabe-535b-4c34-852b-6cd63782e3e5", "af8ff570-8f72-4343-b7e1-e977221f5b01", "b8f68d9d-2d3a-414a-e053-2a95a90a15ec", "ec6b4e86-ac27-e1f2-e053-2a95a90ab3e1", "268170c9-b6a7-4851-b7d3-33dd1d733e39", "2a7a27ab-1b4c-40d1-98bf-e4297aa25682", "67207357-5f8a-4424-9901-d2717a43cf1b", "9163cd2e-0be7-4009-b905-729014773d6e", "98f3f2c6-da18-4055-81f1-962261360f9b", "a1edc2e6-3661-4d7a-884c-709d73cb89e0", "ba7d3995-c992-457c-a628-f036d77cc638", "2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e", "379756fd-f92d-4773-94fd-2682fcbdfba2", "54d72d7a-1f5b-4b36-bf76-ab7aef6243ab", "6ce39876-47bf-4147-885d-4eb0aeb66fd0", "a8fd50c6-1a27-4ed2-8a63-f9b9918ffb4a", "f7deb8ca-4a26-aece-e053-6294a90aa685", "214936a2-adc4-422a-a8fe-4c3ce9e01f36", "3b5908f1-faba-c317-e063-6294a90aa8a7", "5267f7c0-e62f-35da-e063-6394a90a9346", "5d3e4c52-b697-4b91-af28-124f74d937e5", "831d4141-b3be-4d98-a372-9c4d57ad296c", "a0a063a1-e067-480e-afab-7f01165025f4", "adcd0e8e-cca7-e1bb-e053-2995a90a83be", "cd895177-3c25-4a1b-81a0-b85f4877787a", "ce93ca5b-2a65-4873-9686-926c44076c6c", "06cdcbe0-6c7c-4b91-8158-08ef2e0876dc", "2a62f905-663f-4aae-991f-a368b5120f6f", "737492bf-96bd-4f7c-aa42-4910746f44bb", "7d214cba-951d-464e-b37e-e83098944fe6", "b92d959d-dd35-b2a3-e053-2995a90af3ff", "c2cf555d-986c-4e89-ac4f-938e92c418e2", "c9eb5102-5514-4e69-8169-be7341e9fb66", "d9ebebb5-736a-4019-8c1a-030148de9d02", "4a8d2887-8ac3-4d54-9e67-4a271d416426", "6eb22b5a-ff30-44f8-aca2-3f73614515a8", "760dd0e4-280a-4d95-8938-cecaa7ec75f2", "86ade508-8841-47d8-addb-418ecd6dc8de", "a210d6b7-0829-4120-bb6d-fee0c2e57b26", "bcbb9f5a-10b6-4a5e-a237-d29693d78103", "d9437d88-da59-5567-e053-2995a90a362b", "0956baea-f0ad-4aac-9464-831840db9230", "7d16ccca-6aa3-4575-9fa7-f57301801a81", "ac22558b-5c82-4ab9-95b8-53eedea46282", "aeb73ab9-3b05-4062-a7fd-352cf2094a56", "b452bca6-2c51-d0a1-e053-2995a90aff67", "ee8695ac-1293-4e43-ac7c-a64e21a0ca0a", "f2919aad-9ed4-40b8-b233-4aec06df33ea", "f45f5920-d82f-6549-e053-2995a90ad58a", "4de4f544-79cd-4a89-aafb-f2e2688b3c81", "8227edbe-88d5-4d79-9175-891dd9566357", "9c0549cf-4c93-45d9-9eac-3948fa45554e", "a4ebeec7-0245-4f77-e053-2995a90a7e7f", "b165db38-b302-4220-8627-77cb07bb078c", "edbefbee-26b6-46bc-abcc-f7b2817705e5", "05324e41-ee3f-0e4b-e063-6294a90a102c", "0eaf9d27-e221-4cdd-97bc-478c775e3d67", "41d7af88-87b4-370e-e063-6294a90a8af6", "491fae66-83b6-4beb-945b-39b9e4e021c5", "c568e388-60ab-47be-b362-7832b83d06ad", "c8d711cd-7214-c7d5-e053-2995a90a6b67", "dc66bf53-820f-40a3-b5ef-c653dd375544", "f0f486e1-2eeb-4eaa-b557-908bcbf973a8", "f30900e6-425f-43e0-81b6-1fa3bd321f0b", "f4ba3e0c-e6b3-2596-e053-2a95a90ab850", "03c0a599-072a-10ef-e063-6394a90a9698", "1f37c327-cd4c-4bc1-ae70-713569694e2e", "487ae0f0-320c-4534-b9e2-0e215f167cea", "640583b6-379d-4ad3-b00c-383377c54eed", "71448ab0-e23e-4cf7-940e-7d67e7362fb4", "b47b0c8b-59d5-4e17-95be-a992c6861ee7", "e64db82c-6632-421e-8212-e0879445c4d6", "6d94d302-b79a-4143-bb3c-c74da2a6a72e", "a9fd9b8f-509b-1ffa-e053-2a95a90a6d0f", "e340cd4b-5413-42c6-a956-eb15c3807aeb", "6685a843-9dbe-4f9e-b75b-fe0e258f4155", "cbb270c3-34a4-4af8-9da0-2e545787cb55", "14317ee7-1061-4c2b-9427-3433e27f13f5", "cd13a70e-b9e2-41be-97ea-f022442b6460" ], "package_ndc": [ "80267-409-95", "41520-715-63", "72559-003-48", "55910-458-00", "55910-458-39", "55910-458-95", "55910-458-58", "55910-458-66", "50580-116-30", "61037-480-02", "61037-480-03", "61037-480-04", "61037-480-06", "61037-480-12", "63868-865-04", "51672-2147-8", "51672-2147-1", "68210-4159-1", "70677-0149-1", "14445-152-30", "14445-152-90", "14445-152-01", "14445-152-03", "14445-152-05", "50580-754-35", "50580-754-15", "58602-444-09", "58602-444-17", "58602-444-47", "58602-444-41", "58602-444-21", "58602-445-09", "58602-445-17", "58602-445-47", "58602-445-15", "58602-445-19", "58602-445-94", "58602-445-38", "58602-445-40", "58602-445-41", "58602-445-21", "58602-445-01", "58602-445-60", "58602-445-54", "58602-445-65", "58602-812-09", "58602-812-17", "58602-812-99", "58602-812-23", "58602-812-39", "58602-812-41", "58602-812-83", "58602-812-04", "51316-182-10", "51672-4070-8", "51660-066-30", "0363-1794-38", "0363-1794-46", "61037-480-22", "61037-480-23", "61037-480-24", "61037-480-26", "61037-480-32", "72288-007-49", "11822-4228-1", "11822-4228-2", "65162-005-86", "55910-269-58", "36800-448-63", "36800-448-09", "36800-448-49", "65162-046-03", "65162-046-50", "68196-102-02", "68196-102-01", "68196-102-07", "68118-100-02", "68118-100-25", "68118-100-10", "23155-929-51", "23155-929-52", "68391-400-00", "68391-400-01", "58602-860-76", "21130-425-95", "71141-294-14", "55910-934-49", "55910-934-63", "42507-458-30", "42507-458-39", "42507-458-66", "42507-458-60", "42507-458-72", "42507-458-45", "42507-458-95", "42507-458-90", "42507-458-75", "42507-458-06", "42507-458-00", "42507-458-87", "56062-106-08", "49035-458-95", "49035-458-75", "49035-458-66", "49035-458-87", "49035-458-48", "69842-234-76", "30142-058-76", "64024-499-39", "58602-030-24", "58602-030-20", "58602-030-26", "69729-137-14", "50580-753-24", "37808-106-08", "58602-863-12", "41250-458-66", "41250-458-39", "41250-458-95", "41250-458-72", "41250-458-75", "41250-458-87", "41250-458-58", "41250-458-13", "72476-194-01", "72476-194-14", "72476-194-15", "72476-194-16", "72476-194-13", "85293-001-01", "68001-436-16", "68001-436-96", "68001-436-04", "68001-436-97", "0363-0068-53", "0363-0068-12", "82442-475-26", "82442-475-34", "0363-2106-08", "0363-2106-01", "70010-293-14", "70010-293-10", "70010-293-56", "70010-293-79", "68016-165-00", "58602-861-21", "58602-861-29", "58602-861-40", "49483-682-01", "55910-699-66", "50580-778-12", "50580-778-24", "50580-778-66", "55301-076-95", "55301-076-39", "25000-219-03", "25000-219-08", "25000-219-14", "25000-220-03", "25000-220-08", "25000-220-14", "25000-220-78", "25000-220-81", "25000-160-81", "25000-160-03", "25000-160-14", "50580-730-05", "50580-730-06", "50580-730-01", "50580-730-17", "50580-730-18", "50580-730-19", "54257-270-02", "54257-270-05", "72288-691-09", "72288-691-19", "72288-691-38", "72288-691-39", "51660-939-54", "51660-939-30", "51660-939-90", "51660-939-13", "51660-939-01", "51660-939-53", "36800-180-09", "36800-180-63", "55315-354-31", "0363-4101-75", "0363-4101-39", "0363-4101-88", "0363-4101-13", "0363-4101-47", "0363-4101-58", "0363-4101-66", "0363-4101-72", "0363-4101-95", "68196-475-34", "68196-475-43", "56062-102-08", "58602-036-15", "58602-036-16", "58602-036-17", "63981-458-88", "63981-458-00", "55111-699-90", "55111-699-45", "55111-699-30", "55111-699-51", "55111-699-04", "55111-699-19", "55111-699-47", "55111-699-60", "55111-699-73", "55111-699-52", "55111-699-74", "55111-699-31", "55111-699-15", "55111-351-30", "55111-351-45", "55111-351-60", "55111-351-90", "55111-351-04", "55111-351-47", "55111-351-51", "55111-351-74", "68210-0119-0", "68210-0119-3", "68210-0119-1", "72288-980-49", "58602-806-04", "58602-806-53", "58602-806-12", "58602-806-16", "70000-0047-1", "50580-786-12", "50580-786-25", "50580-786-40", "50580-786-65", "50580-786-13", "50580-786-26", "50580-786-41", "50580-786-66", "0363-0471-76", "0904-6717-41", "0904-6717-43", "0904-6717-40", "0904-6717-72", "0904-6717-60", "0904-6717-86", "0904-6717-46", "0904-6717-61", "70000-0380-3", "70000-0380-2", "70000-0380-4", "70000-0380-1", "21130-090-66", "21130-090-76", "21130-090-39", "21130-090-95", "21130-090-72", "21130-090-75", "21130-090-48", "49035-276-01", "49035-276-08", "49035-276-09", "49035-276-02", "49035-106-08", "68210-4219-1", "58602-422-12", "58602-422-20", "58602-422-17", "21130-712-58", "21130-712-03", "21130-712-46", "21130-712-09", "21130-712-81", "21130-712-12", "10135-762-30", "10135-762-90", "10135-762-03", "10135-762-05", "10135-762-01", "50580-790-01", "50580-790-02", "50580-790-03", "58602-838-74", "58602-838-75", "58602-838-76", "58602-838-14", "58602-838-19", "70677-1007-3", "70677-1007-1", "70677-1007-2", "70677-1007-4", "70677-1241-1", "37808-583-06", "37808-583-58", "37808-583-39", "37808-583-66", "37808-583-76", "37808-583-00", "37808-583-87", "65162-145-03", "65162-145-50", "0363-9602-09", "43598-811-30", "43598-811-05", "43598-811-90", "43598-811-12", "43598-811-15", "43598-811-13", "16571-402-10", "16571-402-30", "16571-402-50", "0363-3393-26", "0363-3393-34", "57483-190-14", "45802-919-87", "45802-919-39", "41226-692-65", "41226-692-14", "41226-692-70", "16714-799-01", "16714-799-02", "16714-799-03", "16714-799-04", "85828-194-14", "79903-406-10", "68016-106-08", "0781-5283-06", "0781-5283-64", "68998-194-02", "68998-194-07", "49483-692-65", "49483-692-50", "49483-692-01", "49483-692-20", "70720-100-01", "70720-100-25", "70720-100-10", "82725-1103-3", "82725-1103-2", "82725-1103-1", "70677-1236-1", "69230-316-11", "0781-5284-06", "0781-5284-64", "70010-163-05", "70010-163-09", "61504-194-14", "61504-194-16", "21130-098-23", "21130-098-39", "73581-202-01", "73581-202-05", "63868-132-14", "63868-132-30", "63868-132-90", "16571-401-10", "62207-764-55", "62207-764-49", "62207-764-73", "37808-102-08", "68016-939-54", "68016-939-30", "68016-939-60", "68016-939-90", "72476-764-16", "72476-764-09", "72476-764-23", "72476-764-03", "72476-764-70", "55319-939-30", "55319-939-54", "21130-653-26", "58602-716-16", "82725-3103-3", "57237-357-12", "57237-357-24", "58602-446-09", "58602-446-17", "58602-446-47", "58602-446-41", "58602-446-21", "58602-447-09", "58602-447-17", "58602-447-47", "58602-447-41", "58602-447-21", "58602-813-09", "58602-813-17", "58602-813-99", "58602-813-23", "58602-813-39", "58602-813-41", "58602-813-04", "58602-813-83", "50580-128-04", "63868-665-14", "63868-665-30", "63868-665-90", "41520-781-66", "41520-781-06", "41520-781-39", "41520-781-75", "41520-781-95", "41520-781-76", "41520-781-58", "0113-0981-63", "53943-194-13", "69842-961-76", "21130-640-03", "21130-640-18", "21130-640-09", "16571-134-12", "16571-134-48", "82725-1003-1", "50580-791-01", "50580-791-03", "50580-791-02", "50580-791-72", "66424-564-05", "66424-564-01", "65162-684-86", "65162-684-90", "72288-411-87", "72288-411-75", "72288-411-39", "72288-411-88", "72036-194-01", "72036-194-02", "72036-194-04", "72036-194-07", "81522-194-04", "81522-194-16", "56062-111-63", "0113-9458-13", "0113-9458-66", "0113-9458-95", "0113-9458-39", "0113-9458-88", "0113-9458-58", "0113-9458-04", "0113-9458-75", "51672-2106-8", "51672-2106-1", "51672-2106-4", "70752-103-06", "70752-104-06", "59779-458-13", "59779-458-39", "59779-458-95", "59779-458-75", "59779-458-76", "59779-458-88", "59779-458-66", "59779-458-72", "59779-458-70", "59779-458-58", "59779-458-06", "59779-458-00", "59779-458-05", "59779-458-01", "50580-782-12", "50580-782-24", "50580-782-01", "55910-710-63", "55910-710-49", "45802-626-26", "68196-413-82", "68196-413-79", "51672-2102-4", "51672-2102-8", "51672-2102-1", "51672-2102-2", "51672-2102-7", "46122-101-26", "64024-475-26", "21130-099-97", "65162-045-03", "65162-045-50", "61037-479-04", "81469-353-90", "81469-353-03", "81469-353-05", "81469-353-01", "21130-465-34", "69452-465-81", "56062-939-54", "56062-939-30", "56062-939-60", "41163-197-08", "58602-856-75", "58602-856-76", "58602-856-14", "11673-502-58", "11673-502-75", "11673-502-48", "11673-502-06", "11673-502-39", "11673-502-74", "11673-502-87", "11673-502-76", "11673-502-72", "11673-502-00", "57237-358-12", "57237-358-24", "0363-3311-26", "0363-3311-34", "80513-731-12", "80513-731-05", "58602-823-09", "58602-823-19", "58602-823-39", "30142-172-09", "30142-172-54", "45802-974-26", "68210-4230-1", "58602-862-76", "63941-939-54", "63941-939-30", "63941-939-60", "83324-091-14", "83324-091-30", "83324-091-90", "0781-1684-01", "0781-1684-64", "82501-0422-0", "82501-0422-1", "71141-133-32", "11822-1002-4", "11822-1002-2", "11822-1002-1", "11822-1002-3", "11822-1002-8", "11822-1002-7", "55681-302-03", "72888-480-01", "65162-003-86", "57344-194-01", "57344-194-14", "57344-194-20", "69206-990-01", "69729-139-14", "50580-721-05", "36800-458-13", "36800-458-66", "36800-458-39", "36800-458-95", "36800-458-72", "36800-458-75", "36800-458-47", "36800-458-87", "36800-458-06", "36800-458-58", "67091-494-14", "58602-028-24", "58602-028-20", "58602-028-26", "70692-180-14", "70692-180-31", "83745-188-04", "83745-188-08", "83745-188-16", "83745-188-12", "83745-188-24", "83745-188-48", "70692-139-14", "50580-726-03", "50580-726-13", "50580-726-30", "50580-726-32", "50580-726-36", "50580-726-50", "50580-726-51", "50580-726-38", "50580-726-70", "50580-726-90", "50580-726-66", "50580-726-40", "50580-726-91", "50580-726-92", "50580-726-93", "50580-726-94", "50580-726-95", "50580-726-96", "50580-726-97", "50580-726-05", "50580-726-25", "50580-726-71", "50580-726-72", "50580-726-73", "50580-726-74", "50580-726-45", "50580-726-75", "11822-2106-8", "61037-479-02", "61037-479-03", "61037-479-06", "61037-479-12", "82725-3003-2", "69452-426-88", "69452-426-55", "41163-458-39", "41163-458-66", "41163-458-72", "41163-458-76", "41163-458-95", "41163-458-58", "24385-998-74", "24385-998-65", "24385-998-75", "24385-998-58", "69848-006-09", "63941-194-01", "63941-194-02", "63941-194-05", "58602-808-04", "58602-808-53", "58602-808-12", "58602-808-16", "68998-939-30", "76162-009-76", "72789-458-51", "72789-458-30", "72789-458-90", "72789-458-10", "82442-617-26", "0378-3635-01", "0378-3637-01", "0378-3637-05", "57483-250-01", "0121-0874-04", "0121-0874-16", "68016-023-43", "41250-618-63", "72476-623-63", "0363-4025-76", "69842-237-91", "69842-237-09", "69842-237-17", "69842-237-54", "69842-237-19", "69842-237-23", "69842-237-45", "69842-237-39", "69842-237-60", "69842-237-57", "69842-237-01", "50580-752-01", "37835-611-14", "37835-611-35", "37835-611-90", "55681-073-03", "82725-4103-2" ], "unii": [ "64O047KTOA" ] } }, { "drugcharacterization": "1", "medicinalproduct": "MONTELUKAST SODIUM.", "drugauthorizationnumb": "020829", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, QD, NOCTURNAL, FOR TWO WEEKS", "drugdosageform": "TABLET", "drugadministrationroute": "065", "drugstartdateformat": "610", "drugstartdate": "201309", "drugenddateformat": "602", "drugenddate": "2013", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "MONTELUKAST SODIUM" }, "openfda": { "application_number": [ "ANDA204093", "ANDA204604", "ANDA090984", "ANDA201515", "ANDA210431", "ANDA202096", "ANDA202468", "ANDA202843", "ANDA205107", "ANDA202717", "ANDA203438", "ANDA203328", "ANDA203432", "ANDA203582", "ANDA213471", "ANDA200405", "ANDA204290", "ANDA208621", "ANDA205683", "ANDA209012", "ANDA201581", "ANDA201582", "NDA020830", "NDA021409", "NDA020829" ], "brand_name": [ "MONTELUKAST SODIUM", "SINGULAIR" ], "generic_name": [ "MONTELUKAST SODIUM", "MONTELUKAST" ], "manufacturer_name": [ "Camber Pharmaceuticals, Inc.", "Amneal Pharmaceuticals LLC", "Torrent Pharmaceuticals Limited", "Rising Pharma Holdings, Inc.", "Accord Healthcare Inc.", "Ajanta Pharma USA Inc.", "Aurobindo Pharma Limited", "Macleods Pharmaceuticals Limited", "Lannett Company, Inc.", "Chartwell RX, LLC", "Unichem Pharmaceuticals (USA), Inc.", "Westminster Pharmaceuticals, LLC", "Dr.Reddy's Laboratories Limited", "Organon LLC" ], "product_ndc": [ "31722-727", "31722-728", "65162-732", "13668-079", "13668-080", "13668-081", "13668-531", "57237-212", "57237-213", "57237-255", "31722-726", "65162-771", "65162-772", "16729-119", "27241-015", "27241-016", "27241-017", "27241-018", "65862-567", "65862-568", "65862-574", "33342-110", "33342-111", "59651-329", "62175-204", "62175-205", "62135-781", "62135-782", "29300-220", "29300-221", "29300-222", "69367-287", "16571-100", "55111-593", "55111-725", "55111-594", "78206-170", "78206-171", "78206-173", "78206-172" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MONTELUKAST", "MONTELUKAST SODIUM" ], "rxcui": [ "242438", "311759", "200224", "351246", "153892", "153893", "261367", "404406" ], "spl_id": [ "c503ea71-c663-3cfc-e053-2a95a90a9aaa", "ce5720a0-a4c1-4532-8112-53201502c0eb", "3ad1ce49-1a92-4068-9006-04fe04136a62", "b17c2611-11a0-4762-a99d-3552a93b79cd", "30387eb8-222d-146e-e063-6294a90a12a7", "ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c", "d481e75b-ffed-a218-e053-2995a90a19c5", "c7998daa-0220-4f57-a2b7-a2e468b10471", "035c2d56-5707-4d1e-96b8-7c9c2e848bb6", "a12af8c6-41af-4850-b725-4f8226b35b67", "2fcb1880-c88e-4c82-829e-6177a07814c4", "a4215d29-ef78-4b4d-9683-9dc4d35e345a", "462a5e7c-f204-7e57-e063-6294a90a896e", "57f07f65-1a14-4423-9da8-975664ca0684", "1026f850-9f36-346f-e063-6394a90a2373", "c3c93ca9-9367-4426-b310-5507dd588b08", "8bc013e8-5324-099d-e603-d78012b126bd", "57a12189-3bb3-4a5d-b5fe-fc57db87c134" ], "spl_set_id": [ "23964723-2df8-4d0a-a53d-8538469672f1", "ccbbf0d6-efd9-4fdd-9e7b-e3d293062609", "da038cf6-cfad-43a4-ab8e-d81d028d6087", "49669ac0-0bb5-4576-bed5-9e85e0d76a44", "97a682c2-7e00-4d07-a5ac-4436c977f842", "bcd49102-a21c-4628-a322-6cdd934e7f09", "6eea668f-a2fa-447f-b2d5-4c754d13d9fa", "67070e4e-f755-46b3-b900-fcc1993a0546", "ba42b0a9-83f1-4283-a853-f99cdd0761b9", "ce512844-5220-4661-809f-56d088699c9c", "9a3bfc59-0ca6-4433-abf5-41659bfe0a8f", "c43d1edb-c162-4317-9a89-d84e4eff5512", "5cb4298c-10b1-4d6f-95ad-4aad72daf249", "9e375c07-70db-458c-9336-22a7037b0a5f", "c0daaaf3-6717-4a01-e053-2995a90af2d8", "75723c5a-3c9e-468a-bc65-57b4c755889a", "3d4451a9-d73d-b9de-68ec-853bfeff6e4b", "482dcc92-b47f-4ea6-854a-f5ac2aea7842" ], "package_ndc": [ "31722-727-30", "31722-727-01", "31722-727-10", "31722-727-31", "31722-727-32", "31722-727-90", "31722-728-30", "31722-728-01", "31722-728-10", "31722-728-31", "31722-728-32", "31722-728-90", "65162-732-03", "65162-732-09", "65162-732-11", "13668-079-30", "13668-079-05", "13668-079-90", "13668-080-05", "13668-080-90", "13668-080-30", "13668-081-74", "13668-081-32", "13668-081-05", "13668-081-90", "13668-081-30", "13668-531-11", "13668-531-94", "57237-212-30", "57237-212-90", "57237-213-30", "57237-213-90", "57237-255-30", "57237-255-90", "31722-726-30", "31722-726-90", "31722-726-01", "31722-726-10", "31722-726-31", "31722-726-32", "65162-771-03", "65162-772-03", "16729-119-10", "16729-119-15", "16729-119-17", "27241-015-31", "27241-016-03", "27241-016-09", "27241-017-03", "27241-017-09", "27241-018-03", "27241-018-09", "27241-018-90", "65862-567-30", "65862-567-90", "65862-567-05", "65862-568-30", "65862-568-90", "65862-568-05", "65862-574-30", "65862-574-90", "65862-574-19", "65862-574-10", "33342-110-07", "33342-110-10", "33342-110-15", "33342-110-12", "33342-110-39", "33342-110-44", "33342-111-07", "33342-111-10", "33342-111-15", "33342-111-12", "33342-111-39", "33342-111-44", "59651-329-05", "59651-329-30", "62175-204-32", "62175-204-46", "62175-204-43", "62175-205-32", "62175-205-46", "62175-205-43", "62135-781-30", "62135-782-30", "29300-220-13", "29300-220-19", "29300-220-01", "29300-220-10", "29300-221-13", "29300-221-19", "29300-221-10", "29300-222-13", "29300-222-19", "29300-222-10", "69367-287-09", "69367-287-05", "16571-100-09", "16571-100-10", "55111-725-30", "55111-725-90", "55111-725-01", "55111-725-10", "55111-725-79", "55111-725-78", "55111-593-30", "55111-593-90", "55111-593-05", "55111-593-79", "55111-593-78", "55111-594-30", "55111-594-90", "55111-594-05", "55111-594-79", "55111-594-78", "78206-171-01", "78206-170-01", "78206-173-01", "78206-172-01", "78206-172-02" ], "nui": [ "N0000175777", "N0000000083" ], "pharm_class_epc": [ "Leukotriene Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Leukotriene Receptor Antagonists [MoA]" ], "unii": [ "MHM278SD3E", "U1O3J18SFL" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE.", "drugdosagetext": "FOR A MONTH", "drugadministrationroute": "065", "drugstartdateformat": "610", "drugstartdate": "201310", "drugenddateformat": "610", "drugenddate": "201311", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "CYCLOSPORINE" }, "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "1", "medicinalproduct": "RANITIDINE", "drugstructuredosagenumb": "150", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "150 MG, BID", "drugadministrationroute": "065", "drugindication": "CHRONIC SPONTANEOUS URTICARIA", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "RANITIDINE\\RANITIDINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA078192", "ANDA075294", "ANDA209859", "ANDA077824", "ANDA210243", "ANDA211289", "ANDA077405" ], "brand_name": [ "RANITIDINE", "RANITIDINE COOL MINT" ], "generic_name": [ "RANITIDINE" ], "manufacturer_name": [ "Dr. Reddy's Laboratories Limited", "Ajanta Pharma USA Inc.", "Amneal Pharmaceuticals of New York LLC", "Granules India Ltd", "Rising Pharma Holdings, Inc.", "Pharmaceutical Associates, Inc." ], "product_ndc": [ "55111-404", "55111-131", "27241-109", "27241-110", "53746-253", "53746-254", "62207-773", "62207-774", "64980-636", "64980-637", "0121-0727", "0121-4727" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RANITIDINE HYDROCHLORIDE", "RANITIDINE" ], "rxcui": [ "198191", "312773", "198190", "198192", "198193", "705610" ], "spl_id": [ "c47f1d10-c4d9-5df4-84e8-55956b47568b", "210e3c0b-be93-aa50-550d-e383e7d5f19e", "d7fd99da-f17a-4124-9014-70bbe43d78f6", "906b462d-e4a3-4f23-8d1b-2605476c40e8", "44f2b222-ae43-eef4-e063-6394a90ab2b6", "b4d3aa30-82b1-45e5-89bb-829c5ccf7ffe", "d56a22ea-5dab-e98a-e053-2a95a90a34c4" ], "spl_set_id": [ "00df8a42-296f-80dd-98af-ee8b30eb38cc", "12a38e29-130c-6d41-1753-acccb0b41efe", "fb67e8c7-b817-4253-a1a1-5ecdcee694cf", "b38a3332-5c54-453f-aeb7-070f830955c2", "aab81d9f-397d-49fb-8083-77a1872cc71f", "0fba6615-37c2-4ba6-b6e5-09599369a5bc", "d0da9dd6-c691-4614-99c7-531b0bf34837" ], "package_ndc": [ "55111-404-34", "55111-404-32", "55111-404-36", "55111-404-50", "55111-404-61", "55111-404-55", "55111-404-62", "55111-404-90", "55111-404-02", "55111-404-65", "55111-404-17", "55111-404-24", "55111-404-38", "55111-404-40", "55111-131-30", "55111-131-60", "55111-131-80", "55111-131-90", "55111-131-04", "55111-131-37", "55111-131-79", "55111-131-14", "55111-131-81", "55111-131-45", "27241-109-06", "27241-109-50", "27241-110-03", "27241-110-10", "53746-253-60", "53746-253-01", "53746-253-18", "53746-253-05", "53746-253-10", "53746-254-30", "53746-254-01", "53746-254-02", "62207-774-58", "62207-774-41", "62207-774-47", "62207-774-36", "62207-773-58", "62207-773-41", "62207-773-47", "62207-773-32", "62207-773-36", "64980-636-03", "64980-637-03", "0121-0727-16", "0121-4727-10" ], "unii": [ "BK76465IHM", "884KT10YB7" ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "HYDROXYZINE", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "50 MG, QD", "drugadministrationroute": "065", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "HYDROXYZINE\\HYDROXYZINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA040808" ], "brand_name": [ "HYDROXYZINE HYDROCHLORIDE" ], "generic_name": [ "HYDROXYZINE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC" ], "product_ndc": [ "65162-575", "65162-671", "65162-577" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "HYDROXYZINE DIHYDROCHLORIDE" ], "rxcui": [ "995218", "995258", "995281" ], "spl_id": [ "6c929cf4-2a16-4956-b410-8e44db920604" ], "spl_set_id": [ "89901966-724b-4773-98b8-ea663ceabd53" ], "package_ndc": [ "65162-575-10", "65162-575-50", "65162-575-11", "65162-671-10", "65162-671-50", "65162-671-11", "65162-577-10", "65162-577-50", "65162-577-11" ], "unii": [ "76755771U3" ] } }, { "drugcharacterization": "1", "medicinalproduct": "MONTELUKAST SODIUM.", "drugauthorizationnumb": "020829", "drugdosagetext": "ANOTHER DOSAGE", "drugdosageform": "TABLET", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "MONTELUKAST SODIUM" }, "openfda": { "application_number": [ "ANDA204093", "ANDA204604", "ANDA090984", "ANDA201515", "ANDA210431", "ANDA202096", "ANDA202468", "ANDA202843", "ANDA205107", "ANDA202717", "ANDA203438", "ANDA203328", "ANDA203432", "ANDA203582", "ANDA213471", "ANDA200405", "ANDA204290", "ANDA208621", "ANDA205683", "ANDA209012", "ANDA201581", "ANDA201582", "NDA020830", "NDA021409", "NDA020829" ], "brand_name": [ "MONTELUKAST SODIUM", "SINGULAIR" ], "generic_name": [ "MONTELUKAST SODIUM", "MONTELUKAST" ], "manufacturer_name": [ "Camber Pharmaceuticals, Inc.", "Amneal Pharmaceuticals LLC", "Torrent Pharmaceuticals Limited", "Rising Pharma Holdings, Inc.", "Accord Healthcare Inc.", "Ajanta Pharma USA Inc.", "Aurobindo Pharma Limited", "Macleods Pharmaceuticals Limited", "Lannett Company, Inc.", "Chartwell RX, LLC", "Unichem Pharmaceuticals (USA), Inc.", "Westminster Pharmaceuticals, LLC", "Dr.Reddy's Laboratories Limited", "Organon LLC" ], "product_ndc": [ "31722-727", "31722-728", "65162-732", "13668-079", "13668-080", "13668-081", "13668-531", "57237-212", "57237-213", "57237-255", "31722-726", "65162-771", "65162-772", "16729-119", "27241-015", "27241-016", "27241-017", "27241-018", "65862-567", "65862-568", "65862-574", "33342-110", "33342-111", "59651-329", "62175-204", "62175-205", "62135-781", "62135-782", "29300-220", "29300-221", "29300-222", "69367-287", "16571-100", "55111-593", "55111-725", "55111-594", "78206-170", "78206-171", "78206-173", "78206-172" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MONTELUKAST", "MONTELUKAST SODIUM" ], "rxcui": [ "242438", "311759", "200224", "351246", "153892", "153893", "261367", "404406" ], "spl_id": [ "c503ea71-c663-3cfc-e053-2a95a90a9aaa", "ce5720a0-a4c1-4532-8112-53201502c0eb", "3ad1ce49-1a92-4068-9006-04fe04136a62", "b17c2611-11a0-4762-a99d-3552a93b79cd", "30387eb8-222d-146e-e063-6294a90a12a7", "ed8a8093-3cde-44cf-9bdc-c8bc5fb9909c", "d481e75b-ffed-a218-e053-2995a90a19c5", "c7998daa-0220-4f57-a2b7-a2e468b10471", "035c2d56-5707-4d1e-96b8-7c9c2e848bb6", "a12af8c6-41af-4850-b725-4f8226b35b67", "2fcb1880-c88e-4c82-829e-6177a07814c4", "a4215d29-ef78-4b4d-9683-9dc4d35e345a", "462a5e7c-f204-7e57-e063-6294a90a896e", "57f07f65-1a14-4423-9da8-975664ca0684", "1026f850-9f36-346f-e063-6394a90a2373", "c3c93ca9-9367-4426-b310-5507dd588b08", "8bc013e8-5324-099d-e603-d78012b126bd", "57a12189-3bb3-4a5d-b5fe-fc57db87c134" ], "spl_set_id": [ "23964723-2df8-4d0a-a53d-8538469672f1", "ccbbf0d6-efd9-4fdd-9e7b-e3d293062609", "da038cf6-cfad-43a4-ab8e-d81d028d6087", "49669ac0-0bb5-4576-bed5-9e85e0d76a44", "97a682c2-7e00-4d07-a5ac-4436c977f842", "bcd49102-a21c-4628-a322-6cdd934e7f09", "6eea668f-a2fa-447f-b2d5-4c754d13d9fa", "67070e4e-f755-46b3-b900-fcc1993a0546", "ba42b0a9-83f1-4283-a853-f99cdd0761b9", "ce512844-5220-4661-809f-56d088699c9c", "9a3bfc59-0ca6-4433-abf5-41659bfe0a8f", "c43d1edb-c162-4317-9a89-d84e4eff5512", "5cb4298c-10b1-4d6f-95ad-4aad72daf249", "9e375c07-70db-458c-9336-22a7037b0a5f", "c0daaaf3-6717-4a01-e053-2995a90af2d8", "75723c5a-3c9e-468a-bc65-57b4c755889a", "3d4451a9-d73d-b9de-68ec-853bfeff6e4b", "482dcc92-b47f-4ea6-854a-f5ac2aea7842" ], "package_ndc": [ "31722-727-30", "31722-727-01", "31722-727-10", "31722-727-31", "31722-727-32", "31722-727-90", "31722-728-30", "31722-728-01", "31722-728-10", "31722-728-31", "31722-728-32", "31722-728-90", "65162-732-03", "65162-732-09", "65162-732-11", "13668-079-30", "13668-079-05", "13668-079-90", "13668-080-05", "13668-080-90", "13668-080-30", "13668-081-74", "13668-081-32", "13668-081-05", "13668-081-90", "13668-081-30", "13668-531-11", "13668-531-94", "57237-212-30", "57237-212-90", "57237-213-30", "57237-213-90", "57237-255-30", "57237-255-90", "31722-726-30", "31722-726-90", "31722-726-01", "31722-726-10", "31722-726-31", "31722-726-32", "65162-771-03", "65162-772-03", "16729-119-10", "16729-119-15", "16729-119-17", "27241-015-31", "27241-016-03", "27241-016-09", "27241-017-03", "27241-017-09", "27241-018-03", "27241-018-09", "27241-018-90", "65862-567-30", "65862-567-90", "65862-567-05", "65862-568-30", "65862-568-90", "65862-568-05", "65862-574-30", "65862-574-90", "65862-574-19", "65862-574-10", "33342-110-07", "33342-110-10", "33342-110-15", "33342-110-12", "33342-110-39", "33342-110-44", "33342-111-07", "33342-111-10", "33342-111-15", "33342-111-12", "33342-111-39", "33342-111-44", "59651-329-05", "59651-329-30", "62175-204-32", "62175-204-46", "62175-204-43", "62175-205-32", "62175-205-46", "62175-205-43", "62135-781-30", "62135-782-30", "29300-220-13", "29300-220-19", "29300-220-01", "29300-220-10", "29300-221-13", "29300-221-19", "29300-221-10", "29300-222-13", "29300-222-19", "29300-222-10", "69367-287-09", "69367-287-05", "16571-100-09", "16571-100-10", "55111-725-30", "55111-725-90", "55111-725-01", "55111-725-10", "55111-725-79", "55111-725-78", "55111-593-30", "55111-593-90", "55111-593-05", "55111-593-79", "55111-593-78", "55111-594-30", "55111-594-90", "55111-594-05", "55111-594-79", "55111-594-78", "78206-171-01", "78206-170-01", "78206-173-01", "78206-172-01", "78206-172-02" ], "nui": [ "N0000175777", "N0000000083" ], "pharm_class_epc": [ "Leukotriene Receptor Antagonist [EPC]" ], "pharm_class_moa": [ "Leukotriene Receptor Antagonists [MoA]" ], "unii": [ "MHM278SD3E", "U1O3J18SFL" ] } }, { "drugcharacterization": "1", "medicinalproduct": "FEXOFENADINE HYDROCHLORIDE.", "drugdosagetext": "360 MG DIALY", "drugadministrationroute": "065", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "FEXOFENADINE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA208123", "ANDA212971", "ANDA210137", "ANDA211075", "ANDA091567", "ANDA076502", "ANDA204097", "NDA021909", "ANDA204507", "NDA201373", "NDA020872", "ANDA213466", "ANDA202039", "ANDA203330" ], "brand_name": [ "CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY", "ALLERGY RELIEF", "FEXOFENADINE HYDROCHLORIDE", "BASIC CARE ALLERGY", "24HR ALLERGY RELIEF", "CHILDRENS ALLEGRA ALLERGY", "BERKLEY JENSEN ALLERGY RELIEF", "ALLEGRA HIVES 24HR", "GOOD SENSE ALLER EASE", "HIVES RELIEF", "CVS FEXOFENADINE HYDROCHLORIDE", "CAREONE ALLERGY RELIEF", "VALUMEDS NON-DROWSY ALLERGY RELIEF FEXOFENADINE HCL", "KIRKLAND SIGNATURE ALLER FEX", "VALUMEDS 24-HOUR ALLERGY RELIEF", "NUVICARE HIVES RELIEF", "TOPCARE ALLERGY RELIEF", "CRCLE FEXOFENADINE HYDROCHLORIDE", "ALLEGRA ALLERGY", "GENCARE-ALLERGY RELIEF", "CABINET ALLERGY RELIEF FEXOFENADINE", "UP AND UP NON DROWSY ALLERGY RELIEF", "EXCHANGE SELECT ALLER EASE", "GOODMEDS NON DROWSY ALLERGY RELIEF", "CHILDRENS ALLERGY", "LEADER 24HR ALLERGY RELIEF", "ALLEGRA ALLERGY, TRAVEL BASIX", "DG HEALTH ALLER EASE", "GENCARE HIVES RELIEF", "12HR ALLERGY RELIEF" ], "generic_name": [ "FEXOFENADINE HYDROCHLORIDE", "FEXOFENADINE HYDROCHLORIDE ORAL", "FEXOFENADINE HCL" ], "manufacturer_name": [ "Wal-Mart Stores Inc", "Publix Super Markets Inc", "Pioneer Life Sciences, LLC", "AMERIFOODS TRADING COMPANY", "CVS PHARMACY", "HEB", "Amazon.com Services LLC", "AMERISOURCE BERGEN", "Dr. Reddy's Laboratories Limited", "CARDINAL HEALTH 110, LLC. DBA LEADER", "Chain Drug Marketing Association, Inc.", "Chattem, Inc.", "Kroger Company", "NUVICARE LLC", "CHAIN DRUG CONSORTIUM", "YYBA CORP", "BJWC", "L. Perrigo Company", "Aurohealth LLC", "Grocery Outlet, Inc.", "Walgreen Company", "RETAIL BUSINESS SERVICES , LLC.", "CVS PHARMACY, INC", "CVS Pharmacy", "YYBA Corp", "United Natural Foods, Inc. dba UNFI", "Magno-Humphries, Inc.", "AAA PHARMACEUTICAL, INC.", "Retail Business Services, LLC", "SPIRIT PHARMACEUTICALS LLC", "Padagis Israel Pharmaceuticals Ltd", "Cabinet Health P.B.C.", "Costco Wholesale Company", "MARC GLASSMAN, INC.", "TOPCO ASSOCIATES LLC", "Meijer, Inc.", "Topco Associates LLC", "DISCOUNT DRUG MART", "Innovus Pharmaceuticals, Inc.", "OHM LABORATORIES INC.", "AMZ789 LLC", "Major Pharmaceuticals", "Target Corporation", "HARRIS TEETER", "Granules India Limited", "7-eleven", "Army & Air Force Exchange Service", "HYVEE INC", "Sun Pharmaceutical Industries, Inc.", "FSA STORE INC.", "H2-Pharma, LLC", "Cardinal Health 110, LLC. dba Leader", "Safrel Pharmaceuticals, LLC.", "BluePoint Laboratories", "Lil' Drug Store Products, Inc", "Walgreens Company", "CHAIN DRUG MARKETING ASSOCIATION INC", "Dolgencorp Inc", "Granules India Ltd", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "HyVee Inc", "CARDINAL HEALTH" ], "product_ndc": [ "79903-306", "56062-847", "72090-010", "61504-192", "69842-492", "37808-392", "72288-722", "46122-779", "55111-782", "55111-783", "55111-784", "70000-0726", "83324-009", "41167-4232", "30142-856", "84324-040", "68016-887", "84324-008", "73581-011", "41167-4244", "41167-4246", "68391-847", "41167-4126", "0113-0847", "58602-426", "85828-192", "0363-4071", "72476-192", "51316-800", "37808-391", "51316-183", "73581-027", "41163-292", "54257-170", "69842-914", "57344-292", "72476-847", "68210-4090", "45802-847", "82725-1202", "63981-847", "72288-847", "68998-292", "36800-653", "82725-1002", "84324-031", "73581-103", "79481-0847", "36800-691", "53943-392", "57483-230", "57483-240", "51660-998", "73629-008", "41167-4120", "41167-4131", "41167-4121", "41167-4124", "0363-7011", "72090-068", "41167-4122", "84324-045", "82725-3002", "0904-7050", "82442-300", "72036-191", "62207-623", "10202-229", "55301-847", "82725-4202", "42507-192", "51672-2141", "81522-192", "61269-527", "62207-889", "62207-891", "70000-0725", "71309-091", "0363-1847", "68001-439", "68001-440", "68210-2210", "66715-6507", "66715-9707", "0363-2141", "73581-025", "73581-026", "72288-537", "63868-334", "72036-292", "55910-609", "62207-765", "62207-766", "83324-095", "72090-058", "42507-847", "70000-0586" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE" ], "rxcui": [ "997491", "997420", "997501", "997488", "997482", "997484", "997493", "997422", "997502" ], "spl_id": [ "2905c49e-1ab8-3d84-e063-6394a90ac1a4", "bdd76b8f-ab6c-477a-81d1-74256944dd62", "2aa6e396-3103-48d1-bcd7-43b140549307", "092d5198-d6e3-10b7-e063-6294a90ac4d8", "561af7a3-2594-1384-e063-6394a90abb59", "e051ea08-74a0-5897-e053-2a95a90a7efd", "c6e01971-d70a-4d6a-be69-9e1f03d99a54", "76ea7e25-e968-4c78-9eca-ac960ad55985", "c5d24cd6-8212-e647-78b1-27906e6f62bd", "f41aacbe-2d4d-484a-8f88-a8ca080d6c8a", "fc49fe88-56a3-6dcf-e053-6294a90adb84", "44cdb5d9-8c36-41e1-af5a-35983ab0cc52", "55fb81c8-4279-4d90-b663-f6d14c40f599", "b395f46e-4c20-44f7-8d87-499b016cd1d2", "24340f37-44e1-b094-e063-6294a90a7886", "3fd79863-077e-4c9c-958d-91f709c6d033", "5788217f-a09d-407f-a749-d7fed955ea1b", "4d4f7664-67db-7fab-e063-6394a90a2852", "606e69ed-df38-4228-942d-a2625c26a803", "fa75f437-073a-439d-8282-d6a60fe2cbcf", "942f38c8-c652-49b9-b98f-e8edcf66db1c", "5cd21fe5-5a25-4beb-a480-924996e65ee1", "a75ff860-f7e0-4e19-846b-fbe33e0e1dfd", "5256db44-d05b-1661-e063-6394a90af899", "afdade59-1f22-4ba8-beb3-46a0364a4c95", "cf22d677-c125-1721-e053-2a95a90a1c3e", "e6bae65e-9f41-4976-bebd-c14e86da14cb", "e051ce8b-3163-69b9-e053-2a95a90ab739", "41c5bbff-5362-e7e2-e063-6294a90a5fc2", "53fea010-2c55-9819-e063-6394a90a103e", "fbe573d6-e133-8c02-e053-6294a90a3f1f", "0e12b912-5db1-bb3e-e063-6394a90aa446", "de7c79d2-f103-48b3-9d1d-194e6132ef3b", "1e038697-ba15-dca2-e063-6394a90a0bee", "bc16dd0f-6137-411f-a853-89e616283339", "292e4a33-9cc0-d8a2-e063-6394a90a50b3", "e43b561e-d68a-47af-be93-d710f0f77505", "47babe95-180f-19ec-e063-6394a90ae802", "9d7724ba-f3b3-4ac8-9558-42753f6fe838", "dfe50cbe-dfde-499d-9366-3b9e66421cad", "ea60b4c2-b62a-61cf-e053-2995a90a6f56", "08f3ce32-81a9-f9d2-e063-6394a90ab17d", "41db4a75-4edb-8ee4-e063-6294a90aa7bd", "8a758eab-e855-4cac-85e1-c7df0aa2150d", "4482573c-af39-436a-e063-6294a90ac4ea", "dfa09879-a814-421c-8ea8-09193bc1c09d", "9cb64047-5e7e-4fbc-913a-e3831cf557f4", "d202451e-1f9e-8680-e053-2995a90ad35d", "f672cd27-4516-4e54-8c4f-8bbdc22dfabd", "5110b287-1464-50d9-e063-6394a90abe0f", "47d41023-701b-09eb-e063-6294a90a7298", "fb8ea8ca-b8a9-46af-9c21-d2df1100e9ff", "0d3aa246-3316-4686-b69c-330ef3b21fcd", "67a36c39-7307-4c2c-b656-2d6ef5014627", "9bcf6745-5989-41ba-beef-1108fcecc020", "fdf1d6d1-054f-42e6-b4fc-b72f70bbe235", "41c5ac14-1e89-8cd8-e063-6394a90a7a43", "33be2075-3e84-4738-af91-6f2f971cc0b4", "bd226cd0-be8c-4db9-878f-5c84f6016dcc", "ee298d18-1da3-f7be-e053-2a95a90afcc0", "1d43d4d6-9021-eac7-e063-6294a90ad21a", "d5914c05-e8db-4c79-82d0-a279d1304118", "90602f30-0627-446f-bd62-4dc80ead187d", "4fe9539f-ac36-4690-e063-6394a90a3274", "48494f6f-18ce-2479-e063-6394a90a09a9", "4e3fea44-8570-1aa3-e063-6294a90aa7f5", "2fc2551f-18bf-99de-e063-6394a90a6523", "67f3284f-3041-44b7-9daf-ec9e87fd6701", "5447e2c4-49cb-5f8d-e063-6294a90a2457", "c82dd837-c3bd-4762-9b4c-d7ce25393a9b", "16dc8e4f-54e3-4edd-87f8-30d072fabad1", "f7f18cee-5649-13c4-e053-6294a90ad4a8", "750c2665-b051-4585-94d7-70a9671796d2", "56816fcb-3ed9-be09-e063-6294a90a18ae", "292e71ee-f44d-0821-e063-6394a90a4187", "5076f5eb-2ebc-5623-e063-6394a90a3fff", "374f99cb-1562-7532-e063-6394a90a95b4", "53e87c12-47d6-9a2f-e063-6294a90aaa6f", "eee34268-6f37-4eac-ac56-eab0e631f15d", "24357d51-61dd-61b5-e063-6294a90a12c3", "42da3220-d6d7-3f7f-e063-6394a90a95ef", "2433748b-8030-b5d9-e063-6394a90a2e28", "6e5b57ee-79e1-4e8f-84d1-ae0df5229e53", "5447dc7c-b363-56c6-e063-6294a90a729d", "1fd10e81-a917-79e0-e063-6394a90ac51c", "bc8f944b-f445-42b6-b479-3d50623cd839", "2f62c704-3d00-4d7c-98f7-091b3acf966b", "63814542-4e9d-4891-bcfc-e0182eb49651", "ccc271cc-6aa2-f753-e053-2995a90a1161" ], "spl_set_id": [ "2432f862-6d7e-666d-e063-6294a90acf74", "76014f1e-fa48-4d64-9ce6-1eaebd0419fc", "d7fe71e4-aada-40f5-86a8-bf0d7eb9b851", "f6dc0893-b81b-4f96-e053-6294a90a856f", "c77ee2bb-dc95-d8c9-e053-2995a90a9602", "d8b852a1-7315-4047-aed6-cd40c7a39e70", "27202f58-a488-42cc-b63f-be892c5b4de2", "2a578643-adc1-44ca-83f2-9d48527bd3a4", "864e3052-5787-bf11-9d17-11274ca2304f", "b72c4802-1bcb-48bc-b4b9-72167ea4643e", "fabb8c0d-b4da-ab73-e053-6394a90ab8b5", "06115cea-5a44-409d-85ed-bb71743491c1", "2718d6a2-0678-4703-9a5a-26b27d753942", "895de6e9-c5b6-42fe-b450-f5d8331ce2e3", "8eee26c2-af58-469c-b855-c3bfc8bd7e2d", "d3b6f04c-60d6-4ac3-9fb2-19eeb80f00a5", "ec55732c-a3db-4445-a06d-0f98b21ed134", "2dd5e6b0-2445-4419-b0e6-c62aadee6ea4", "e2bd23c7-dfba-463a-adbe-2183970da740", "2c6d9f8c-bc74-4e1a-bd51-50f84ab63a15", "490b4c5f-448b-4563-928b-837117b59b9f", "e533a008-b437-401e-ab50-bda31e6662d3", "e8e35d7a-a86b-4d37-979b-f454978f070b", "441ce66e-515a-d380-e063-6394a90aec7d", "a79edb5d-02d9-4c53-9509-c69fd6115686", "c1be67ea-9973-49e2-e053-2995a90a423c", "7bc13851-291a-4582-8261-13c5022fbdd1", "7cb25829-3aee-4a82-869d-ab4259626584", "3d6c7b10-ed05-bbde-e063-6294a90ae92f", "53fe8ef5-ab65-f23e-e063-6394a90a30f0", "ccff9b0f-8ae5-057f-e053-2a95a90ac2b1", "1f8a2f98-7eba-48df-9589-58587d67ae0e", "7cac266a-4de8-4af1-8324-b01823a3989a", "c547c163-2a19-10d8-e053-2a95a90ac817", "ce398856-e9a6-401d-8636-bc5771a7e28b", "5307b7ef-0c22-4aae-a2f6-033d31032f55", "e43b561e-d68a-47af-be93-d710f0f77505", "f9ccd673-c65f-45c6-9863-26136eb816db", "651d14d1-c5de-4cb9-9484-b05986e641ac", "c2f30390-3d32-4489-9df2-caf848ce040b", "c4f93336-cfd8-e023-e053-2995a90a9df0", "c4f9224c-4c3d-74bd-e053-2995a90a1452", "036f8eaa-7eb9-46f4-b42e-3c8c7e49e450", "a8e11094-ca69-488d-a720-b8129f17f505", "a1e80757-346f-4d88-8da7-55583c3a902b", "deecbf76-be1d-4b27-85c6-17cfb7e7d1a1", "e7658b5f-2d78-4f25-b1a3-e49198ca8f32", "c5106c63-af53-c169-e053-2a95a90afef2", "f7784610-7ca5-4489-b391-f2b3f3f6549b", "1a1afa95-570d-456e-b436-a0fcfaf68517", "1e46343f-d6b6-73ba-e063-6394a90acd94", "81c1dcbb-28b3-4ad5-9f3d-9ccc16ddd173", "a0738300-7262-4e43-89a6-0d0a60bd14bd", "a8595b29-1ea3-44aa-b131-030f34f408fc", "f061d6b1-89f7-4d5f-ac59-9c73408517c1", "dd0da52b-fc82-4ec9-854c-0d7c52e926fb", "5237c8bd-0b20-4639-a740-f3001c4c2c94", "c34cda59-8a63-48ab-a19d-c06a1878f5da", "d251b0a6-bc31-45b6-aaa8-f50f8336d959", "e5429440-fc89-4200-e053-2995a90afc7d", "1d46555d-827b-b154-e063-6294a90ad3d5", "d5914c05-e8db-4c79-82d0-a279d1304118", "6a9597a1-f024-4497-bc52-3d5482758822", "ae1322f5-85d6-4243-b384-2ce7f8c8d692", "3e61ffb1-1c52-1ad5-e063-6294a90a6e3f", "b21bb11d-bf74-4ee7-9cfe-5b599a3c4775", "276e9767-93c0-5932-e063-6394a90ab2d9", "84988f6d-85b1-45dd-89be-0333acc6b180", "e0537b71-fdee-4122-9c09-868ce7352080", "e509800a-e33d-4d22-a6b4-97b7c73b1486", "bb47b839-3f49-4818-a62c-b6d2b09b15dc", "d6120f56-ab28-2696-e053-2995a90adf47", "99f03481-d169-4aac-8370-20011ff530ea", "a86aebd0-937e-5d73-e053-2995a90a656a", "ae0f16f6-d07a-47e1-adb8-07803c6cfb13", "b82d993a-16ff-4037-a182-7010de8e1cdd", "374f9271-b65b-69a9-e063-6394a90af36a", "53e87aa4-9db3-9ded-e063-6294a90a319e", "c29d281f-89dd-4c69-8572-6599400c660f", "c5d58d74-da08-eb72-e053-2a95a90adc27", "9ed710e1-47f4-4d04-a509-12c8c97c192c", "c4f9e849-f286-4167-e053-2a95a90a38f9", "f9239aa4-b3d0-4817-b639-61ad1383f707", "3151bc6d-b40b-4200-a5cf-e57b6791d92a", "5059ffc9-b116-4d11-9678-56c696f4e3db", "ad0944f1-c5af-42cf-96c9-3140cbda66d8", "0a4f4178-bea5-4995-99dc-96980cccdc8a", "54635220-dd44-4baa-b929-9e52deb4c368", "ea5d0e55-2191-4094-b082-24b317f95752" ], "package_ndc": [ "79903-306-04", "56062-847-22", "56062-847-39", "56062-847-95", "72090-010-01", "61504-192-03", "69842-492-02", "69842-492-03", "37808-392-03", "37808-392-17", "37808-392-18", "37808-392-19", "37808-392-20", "72288-722-01", "46122-779-61", "46122-779-66", "46122-779-58", "55111-782-30", "55111-782-90", "55111-782-01", "55111-782-79", "55111-782-78", "55111-783-30", "55111-783-60", "55111-783-90", "55111-783-01", "55111-783-79", "55111-783-78", "55111-783-28", "55111-783-24", "55111-784-30", "55111-784-43", "55111-784-40", "55111-784-45", "55111-784-59", "55111-784-75", "55111-784-90", "55111-784-01", "55111-784-15", "55111-784-18", "55111-784-05", "55111-784-23", "55111-784-07", "55111-784-35", "55111-784-29", "55111-784-79", "55111-784-78", "55111-784-28", "70000-0726-1", "83324-009-12", "83324-009-24", "41167-4232-1", "41167-4232-6", "30142-856-24", "30142-856-62", "84324-040-01", "68016-887-15", "68016-887-30", "68016-887-45", "72090-010-99", "84324-008-02", "73581-011-20", "73581-011-80", "73581-011-40", "73581-011-10", "41167-4244-4", "41167-4244-1", "41167-4244-7", "41167-4246-4", "41167-4246-2", "68391-847-47", "68391-847-48", "41167-4126-8", "41167-4126-3", "41167-4126-4", "0113-0847-39", "0113-0847-95", "0113-0847-22", "0113-0847-00", "0113-0847-47", "58602-426-24", "58602-426-20", "85828-192-03", "0363-4071-30", "0363-4071-39", "72476-192-04", "72476-192-06", "72476-192-09", "51316-800-90", "51316-800-70", "51316-800-45", "51316-800-30", "51316-800-15", "51316-800-08", "37808-391-02", "51316-183-00", "73581-027-04", "73581-027-10", "73581-027-20", "73581-027-01", "41163-292-03", "41163-292-04", "41163-292-08", "54257-170-02", "69842-914-39", "69842-914-95", "69842-914-75", "69842-914-22", "69842-914-01", "69842-914-49", "69842-914-00", "69842-914-47", "57344-292-03", "57344-292-04", "57344-292-06", "57344-292-02", "57344-292-17", "72476-847-22", "72476-847-39", "72476-847-95", "68210-4090-1", "45802-847-78", "82725-1202-1", "82725-1202-2", "63981-847-48", "72288-847-39", "72288-847-47", "68998-292-04", "36800-653-03", "36800-653-16", "36800-653-14", "36800-653-06", "36800-653-07", "36800-653-11", "82725-1002-1", "82725-1002-2", "82725-1002-3", "84324-031-01", "73581-103-10", "73581-103-20", "73581-103-60", "73581-103-01", "79481-0847-1", "79481-0847-0", "79481-0847-2", "79481-0847-4", "79481-0847-3", "36800-691-13", "36800-691-39", "36800-691-22", "36800-691-49", "36800-691-95", "36800-691-75", "53943-392-04", "53943-392-06", "57483-230-01", "57483-240-02", "51660-998-30", "51660-998-55", "73629-008-03", "41167-4131-2", "41167-4131-4", "41167-4131-6", "41167-4120-1", "41167-4120-0", "41167-4120-2", "41167-4120-3", "41167-4120-4", "41167-4120-5", "41167-4120-6", "41167-4121-2", "41167-4121-3", "41167-4121-6", "41167-4121-7", "41167-4121-4", "41167-4121-5", "41167-4121-0", "41167-4121-1", "41167-4124-7", "41167-4124-0", "41167-4124-5", "41167-4124-3", "41167-4124-8", "0363-7011-39", "72090-068-01", "41167-4122-5", "41167-4122-6", "41167-4122-7", "41167-4122-9", "41167-4122-2", "41167-4122-0", "84324-045-01", "82725-3002-3", "0904-7050-40", "0904-7050-60", "82442-300-72", "72036-191-03", "62207-623-71", "62207-623-41", "62207-623-57", "62207-623-45", "10202-229-66", "55301-847-39", "82725-4202-1", "42507-192-03", "42507-192-07", "42507-192-09", "51672-2141-8", "51672-2141-1", "81522-192-09", "61269-527-94", "61269-527-98", "62207-889-51", "62207-889-49", "62207-889-60", "62207-891-51", "62207-891-49", "62207-891-58", "70000-0725-4", "70000-0725-1", "70000-0725-2", "70000-0725-3", "84324-008-01", "71309-091-01", "0363-1847-39", "0363-1847-75", "0363-1847-95", "0363-1847-49", "68001-439-00", "68001-440-00", "68001-440-04", "68210-2210-1", "66715-9707-1", "66715-9707-2", "66715-9707-8", "66715-6507-2", "0363-2141-08", "0363-2141-01", "73581-025-20", "73581-025-06", "73581-025-01", "73581-026-20", "73581-026-01", "73581-026-10", "72288-537-72", "63868-334-15", "63868-334-30", "63868-334-45", "82725-3002-1", "72036-292-04", "72036-292-03", "72036-292-06", "72036-292-09", "55910-609-46", "62207-765-51", "62207-765-49", "62207-765-60", "62207-765-88", "62207-766-51", "62207-766-49", "62207-766-58", "62207-766-35", "83324-095-15", "83324-095-30", "83324-095-45", "72090-058-01", "72090-010-03", "72090-010-04", "72090-010-02", "42507-847-30", "42507-847-39", "70000-0586-1" ], "unii": [ "2S068B75ZU" ] } } ] } }, { "safetyreportversion": "2", "safetyreportid": "10010846", "primarysourcecountry": "CR", "occurcountry": "CR", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20140314", "fulfillexpeditecriteria": "1", "companynumb": "CR-AMGEN-CRISP2014015672", "duplicate": "1", "reportduplicate": { "duplicatesource": "AMGEN", "duplicatenumb": "CR-AMGEN-CRISP2014015672" }, "primarysource": { "reportercountry": "CR", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "15", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Face oedema", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug effect incomplete", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Oedema", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Skin lesion", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug intolerance", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Otitis media", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ENBREL", "drugauthorizationnumb": "103795", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "50 MG, WEEKLY", "drugdosageform": "POWDER AND SOLVENT FOR SOLUTION FOR INJECTION", "drugadministrationroute": "058", "drugindication": "PSORIASIS", "actiondrug": "1", "openfda": { "application_number": [ "BLA103795" ], "brand_name": [ "ENBREL" ], "generic_name": [ "ETANERCEPT" ], "manufacturer_name": [ "Immunex Corporation" ], "product_ndc": [ "58406-010", "58406-425", "58406-021", "58406-032", "58406-044", "58406-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS" ], "substance_name": [ "ETANERCEPT" ], "rxcui": [ "253014", "261105", "727757", "802652", "809158", "809159", "1653223", "1653225", "2182338", "2182340", "2392140", "2392142" ], "spl_id": [ "de3ee3bd-0047-4365-a4c7-5786521a1649" ], "spl_set_id": [ "a002b40c-097d-47a5-957f-7a7b1807af7f" ], "package_ndc": [ "58406-425-41", "58406-425-34", "58406-424-01", "58406-910-01", "58406-021-01", "58406-021-04", "58406-021-96", "58406-032-01", "58406-032-04", "58406-032-96", "58406-032-90", "58406-010-01", "58406-010-04", "58406-010-96", "58406-044-01", "58406-044-04", "58406-044-96", "58406-044-24", "58406-044-90", "58406-055-01", "58406-055-04", "58406-055-96", "58406-055-90" ], "nui": [ "N0000175610", "N0000175451" ], "pharm_class_epc": [ "Tumor Necrosis Factor Blocker [EPC]" ], "pharm_class_moa": [ "Tumor Necrosis Factor Receptor Blocking Activity [MoA]" ], "unii": [ "OP401G7OJC" ] } }, { "drugcharacterization": "1", "medicinalproduct": "METHOTREXATE", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA210454", "NDA011719", "NDA212479", "ANDA040385", "ANDA040263", "ANDA220225", "ANDA040632", "ANDA201529", "ANDA201749", "ANDA081235", "NDA205776", "NDA208400", "ANDA040266", "ANDA040843", "ANDA207812", "ANDA081099", "ANDA040716", "ANDA089343", "ANDA089342", "ANDA089341", "ANDA089340", "ANDA213343", "ANDA217552", "NDA204824" ], "brand_name": [ "METHOTREXATE", "JYLAMVO", "TREXALL", "RASUVO", "XATMEP", "OTREXUP" ], "generic_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Chartwell RX, LLC", "Hospira, Inc.", "SHORLA ONCOLOGY INC.", "Teva Women's Health LLC", "Fresenius Kabi USA, LLC", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "Alembic Pharmaceuticals Limited", "Eugia US LLC", "Sun Pharmaceutical Industries, Inc.", "Mylan Pharmaceuticals Inc.", "Medexus Pharma Inc.", "Aurobindo Pharma Limited", "Azurity Pharmaceuticals, Inc.", "Teva Parenteral Medicines, Inc.", "Zydus Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc.", "Accord Healthcare, Inc.", "Zydus Lifesciences Limited", "Accord Healthcare Inc.", "Antares Pharma, Inc." ], "product_ndc": [ "62135-772", "61703-350", "61703-408", "81927-204", "51285-366", "51285-367", "51285-368", "51285-369", "63323-123", "62332-711", "62332-712", "0143-9830", "46708-711", "46708-712", "55150-510", "55150-511", "55150-512", "55150-513", "47335-235", "61703-124", "61703-161", "0378-0014", "0143-9367", "59137-505", "59137-510", "59137-515", "59137-520", "59137-525", "59137-530", "59137-535", "59137-540", "59137-550", "59651-182", "52652-2001", "63323-122", "0703-3671", "0703-3675", "0703-3678", "68382-775", "0555-0572", "16729-277", "0143-9516", "0143-9519", "0143-9518", "0143-9517", "70771-1058", "16729-486", "62332-730", "54436-010", "54436-075", "54436-012", "54436-015", "54436-017", "54436-020", "54436-022", "54436-025", "46708-730" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "INTRATHECAL", "INTRA-ARTERIAL" ], "substance_name": [ "METHOTREXATE SODIUM", "METHOTREXATE" ], "rxcui": [ "105585", "1655956", "1946772", "2671456", "2671462", "105586", "283510", "283511", "283671", "284592", "284593", "284594", "284595", "311625", "1655959", "1655960", "1655967", "1655968", "1441416", "1544378", "1544383", "1544385", "1544386", "1544387", "1544388", "1544389", "1544390", "1544394", "1544395", "1544396", "1544397", "1544398", "1544401", "1544402", "1544403", "1544404", "1921592", "1921598", "1441402", "1441407", "1441411", "1441413", "1441418", "1441422", "1441424", "1594757", "1594759", "1747179", "1747181", "1747185", "1747187", "1747192", "1747194" ], "spl_id": [ "462a5023-e5a1-692a-e063-6294a90a7236", "95b8b8da-da4e-4bba-9038-3cf65f3d5c1a", "37b3e76b-ac3d-4f93-adf1-91f52f676b8a", "53bd9776-70ec-46f9-e063-6294a90a7011", "d1e7432e-253d-49f0-ab0a-bb859210ccd6", "880c2caa-1b11-45ce-a54e-a3733da367f0", "91ce9c78-370f-49a1-ae22-428bdddb389f", "49eb25b2-c59c-4374-a216-076767fe1126", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "adc6f7e8-b3a3-476a-9939-0c5cbda63dbd", "524f657e-d138-9c87-e063-6294a90a93ad", "6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910", "01ad6cb9-5879-4c06-801b-0de84eebaae7", "7950579c-084b-472b-a7ce-f342691aff97", "29d04017-dd64-4dea-a064-7b3b0805f423", "9fe03573-fff3-4051-8598-8542eee1273f", "4e3b0925-2cdc-4743-91cf-860d98dd4661", "3d21237a-ef53-4592-bf06-0c739696203d", "e81074cc-12b4-4ac9-a5bb-749188989b2c", "5d9b7269-19d4-4d2c-b252-f3ff759dffa5", "9c7cf5a6-e720-4e83-bb08-f371e9bb9c9e", "2bae3cfe-7aa0-c14c-e063-6294a90a19f4", "3046ff78-3565-46d1-a88b-283e5ff6e7c3", "ae399908-cfb6-44dc-83da-8981f5dabbb8", "52d366f6-f339-ff1a-e063-6294a90a1577", "9dd138d6-6889-400e-a994-9931af68244a", "2d07eb50-d314-a6a0-e063-6394a90ac970", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "spl_set_id": [ "2609da8f-80dc-448e-8eba-35d11488ce7f", "0d63ba29-b692-41b4-87e8-351265c8273f", "0e30eaef-5a09-4104-8a11-c32933eadeab", "96e931f5-51ae-4bdf-a441-bb0dd26d4c0e", "e942f8db-510f-44d6-acb5-b822196f5e8c", "b585f621-f6c9-4735-ab61-bd1b401f3df0", "a63364d5-4dfa-49d7-8a5e-c8959ae1d37a", "b080eb92-fc72-4ce6-a7ab-3f9ce2415526", "e98b2abd-8068-482e-9ce3-1ab262f0838e", "63bb6fbf-dd59-4edc-af8f-d0c397ca1262", "8f1260de-b60c-4f0e-8af6-0e957b0a281b", "bd287e89-32f9-4396-95fa-4b562869f476", "70c09984-2b36-424f-8b27-3fd0cd4e833d", "8593f7fc-eabe-44ae-bb05-b3d7d408e4f7", "d0075461-0e7e-4967-9c9b-d6440e912c0e", "09931d44-a3f8-49dc-a3f2-b527ee4214bf", "aec9984e-34c5-481b-b6bf-9bb5caf1daf8", "ec476b11-0b3c-4139-b1eb-a3daa76bc271", "346ec9ce-dc98-4a55-b55e-d3af11f2d703", "948e0bab-6524-4b87-9853-1799d4415558", "9b34b1d8-d125-41a2-9f6f-3fab67b573bd", "dd035a9f-cd40-4314-b9d8-2294b8a924e2", "3989d30d-56e5-4e8d-9379-c30fecc894f2", "59ea7b32-2b6d-4197-92c3-015936f04ebe", "874c7f43-a3be-4236-89cc-24c44e3c5813", "04a95db9-a124-4b97-bd71-1c37a6b3b0c8", "9ab8ce16-f7de-41d4-a4c8-1c742621b6d5", "ff55c573-dc84-4ff3-9d10-2b24c47dd679" ], "package_ndc": [ "62135-772-35", "61703-350-37", "61703-350-38", "61703-408-41", "61703-350-09", "61703-350-10", "61703-408-25", "81927-204-01", "51285-366-01", "51285-367-01", "51285-368-01", "51285-369-01", "63323-123-10", "62332-711-01", "62332-711-05", "62332-712-01", "0143-9830-01", "46708-711-01", "46708-711-05", "46708-712-01", "55150-510-01", "55150-510-05", "55150-511-01", "55150-511-10", "55150-512-01", "55150-512-10", "55150-513-01", "47335-235-96", "47335-235-83", "61703-124-40", "61703-161-02", "61703-161-05", "0378-0014-01", "0143-9367-01", "59137-505-00", "59137-505-01", "59137-505-04", "59137-510-00", "59137-510-01", "59137-510-04", "59137-515-00", "59137-515-01", "59137-515-04", "59137-520-00", "59137-520-01", "59137-520-04", "59137-525-00", "59137-525-01", "59137-525-04", "59137-530-00", "59137-530-01", "59137-530-04", "59137-535-00", "59137-535-01", "59137-535-04", "59137-540-00", "59137-540-01", "59137-540-04", "59137-550-00", "59137-550-01", "59137-550-04", "59651-182-36", "59651-182-01", "52652-2001-1", "52652-2001-6", "63323-122-50", "0703-3671-01", "0703-3675-01", "0703-3678-01", "68382-775-60", "68382-775-16", "68382-775-01", "68382-775-05", "68382-775-10", "68382-775-77", "0555-0572-35", "0555-0572-02", "16729-277-30", "16729-277-03", "16729-277-35", "0143-9519-10", "0143-9518-01", "0143-9517-01", "0143-9516-01", "70771-1058-3", "70771-1058-9", "70771-1058-1", "70771-1058-5", "70771-1058-0", "70771-1058-2", "70771-1058-7", "16729-486-36", "16729-486-01", "62332-730-36", "62332-730-31", "54436-075-01", "54436-075-02", "54436-075-04", "54436-010-01", "54436-010-03", "54436-010-02", "54436-010-04", "54436-012-01", "54436-012-03", "54436-012-02", "54436-012-04", "54436-015-01", "54436-015-03", "54436-015-02", "54436-015-04", "54436-017-01", "54436-017-03", "54436-017-02", "54436-017-04", "54436-020-01", "54436-020-03", "54436-020-02", "54436-020-04", "54436-022-01", "54436-022-03", "54436-022-02", "54436-022-04", "54436-025-01", "54436-025-03", "54436-025-02", "54436-025-04", "46708-730-36", "46708-730-31" ], "unii": [ "3IG1E710ZN", "YL5FZ2Y5U1" ], "nui": [ "N0000175584", "N0000000111" ], "pharm_class_epc": [ "Folate Analog Metabolic Inhibitor [EPC]" ], "pharm_class_moa": [ "Folic Acid Metabolism Inhibitors [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } } ] } }, { "safetyreportversion": "4", "safetyreportid": "10012586", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20140522", "fulfillexpeditecriteria": "1", "companynumb": "JP-PFIZER INC-2014073545", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "JP-PFIZER INC-2014073545" }, "primarysource": { "reportercountry": "JP", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "68", "patientonsetageunit": "801", "patientweight": "52.2", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pyelonephritis", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "AMLODIN", "drugauthorizationnumb": "019787", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "5 MG, 2X/DAY (AFTER BREAKFAST AND AFTER DINNER 0.5 TABLET/TIME)", "drugdosageform": "TABLET", "actiondrug": "5" }, { "drugcharacterization": "1", "medicinalproduct": "PREDNISOLONE", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "5 MG, 2X/DAY (AFTER BREAKFAST AND AFTER DINNER 0.5 TABLET/TIME )", "drugdosageform": "TABLET", "drugindication": "IMMUNOSUPPRESSION", "actiondrug": "5", "openfda": { "application_number": [ "ANDA080531", "ANDA040571", "ANDA215673", "ANDA040323", "ANDA219509", "ANDA218083", "ANDA040775" ], "brand_name": [ "PREDNISOLONE" ], "generic_name": [ "PREDNISOLONE", "PREDNISOLONE ORAL", "PREDNISOLONE ORAL SOLUTION" ], "manufacturer_name": [ "Chartwell RX, LLC", "PAI Holdings, LLC dba PAI Pharma", "Aurobindo Pharma Limited", "Tulex Pharmaceuticals Inc", "Zhejiang Xianju Pharmaceutical Co., Ltd.", "Hisun Pharmaceuticals USA, Inc.", "Lannett Company, Inc.", "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "Chartwell Governmental & Specialty RX, LLC." ], "product_ndc": [ "62135-437", "0121-0885", "59651-491", "62135-250", "70404-077", "60722-5011", "42658-160", "0527-5406", "23155-927", "68999-250" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISOLONE" ], "rxcui": [ "198142", "283077" ], "spl_id": [ "1b180b1a-f4e2-e1ee-e063-6294a90adc05", "1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "c535b93f-b31f-411f-848c-b5e6782f321f", "19febba3-956f-d1a9-e063-6394a90afda5", "561d8c9c-b67f-7fb2-e063-6394a90a0316", "da9dfcf4-1631-4923-9536-72c27fc0b307", "9f93400d-a8c0-435a-ad65-48717cc455cf", "5122ba73-5783-49f0-9b9c-a03d59d8899c", "d2e4ebab-8c9d-44cb-b665-293007f7e058", "43e3bba6-a836-f5e7-e063-6294a90a10e4" ], "spl_set_id": [ "2e965355-f7f2-4dd3-9c5c-1524c6f39c91", "cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3", "070f1937-50a5-457f-bef5-4e597014e26d", "aa40f582-cced-4e6e-90f0-10ab310ab2a7", "757b41c4-a0fe-4a09-8816-a4cdb7558f41", "52e6e21d-94b8-41a0-8d13-371c0e66bcee", "16d4e064-66d3-4497-8c7d-3aa355f91e1d", "86652e2d-664a-4388-a611-c2a9aa4a4bc8", "b079834f-9aa3-4db9-bd53-de28e8f81c04", "2dac9898-6492-4f34-ad86-83a902e0fe0b" ], "package_ndc": [ "62135-437-30", "0121-0885-08", "0121-0885-16", "59651-491-50", "59651-491-01", "62135-250-37", "62135-250-47", "62135-250-45", "62135-250-24", "70404-077-14", "70404-077-16", "60722-5011-0", "60722-5011-1", "42658-160-05", "0527-5406-68", "0527-5406-70", "23155-927-51", "23155-927-52", "68999-250-45", "68999-250-24" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "9PHQ9Y1OLM" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "25 MG, 2X/DAY (AFTER BREAKFAST AND AFTER DINNER 1 CAPSULE/TIME)", "drugdosageform": "CAPSULE", "drugindication": "IMMUNOSUPPRESSION", "actiondrug": "5", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "1", "medicinalproduct": "AZATHIOPRINE", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "50 MG, 1X/DAY (AFTER BREAKFAST 0.5 TABLET/TIME)", "drugdosageform": "TABLET", "drugindication": "IMMUNOSUPPRESSION", "actiondrug": "5", "openfda": { "application_number": [ "ANDA074069", "ANDA075252", "ANDA077621", "ANDA075568", "NDA016324", "ANDA208687" ], "brand_name": [ "AZATHIOPRINE", "AZASAN", "IMURAN" ], "generic_name": [ "AZATHIOPRINE" ], "manufacturer_name": [ "AvKARE", "Salix Pharmaceuticals", "Amneal Pharmaceuticals NY LLC", "Oceanside Pharmaceuticals", "Zydus Lifesciences Limited", "Zydus Pharmaceuticals USA Inc.", "Glenmark Pharmaceuticals, Inc", "Rising Pharma Holdings, Inc.", "Sebela Pharmaceuticals Inc.", "Ascend Laboratories, LLC" ], "product_ndc": [ "42291-071", "65649-231", "65649-241", "69238-1076", "68682-231", "68682-241", "65841-602", "68382-003", "68382-118", "68382-119", "68382-120", "60219-1076", "60219-2036", "60219-2037", "68462-502", "16571-835", "54766-590", "67877-492", "67877-493", "67877-494", "67877-495", "70771-1139", "70771-1140", "70771-1141" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AZATHIOPRINE" ], "rxcui": [ "197388", "359228", "359229", "404475", "404476", "199310", "105611" ], "spl_id": [ "485b4c20-1aec-8ffd-e063-6294a90a104f", "85aaaf8a-26bf-4878-9356-490f17fe65ef", "d4549001-c251-4461-b3ff-5d25e9243918", "72e365c2-ab18-4c84-8252-d5287ceeb95f", "b1337f9b-c728-4b49-b29a-4f593c100f9c", "64e1751f-fdf5-45e7-ac57-6499c0b5aa91", "7b890b18-936a-43f1-9980-e94a417762f6", "26e47a7e-a3b4-036a-e063-6394a90ae208", "99588075-8b4a-45ec-90ca-2a23fdd8262a", "431426e8-80d4-a4e2-e063-6394a90af918", "7fdec2f6-c3b5-483f-8bfc-0afb292781da", "1277f50f-59f8-4c65-88de-011424884c3b" ], "spl_set_id": [ "d4c7d621-9642-4027-e053-2995a90a9220", "9050af7a-19c6-4670-937a-9445605de995", "c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c", "d72ede2c-1a9b-4717-80a7-b76a6a499936", "d65bc662-2ae8-4ddb-acc8-f616e72e6140", "b1b0fa3e-11c3-46d0-9537-6b372c2a1b56", "59f3219f-898f-4d05-a430-c2b3f5255af1", "ceab8e8b-d022-4d0c-a552-cc5782446248", "2ffa2fce-895d-469e-8667-b078560aec5f", "606101a0-6244-7eff-e053-2a91aa0acadd", "bc6dc4bd-2121-4613-9d90-4a504010c98a", "89b272f0-ef5c-49e4-820f-fcd7ea8ef066" ], "package_ndc": [ "42291-071-01", "65649-231-41", "65649-241-41", "69238-1076-1", "68682-231-01", "68682-241-01", "65841-602-01", "65841-602-05", "68382-003-01", "68382-003-05", "68382-118-01", "68382-118-05", "68382-119-01", "68382-119-05", "68382-120-01", "68382-120-05", "60219-1076-1", "60219-2036-1", "60219-2037-1", "68462-502-01", "16571-835-01", "54766-590-10", "67877-492-01", "67877-492-05", "67877-492-10", "67877-492-14", "67877-492-33", "67877-492-38", "67877-493-01", "67877-493-05", "67877-493-10", "67877-493-33", "67877-493-38", "67877-494-01", "67877-494-05", "67877-494-10", "67877-494-33", "67877-494-38", "67877-495-01", "67877-495-05", "67877-495-10", "67877-495-33", "67877-495-38", "70771-1139-1", "70771-1139-5", "70771-1140-1", "70771-1140-5", "70771-1141-1", "70771-1141-5" ], "nui": [ "N0000000233", "M0015066", "N0000175712", "M0018169" ], "pharm_class_moa": [ "Nucleic Acid Synthesis Inhibitors [MoA]" ], "pharm_class_cs": [ "Nucleosides [CS]", "Purines [CS]" ], "pharm_class_epc": [ "Purine Antimetabolite [EPC]" ], "unii": [ "MRK240IY2L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ATENOLOL", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "25 MG, 1X/DAY (AFTER BREAKFAST 1 TABLET/TIME)", "drugdosageform": "TABLET", "actiondrug": "5", "openfda": { "application_number": [ "NDA018240", "ANDA078512", "ANDA213136", "ANDA077443", "ANDA076900", "ANDA077877", "ANDA073457", "ANDA074056" ], "brand_name": [ "TENORMIN", "ATENOLOL" ], "generic_name": [ "ATENOLOL" ], "manufacturer_name": [ "Almatica Pharma LLC", "Aurobindo Pharma Limited", "Unichem Pharmaceuticals (USA), Inc.", "Rising Pharma Holdings, Inc.", "Zydus Lifesciences Limited", "Upsher-Smith Laboratories, LLC", "Ipca Laboratories Limited", "Mylan Pharmaceuticals Inc.", "Zydus Pharmaceuticals USA Inc.", "Teva Pharmaceuticals USA, Inc." ], "product_ndc": [ "52427-430", "52427-429", "52427-431", "65862-168", "65862-169", "65862-170", "29300-410", "29300-411", "29300-412", "64980-437", "64980-438", "64980-439", "65841-022", "65841-023", "65841-024", "24979-244", "24979-245", "24979-246", "83980-022", "83980-023", "83980-024", "0378-0218", "0378-0231", "0378-0757", "68382-022", "68382-023", "68382-024", "0093-0752", "0093-0787", "0093-0753" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATENOLOL" ], "rxcui": [ "150750", "152414", "197379", "197380", "197381", "201322" ], "spl_id": [ "ecd0de7b-801e-a5d6-01b7-01b89a8f3a78", "c5b37783-b0a1-4d21-b0cc-69a13cc4d2db", "b84110b2-cefb-49d0-8b08-1057dbdc258b", "7bf7d854-7736-4159-81e0-2f9f0c12d73c", "f4fb6b85-6379-4e8a-9ee3-402819d128a0", "c804fa73-5b5a-4e20-a1f5-6a13155df21f", "d32b777e-6c64-4899-934b-4fb73d9eba85", "9df3aeb2-2d70-4d49-9b45-a25e3a371cf9", "860eb406-b330-4b72-b768-122d57c74293", "19103c06-1fed-45a4-a110-66465b4f2233" ], "spl_set_id": [ "746db603-a6e1-4dc3-c2d8-92314419098c", "1b8a4689-3916-4f4b-b54a-bbb4e322d79b", "35d99c43-7305-4a4a-886e-a9bf3ee88fa8", "96dd038f-b363-4e24-9c67-82b7c85c3bc4", "2492d5f6-00b0-42c9-a793-2be83ea81ad1", "6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "98d29958-b026-4888-a516-7bb85bb7d479", "a7048c81-6769-436b-8397-fbaa7489fcdf", "db801706-1362-44c7-92ab-f584f96c7e1c", "25a72ec9-de0f-44e5-90b8-da1aab0d3588" ], "package_ndc": [ "52427-429-90", "52427-430-90", "52427-431-90", "65862-168-01", "65862-168-99", "65862-169-01", "65862-169-99", "65862-170-01", "65862-170-99", "29300-410-01", "29300-410-05", "29300-410-10", "29300-411-05", "29300-411-01", "29300-411-10", "29300-412-01", "29300-412-05", "29300-412-10", "64980-437-01", "64980-437-10", "64980-438-01", "64980-438-10", "64980-439-01", "64980-439-10", "65841-022-16", "65841-022-01", "65841-022-10", "65841-022-40", "65841-022-24", "65841-023-16", "65841-023-01", "65841-023-10", "65841-023-02", "65841-023-40", "65841-023-24", "65841-024-01", "65841-024-10", "65841-024-40", "65841-024-16", "24979-244-07", "24979-245-07", "24979-246-07", "83980-022-97", "83980-022-01", "83980-022-10", "83980-023-97", "83980-023-01", "83980-023-10", "83980-024-97", "83980-024-01", "83980-024-10", "0378-0218-01", "0378-0218-10", "0378-0231-01", "0378-0231-10", "0378-0757-01", "0378-0757-10", "68382-022-16", "68382-022-01", "68382-022-10", "68382-022-40", "68382-022-24", "68382-023-16", "68382-023-01", "68382-023-10", "68382-023-02", "68382-023-40", "68382-023-24", "68382-024-16", "68382-024-01", "68382-024-10", "68382-024-40", "0093-0787-01", "0093-0787-10", "0093-0752-01", "0093-0752-10", "0093-0753-01", "0093-0753-05" ], "nui": [ "N0000000161", "N0000175556" ], "pharm_class_moa": [ "Adrenergic beta-Antagonists [MoA]" ], "pharm_class_epc": [ "beta-Adrenergic Blocker [EPC]" ], "unii": [ "50VV3VW0TI" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PRAVASTATIN", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, 1X/DAY (BEFORE BED 0.5 TABLET/TIME)", "drugdosageform": "TABLET" }, { "drugcharacterization": "2", "medicinalproduct": "ALFACALCIDOL", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "004", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 UG, 1X/DAY (AFTER BREAKFAST 1 CAPSULE/TIME)", "drugdosageform": "CAPSULE" }, { "drugcharacterization": "2", "medicinalproduct": "PREGABALIN", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "75 MG, 2X/DAY (AFTER BREAKFAST AND AFTER DINNER 1 CAPSULE/TIME)", "drugdosageform": "CAPSULE", "openfda": { "application_number": [ "ANDA206912", "ANDA208113", "ANDA219593", "ANDA203459", "ANDA091157", "ANDA212604", "ANDA205321", "ANDA207623", "ANDA210432", "NDA021446", "ANDA214322", "ANDA206942", "ANDA209664", "ANDA215249", "ANDA208677", "NDA022488", "ANDA212988", "ANDA207799", "ANDA211384", "ANDA209743", "ANDA218529", "ANDA209357", "ANDA207883", "ANDA213226", "ANDA215675", "NDA209501", "ANDA216197", "ANDA212865", "ANDA206452", "ANDA213423" ], "brand_name": [ "PREGABALIN", "LYRICA", "PREGABALIN EXTENDED RELEASE", "LYRICA CR" ], "generic_name": [ "PREGABALIN" ], "manufacturer_name": [ "Camber Pharmaceuticals, Inc.", "Indoco Remedies Limited", "Unichem Pharmaceuticals (USA), Inc.", "Alembic Pharmaceuticals Inc.", "Alembic Pharmaceuticals Limited", "Sun Pharmaceutical Industries, Inc.", "Patrin Pharma, Inc.", "Aurobindo Pharma Limited", "Ascend Laboratories, LLC", "Rising Pharma Holdings, Inc.", "Parke-Davis Div of Pfizer Inc", "Tris Pharma Inc", "Torrent Pharmaceuticals Limited", "Dr.Reddys Laboratories Inc", "Advagen Pharma Ltd.", "ScieGen Pharmaceuticals, Inc", "Mylan Pharmaceuticals Inc.", "Viatris Specialty LLC", "Eskayef Pharmaceuticals Limited", "Cipla USA, Inc.", "Amneal Pharmaceuticals NY LLC", "FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED", "AvPAK", "NorthStar RxLLC", "Solco Healthcare US, LLC", "Exelan Pharmaceuticals Inc.", "Westminster Pharmaceuticals, LLC", "AvKARE", "Novadoz Pharmaceuticals LLC", "ScieGen Pharmaceuticals, INC.", "MARKSANS PHARMA LIMITED", "Chartwell RX, LLC", "Cadila Pharmaceuticals Limited", "Creekwood Pharmaceuticals LLC" ], "product_ndc": [ "31722-610", "31722-611", "31722-612", "31722-613", "31722-614", "31722-615", "31722-616", "31722-617", "14445-123", "14445-173", "14445-174", "14445-124", "14445-125", "14445-126", "14445-127", "14445-128", "29300-439", "29300-440", "29300-441", "29300-442", "29300-443", "29300-444", "29300-445", "29300-446", "62332-119", "62332-120", "62332-121", "62332-122", "62332-123", "62332-124", "62332-125", "62332-126", "46708-119", "46708-120", "46708-121", "46708-122", "46708-123", "46708-124", "46708-125", "46708-126", "47335-686", "47335-687", "47335-688", "47335-689", "47335-690", "47335-691", "47335-692", "47335-693", "39328-090", "65862-758", "65862-759", "65862-760", "65862-761", "65862-762", "65862-763", "65862-764", "65862-765", "67877-457", "64980-410", "64980-411", "64980-412", "64980-413", "64980-414", "64980-415", "64980-416", "64980-417", "0071-1018", "0071-1012", "0071-1013", "0071-1014", "0071-1015", "0071-1016", "0071-1017", "0071-1019", "0071-1020", "27808-235", "27808-236", "27808-237", "27808-238", "27808-239", "27808-240", "27808-241", "13668-358", "13668-359", "13668-360", "13668-361", "13668-362", "13668-363", "13668-364", "13668-365", "43598-291", "43598-292", "43598-293", "43598-294", "43598-295", "43598-296", "43598-297", "43598-298", "72888-049", "72888-050", "72888-051", "50228-350", "50228-351", "50228-352", "50228-353", "50228-354", "50228-355", "50228-356", "50228-357", "59762-1576", "58151-236", "58151-237", "58151-238", "58151-239", "58151-240", "58151-241", "58151-243", "58151-242", "58151-244", "72658-0808", "72658-0809", "72658-0810", "72658-0811", "72658-0812", "72658-0849", "72658-0813", "72658-0814", "67877-462", "67877-464", "67877-465", "67877-466", "67877-467", "67877-468", "67877-469", "67877-463", "69097-954", "69097-955", "69097-956", "69097-957", "69097-958", "69097-959", "69097-961", "69097-962", "69238-1310", "69238-1311", "69238-1312", "69238-1313", "69238-1314", "69238-1315", "69238-1316", "69238-1317", "82968-006", "82968-007", "82968-008", "82968-009", "82968-010", "82968-011", "82968-012", "82968-013", "50268-497", "50268-498", "50268-499", "50268-500", "50268-501", "60219-1310", "60219-1311", "60219-1312", "60219-1313", "60219-1314", "60219-1315", "60219-1316", "60219-1317", "72603-352", "72603-353", "72603-354", "72603-355", "72603-356", "72603-357", "72603-358", "43547-506", "43547-507", "43547-508", "43547-509", "43547-510", "43547-511", "43547-512", "43547-513", "76282-568", "76282-569", "76282-570", "76282-571", "76282-572", "76282-573", "76282-574", "76282-575", "69367-324", "69367-325", "69367-326", "69367-327", "69367-328", "69367-329", "69367-330", "69367-331", "73190-053", "73190-054", "73190-055", "73190-056", "73190-057", "73190-058", "73190-059", "73190-060", "72205-077", "72205-078", "72205-079", "50228-462", "50228-463", "50228-464", "58151-245", "58151-246", "58151-247", "72205-011", "72205-012", "72205-013", "72205-014", "72205-015", "72205-016", "72205-017", "72205-018", "25000-179", "25000-180", "25000-181", "25000-182", "25000-183", "25000-184", "25000-185", "25000-186", "62135-444", "62135-445", "62135-446", "62135-447", "69367-424", "69367-425", "69367-426", "69367-427", "69367-428", "69367-429", "69367-430", "69367-431", "50228-645", "50228-646", "50228-647", "50228-648", "50228-649", "50228-650", "50228-651", "50228-652", "71209-032", "71209-033", "71209-034", "71209-035", "71209-036", "71209-037", "71209-038", "71209-039", "82619-122", "82619-123", "82619-124", "82619-125", "82619-126", "82619-127", "82619-128", "82619-129" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREGABALIN" ], "rxcui": [ "483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127", "898715", "607018", "607020", "607022", "607024", "607026", "607028", "607033", "607038", "898718", "1988974", "1988977", "1988980", "1994389", "1994392", "1994395" ], "spl_id": [ "3ff00691-3fde-ae93-e063-6294a90adcc5", "522b3d6c-10fb-4581-afb7-2e48150b6048", "18bd1b03-be06-46c7-9f4f-eec4a218ff40", "1e87ec6d-6f2d-400f-bf21-08fcce28bb6c", "b746d2ae-57e4-4a36-9524-35c4aa6b4ef2", "52bb3d43-24c1-4789-8423-6c2d54850e75", "3a08157d-abaf-445c-b333-c209ef961bc0", "03c24a38-f80a-4acb-ab38-c747c13125d4", "59a80208-5cc1-476c-a24b-296bc68e1e0d", "ed8357e8-6f9d-4b09-b3f0-48417fe7f481", "e7c79058-03ba-4e7f-9a31-9ec5ce245161", "34723420-dabe-4070-83f1-5de1db603532", "f28a120a-aea5-45b9-84f7-06f48f41bc03", "4a1e5038-d049-606f-c087-48bc353a8a69", "49fe33c0-b2ae-e0c1-e063-6294a90a36a4", "955253a7-d80a-44ef-83c4-74b33ee6a622", "7aa334e7-3c46-4680-a266-9049af3bf566", "1c2af07d-faf4-4fc7-b724-c5166746956d", "4739c18b-9a48-41df-e063-6394a90a3589", "a59cea51-015e-4eb2-bdd0-08fa82f32f75", "96d9d734-42e6-474d-a75e-0381de0a8ec1", "80e6a2ec-3378-4160-aa74-2a7deff71e91", "4c41b54b-827a-1d04-e063-6394a90a55ea", "40c0f60f-acca-0215-e063-6394a90adfd1", "05638bed-2d09-47d9-8378-1265cf468389", "45bca2c9-2de2-8684-e063-6294a90a1bdd", "a56adbdc-8347-4165-8b9f-f826ff51440c", "b26b72af-62e4-4eb5-9cb8-e4eb05a22435", "0efc2eea-ebae-47f9-a13a-f2df4331cf04", "458708b4-56b8-8d18-e063-6294a90a8c47", "19d54064-0d2c-447e-93a7-84d2b99c4bc9", "e90bfe09-9adb-03c0-e053-2a95a90a061e", "67715d17-5ade-44ba-a5db-ba20d30d6da1", "d1428cf2-1243-43cb-8b54-f46024dbca29", "b8d46cc7-2959-411f-839c-eced90c38e92", "4361bef4-846b-7589-e063-6294a90a9292", "da37b9bc-466b-4bef-8c28-36586538df59", "459f0d45-9805-26f8-e063-6394a90a7e6e", "be6557c8-0d68-4313-a689-c2fdfb1d505e", "40b92ce3-6161-36b7-e063-6394a90af51e" ], "spl_set_id": [ "241c4b7e-f719-4828-8639-ea613b8a6583", "0a8d9e35-46fd-4c70-bb7f-4e8b754f2794", "284f2c15-24ef-466b-8110-3c2e87483509", "cf7b4b67-b017-47ac-af3f-bde5bd07bb0c", "78a36538-701d-4dd9-a7fc-87d505784c83", "ee7b9119-e88f-48ad-ae97-55e53374e62f", "d92c94e5-e542-4177-afa8-fa00ba17634c", "11034861-eef2-4996-8082-afc3c1769171", "1b731dd5-b000-4c38-bfc8-2505b076e316", "dbebfa61-0685-41b4-8364-00b8d8b73714", "60185c88-ecfd-46f9-adb9-b97c6b00a553", "62aa850d-199c-44d5-a730-45f43efa850e", "a062e78a-16ff-4d83-b700-0badb7d812d5", "ceed457b-8f43-4021-fd70-071c96e09470", "2ffee7e7-bfa0-4933-9baf-7df55080816e", "33ef1a3b-554f-4a51-afdb-92a019e8c16c", "ebe34db4-816d-4f0a-adbb-826693662754", "d4734e7d-5079-455e-8ff5-8f4539c998a9", "65d9e751-61c2-4741-85c0-2526cfdc765c", "e48db3c2-7351-41f2-a451-5a8341c4125c", "17a8087c-579f-42de-ae92-006ea64def2a", "3d9d7123-5886-4b61-a7ea-471b213e77d9", "9bdea600-b561-4049-aa1c-3867b62fc1d3", "40c0f658-2a0a-034b-e063-6394a90a1097", "3099759f-cb24-40e8-b482-9388c38c73b9", "4a4d4c76-31c5-413b-be7c-82cb8091c19d", "085db834-3735-40d9-ac67-f9dbb82390c5", "3fdc6e94-2504-416c-81dd-2db9bc194ebb", "781cb1ac-a0d2-4b47-b319-f0b90de86384", "458705af-06fa-57d1-e063-6394a90a3b2e", "f6aa5977-97c8-4a56-8e35-d9ab5cc24369", "1544a657-353c-47f8-96ac-a63fa78373f0", "f280bbd8-2af2-444a-bd96-e409337ca6dd", "193666f7-3c55-43b1-947a-2ffec40c687f", "b2b81bb6-5423-4221-8a61-f70a38d6a1e9", "13d03119-e49b-482e-b5f9-d40dc3f4862e", "6b0ee2cf-52c3-4052-bea0-1458a4233745", "459f0d31-a73f-2c62-e063-6394a90a810c", "170c0c95-2ee8-4dff-bbd6-b87a21e8cf81", "bfe4108e-b2d2-4059-be16-21d3276c3ae4" ], "package_ndc": [ "31722-610-60", "31722-610-90", "31722-610-05", "31722-610-31", "31722-610-32", "31722-611-60", "31722-611-90", "31722-611-05", "31722-611-31", "31722-611-32", "31722-612-60", "31722-612-90", "31722-612-05", "31722-612-31", "31722-613-60", "31722-613-90", "31722-613-05", "31722-613-31", "31722-614-60", "31722-614-90", "31722-614-05", "31722-614-31", "31722-615-60", "31722-615-90", "31722-615-05", "31722-615-31", "31722-616-60", "31722-616-90", "31722-616-05", "31722-616-31", "31722-617-60", "31722-617-90", "31722-617-05", "31722-617-31", "31722-617-32", "14445-173-90", "14445-174-90", "14445-174-10", "14445-174-00", "14445-123-90", "14445-123-10", "14445-123-00", "14445-124-90", "14445-124-10", "14445-124-00", "14445-125-90", "14445-125-10", "14445-125-00", "14445-126-90", "14445-127-90", "14445-128-90", "29300-439-19", "29300-440-19", "29300-441-19", "29300-442-19", "29300-443-19", "29300-444-19", "29300-445-19", "29300-446-19", "62332-119-30", "62332-119-90", "62332-119-91", "62332-119-10", "62332-120-30", "62332-120-90", "62332-120-91", "62332-120-10", "62332-121-30", "62332-121-90", "62332-121-91", "62332-121-10", "62332-122-30", "62332-122-90", "62332-122-91", "62332-122-10", "62332-123-30", "62332-123-90", "62332-123-91", "62332-123-10", "62332-124-30", "62332-124-90", "62332-124-91", "62332-124-10", "62332-125-30", "62332-125-90", "62332-125-91", "62332-125-10", "62332-126-30", "62332-126-90", "62332-126-71", "62332-126-10", "46708-119-30", "46708-119-90", "46708-119-91", "46708-119-10", "46708-120-30", "46708-120-90", "46708-120-91", "46708-120-10", "46708-121-30", "46708-121-90", "46708-121-91", "46708-121-10", "46708-122-30", "46708-122-90", "46708-122-91", "46708-122-10", "46708-123-30", "46708-123-90", "46708-123-91", "46708-123-10", "46708-124-30", "46708-124-90", "46708-124-91", "46708-124-10", "46708-125-30", "46708-125-90", "46708-125-91", "46708-125-10", "46708-126-30", "46708-126-90", "46708-126-71", "46708-126-10", "47335-686-83", "47335-686-88", "47335-686-08", "47335-686-18", "47335-687-83", "47335-687-88", "47335-687-08", "47335-687-18", "47335-688-83", "47335-688-88", "47335-688-08", "47335-688-18", "47335-689-83", "47335-689-88", "47335-689-08", "47335-689-18", "47335-690-83", "47335-690-88", "47335-690-08", "47335-690-18", "47335-691-83", "47335-691-88", "47335-691-08", "47335-691-18", "47335-692-83", "47335-692-88", "47335-692-08", "47335-692-18", "47335-693-83", "47335-693-88", "47335-693-08", "47335-693-18", "39328-090-16", "65862-758-90", "65862-758-05", "65862-758-10", "65862-758-78", "65862-759-90", "65862-759-01", "65862-759-05", "65862-759-10", "65862-759-78", "65862-760-90", "65862-760-01", "65862-760-05", "65862-760-10", "65862-760-78", "65862-761-90", "65862-761-01", "65862-761-05", "65862-761-10", "65862-761-78", "65862-762-90", "65862-762-01", "65862-762-05", "65862-762-10", "65862-762-78", "65862-763-90", "65862-763-05", "65862-763-10", "65862-763-78", "65862-764-90", "65862-764-05", "65862-764-10", "65862-764-78", "65862-765-90", "65862-765-05", "65862-765-10", "65862-765-78", "67877-457-47", "64980-410-09", "64980-410-10", "64980-410-01", "64980-411-09", "64980-411-10", "64980-411-01", "64980-412-09", "64980-412-10", "64980-412-01", "64980-413-09", "64980-413-10", "64980-413-01", "64980-414-09", "64980-414-10", "64980-414-01", "64980-415-09", "64980-415-10", "64980-415-01", "64980-416-09", "64980-416-10", "64980-416-01", "64980-417-09", "64980-417-10", "64980-417-01", "0071-1012-68", "0071-1013-41", "0071-1013-68", "0071-1014-41", "0071-1014-68", "0071-1015-41", "0071-1015-68", "0071-1016-41", "0071-1016-68", "0071-1017-68", "0071-1019-68", "0071-1018-68", "0071-1020-01", "27808-235-01", "27808-236-01", "27808-237-01", "27808-238-01", "27808-239-01", "27808-240-01", "27808-241-01", "13668-359-30", "13668-359-60", "13668-359-01", "13668-359-05", "13668-360-30", "13668-360-90", "13668-360-01", "13668-360-05", "13668-361-30", "13668-361-01", "13668-361-60", "13668-361-05", "13668-362-30", "13668-362-90", "13668-362-01", "13668-362-05", "13668-363-30", "13668-363-60", "13668-363-01", "13668-363-05", "13668-364-30", "13668-364-60", "13668-364-01", "13668-364-05", "13668-365-30", "13668-365-60", "13668-365-01", "13668-365-05", "13668-365-02", "13668-358-30", "13668-358-60", "13668-358-01", "13668-358-05", "43598-291-90", "43598-291-05", "43598-291-79", "43598-291-66", "43598-291-78", "43598-292-90", "43598-292-05", "43598-292-79", "43598-292-66", "43598-292-78", "43598-293-90", "43598-293-05", "43598-293-79", "43598-293-66", "43598-293-78", "43598-294-90", "43598-294-05", "43598-294-79", "43598-294-66", "43598-294-78", "43598-295-90", "43598-295-05", "43598-295-79", "43598-295-66", "43598-295-78", "43598-296-90", "43598-296-05", "43598-296-79", "43598-296-66", "43598-296-78", "43598-297-90", "43598-297-05", "43598-297-79", "43598-297-66", "43598-297-78", "43598-298-90", "43598-298-05", "43598-298-79", "43598-298-66", "43598-298-78", "72888-049-30", "72888-050-30", "72888-051-30", "50228-350-30", "50228-350-90", "50228-350-10", "50228-351-30", "50228-351-90", "50228-351-10", "50228-352-30", "50228-352-90", "50228-352-10", "50228-353-30", "50228-353-90", "50228-353-10", "50228-354-30", "50228-354-90", "50228-354-10", "50228-355-30", "50228-355-90", "50228-355-05", "50228-356-30", "50228-356-90", "50228-356-05", "50228-357-30", "50228-357-90", "50228-357-05", "59762-1576-1", "58151-236-77", "58151-237-32", "58151-237-88", "58151-237-77", "58151-238-32", "58151-238-88", "58151-238-77", "58151-239-32", "58151-239-88", "58151-239-77", "58151-240-32", "58151-240-88", "58151-240-77", "58151-241-77", "58151-243-77", "58151-242-77", "58151-244-35", "72658-0808-1", "72658-0808-2", "72658-0808-6", "72658-0809-1", "72658-0809-2", "72658-0809-6", "72658-0809-3", "72658-0809-5", "72658-0810-1", "72658-0810-2", "72658-0810-6", "72658-0810-3", "72658-0810-5", "72658-0811-1", "72658-0811-2", "72658-0811-6", "72658-0811-4", "72658-0811-5", "72658-0812-1", "72658-0812-2", "72658-0812-6", "72658-0812-3", "72658-0812-5", "72658-0849-1", "72658-0849-2", "72658-0849-6", "72658-0813-1", "72658-0813-2", "72658-0813-6", "72658-0814-1", "72658-0814-2", "72658-0814-6", "67877-464-30", "67877-464-90", "67877-464-05", "67877-464-38", "67877-464-33", "67877-465-30", "67877-465-90", "67877-465-05", "67877-465-38", "67877-465-33", "67877-466-30", "67877-466-90", "67877-466-05", "67877-466-38", "67877-466-33", "67877-467-30", "67877-467-90", "67877-467-05", "67877-467-38", "67877-467-33", "67877-468-30", "67877-468-90", "67877-468-05", "67877-468-38", "67877-468-33", "67877-469-30", "67877-469-90", "67877-469-05", "67877-469-38", "67877-469-33", "67877-462-30", "67877-462-90", "67877-462-05", "67877-462-38", "67877-462-33", "67877-463-30", "67877-463-90", "67877-463-05", "67877-463-38", "67877-463-33", "69097-954-05", "69097-954-12", "69097-955-05", "69097-955-12", "69097-956-05", "69097-956-12", "69097-957-05", "69097-957-12", "69097-958-05", "69097-958-12", "69097-959-05", "69097-961-05", "69097-962-05", "69238-1310-9", "69238-1310-5", "69238-1311-9", "69238-1311-5", "69238-1312-9", "69238-1312-5", "69238-1313-9", "69238-1313-5", "69238-1314-9", "69238-1314-5", "69238-1315-9", "69238-1315-5", "69238-1316-9", "69238-1316-5", "69238-1317-9", "69238-1317-5", "82968-006-01", "82968-007-03", "82968-007-01", "82968-008-04", "82968-008-02", "82968-009-04", "82968-009-02", "82968-010-03", "82968-010-01", "82968-011-01", "82968-012-01", "82968-013-01", "50268-497-11", "50268-497-01", "50268-498-11", "50268-498-01", "50268-499-11", "50268-499-01", "50268-500-11", "50268-500-01", "50268-501-11", "50268-501-01", "60219-1310-9", "60219-1311-9", "60219-1312-9", "60219-1313-9", "60219-1314-9", "60219-1315-9", "60219-1316-9", "60219-1317-9", "72603-352-01", "72603-353-01", "72603-354-01", "72603-355-01", "72603-356-01", "72603-357-01", "72603-358-01", "43547-506-09", "43547-506-11", "43547-507-09", "43547-507-11", "43547-508-09", "43547-508-11", "43547-509-09", "43547-509-11", "43547-510-09", "43547-510-11", "43547-511-09", "43547-511-50", "43547-512-09", "43547-512-50", "43547-513-09", "43547-513-50", "76282-568-90", "76282-568-05", "76282-569-90", "76282-569-05", "76282-570-90", "76282-570-05", "76282-571-90", "76282-571-05", "76282-572-90", "76282-572-05", "76282-573-90", "76282-573-05", "76282-574-90", "76282-574-05", "76282-575-90", "76282-575-05", "69367-324-09", "69367-325-09", "69367-326-09", "69367-327-09", "69367-328-09", "69367-329-09", "69367-330-09", "69367-331-09", "73190-053-50", "73190-053-90", "73190-054-50", "73190-054-90", "73190-055-50", "73190-055-90", "73190-056-50", "73190-056-90", "73190-057-50", "73190-057-90", "73190-058-50", "73190-058-90", "73190-059-50", "73190-059-90", "73190-060-50", "73190-060-90", "72205-077-30", "72205-078-30", "72205-079-30", "50228-462-30", "50228-462-05", "50228-463-30", "50228-463-05", "50228-464-30", "50228-464-05", "58151-245-93", "58151-246-93", "58151-247-93", "72205-011-90", "72205-011-99", "72205-011-11", "72205-011-06", "72205-012-90", "72205-012-99", "72205-012-11", "72205-012-06", "72205-013-90", "72205-013-99", "72205-013-11", "72205-013-06", "72205-014-90", "72205-014-99", "72205-014-11", "72205-014-06", "72205-015-90", "72205-015-05", "72205-015-11", "72205-015-06", "72205-016-90", "72205-016-99", "72205-016-11", "72205-016-06", "72205-017-90", "72205-017-99", "72205-017-11", "72205-017-06", "72205-018-90", "72205-018-05", "72205-018-11", "72205-018-06", "25000-179-07", "25000-180-07", "25000-181-07", "25000-182-07", "25000-183-07", "25000-184-07", "25000-185-07", "25000-186-07", "62135-444-90", "62135-445-90", "62135-446-90", "62135-447-90", "69367-424-09", "69367-424-05", "69367-425-09", "69367-425-05", "69367-426-09", "69367-426-05", "69367-427-09", "69367-427-05", "69367-428-09", "69367-428-05", "69367-429-09", "69367-429-05", "69367-430-09", "69367-430-05", "69367-431-09", "69367-431-05", "50228-645-90", "50228-645-05", "50228-646-90", "50228-646-05", "50228-647-90", "50228-647-05", "50228-648-90", "50228-648-05", "50228-649-90", "50228-649-05", "50228-650-90", "50228-650-05", "50228-651-90", "50228-651-05", "50228-652-90", "50228-652-05", "71209-032-04", "71209-033-04", "71209-034-04", "71209-035-04", "71209-036-04", "71209-037-04", "71209-038-04", "71209-039-04", "82619-122-01", "82619-122-02", "82619-123-01", "82619-123-02", "82619-124-01", "82619-124-02", "82619-125-01", "82619-125-02", "82619-126-01", "82619-126-02", "82619-127-01", "82619-127-02", "82619-128-01", "82619-128-02", "82619-129-01", "82619-129-02" ], "unii": [ "55JG375S6M" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CLOPIDOGREL", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "75 MG, 1X/DAY (AFTER BREAKFAST 1 TABLET/TIME)", "drugdosageform": "TABLET", "openfda": { "application_number": [ "ANDA202928", "ANDA076999", "ANDA203751", "ANDA090844", "NDA020839", "ANDA204165", "ANDA213351", "ANDA090540", "ANDA076274", "ANDA203632", "ANDA205345", "ANDA215388" ], "brand_name": [ "CLOPIDOGREL", "PLAVIX" ], "generic_name": [ "CLOPIDOGREL", "CLOPIDOGREL BISULFATE" ], "manufacturer_name": [ "NorthStar RxLLC", "Teva Pharmaceuticals USA, Inc.", "Amneal Pharmaceuticals LLC", "Torrent Pharmaceuticals Limited", "Macleods Pharmaceuticals Limited", "Sanofi-Aventis U.S. LLC", "Westminster Pharmaceuticals, LLC", "POLYGEN PHARMACEUTICALS INC.", "Aurobindo Pharma Limited", "Apotex Corp.", "Vensun Pharmaceuticals, Inc.", "Ascend Laboratories, LLC", "Camber Pharmaceuticals, Inc.", "Novadoz Pharmaceuticals LLC" ], "product_ndc": [ "16714-052", "0093-7314", "65162-414", "13668-141", "33342-060", "0024-1171", "0024-1332", "69367-194", "69367-200", "52605-082", "52605-083", "65862-357", "60505-0253", "60505-3992", "60505-3532", "42543-713", "42543-714", "67877-276", "31722-758", "31722-759", "72205-199" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CLOPIDOGREL BISULFATE", "CLOPIDOGREL" ], "rxcui": [ "309362", "213169", "749196", "749198" ], "spl_id": [ "dbf6d86e-5d4f-40da-a933-b928843053b7", "a9df5ba4-ab12-4f72-9264-a1f7f377e35b", "360ed8dd-4f92-46fc-b31b-abe0d75e9bb3", "3cbfb162-4652-4a90-9afa-489e743fc16a", "05355b6d-3802-4542-bda2-cd6a17e57266", "ed60a9e7-49f4-469c-bb7a-08e1bb6057e2", "175ba166-6dc4-41d9-a75e-853cb6d47aeb", "9e3256b5-2032-4615-967d-449d49b09921", "ff58c1f3-4875-4d10-aca7-c622af163cef", "936a8707-dc3c-ebe4-6a66-0f726988c764", "4b480542-0dd3-4694-9d43-d5fdcdd64a0f", "21dbc638-2bc8-4ad0-bacd-e79907affc2b", "04d99965-cea0-8e7d-e063-6394a90ab281", "0b4edca9-12af-4534-baad-4fa5c1cc9ac8" ], "spl_set_id": [ "d176de1d-b1b3-4aa9-b783-d53f65a79e50", "bc747f6d-f52c-4dcb-bda5-2d0a9f954147", "0d010775-1160-4b2e-a928-563a02edd191", "ae07b785-b522-41c6-b27c-24c4d5cd814d", "063cd1eb-98fd-422e-8145-bba04c497efe", "de8b0b67-eb25-4684-83b5-7ad785314227", "bb3b5e96-e629-4db5-8ad5-40c17c6dae18", "56b5d12b-b3fe-4de9-a5ef-80377c72d843", "0078fb3d-3595-4ae1-a059-1d5e81c879cf", "edae8df1-caf9-ff72-1304-5ae8b355f8e7", "86ee71f2-850e-4c8e-87f3-c7a618d59d95", "db1161c9-6efd-4361-a766-6a37c241ccee", "b573aefa-e337-478f-97e4-eb8472a7e497", "1447a095-c663-4f05-91d4-f09bfc0c3d42" ], "package_ndc": [ "16714-052-01", "16714-052-03", "16714-052-11", "16714-052-02", "16714-052-04", "16714-052-10", "0093-7314-56", "0093-7314-98", "0093-7314-05", "65162-414-03", "65162-414-09", "65162-414-50", "65162-414-11", "13668-141-44", "13668-141-05", "13668-141-10", "13668-141-01", "13668-141-90", "13668-141-30", "33342-060-07", "33342-060-15", "33342-060-12", "33342-060-10", "33342-060-44", "0024-1171-90", "0024-1332-30", "69367-194-30", "69367-194-05", "69367-200-05", "52605-082-13", "52605-082-10", "52605-083-13", "52605-083-05", "65862-357-30", "65862-357-90", "65862-357-01", "65862-357-05", "65862-357-99", "65862-357-10", "60505-0253-1", "60505-0253-2", "60505-0253-3", "60505-0253-4", "60505-0253-5", "60505-3992-3", "60505-3532-5", "42543-713-30", "42543-713-90", "42543-713-01", "42543-713-05", "42543-713-10", "42543-714-30", "42543-714-90", "42543-714-01", "42543-714-05", "67877-276-30", "67877-276-90", "67877-276-05", "31722-758-30", "31722-758-90", "31722-758-05", "31722-759-30", "31722-759-05", "72205-199-30", "72205-199-90", "72205-199-05", "72205-199-11", "72205-199-06", "72205-199-01" ], "unii": [ "08I79HTP27", "A74586SNO7" ], "nui": [ "N0000008832", "N0000182142", "N0000182143", "N0000187062" ], "pharm_class_pe": [ "Decreased Platelet Aggregation [PE]" ], "pharm_class_epc": [ "P2Y12 Platelet Inhibitor [EPC]" ], "pharm_class_moa": [ "P2Y12 Receptor Antagonists [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FAMOTIDINE", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 2X/DAY (AFTER BREAKFAST AND AFTER DINNER 1 TABLET/TIME)", "drugdosageform": "TABLET", "openfda": { "application_number": [ "ANDA218003", "ANDA077351", "ANDA075400", "ANDA206531", "ANDA215767", "ANDA215043", "ANDA217543", "ANDA078916", "ANDA075511", "ANDA091020", "ANDA206530", "ANDA075488", "ANDA075486", "ANDA201995", "ANDA217669", "ANDA217137", "ANDA215766", "ANDA215822", "ANDA075622", "ANDA075651", "ANDA215689", "ANDA075813", "ANDA090440", "ANDA217982", "ANDA217400", "ANDA216441", "ANDA077367", "NDA020325", "ANDA201695", "ANDA217529", "ANDA075805", "ANDA215630", "ANDA219863", "ANDA075591", "ANDA078642", "ANDA078641", "ANDA217330", "ANDA216400", "ANDA216427", "ANDA217605", "ANDA217655", "ANDA075718", "ANDA218181", "ANDA075709", "ANDA216030", "M001", "ANDA217842", "ANDA075302", "ANDA219091", "ANDA075786", "NDA219935" ], "brand_name": [ "FAMOTIDINE", "ACID RELIEF", "ACID REDUCER", "ACID CONTROLLER", "ZANTAC 360", "HEARTBURN PREVENTION", "RUGBY FAMOTIDINE", "ORIGINAL STRENGTH HEARTBURN PREVENTION", "FOSTER AND THRIVE ACID REDUCER", "SIGNATURE CARE ACID CONTROLLER", "BASIC CARE ACID REDUCER", "TOPCARE ACID REDUCER", "MEMBERS MARK ACID PEP", "CAREONE ACID RELIEF", "ZANTAC 360 COOL MINT", "DG HEALTH ACID REDUCER", "MAXIMUM STRENGTH ACID CONTROLLER", "ACID CONTROLLER ORIGINAL STRENGTH", "DG HEALTH HEARTBURN PREVENTION ORIGINAL STRENGTH", "PEPCID AC MAXIMUM STRENGTH", "EQUALINE HEARTBURN PREVENTION", "HEARTBURN RELIEF", "EQUATE FAMOTIDINE", "GOOD SENSE ACID REDUCER", "PEPCID AC", "PEPCID", "MAXIMUM STRENGTH PEPCID AC ICY COOL MINT", "MAXIMUM STRENGTH ACID REDUCER", "BERKLEY AND JENSEN FAMOTIDINE", "AMAZON BASIC CARE ACID REDUCER", "CALMICID AC ACID REDUCER", "PEPCID AC ORIGINAL STRENGTH", "HEARTBURN RELIEF ORIGINAL STRENGTH", "DG HEALTH HEARTBURN PREVENTION", "SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH", "KIRKLAND SIGNATURE ACID CONTROLLER", "ACID REDUCER ORIGINAL STRENGTH", "LEADER ACID REDUCER", "BASIC CARE HEARTBURN PREVENTION", "MAXIMUM STRENGTH", "MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH" ], "generic_name": [ "FAMOTIDINE" ], "manufacturer_name": [ "LEADER/ Cardinal Health 110, Inc.", "Rite Aid Corporation", "Publix Super Markets Inc", "H E B", "Chattem, Inc.", "Camber Pharmaceuticals, Inc.", "Kroger Company", "Wal-Mart Stores, Inc.", "Aurohealth LLC", "ANI Pharmaceuticals, Inc.", "Rugby Laboratories", "KROGER COMPANY", "Alembic Pharmaceuticals Inc.", "Safeway", "Magno-Humphries, Inc.", "Teva Pharmaceuticals USA, Inc.", "Allegiant Health", "Amerisource Bergen", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Navinta LLC", "Walgreen Company", "Aurobindo Pharma Limited", "HARRIS TEETER, LLC", "Strategic Sourcing Services LLC", "Hikma Pharmaceuticals USA Inc.", "Akorn", "Westminster Pharmaceuticals, LLC", "Biocon Pharma Inc.", "Camber Consumer Care Inc", "SAFEWAY", "Sagent Pharmaceuticals", "Amazon.com Services LLC", "XLCare Pharmaceuticals, Inc.", "Alembic Pharmaceuticals Limited", "Topco Associates LLC", "BluePoint Laboratories", "Sam's West Inc", "NorthStar Rx LLC", "Contract Pharmacal Corp.", "Harris Teeter", "Fresenius Kabi USA, LLC", "Retail Business Services, LLC", "CVS Pharmacy, Inc.", "Lupin Pharmaceuticals, Inc.", "Lannett Company, Inc.", "Dolgencorp Inc", "Novadoz Pharmaceuticals LLC", "BETTER LIVING BRANDS LLC.", "GERI-CARE PHARMACEUTICAL CORP", "Zydus Lifesciences Limited", "Chain Drug Consortium, LLC", "CVS Pharmacy", "Dolgencorp, LLC", "Kenvue Brands LLC", "Lupin Pharmaceuticals,Inc.", "Ajanta Pharma USA Inc.", "United Natural Foods, Inc. dba UNFI", "Meijer Distribution Inc", "Wal-Mart Stores Inc", "FAMILY DOLLAR", "Carlsbad Technology, Inc", "American Sales Company", "Little Pharma, Inc.", "L. Perrigo Company", "TWIN MED LLC", "Ascend Laboratories, LLC", "LEADER/ CARDINAL HEALTH 110, INC.", "Lil' Drug Store Products, Inc.", "Geri-Care Pharmaceutical Corp", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Baxter Healthcare Corporation", "Bi-Mart", "Bausch Health US LLC", "Mylan Institutional LLC", "Better Living Brands LLC", "TARGET CORPORATION", "Family Dollar Stores, LLC", "Amneal Pharmaceuticals NY LLC", "Carnegie Pharmaceuticals LLC", "DR. REDDY'S LABORATORIES INC", "BJWC", "Shield Pharmaceuticals Corp", "WALGREEN CO.", "Fred's, Inc.", "Upsher-Smith Laboratories, LLC", "Dr.Reddy's Laboratories Limited", "Rising Pharma Holdings, Inc.", "Zydus Pharmaceuticals USA Inc.", "WALMART INC.", "Ascent Pharmaceuticals, Inc.", "Family Dollar Stores, Inc.", "Melaleuca, Inc.", "VKT Pharma Private Limited", "Albertsons Companies", "Major Pharmaceuticals", "TIME CAP LABORATORIES,INC", "HyVee Inc", "Dr.Reddys Laboratories Limited", "Better Living Brands, LLC", "Micro Labs Limited", "Costco Wholesale Company", "GLENMARK THERAPEUTICS INC., USA", "Best Choice", "Lifestar Pharma LLC", "Cardinal Health 110, LLC. dba Leader", "Chartwell RX, LLC" ], "product_ndc": [ "70000-0710", "11822-1014", "56062-088", "37808-301", "41167-0361", "41167-0360", "31722-017", "31722-018", "30142-194", "49035-589", "58602-705", "70954-316", "37808-042", "0536-1298", "41226-719", "62332-001", "62332-002", "21130-521", "49035-505", "54257-802", "0172-5728", "0172-5729", "69168-445", "46122-735", "58602-706", "51316-511", "68475-400", "0363-0701", "21130-771", "65862-859", "65862-860", "69256-002", "70677-1101", "0641-6021", "0641-6022", "0641-6023", "50383-913", "11822-1194", "69367-400", "69367-401", "56062-141", "21130-249", "70377-113", "69230-326", "69230-327", "21130-191", "25021-753", "25021-754", "72288-141", "72865-214", "72865-215", "46708-293", "46708-294", "36800-141", "68001-397", "68001-398", "68196-121", "72603-171", "10267-5689", "10267-5690", "72036-026", "63323-739", "72288-194", "72476-150", "69842-063", "41167-0364", "68180-150", "76162-300", "0527-5190", "11822-6123", "55910-814", "72205-145", "72205-146", "21130-027", "57896-317", "70771-1702", "70771-1703", "68016-800", "68016-801", "11822-6141", "59640-001", "72476-299", "59779-141", "55910-141", "16837-855", "58602-859", "43386-500", "27241-249", "68001-494", "41163-001", "41250-493", "49035-650", "0363-0141", "55319-408", "55319-409", "61442-121", "61442-122", "59640-023", "41520-707", "72559-038", "0113-0194", "55681-343", "67877-842", "67877-889", "70000-0048", "67877-843", "54257-180", "66715-9748", "59779-194", "72205-233", "57896-319", "69842-087", "83324-003", "83324-008", "0338-5197", "70677-1102", "37835-165", "69842-659", "55681-342", "37835-161", "0187-4420", "0187-4440", "36800-194", "0113-0141", "67457-433", "67457-448", "67457-457", "21130-039", "16837-889", "31722-063", "11673-697", "55319-057", "70000-0049", "67877-775", "0363-1203", "60219-2090", "80005-119", "43598-572", "68391-300", "83059-0031", "0363-9607", "55315-435", "69238-2090", "0832-6045", "55111-119", "55111-120", "64980-623", "64980-624", "58602-828", "63323-738", "0363-1899", "72288-363", "0363-5300", "70710-1683", "70710-1684", "69842-928", "79903-115", "43602-511", "43602-602", "55319-426", "55319-427", "49035-507", "41250-712", "54473-411", "72288-329", "71821-010", "71821-012", "21130-022", "21130-023", "83059-0005", "16837-872", "0904-5529", "49483-720", "42507-194", "55111-118", "55111-396", "55910-665", "69842-924", "46122-737", "21130-033", "58602-829", "21130-777", "42571-433", "0363-4400", "63981-194", "41163-313", "72657-112", "72657-113", "72657-132", "42507-141", "63941-009", "70756-051", "70756-052", "59651-701", "70000-0654", "55910-194", "62135-807", "62135-808", "72288-151", "41520-901", "56062-194", "63941-011", "25021-755", "25021-756", "68382-444", "69168-443", "0904-5780" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "FAMOTIDINE" ], "rxcui": [ "310273", "199047", "2607015", "2609246", "284245", "310274", "204441", "1743833", "104094", "199739", "104095", "1091399", "212072", "2727402", "2727403" ], "spl_id": [ "2de46de3-c99e-22ea-e063-6394a90a165d", "eccc9398-693b-4682-b298-fcdc4fb6edf8", "b3862f03-3efe-4e65-a637-46441e9ab01f", "baac0d4f-1e8d-4ce2-ab82-5906c63c8654", "efcd0b2f-86c9-43c6-889f-7962e191a9cb", "d1215804-20c7-e3f3-e053-2a95a90aa13b", "c1cf5e39-9332-4823-9c3f-f6976bda5b1c", "7c87bb9a-900d-48e3-9c09-8815aeff2504", "83d5769e-ef9c-4ce5-afd5-a2dd7496274a", "5dd78321-82a9-48a6-9974-d8d27e9785cf", "7c6af311-afd5-4885-bf28-97d831828dfc", "12c5ddd1-e203-4e79-ab9b-5fab9bb7933a", "1cb86ee4-41c1-1196-e063-6394a90a9199", "bd221da3-ca77-4407-856b-489a8903c842", "2e7c8340-ff76-4d41-bda4-e47fd0f7e10a", "90ec3bbe-d56a-4536-a15a-3b577297fb1a", "54c5dd3f-7261-47e2-adfc-23ef9955eb39", "4f26d0af-7f08-49a1-8bba-46741aa83ad5", "8b9d16df-e73f-45e1-b5f9-3dfaa8c4b5f7", "791e2d0f-6c6d-4b46-9b4b-a672a7452967", "4329025b-5cdd-4287-955f-028e6aca198c", "59ec6c2c-f06f-458c-9dc5-1c9741569d86", "12419fdc-7a4c-4762-806c-0d56b478ef9d", "66b3969f-1536-48ad-9e8b-5a25f5eb1c5e", "cafa4061-7e52-4374-9f4b-4a01ff6e4c07", "e0c726f6-8257-4dba-b2f9-d78d28097bd9", "a5ae82c1-a463-40bd-a5d4-4dcc4bfede3f", "79556483-cc8c-4584-861b-a37cdd6d96a9", "021158a6-1da8-477a-af20-4ce26c147b32", "f448e568-540e-4027-be47-e7a5aa1051d3", "57af3698-0335-483a-a150-29e6b6468284", "497a1a19-03b2-4e3d-b5c7-0b94a29b9cc5", "edd72fec-0dfc-4862-8d07-476e74b2fe69", "94c22818-03bf-4274-9088-7d5ead948d6d", "c9c5c51c-c406-82ad-ad7b-ff0dac43503a", "eabd2ff8-a7d9-2ac4-e053-2995a90a3b40", "463f1b83-03cb-ec46-e063-6294a90a7168", "11856fb6-3d0b-4db4-889f-083e7f4285be", "82be7b45-4550-479f-a8df-29474f3ef44b", "b37fe9a5-6465-4518-823d-5d369a4c7793", "02d57009-ba37-4b5d-af59-7a62f1d9e29c", "c15b21b3-6e50-4ed4-90ef-28483e1cf535", "bfda441a-c4ae-7bf3-e053-2a95a90adfe2", "e318316a-bbad-4640-9388-ccb3ce3d2cc0", "04aaf2b3-3610-056f-e063-6394a90a91df", "1c656b34-6eeb-cc3f-e063-6294a90ad3f8", "de696fdd-0e99-4d29-840d-4e198f1b908c", "241710d5-bcef-4852-a09c-0e681250e6aa", "c2571299-d298-49de-84b3-be58dd9451ec", "08c351f4-afdd-4e86-8f95-b008922e535e", "d76a18c6-fe25-4fca-9110-64a26a54f63f", "a185b361-cf81-4912-8020-d8f778903597", "ce0e39ea-0d29-4922-95cb-8777326a994e", "8a5a69da-3a67-4ecc-97d1-39ffea001485", "4aedf984-0009-404b-8c21-8af5f225f9db", "36acfd2a-4d54-46f2-bd9d-4b30eaa2cabe", "3ffa405e-bc85-4614-afd0-7a8dfc288dad", "34acb853-6632-49cd-970a-e6fd840852d3", "01af6236-f4ba-5999-e063-6394a90a3806", "2875fd94-dabd-960e-e063-6394a90a623c", "33e9f14f-e971-4fbb-9912-991661ae4d05", "b45a96e7-fbe0-e686-e75d-1629dd2cda40", "b6311ca1-253b-4acd-ba12-5bc50761a455", "99940a26-a005-4bc3-a9cb-33fd6475132d", "39520d4f-2d17-49d3-9734-a5e57ad6284f", "319f7550-dc5a-49eb-9ef9-3eb602cd8af9", "c6116c01-663b-4e6f-ae74-7930ff6fdbca", "21af0de6-18c5-b8e8-e063-6394a90af51f", "869e7d93-e5d5-4093-8f85-b3aceffc908c", "82462011-668a-4fbd-9653-48049901eacc", "041ec6f5-5445-4403-9e76-12c2cda8eea7", "f79353ac-03fd-35b1-e053-6394a90a86ae", "86987736-810a-4fda-93b9-2f62faf9e607", "b7a57732-f641-4f06-aff4-7ee6a96b3025", "f58d95e7-ece2-4080-adf8-8cb66cd19d71", "a76613fb-27ac-4c92-86c0-220e9ae06c55", "99698eea-6bf1-42e8-9f48-d58fc0437324", "206161c2-b8ce-04c1-e063-6294a90ac404", "b8b7bb2e-3c48-4aba-a4cb-b33b70383fd0", "cfef527e-520d-460c-9658-c51195beb1ee", "39334fb3-e395-7819-e063-6294a90a9073", "80ef8ca0-0d3d-400f-be18-9b125b11ee76", "545929ff-ca70-7cec-e063-6294a90a12db", "23381364-14e1-4f63-aea4-66d605fd14f1", "7718b199-6ce8-41c1-90fe-533d5a6d26cc", "ea50552f-f9b9-467f-a925-62ff027df607", "987a1083-d606-4ebf-bf83-2742128915d8", "0e8487fc-3e0e-bbfc-e063-6394a90a3073", "a437ab2b-07b7-44d2-8326-3de4df3c7b88", "21953598-e7ec-45c2-8fca-05550a1ddf38", "288ab319-e163-0a6b-e063-6394a90a9205", "1180f756-b6a5-4bc8-a16d-f54945aa6232", "14a35301-b682-06ca-e063-6394a90a7bc6", "bb9e28a8-1076-4c48-9a19-cc43bcd64862", "3ed850a5-b60a-42b5-8134-36d68300e31f", "7411dc23-e297-42cb-b491-b90d70c841a3", "37e78f4b-58fb-8c28-e063-6294a90ad0b0", "3f788e2f-ca72-48dc-9c29-866f5a6137c6", "54593493-aee3-759e-e063-6394a90a4b60", "36d0b020-635f-6e30-e063-6394a90a0053", "7d2d8240-b53a-4395-bd8d-d326522d5865", "4f159fc7-8379-465d-9a92-d3c8bffefdc6", "80d877f6-38a1-49d8-96ac-40b56c87cd02", "04ba0afe-908e-4948-a757-44b59de09ae3", "9a5fcce4-20af-4bb7-ad99-85b37d8e2ff6", "21af4ff4-5892-565e-e063-6394a90aa728", "03961211-aab3-1a19-e063-6394a90a2268", "18567eaf-6b97-8c6f-e063-6294a90a986d", "b70c77e5-838a-45e6-955a-79747d3227ed", "1e0b3110-f090-418a-9ade-612f7e8ff90f", "cec5a9cd-3305-4318-873c-89da025ae1ee", "a781400e-15a6-4d62-abb7-c92680a18e51", "ec5e06f5-b43c-4f18-848f-590cb7948210", "7753e6db-5fe8-4b35-8817-c50abda35144", "ee807d5f-c588-4526-a1fc-6ae83a5aedb2", "8459c675-5144-445c-afdb-c09b445fc14b", "4276c109-6851-5045-e063-6294a90a592e", "d36b4f1f-6750-4477-b78c-f2ae89eec9c8", "8dd0ce14-1eb8-4c4a-9f4a-2671fabfa7c0", "ddc06a12-1bc6-4006-ba9c-ed389599b532", "266982a6-6b63-69ae-e063-6394a90af64a", "b30502a9-c0c8-909c-ec34-956a5e058223", "3f43a0a4-1606-4d45-95c0-46b73e504010", "01351d50-0222-4f6c-93cc-66b2afb98669", "14c82153-53c9-4457-8cd3-fbb045885412", "f1138f9a-9f0a-46ee-b1de-ee1baea25269", "48e68389-fd2a-42d7-baf2-55dc94eed23c", "d8272405-523e-4572-ac4c-721ef990cf51", "5a3e9c70-b8f8-4866-b128-9f50272c03c0", "f02c31f3-5512-4d89-b91e-ec7505a3ced8", "a86c3104-c728-4a39-af2b-f42a6909025d", "a2adad08-283e-4617-b3db-1eade7f5b296", "7fb4e13d-ec82-e5a6-6cd5-f0f6eebf7635", "6a60f2e7-461e-4049-aed2-cf0f8a015c58", "889e4edf-e58d-4fa4-8ed1-5b4eab8c8e49", "369ae213-cd24-57ba-e063-6394a90a87a6", "0829b878-8bb7-4881-b22b-c51c7c027f5c", "6363f098-8bab-4879-bea8-41b60c4530eb", "53be867e-a578-91cd-9f9d-a0bec097a4ae", "458b9ea6-72d7-b5af-e063-6294a90a4430", "4a227807-355e-b37d-e063-6394a90a7639", "4bbca900-8593-427c-8595-c5c6c3456967", "12f9b308-9375-2df3-e063-6394a90a8d22", "ad62930b-1add-4138-b290-5174d04508e1", "e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82", "0fc43ab9-0e23-258f-e063-6394a90a0c40", "a8383769-ce8b-43eb-b1a6-5d73e7fcf30d", "0842b304-df34-4844-b70e-ce059c9a9edb", "d51e75bd-4703-4fc4-b5cd-94b17f72b9a6", "40a6d1b8-f8bd-4d21-9bde-425d5e9e2c8b", "d4587b3e-852f-49b4-8237-1cd6e20e063a", "aadf717d-08e0-4aa5-9cfd-6ab895f9f6f4", "3b0aa4df-ee1f-e4e3-e063-6394a90a4c66", "7330a3e3-b645-4725-9565-41a7540a1b18", "1a55314f-d2d3-420c-af92-e4fdf1de9f57", "cba9708b-b93e-421d-8b48-a631d496ceff", "5502899d-30bd-4954-8aae-9ab1c034f65f", "d614f778-d1b8-4fa4-94f8-59978dfbfb52", "0e79e056-7032-43ba-8e0d-92d5d7ee7180", "8c901736-6453-4cbd-824d-073bc083e6aa", "186342b3-2a01-4582-8978-41f059d4307d", "563bca3a-1a43-4520-ac66-3aecd0d3c5fd", "c43bc6c6-105f-4e21-b6ec-11e87ce0e847", "42c9eb63-96d0-3757-e063-6394a90ad58f", "1a96c8a0-8899-41e4-8038-dac06cbf5a10", "1eef1d05-229f-48b0-b8da-d4d35c2986f5", "106cff2c-1d3b-4f5d-ab79-5f67e04594d6", "16e4c5b4-83a7-4b23-b77f-e742ed68c9df", "8fa9902c-ea0d-489f-99dc-d47cb615d471", "707e6805-7f07-43d1-b65b-4afbb9e9e95e", "10efebb0-5d63-4c46-8934-9e91b213a543", "2b99e188-08ce-4160-bf19-136bc4dd39be" ], "spl_set_id": [ "287525d8-83ef-7110-e063-6294a90ad373", "34034d16-dc3b-436d-8ec8-84b3c1f8e48a", "3455be3c-696e-402a-a5df-830544fa525a", "813d742f-8f3d-4f18-a6c5-03eea946f976", "89f60eb1-359b-40e8-ae8b-65aec9cd5b1f", "902b5d4b-1707-4312-9f46-ef5ab86b00f0", "c97851ef-7b49-4f6c-b165-147555db101a", "018b02e8-1005-4736-a4fc-962881f52adf", "756c7234-6a63-4b1b-be36-2b1ed09e67a0", "8e41e259-b161-4f11-a6f7-14e6b60885b8", "cbe72270-b172-4662-9b9b-557e8cf53ffe", "cdb6caa5-5be6-4597-a930-b8c816ac3040", "ea1c2838-acbd-18e0-e053-2a95a90a3522", "f149ecc1-d66c-42f9-a3f4-2ab6a522942b", "f3d08f06-a676-43b0-8f77-611f0af737a7", "43fb44ea-07a1-4df9-8b4a-b2249757208e", "f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9", "4c6f4f9e-f3f5-4ecf-9f40-887e037e8847", "5c6c6665-cb0a-41d1-af28-85b4f061bd1b", "a5d88925-efca-4240-9eb5-6a9d0ac7a67e", "f2b911c7-ce24-4d3d-8fb6-c34980191f40", "f347f870-1da4-4a77-8c20-63b703d24071", "0f34a3be-7554-4040-b808-5ba8bf064abc", "42392cb1-7958-4a2f-8622-f00f02afd961", "9ddfb9fd-1b84-4e9a-90b5-6a3362d345dd", "b0798337-1a73-415e-8416-613984ce5c65", "e49e087c-ee20-3174-e053-2995a90a1d09", "0c480ba4-b07e-4109-a9a9-5480b4a39a1d", "1fdf16e5-145d-4c19-a318-fc6c10794b50", "354a5a02-45cb-4ab0-88ee-6635d5a43b01", "45789b7a-e9c7-4813-b07b-f88d9108455d", "c0e15f57-ab20-4030-b1d1-6aff33be7d76", "a3ba9983-6747-45b2-b270-4ac1fb9d6e40", "adbf2c58-cd1c-4444-b133-21a18a348931", "ea7287a4-75e0-39d2-5b2e-b72b7cb386b9", "ebe3ca30-df25-4c56-8935-414a3431b5b9", "f18c1195-48a1-69dc-e053-2a95a90a4077", "2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c958", "52e3b2f5-f3b9-4f4e-a70f-322eb04e6e8a", "7b550cf9-221f-4f28-ba99-414ad7d5612f", "7c0f3fa5-0a44-4a98-bc43-8bff8e95c462", "88722f84-dac8-4130-93b3-9e0dc1cc5acc", "8c7ca3cc-ff90-42a7-9218-554cf15348a3", "f9f4a91c-60a2-4893-88e6-639d24237375", "04aaf296-f136-29d7-e063-6294a90affe1", "273deac8-c2b0-423f-8662-4f16d91df216", "bc548297-7646-4dbf-bfc5-65f2bc629676", "ce533636-cc9b-45d0-87a6-5390377ff28a", "0983cef7-b8b6-4ed9-a01e-c699fa6d2d06", "2f0f90cf-8f9a-4102-aab6-941aa0d35e4f", "7357f67e-0fc6-4555-aa8b-1df09cba9feb", "19fe7c6e-243c-4005-a63a-f8cac1ce55c8", "2caaf94b-b382-4573-8614-57815776b659", "7824fdab-cdd5-457d-9b14-b82b19ea9529", "7e0da8be-b001-400e-99d1-37f335b1d7b3", "8c6d5419-088b-4b3e-80b8-2a0d06926ff1", "3ffa405e-bc85-4614-afd0-7a8dfc288dad", "74a24590-a0b6-4607-8e67-9fadce53389b", "f2c031b4-de86-3a8e-e053-2a95a90a21e0", "287601b0-04ba-9611-e063-6394a90a9180", "8c17f9e3-9827-4bf9-85ca-72e08a8518ca", "937f7bce-955b-9418-5aed-2e84aee50de3", "9826dd26-5592-4f96-9274-005ef9462cb4", "8aac5a0d-074b-4cf4-ab10-549e1ed09e2f", "8f654234-b25d-47d6-b1f8-f7f353569795", "c7cb4e19-3442-45d2-b60a-87d4beea862a", "f5c0ff75-77da-443c-a510-9c6a065ddc6c", "2854047f-c5c4-43c3-8ef2-5c0a84a307f2", "6d0d8839-0680-45f6-96db-2d8edc9d4682", "a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8", "a88e7069-230c-4105-ade0-a98968e18671", "befd8d44-c6f7-eca2-e053-2995a90a714b", "f40f1dcf-249a-4ccb-bdfc-acff49dd4a15", "05c03fd8-abc8-47f7-868c-895b9a38c5b3", "8ac94821-aa78-4e57-bc9a-f1f2a0e47b07", "98c6ddc9-8103-40b3-a145-ffbe3374ab6c", "99698eea-6bf1-42e8-9f48-d58fc0437324", "a8b5c855-053d-4295-8f57-1a96a6ccaa92", "140f0e60-c809-4d86-a750-7649ee2881b5", "206f5483-7de1-4bc3-af27-190e211bcb95", "33dc93a5-ee03-2e68-e063-6294a90aeee1", "39cb0f15-d177-46eb-a549-7acb885fbf07", "795afb99-a3f4-4ffc-a905-2f84f3d86e4c", "be69d9f9-f4ad-4cfe-bab2-e07186b25c1e", "cdd509c4-331b-4aee-935c-dfc44d5943ed", "ea50552f-f9b9-467f-a925-62ff027df607", "ed32f72a-e220-440f-a74f-b754a313f004", "14406cd8-468b-403d-9be2-43decd304214", "1531aa51-02e9-45ed-99aa-53b21732dd2e", "21953598-e7ec-45c2-8fca-05550a1ddf38", "288a8f87-e84a-a77a-e063-6294a90a86db", "479a1437-a212-49d9-b272-758c0e5b7203", "6daf1ebe-b0a2-4413-bf25-3de6eb64b0c6", "97c33213-f415-4718-8466-9aa50371af70", "9ff8539f-cdcd-4823-8baa-10a249c9220d", "aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7", "140440fb-d420-490d-8d7d-4b01c8ed3a83", "373f5e28-e9e2-4af7-8a27-29b5d8f28b50", "6d97c60e-e39d-4541-ab49-d0fe3b3fa840", "9974aa5e-e03f-4459-934a-ece27a830746", "a06502d9-7903-4f37-833e-e5763d502def", "c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe", "cc77f6ff-a534-4731-b971-491280840899", "e3b13e23-122b-4bd4-95cf-b5a14b7afc05", "f6f07e25-2b31-b0c4-e053-6294a90a8ffb", "0f343092-4fc7-1fff-e063-6294a90aba6e", "8e7f9c85-d165-47c7-8950-b22adcd6cece", "07a924f1-14cc-4e7d-e063-6394a90ac7f3", "4dc7c2c4-83c7-608d-e063-6294a90a90eb", "78b168f1-846d-4e88-a8ee-845c41c9dcbe", "b2228be0-472b-4e47-9910-af0bf12fde77", "c16d9977-39ad-4386-8867-72aab97c99d5", "443e8ea6-7d51-4db7-8f0b-7a854d45bf23", "45df5fae-b28a-4b48-95ef-96e4faad883f", "88ac92eb-5684-46c8-8cd2-3d4aefee26cf", "93c857e4-72b3-433e-ae6f-281cd57e3996", "a12ec91d-244f-45c5-8590-d1e4485fe361", "e9ded705-85c7-1380-e053-2995a90a68ec", "81b105a1-01fe-51d7-e053-2991aa0a71bc", "bb602b05-0ce6-4029-bd6e-291076e64efb", "d528fadf-316f-4fea-9bec-070c01f80d64", "06d286ce-14b3-4b66-8b42-ac4a10a0fc90", "15b87f7f-1abf-4d8a-bdbe-03bea0021a68", "27ecf5c1-202a-44cf-94f9-d7fefa027e1e", "5995d726-f3f8-4c2d-af19-1b12e3f769c6", "d0f74e78-7afb-49c2-e053-2a95a90a31dc", "10ed726b-9792-4d8d-e063-6294a90ae61d", "2766ffe7-2f1c-48c8-8f67-0a2819dcc3be", "b165979b-7ed0-423e-9aeb-2e061df0cd45", "c4e1ef3d-7391-66f5-e053-2995a90abc00", "f38f8a8f-3292-4fe5-b83f-ffd634196d42", "b481dd30-7d64-43ec-85d4-2289db62cad7", "0f81e8ac-ddad-13d6-e883-6a5310e058de", "15973213-0e11-4d18-b437-50b0a593cb7b", "263ee489-fc3f-4578-b3a5-44f6d7757898", "369ae213-cd23-57ba-e063-6394a90a87a6", "94fbcebe-7d75-47c1-9eca-cfa9b952a3d5", "1c2cfb3c-eaa0-403f-9589-d706afc06f51", "27314f55-5e31-703c-b98c-ec89bf308472", "4e02a443-1e4c-46a5-8323-03d749b8634a", "54f4086f-e443-4e7e-8c7e-94e152e1c256", "be275c48-18bf-45f6-891d-36d89327813e", "fe25e1e2-7158-6fe0-e053-6394a90a3bb1", "381db08e-5756-4255-8202-1d8e6a1cf038", "387088a6-8eaa-fc49-8050-a546d0f0fd32", "4e5db906-992f-476b-9d97-63a4c582bbdc", "a8383769-ce8b-43eb-b1a6-5d73e7fcf30d", "c4e35c7e-5c2f-4252-e053-2a95a90a8268", "d8df03ab-7c5c-4c8b-a3fb-6c6081e081e7", "f6f0230c-44fb-6c36-e053-6394a90ac43e", "5b161f25-c578-4ff4-a931-ff3a1e681c50", "ca5edcf8-1ed2-403a-a01b-0deb692bee0c", "1756ab7d-05c4-4726-8f72-4e8363440968", "316e3815-6ae1-47c3-8a75-fd57f8434a6f", "d5d96078-ba87-4593-b15b-b7a646a8ab10", "4b78d0c8-7d0c-45e6-9b36-b248f002f2b8", "95f51f27-d367-4cfd-a15f-7856c9e361fb", "a0f2683f-59ad-4f65-a108-696430d577ab", "fadb9d53-4cc6-83d6-e053-6394a90aa2e3", "044a510f-33df-4484-8f07-d821f52b9376", "18066b80-1ec6-4092-80d9-70adb0ecac85", "321b83f9-4bbf-494a-9279-80b0742049b6", "679cdecb-9e25-4f43-b4f4-7f5f3fbf2296", "70714491-1368-4824-98af-03fda52139a9", "8d57f6db-a9f0-4416-9f49-17ce3571b0aa", "ed474c9d-c08b-4f52-8b24-5887978e4275", "f692ed61-d09a-484e-bf07-8afcedfb3208", "fadbd056-6510-f864-e053-6294a90aa67b", "9710995d-b518-40ce-bc2b-8b5dcf002c31", "a8010e10-68fd-455f-968f-d62a1c3e0ffd", "adc2721d-2ca7-4a47-bae1-be298fa1c155", "ee0a263e-3f78-4534-9a30-803de636f92b" ], "package_ndc": [ "70000-0710-1", "11822-1014-0", "56062-088-02", "37808-301-65", "37808-301-72", "41167-0360-2", "41167-0361-0", "41167-0361-2", "41167-0361-4", "41167-0361-9", "41167-0361-6", "41167-0361-8", "41167-0361-1", "31722-017-01", "31722-017-10", "31722-018-01", "31722-018-05", "31722-018-10", "30142-194-71", "30142-194-02", "30142-194-72", "30142-194-01", "30142-194-98", "49035-589-19", "49035-589-77", "58602-705-15", "58602-705-19", "58602-705-84", "58602-705-03", "58602-705-09", "58602-705-12", "58602-705-93", "58602-705-14", "58602-705-34", "58602-705-39", "58602-705-44", "58602-705-40", "58602-705-88", "58602-705-41", "58602-705-32", "70954-316-10", "37808-042-82", "37808-042-63", "37808-042-71", "0536-1298-01", "41226-719-06", "41226-719-09", "62332-001-30", "62332-001-31", "62332-001-71", "62332-001-91", "62332-001-10", "62332-002-30", "62332-002-31", "62332-002-71", "62332-002-91", "62332-002-10", "21130-521-82", "49035-505-35", "49035-505-14", "49035-505-21", "49035-505-34", "49035-505-95", "49035-505-80", "49035-505-39", "54257-802-02", "0172-5728-60", "0172-5728-70", "0172-5728-80", "0172-5729-60", "0172-5729-70", "69168-445-32", "69168-445-52", "46122-735-75", "46122-735-65", "58602-706-53", "58602-706-56", "58602-706-14", "58602-706-16", "58602-706-54", "58602-706-47", "58602-706-18", "58602-706-50", "58602-706-21", "58602-706-60", "58602-706-62", "58602-706-94", "58602-706-79", "58602-706-15", "58602-706-34", "58602-706-39", "58602-706-44", "58602-706-40", "58602-706-88", "58602-706-41", "58602-706-19", "51316-511-63", "51316-511-71", "51316-511-78", "68475-400-01", "0363-0701-71", "0363-0701-72", "0363-0701-01", "0363-0701-02", "0363-0701-39", "0363-0701-82", "0363-0701-98", "21130-771-75", "65862-859-30", "65862-859-01", "65862-859-05", "65862-859-99", "65862-859-10", "65862-859-78", "65862-860-30", "65862-860-01", "65862-860-05", "65862-860-99", "65862-860-10", "65862-860-78", "69256-002-47", "70677-1101-2", "70677-1101-1", "0641-6021-01", "0641-6021-10", "0641-6022-01", "0641-6022-25", "0641-6023-01", "0641-6023-10", "0641-6023-25", "50383-913-40", "11822-1194-1", "11822-1194-2", "11822-1194-4", "11822-1194-3", "11822-1194-5", "69367-400-10", "69367-401-10", "56062-141-65", "21130-249-65", "21130-249-75", "70377-113-11", "69230-326-30", "69230-326-60", "69230-326-01", "69230-326-05", "69230-326-10", "69230-327-30", "69230-327-50", "69230-327-01", "69230-327-05", "69230-327-10", "21130-191-20", "25021-753-02", "25021-754-04", "25021-754-20", "72288-141-65", "72288-141-75", "72865-214-30", "72865-214-01", "72865-214-18", "72865-214-05", "72865-215-30", "72865-215-01", "72865-215-18", "72865-215-05", "46708-293-30", "46708-293-31", "46708-293-71", "46708-293-91", "46708-293-10", "46708-294-30", "46708-294-31", "46708-294-71", "46708-294-91", "46708-294-10", "36800-141-72", "36800-141-65", "36800-141-75", "68001-397-00", "68001-397-08", "68001-398-00", "68001-398-03", "68196-121-78", "68196-121-00", "72603-171-01", "10267-5689-1", "10267-5689-5", "10267-5689-4", "10267-5690-1", "10267-5690-5", "10267-5690-4", "72036-026-53", "72036-026-14", "63323-739-41", "63323-739-16", "72288-194-82", "72288-194-71", "72288-194-02", "72288-194-00", "72476-150-63", "69842-063-84", "69842-063-19", "69842-063-79", "41167-0364-0", "41167-0364-1", "68180-150-01", "76162-300-71", "0527-5190-80", "11822-6123-0", "55910-814-71", "72205-145-30", "72205-145-91", "72205-145-05", "72205-145-99", "72205-145-50", "72205-145-98", "72205-146-30", "72205-146-91", "72205-146-05", "72205-146-99", "21130-027-05", "57896-317-06", "57896-317-03", "70771-1702-3", "70771-1702-1", "70771-1702-5", "70771-1702-0", "70771-1702-2", "70771-1702-4", "70771-1703-3", "70771-1703-1", "70771-1703-5", "70771-1703-2", "70771-1703-4", "70771-1703-0", "68016-800-30", "68016-801-25", "11822-6141-0", "11822-6141-2", "59640-001-63", "72476-299-71", "59779-141-60", "59779-141-72", "59779-141-75", "59779-141-39", "55910-141-60", "55910-141-72", "55910-141-75", "16837-855-05", "16837-855-25", "16837-855-49", "16837-855-50", "16837-855-52", "16837-855-65", "16837-855-67", "16837-855-70", "16837-855-75", "16837-855-90", "16837-855-80", "16837-855-85", "16837-855-09", "16837-855-12", "16837-855-13", "16837-855-14", "16837-855-15", "16837-855-17", "16837-855-18", "16837-855-40", "16837-855-51", "16837-855-16", "16837-855-20", "16837-855-19", "16837-855-24", "16837-855-02", "58602-859-50", "58602-859-34", "43386-500-11", "27241-249-49", "68001-494-04", "68001-494-06", "41163-001-51", "41163-001-02", "41163-001-71", "41250-493-65", "41250-493-72", "49035-650-63", "49035-650-71", "49035-650-72", "49035-650-78", "49035-650-82", "0363-0141-65", "0363-0141-75", "0363-0141-48", "0363-0141-39", "55319-408-01", "55319-409-01", "55319-409-02", "55319-409-03", "61442-121-30", "61442-121-01", "61442-121-05", "61442-121-10", "61442-122-30", "61442-122-01", "61442-122-05", "61442-122-10", "59640-023-71", "41520-707-02", "41520-707-71", "72559-038-23", "0113-0194-02", "0113-0194-63", "0113-0194-71", "0113-0194-82", "0113-0194-00", "55681-343-03", "67877-842-01", "67877-842-10", "67877-842-05", "67877-889-01", "67877-889-05", "70000-0048-1", "67877-843-01", "67877-843-05", "54257-180-07", "66715-9748-8", "59779-194-72", "59779-194-71", "59779-194-78", "59779-194-51", "59779-194-02", "59779-194-63", "59779-194-82", "59779-194-98", "72205-233-84", "57896-319-01", "69842-087-53", "69842-087-14", "69842-087-21", "69842-087-80", "69842-087-79", "83324-003-30", "83324-008-50", "0338-5197-41", "70677-1102-1", "70677-1102-2", "70677-1102-3", "63323-739-11", "63323-739-12", "37835-165-50", "69842-659-63", "69842-659-71", "55681-342-03", "37835-161-50", "0187-4420-30", "0187-4420-10", "0187-4440-30", "0187-4440-10", "36800-194-71", "36800-194-51", "36800-194-02", "36800-194-78", "0113-0141-65", "0113-0141-90", "0113-0141-75", "67457-433-00", "67457-433-22", "67457-448-00", "67457-448-43", "67457-457-00", "67457-457-20", "21130-039-09", "21130-039-19", "16837-889-20", "16837-889-40", "31722-063-31", "11673-697-52", "11673-697-05", "11673-697-01", "11673-697-20", "55319-057-25", "55319-057-50", "55319-057-10", "70000-0049-1", "67877-775-89", "0363-1203-71", "60219-2090-4", "80005-119-16", "43598-572-11", "68391-300-78", "68391-300-82", "68391-300-05", "68391-300-85", "83059-0031-5", "0363-9607-09", "55315-435-53", "69238-2090-4", "0832-6045-50", "0832-6045-10", "0832-6045-15", "55111-119-30", "55111-119-01", "55111-119-10", "55111-120-30", "55111-120-01", "55111-120-10", "64980-623-01", "64980-623-50", "64980-623-10", "64980-624-01", "64980-624-50", "64980-624-10", "58602-828-19", "63323-738-03", "63323-738-09", "63323-738-06", "63323-738-20", "0363-1899-53", "0363-1899-14", "0363-1899-24", "0363-1899-34", "72288-363-53", "72288-363-14", "72288-363-34", "72288-363-40", "0363-5300-53", "0363-5300-14", "0363-5300-50", "0363-5300-34", "0363-5300-47", "70710-1683-3", "70710-1683-1", "70710-1683-5", "70710-1683-0", "70710-1683-2", "70710-1683-4", "70710-1684-3", "70710-1684-1", "70710-1684-5", "70710-1684-0", "70710-1684-2", "70710-1684-4", "69842-928-84", "79903-115-99", "43602-511-30", "43602-511-03", "43602-602-30", "43602-602-03", "55319-426-60", "55319-427-25", "55319-427-50", "55319-427-10", "49035-507-75", "41250-712-02", "41250-712-71", "41250-712-78", "54473-411-50", "54473-411-01", "72288-329-78", "71821-012-09", "71821-010-13", "21130-022-30", "21130-023-25", "83059-0005-5", "16837-872-10", "16837-872-30", "16837-872-31", "16837-872-60", "16837-872-90", "16837-872-20", "16837-872-22", "16837-872-75", "0904-5529-87", "0904-5529-52", "49483-720-20", "49483-720-01", "42507-194-01", "42507-194-50", "42507-194-71", "42507-194-00", "42507-194-78", "55111-118-30", "55111-118-40", "55111-118-60", "55111-118-90", "55111-118-04", "55111-118-18", "55111-118-24", "55111-118-35", "55111-118-81", "55111-118-79", "55111-118-12", "55111-396-35", "55111-396-50", "55111-396-65", "55111-396-90", "55111-396-44", "55111-396-01", "55111-396-13", "55111-396-32", "55111-396-08", "55111-396-16", "71821-012-08", "71821-010-12", "55910-665-71", "55910-665-78", "69842-924-53", "69842-924-14", "69842-924-24", "46122-737-63", "46122-737-71", "21130-033-53", "21130-033-14", "21130-033-34", "58602-829-21", "58602-829-50", "58602-829-34", "21130-777-02", "21130-777-71", "21130-777-82", "42571-433-45", "0363-4400-19", "0363-4400-84", "0363-4400-32", "63981-194-96", "63981-194-85", "63981-194-01", "63981-194-05", "41163-313-65", "41163-313-72", "72657-112-90", "72657-112-20", "72657-113-88", "72657-113-20", "72657-132-01", "42507-141-65", "42507-141-72", "42507-141-90", "42507-141-75", "63941-009-09", "70756-051-11", "70756-051-12", "70756-052-11", "70756-052-12", "59651-701-50", "70000-0654-1", "55910-194-02", "55910-194-39", "55910-194-71", "55910-194-51", "55910-194-82", "55910-194-78", "62135-807-90", "62135-808-90", "72288-151-75", "41520-901-72", "41520-901-65", "56062-194-71", "56062-194-02", "63941-011-53", "25021-755-05", "25021-756-10", "25021-756-50", "68382-444-05", "69168-443-32", "69168-443-52", "69168-443-09", "69168-443-50", "69168-443-99", "0904-5780-51", "0904-5780-17" ], "nui": [ "N0000000151", "N0000175784" ], "pharm_class_moa": [ "Histamine H2 Receptor Antagonists [MoA]" ], "pharm_class_epc": [ "Histamine-2 Receptor Antagonist [EPC]" ], "unii": [ "5QZO15J2Z8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RISEDRONATE", "drugstructuredosagenumb": "17.5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "17.5 MG, WEEKLY (17.5 MG ONCE WEEKLY, UPON GETTING UP IN THE MORNING (ON MONDAY) 1 TABLET/TIME)", "drugdosageform": "TABLET" }, { "drugcharacterization": "2", "medicinalproduct": "ELCATONIN", "drugdosagetext": "(20 UNITS ELCATONIN)/TIME WEEKLY", "drugdosageform": "INJECTION", "drugadministrationroute": "030" }, { "drugcharacterization": "2", "medicinalproduct": "ELCATONIN", "drugdosagetext": "NO. 3 FLUID THERAPY BY INTRAVENOUS DRIP AT RATE OF 500 ML EVERY 24 HOURS WHEN FEVER", "drugdosageform": "INJECTION", "drugadministrationroute": "041" } ] } }, { "safetyreportversion": "1", "safetyreportid": "10013004", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20140314", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2014071294", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014071294" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "36", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Fluid retention", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Muscle twitching", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "LYRICA", "drugauthorizationnumb": "021446", "drugdosagetext": "UNK", "actiondrug": "1", "openfda": { "application_number": [ "NDA021446", "NDA022488" ], "brand_name": [ "LYRICA" ], "generic_name": [ "PREGABALIN" ], "manufacturer_name": [ "Parke-Davis Div of Pfizer Inc", "Viatris Specialty LLC" ], "product_ndc": [ "0071-1018", "0071-1012", "0071-1013", "0071-1014", "0071-1015", "0071-1016", "0071-1017", "0071-1019", "0071-1020", "58151-236", "58151-237", "58151-238", "58151-239", "58151-240", "58151-241", "58151-243", "58151-242", "58151-244" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREGABALIN" ], "rxcui": [ "483438", "483440", "483442", "483444", "483446", "483448", "483450", "577127", "607018", "607020", "607022", "607024", "607026", "607028", "607033", "607038", "898715", "898718" ], "spl_id": [ "e7c79058-03ba-4e7f-9a31-9ec5ce245161", "1c2af07d-faf4-4fc7-b724-c5166746956d" ], "spl_set_id": [ "60185c88-ecfd-46f9-adb9-b97c6b00a553", "d4734e7d-5079-455e-8ff5-8f4539c998a9" ], "package_ndc": [ "0071-1012-68", "0071-1013-41", "0071-1013-68", "0071-1014-41", "0071-1014-68", "0071-1015-41", "0071-1015-68", "0071-1016-41", "0071-1016-68", "0071-1017-68", "0071-1019-68", "0071-1018-68", "0071-1020-01", "58151-236-77", "58151-237-32", "58151-237-88", "58151-237-77", "58151-238-32", "58151-238-88", "58151-238-77", "58151-239-32", "58151-239-88", "58151-239-77", "58151-240-32", "58151-240-88", "58151-240-77", "58151-241-77", "58151-243-77", "58151-242-77", "58151-244-35" ], "unii": [ "55JG375S6M" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE", "drugdosagetext": "UNK", "actiondrug": "5", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "1", "medicinalproduct": "H.P ACTHAR GEL", "drugdosagetext": "UNK", "drugindication": "NEPHRITIC SYNDROME", "drugstartdateformat": "102", "drugstartdate": "20131116", "actiondrug": "5" }, { "drugcharacterization": "1", "medicinalproduct": "H.P ACTHAR GEL", "drugindication": "GLOMERULONEPHRITIS CHRONIC", "actiondrug": "5" } ] } }, { "safetyreportversion": "1", "safetyreportid": "10013846", "primarysourcecountry": "JP", "occurcountry": "JP", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140316", "receiptdateformat": "102", "receiptdate": "20140316", "fulfillexpeditecriteria": "1", "companynumb": "JP-MERCK-1403JPN004702", "duplicate": "1", "reportduplicate": { "duplicatesource": "MERCK", "duplicatenumb": "JP-MERCK-1403JPN004702" }, "primarysource": { "reportercountry": "JP", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "12", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Bronchopulmonary aspergillosis", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "DEXAMETHASONE", "drugauthorizationnumb": "12675", "drugdosagetext": "UNK", "drugdosageform": "Standard Solution", "drugindication": "HISTIOCYTOSIS HAEMATOPHAGIC", "openfda": { "application_number": [ "ANDA216283", "NDA022315", "ANDA217695", "ANDA216282", "ANDA088481", "ANDA216284", "ANDA084754", "ANDA217001", "ANDA215106", "ANDA215604", "ANDA217696", "ANDA201270", "ANDA088149", "ANDA091188", "ANDA218372", "ANDA080399", "NDA013422", "ANDA090891", "ANDA088248", "ANDA084612", "ANDA216295", "NDA211379", "ANDA217538", "NDA208742" ], "brand_name": [ "DEXAMETHASONE", "OZURDEX", "DEXAMETHASONE 1.5 MG", "MAXIDEX", "HEMADY", "DEXTENZA" ], "generic_name": [ "DEXAMETHASONE", "DEXAMETHASONE 1.5 MG" ], "manufacturer_name": [ "Zydus Lifesciences Limited", "Allergan, Inc.", "Apotex Corp.", "Alvogen Inc.", "Viona Pharmaceuticals Inc", "Marlex Pharmaceuticals, Inc", "Bionpharma Inc.,", "Kesin Pharma Corporation", "Amneal Pharmaceuticals NY LLC", "ANI Pharmaceuticals, Inc.", "Larken Laboratories, Inc.", "Pangea Pharmaceuticals, LLC", "NorthStar Rx LLC", "Chartwell RX, LLC", "Advagen Pharma Ltd.", "Kanchan Healthcare Inc", "Prasco Laboratories", "Harrow Eye, LLC", "PD-Rx Pharmaceuticals, Inc.", "Rising Pharma Holdings, Inc.", "Hikma Pharmaceuticals USA, Inc.", "Edenbridge Pharmaceuticals LLC.", "Ocular Therapeutix, Inc." ], "product_ndc": [ "70771-1701", "0023-3348", "60505-6249", "60505-6250", "60505-6251", "60505-6252", "60505-6253", "60505-6254", "60505-6255", "70771-1699", "70771-1700", "70771-1704", "70771-1705", "70771-1707", "47781-914", "47781-916", "72578-166", "70771-1706", "10135-795", "69452-277", "69452-278", "81033-010", "60219-2043", "60219-2044", "70954-398", "70954-401", "70954-403", "70954-404", "70954-402", "70954-399", "68047-702", "81279-117", "72603-187", "72603-189", "72603-190", "72603-188", "72603-213", "72603-212", "62135-114", "72888-235", "72888-236", "72888-237", "72888-238", "72888-239", "72888-240", "72888-241", "70954-872", "85742-004", "66993-730", "82667-600", "72789-534", "72578-168", "72578-171", "72578-172", "72578-169", "72578-170", "64980-509", "0054-3177", "0054-4179", "0054-4180", "0054-4181", "0054-4182", "0054-4183", "0054-4184", "0054-4186", "0054-3176", "0054-8179", "0054-8180", "0054-8174", "0054-8181", "0054-8176", "0054-8175", "0054-8183", "60219-2056", "82111-955", "69452-276", "70382-204", "72578-167" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVITREAL", "OPHTHALMIC", "INTRACANALICULAR" ], "substance_name": [ "DEXAMETHASONE" ], "rxcui": [ "197581", "854177", "854181", "197577", "197579", "197580", "197582", "197583", "343033", "309686", "759481", "759697", "846192", "197576", "205669", "309692", "309684", "2261802", "2286261", "2108015", "2108020" ], "spl_id": [ "6a9c20d5-8b08-4b8e-b422-705383158851", "007c310d-2cfe-4c54-a27e-693e0d7fa78a", "4267b6d1-37d3-7ed2-7a89-251185401d0d", "ebc1bd42-82a5-40dc-ab21-b8d5252518b3", "f5d1d20f-dcb0-9ddf-b436-165cf014f5fa", "57d9469e-8d0d-4a58-a56c-3c266fe36b74", "232c68af-fb83-4b93-9e16-9803c8e680c0", "59cae836-8f84-4276-9289-73ae101b8ddf", "2f9dcbaf-165e-5594-e063-6394a90a9dc5", "43e2a256-e024-5661-e063-6394a90af0e9", "574d26cb-6ade-4619-be52-ef855081c8da", "75141974-8862-4da7-9253-a338cb1fdb84", "4134ccdd-0287-cdf7-e063-6394a90a766d", "55650684-ad57-08dc-e063-6394a90a25bf", "132845af-9ab6-2327-e063-6294a90a6673", "13a14c37-eaf1-7848-e063-6394a90a5479", "99311cd0-f11e-4313-bb8c-eeb09fdcb3f4", "5d9b22ca-c619-4ee3-98eb-74544d0d5cb3", "a155a827-9fc0-4452-888e-379cb34a661e", "64545c32-2309-4fa4-9d9e-bfecf16244b0", "4137ff08-7529-5862-e063-6294a90aade5", "34661206-e37a-6ce7-e063-6394a90aaf85", "4589a128-79eb-aa64-e063-6294a90a953b", "0b2ad1c2-aa4a-4741-ae0b-645a3943dd77", "0bde0d4d-9482-444f-8fa2-07344fc0e5ad", "286734bc-8329-4f44-a20b-610cf7b67591", "e60a85d0-638c-48aa-af07-b34be3c2a334", "d3488fd8-88b2-4f73-9fa4-fbcf14ddd972", "4fcc51f0-654d-a3a8-e063-6394a90aac9a", "2f9d9872-68d7-cdc2-e063-6294a90a6463", "ad2305a4-f888-4800-a31e-1fff3ffee20d", "7118fc32-96e3-49b2-8a41-75d457faca08" ], "spl_set_id": [ "1e84a609-22a0-41b9-83a0-c45019c8cf9a", "4b204f44-6e8a-4d17-803c-268f0b04679f", "bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2", "522a1a49-5540-4245-a15f-e3cdc0a97a5e", "9ab26af9-8196-e3d3-76a3-75227fd4e1c3", "360d3af0-8f69-4e82-ab5f-1f70cc2025d4", "e9012a11-6219-4272-aea2-b7328bbcf523", "7b51ffce-ec64-4b49-8870-b9666537c541", "3166db4f-66a5-496a-a194-3cc01b7347d3", "43e2a24a-4465-5787-e063-6394a90a0b81", "ac71f888-c83a-46a5-921c-1ebdf6cfadc1", "fe8cf911-84ef-47be-acb8-0501b546299b", "7b997c26-e6a3-403c-93fb-b1290cf5dbad", "a41e6e26-9ebb-4b06-866e-a24af21c644c", "05c77a4c-c508-babd-e063-6294a90a450a", "3746066a-3c87-4238-945a-6dfb4d01a072", "3c1729db-8ba3-4cba-9eff-ab4ae2c061c2", "5d9b22ca-c619-4ee3-98eb-74544d0d5cb3", "02f7bf9c-1aa3-4734-8a3e-1f49498055d7", "bfce6b49-f7ff-4ec7-9580-b730f0a207d7", "fcc75691-974e-4a67-b9d7-64dde72b5595", "35e47fcd-e020-43e5-8322-41f8060d220d", "a8d6792e-757e-4dc6-adf5-0d9211075428", "93bb34a7-c8ca-4dab-b2a0-cbe011e1090c", "7cf5c17c-a80b-4547-83b2-0d53e2b933f7", "b15200fb-1826-472b-a907-e677a272513b", "b9eb9a30-c1da-4d38-8ea8-616a254e2afc", "6b9cf32c-6d60-4853-bbfd-2304ffc2c129", "37607468-0331-44c0-9bb4-5c614c7b69d4", "401ec088-984a-49ab-b317-747c2b9b9e22", "7514e6b8-c33f-4fbf-8810-ef520e1eb4bd", "86afd383-7d6b-48f0-a803-9446fa1ded10" ], "package_ndc": [ "70771-1701-1", "0023-3348-07", "0023-3348-08", "60505-6249-1", "60505-6249-7", "60505-6250-1", "60505-6250-7", "60505-6251-1", "60505-6251-7", "60505-6252-1", "60505-6252-7", "60505-6253-1", "60505-6253-7", "60505-6254-1", "60505-6254-7", "60505-6255-1", "60505-6255-7", "70771-1699-1", "70771-1700-1", "70771-1704-1", "70771-1705-1", "70771-1707-1", "47781-914-01", "47781-914-13", "47781-914-51", "47781-916-01", "72578-166-01", "70771-1706-1", "10135-795-71", "69452-277-20", "69452-278-20", "81033-010-05", "81033-010-24", "60219-2043-1", "60219-2044-1", "70954-401-10", "70954-403-10", "70954-403-20", "70954-403-30", "70954-404-10", "70954-402-10", "70954-398-10", "70954-399-10", "68047-702-21", "68047-702-35", "68047-702-51", "81279-117-88", "72603-187-01", "72603-189-01", "72603-190-01", "72603-188-01", "72603-213-01", "72603-212-01", "62135-114-37", "72888-235-01", "72888-236-01", "72888-237-01", "72888-238-01", "72888-239-01", "72888-240-01", "72888-241-01", "70954-872-10", "85742-004-03", "66993-730-02", "66993-730-51", "66993-730-80", "68047-702-01", "82667-600-05", "72789-534-01", "72789-534-95", "72789-534-28", "72578-171-01", "72578-172-01", "72578-168-01", "72578-169-01", "72578-170-01", "64980-509-24", "0054-4179-25", "0054-4180-25", "0054-4181-25", "0054-4182-25", "0054-4182-31", "0054-4183-25", "0054-4184-25", "0054-4186-25", "0054-3176-44", "0054-3177-57", "0054-3177-63", "0054-8179-25", "0054-8180-25", "0054-8174-25", "0054-8181-25", "0054-8176-25", "0054-8175-25", "0054-8183-25", "60219-2056-1", "82111-955-01", "82111-955-02", "81279-117-60", "69452-276-20", "70382-204-88", "70382-204-01", "70382-204-10", "70382-204-99", "72578-167-01" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "7S5I7G3JQL" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PREDNISOLONE", "drugdosagetext": "UNK", "drugadministrationroute": "048", "drugindication": "HISTIOCYTOSIS HAEMATOPHAGIC", "drugstartdateformat": "610", "drugstartdate": "201301", "openfda": { "application_number": [ "ANDA080531", "ANDA040571", "ANDA215673", "ANDA040323", "ANDA219509", "ANDA218083", "ANDA040775" ], "brand_name": [ "PREDNISOLONE" ], "generic_name": [ "PREDNISOLONE", "PREDNISOLONE ORAL", "PREDNISOLONE ORAL SOLUTION" ], "manufacturer_name": [ "Chartwell RX, LLC", "PAI Holdings, LLC dba PAI Pharma", "Aurobindo Pharma Limited", "Tulex Pharmaceuticals Inc", "Zhejiang Xianju Pharmaceutical Co., Ltd.", "Hisun Pharmaceuticals USA, Inc.", "Lannett Company, Inc.", "Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.", "Chartwell Governmental & Specialty RX, LLC." ], "product_ndc": [ "62135-437", "0121-0885", "59651-491", "62135-250", "70404-077", "60722-5011", "42658-160", "0527-5406", "23155-927", "68999-250" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISOLONE" ], "rxcui": [ "198142", "283077" ], "spl_id": [ "1b180b1a-f4e2-e1ee-e063-6294a90adc05", "1166b85b-73c5-4a8f-bc41-f99b406d0ff5", "c535b93f-b31f-411f-848c-b5e6782f321f", "19febba3-956f-d1a9-e063-6394a90afda5", "561d8c9c-b67f-7fb2-e063-6394a90a0316", "da9dfcf4-1631-4923-9536-72c27fc0b307", "9f93400d-a8c0-435a-ad65-48717cc455cf", "5122ba73-5783-49f0-9b9c-a03d59d8899c", "d2e4ebab-8c9d-44cb-b665-293007f7e058", "43e3bba6-a836-f5e7-e063-6294a90a10e4" ], "spl_set_id": [ "2e965355-f7f2-4dd3-9c5c-1524c6f39c91", "cebd7b5b-8e9f-4de9-9fcf-8ee0661fede3", "070f1937-50a5-457f-bef5-4e597014e26d", "aa40f582-cced-4e6e-90f0-10ab310ab2a7", "757b41c4-a0fe-4a09-8816-a4cdb7558f41", "52e6e21d-94b8-41a0-8d13-371c0e66bcee", "16d4e064-66d3-4497-8c7d-3aa355f91e1d", "86652e2d-664a-4388-a611-c2a9aa4a4bc8", "b079834f-9aa3-4db9-bd53-de28e8f81c04", "2dac9898-6492-4f34-ad86-83a902e0fe0b" ], "package_ndc": [ "62135-437-30", "0121-0885-08", "0121-0885-16", "59651-491-50", "59651-491-01", "62135-250-37", "62135-250-47", "62135-250-45", "62135-250-24", "70404-077-14", "70404-077-16", "60722-5011-0", "60722-5011-1", "42658-160-05", "0527-5406-68", "0527-5406-70", "23155-927-51", "23155-927-52", "68999-250-45", "68999-250-24" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "9PHQ9Y1OLM" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CYCLOSPORINE", "drugindication": "HISTIOCYTOSIS HAEMATOPHAGIC", "openfda": { "application_number": [ "NDA050715", "NDA050716", "ANDA203880", "ANDA210721", "NDA214965", "ANDA065078", "ANDA065110", "NDA050573", "NDA050625", "ANDA065044", "NDA050790", "ANDA065040", "ANDA209064", "NDA210913", "ANDA211943", "ANDA216046", "ANDA205894", "ANDA209811", "ANDA065003" ], "brand_name": [ "NEORAL", "CYCLOSPORINE", "CYCLOSPORINE, MODFIED", "VERKAZIA", "CYCLOSPORINE MODIFIED", "SANDIMMUNE", "RESTASIS MULTIDOSE", "RESTASIS", "CEQUA", "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation", "Teva Pharmaceuticals, Inc.", "Apotex Corp.", "Harrow Eye, LLC", "Teva Pharmaceuticals USA, Inc.", "Dr. Reddy's Laboratories Inc", "Apotex Corp", "Santen Incorporated", "Allergan, Inc.", "KVK-TECH, INC.", "Upsher-Smith Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "Saptalis Pharmaceuticals, LLC", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Lupin Pharmaceuticals, Inc.", "Devatis Inc.", "AbbVie Inc." ], "product_ndc": [ "0078-0246", "0078-0248", "0078-0274", "0480-4076", "60505-4630", "60505-4631", "60505-4632", "82667-014", "0172-7313", "0093-9018", "0093-9019", "0093-9020", "0078-0109", "0078-0240", "0078-0241", "75907-047", "75907-048", "60505-6202", "60505-0133", "60505-0134", "65086-001", "0023-5301", "10702-808", "24979-126", "0023-9163", "47335-506", "47335-507", "71656-012", "23155-837", "23155-838", "23155-839", "0378-8760", "68180-214", "73043-005", "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "OPHTHALMIC", "TOPICAL", "INTRAVENOUS" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835886", "835894", "835899", "835909", "835911", "2572292", "835925", "2590608", "2590613", "197552", "197553", "205175", "212810", "212844", "328160", "351291", "402092", "2572293", "2055021", "2055026", "835835", "835896", "1797521" ], "spl_id": [ "32ccb56c-3977-44aa-bbe8-4e4bbb33da2b", "0dc3c832-fe01-4913-ba52-47cca4c890b4", "5cee848b-4ce1-07e1-419d-8664662517d5", "535cafb4-abf9-92cb-e063-6394a90aa3d0", "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "e56d1b6b-27a1-48a9-9f4e-de0c5ba08690", "d94fae26-e557-7f8f-1755-846c8f091506", "58c5fb86-01c3-497b-86f7-a65055732970", "561ed7a8-f342-f4fe-ce36-998d87c33e7f", "2becea0d-7cbe-6b23-e063-6294a90a5a67", "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "795f036f-ee97-42b7-bd36-fff9220ce428", "8bf257be-d4c8-4694-b62b-f05124d378d0", "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "0c4be5cb-4e73-413f-847c-66babed20757", "458a84bc-12a1-5159-e063-6394a90ac45c", "15185077-eec3-40ca-a492-f500a05a045b", "da3fa070-b512-4568-871a-dc8d5a949d13", "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "5135618a-f2f6-49bd-b0ea-636cb2adf84c", "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "94461af3-11f1-4670-95d4-2965b9538ae3", "cc64c1e3-19f5-4bf6-a08d-a9725004c97f", "5baaf78c-90f6-abcf-52c8-814490f3cf9f", "48651d30-9e6e-74b0-e063-6294a90a8337", "f3dc2a50-1084-4190-a6f3-37034a04db86", "2de1e8b1-625f-43ce-a1d5-d543be208b11", "5e5926a7-1de0-4b54-a5c0-286b6200ff82", "64ec430a-e930-145c-e766-13fb49b64644", "70c8a4a6-ebe2-457f-a626-400c338cec2d", "bfca7088-fe93-abb9-3ec3-e6f5710a69c6", "c795cd2f-89da-78e3-e053-2a95a90a9422", "7224d810-bb96-4682-a942-3355e6e8061a", "a7040dc6-063b-40ee-8f2a-153e87b08430", "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850", "8e24af2b-bc1c-4849-94f2-6df950cdca89", "48c3d8a3-4289-4b52-9189-58b48596095c", "ff4dc2fc-667a-489a-b798-8d11cddfe716", "1952d4c7-a40e-4924-b669-c41400774cb9", "da3fa070-b512-4568-871a-dc8d5a949d13", "9aca2026-af86-4e97-925e-c202b87c46ac", "7bb2078d-17c2-4e6a-9f61-26c7ecbce945", "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0078-0246-61", "0078-0246-15", "0078-0248-61", "0078-0248-15", "0078-0274-22", "0480-4076-30", "0480-4076-60", "60505-4630-3", "60505-4631-3", "60505-4632-3", "82667-014-01", "82667-014-00", "0172-7313-20", "0093-9018-19", "0093-9018-65", "0093-9019-19", "0093-9019-65", "0093-9020-19", "0093-9020-65", "0078-0240-61", "0078-0240-15", "0078-0241-61", "0078-0241-15", "0078-0109-61", "0078-0109-01", "75907-047-81", "75907-047-30", "75907-048-81", "75907-048-30", "60505-6202-1", "60505-6202-2", "60505-0133-0", "60505-0133-2", "60505-0133-1", "60505-0134-0", "60505-0134-2", "60505-0134-1", "65086-001-12", "65086-001-05", "0023-5301-05", "0023-5301-08", "10702-808-03", "10702-808-06", "24979-126-19", "24979-126-18", "0023-9163-12", "0023-9163-30", "0023-9163-60", "47335-506-96", "47335-507-97", "71656-012-30", "71656-012-60", "23155-837-11", "23155-837-30", "23155-838-11", "23155-838-30", "23155-839-11", "23155-839-30", "0378-8760-98", "0378-8760-58", "0378-8760-91", "68180-214-30", "68180-214-60", "73043-005-01", "73043-005-02", "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ETOPOSIDE", "drugindication": "HISTIOCYTOSIS HAEMATOPHAGIC", "openfda": { "application_number": [ "NDA019557", "ANDA074513", "ANDA074290", "NDA220200", "ANDA074529", "ANDA075635", "ANDA074983" ], "brand_name": [ "ETOPOSIDE", "AVOPEF", "VEPESID" ], "generic_name": [ "ETOPOSIDE" ], "manufacturer_name": [ "Onesource Specialty Pharma Limited", "Accord Healthcare Inc.", "Hikma Pharmaceuticals USA Inc.", "BluePoint Laboratories", "Avyxa Pharma, LLC", "Meitheal Pharmaceuticals Inc.", "Mylan Pharmaceuticals Inc.", "Amneal Pharmaceuticals NY LLC", "Fresenius Kabi USA, LLC" ], "product_ndc": [ "83270-451", "16729-114", "0143-9376", "68001-265", "0143-9510", "0143-9511", "0143-9512", "83831-144", "83831-145", "71288-175", "71288-176", "71288-177", "0378-3266", "68001-681", "68001-682", "68001-683", "69238-2811", "63323-104" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "ETOPOSIDE" ], "rxcui": [ "197687", "310248", "2735802", "105592" ], "spl_id": [ "5744cb93-0a8c-19ca-e063-6294a90aecd6", "364ac37e-94f0-0dad-e063-6394a90aae33", "47d0c5ee-081e-44f7-9593-9888ae033165", "30d6f51a-8099-4ff9-9be6-fb0559c88e42", "15cf77cf-4207-463d-b6ef-16163db5afb9", "73ced17e-8a58-44b6-b901-347f1561f238", "737a9d5b-1260-408a-a117-b0b3aeba6ad4", "a591eea6-af04-4207-b0f7-61fbada4719c", "52475e80-bf46-f251-e063-6294a90a0e10", "254bddbd-10bf-4415-a1a1-bae57127edc5", "25cb14ea-3672-4f9a-9f4a-56052aec57ac" ], "spl_set_id": [ "7bc994df-ee84-4ed7-80fa-737f70918953", "4f850eb2-3542-43a0-90e8-bb37fa05cf15", "e0cd61b9-2375-4e3d-a610-d87dad962468", "157d4e0f-806d-4011-9dec-97e2449e507b", "6dfedeff-a807-4405-a482-2f7109ad31c9", "acc1e443-ef7b-486f-a638-710a20e81059", "50491106-dddd-4efd-bd83-060e7947a244", "508a418e-985f-4208-9324-2230655bb5c2", "0dddbe44-b4f4-431f-9011-8a54abbd4cbf", "2a40f3ed-4a36-4616-af6c-b616140fd5ee", "fe870629-104d-4d67-a7c6-f53bc588121e" ], "package_ndc": [ "83270-451-05", "16729-114-31", "16729-114-32", "16729-114-08", "16729-114-11", "0143-9376-01", "68001-265-22", "68001-265-25", "68001-265-23", "68001-265-26", "68001-265-24", "68001-265-27", "0143-9510-01", "0143-9511-01", "0143-9512-01", "83831-144-05", "83831-145-25", "71288-175-05", "71288-176-25", "71288-177-50", "0378-3266-94", "68001-681-25", "68001-682-26", "68001-683-27", "69238-2811-2", "63323-104-01", "63323-104-05", "63323-104-25", "63323-104-50", "63323-104-06" ], "nui": [ "N0000175609", "N0000000176" ], "pharm_class_epc": [ "Topoisomerase Inhibitor [EPC]" ], "pharm_class_moa": [ "Topoisomerase Inhibitors [MoA]" ], "unii": [ "6PLQ3CP4P3" ] } }, { "drugcharacterization": "2", "medicinalproduct": "GRANULOCYTE COLONY STIMULATING FACTOR (UNSPECIFIED)", "drugadministrationroute": "042", "drugindication": "REFRACTORY CYTOPENIA WITH MULTILINEAGE DYSPLASIA", "drugrecurreadministration": "3" } ] } }, { "safetyreportversion": "2", "safetyreportid": "10015808", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140317", "receiptdateformat": "102", "receiptdate": "20140813", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-POMAL-14031190", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-POMAL-14031190" }, "primarysource": { "reportercountry": "US", "qualification": "3", "literaturereference": "PAUFF J,GONZALEZ R,SAJNANI K,JAGASIA M. POST-ALLOGRAFT POMALIDOMIDE AND REVERSIBLE HEPATOTOXICITY.." }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "47", "patientonsetageunit": "801", "patientweight": "98", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Chronic graft versus host disease", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Nausea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Hepatic necrosis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Hepatic enzyme increased", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "GENGRAF", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "CYCLOSPORINE" }, "openfda": { "application_number": [ "ANDA065003" ], "brand_name": [ "GENGRAF" ], "generic_name": [ "CYCLOSPORINE" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-3108", "0074-0541", "0074-6479", "0074-6463", "0074-3109" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CYCLOSPORINE" ], "rxcui": [ "241834", "835835", "835894", "835896", "835925", "1797521" ], "spl_id": [ "38f517b9-c5d1-479a-9117-f65ea1d479d4" ], "spl_set_id": [ "e896cbfe-4745-4088-82a3-8dc10b75c41f" ], "package_ndc": [ "0074-0541-30", "0074-6479-32", "0074-6463-32", "0074-3108-32", "0074-3109-32" ], "nui": [ "N0000175457", "N0000175458", "N0000182141", "N0000185503" ], "pharm_class_epc": [ "Calcineurin Inhibitor Immunosuppressant [EPC]" ], "pharm_class_moa": [ "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]" ], "unii": [ "83HN0GTJ6D" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SULFAMETHOXAZOLE -TRIMETHOPRIM", "drugdosagetext": "800-160MG", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "LEVOFLOXACIN", "drugstructuredosagenumb": "500", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "LEVOFLOXACIN" }, "openfda": { "application_number": [ "ANDA090343", "ANDA206908", "ANDA091375", "ANDA078282", "ANDA205222", "ANDA202801", "ANDA200674", "ANDA205600", "ANDA205540", "ANDA202328", "ANDA077652", "ANDA200839", "ANDA091436", "ANDA076890", "ANDA201043", "ANDA076710", "ANDA091678", "ANDA206919", "ANDA078424" ], "brand_name": [ "LEVOFLOXACIN" ], "generic_name": [ "LEVOFLOXACIN", "LEVOFLOXACIN IN 5% DEXTROSE" ], "manufacturer_name": [ "Sagent Pharmaceuticals", "Gland Pharma Limited", "Hikma Pharmaceuticals USA Inc.", "Advagen Pharma Limited", "Hospira, Inc", "Lannett Company, Inc.", "Camber Pharmaceuticals, Inc.", "Fresenius Kabi USA, LLC", "BPI LABS LLC", "Eugia US LLC", "WG Critical Care, LLC", "Zydus Lifesciences Limited", "Macleods Pharmaceuticals Limited", "Baxter Healthcare Corporation", "Chartwell RX, LLC", "Aurobindo Pharma Limited", "Dr. Reddy's Laboratories Limited", "ANI Pharmaceuticals, Inc.", "Viona Pharmaceuticals Inc", "Lupin Pharmaceuticals, Inc." ], "product_ndc": [ "25021-132", "68083-414", "68083-415", "68083-416", "0143-9315", "0143-9316", "0143-9317", "72888-142", "0409-2220", "0409-3330", "0409-4444", "0527-1948", "0143-9720", "0143-9722", "0143-9721", "31722-721", "31722-722", "31722-723", "63323-355", "54288-140", "68083-394", "68083-395", "55150-156", "55150-157", "44567-435", "44567-436", "44567-437", "65841-691", "65841-692", "65841-693", "33342-531", "33342-532", "33342-533", "36000-045", "36000-046", "36000-047", "36000-048", "62135-655", "62135-657", "62135-656", "65862-536", "65862-537", "65862-538", "55111-279", "55111-280", "55111-281", "70954-852", "55150-243", "55150-244", "55150-245", "72578-098", "72578-099", "72578-100", "68180-240", "68180-241", "68180-242" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "OPHTHALMIC", "ORAL" ], "substance_name": [ "LEVOFLOXACIN" ], "rxcui": [ "1665497", "1665507", "1665515", "314080", "477391", "199884", "199885", "311296", "545118", "1665517", "1665519" ], "spl_id": [ "afb9cc71-e644-445b-877d-a7e7f3146e81", "7df12e53-0519-4d42-b89f-dbe83b7e7e7d", "05cdb9d7-2bce-400d-8565-8a76c4a1a8e3", "2ffa08e2-0405-47bb-e063-6294a90a4fe0", "3c0a7c98-14cf-4b2e-a4f8-0e6b7b17cd2b", "7962ed15-bb37-467c-bdea-b6e7e4e79137", "27201c72-46ca-4507-8333-00e8ec582ba0", "1fa0a846-34d8-d6f5-e063-6394a90a8e54", "d2cd980c-648b-4efd-b39d-49c8e0f8f9b9", "4c9a6374-9e83-420d-bc29-20170bfbc6e1", "949f1c99-7067-450e-bc22-504f5aed0de9", "2a91fee4-6952-42e2-8326-c2d4233d11d3", "e6bfbccc-f54c-4d4d-b268-b4fc803e372b", "5aeae448-e53f-4954-9dd9-2bcc3dd791d4", "fc165a6d-24b0-4753-a7ac-94a134dca0d3", "3cbc7b81-fabf-4666-951c-76f19e4f3222", "556839e4-29f5-abd8-e063-6394a90a6164", "00620274-6cae-4cb8-bd5d-8f80732ae3ca", "c51f53eb-2f01-93dc-e7e6-695b20b639ce", "b548d9b8-70c9-41d4-8103-41568d50f561", "8cb7f273-fc11-48e7-b2ef-a5290ab7ac4e", "6295ff00-86a9-454c-987b-a1fe1c4386e8", "04b864a6-b2f7-4e3d-aa12-32a501054b9c" ], "spl_set_id": [ "699fbdb8-a6fd-476a-9b80-08197d869534", "95479f18-76dc-41cf-a359-922febeed0f2", "f23c0df4-ae2a-446c-a9ba-dbbeb6ffaba5", "f2eb9444-333d-4b05-8cf3-2e6690a2bf99", "5a1534af-aa1c-4f1d-ba9f-9415b14e1af2", "362fb864-3afb-4841-a7c4-b64b1346aba0", "e680c759-16c5-4532-9c9c-f42c8c3df74a", "b43e9b51-568c-4d84-bbd1-d237120056c4", "eb30fafa-bbb9-458f-89df-ae610fa6aa96", "b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10", "ba69722b-d7f2-4519-8a63-9ee91294c499", "4d400bf9-988f-42ec-93f1-e71a93a324b2", "9020cdeb-65fe-458f-bbbd-69265a49906e", "ffa121b8-388f-4d7b-af48-d4aa8d9b5961", "fc165a6d-24b0-4753-a7ac-94a134dca0d3", "70c87464-1806-480a-8ebd-3f02987ff436", "5c6c117c-9d91-48f4-9aaa-ee70b99218c2", "529ac72c-c4a0-4001-8cf9-b94f5bf7265c", "9b59428a-a23a-b2d9-982f-98f8a1ed381f", "a894e40b-77e4-439b-b0f8-9a5cc7a1dd90", "7d3f83bf-2db7-4657-9538-406adf321ad5", "0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2", "4be13bd5-0c39-43c3-9232-b1226ccd4dbc" ], "package_ndc": [ "25021-132-81", "25021-132-82", "25021-132-83", "68083-414-01", "68083-415-01", "68083-416-01", "0143-9315-01", "0143-9315-24", "0143-9316-01", "0143-9316-24", "0143-9317-01", "0143-9317-24", "72888-142-22", "0409-2220-01", "0409-2220-24", "0409-3330-01", "0409-3330-24", "0409-4444-01", "0409-4444-24", "0527-1948-66", "0527-1948-68", "0527-1948-70", "0143-9722-01", "0143-9722-24", "0143-9721-01", "0143-9721-24", "0143-9720-01", "0143-9720-24", "31722-721-50", "31722-721-31", "31722-721-32", "31722-722-50", "31722-722-31", "31722-722-32", "31722-723-20", "31722-723-31", "31722-723-32", "63323-355-50", "63323-355-65", "63323-355-60", "54288-140-01", "68083-394-01", "68083-395-01", "55150-156-20", "55150-157-30", "44567-435-24", "44567-436-24", "44567-437-24", "65841-691-18", "65841-691-01", "65841-691-05", "65841-692-18", "65841-692-01", "65841-692-05", "65841-692-10", "65841-693-18", "65841-693-01", "65841-693-05", "65841-693-92", "65841-693-06", "33342-531-08", "33342-531-31", "33342-531-12", "33342-531-11", "33342-532-08", "33342-532-31", "33342-532-12", "33342-532-11", "33342-533-32", "33342-533-31", "33342-533-12", "33342-533-11", "36000-045-01", "36000-046-24", "36000-047-24", "36000-048-24", "62135-657-14", "62135-657-20", "62135-655-14", "62135-656-50", "65862-536-50", "65862-536-99", "65862-536-10", "65862-537-50", "65862-537-99", "65862-537-10", "65862-538-20", "65862-538-05", "65862-538-10", "55111-279-30", "55111-279-50", "55111-279-01", "55111-279-05", "55111-279-79", "55111-279-78", "55111-280-30", "55111-280-50", "55111-280-01", "55111-280-05", "55111-280-79", "55111-280-78", "55111-281-30", "55111-281-50", "55111-281-01", "55111-281-05", "55111-281-79", "55111-281-78", "70954-852-10", "70954-852-20", "70954-852-30", "55150-243-46", "55150-244-47", "55150-245-52", "72578-098-18", "72578-098-01", "72578-098-05", "72578-099-18", "72578-099-01", "72578-099-05", "72578-099-10", "72578-100-18", "72578-100-01", "72578-100-05", "72578-100-92", "72578-100-06", "68180-240-08", "68180-240-01", "68180-240-02", "68180-240-11", "68180-241-08", "68180-241-02", "68180-241-01", "68180-241-11", "68180-242-20", "68180-242-01", "68180-242-02", "68180-242-11" ], "nui": [ "N0000193223", "M0372253" ], "pharm_class_epc": [ "Fluoroquinolone Antibacterial [EPC]" ], "pharm_class_cs": [ "Fluoroquinolones [CS]" ], "unii": [ "6GNT3Y5LMF" ] } }, { "drugcharacterization": "2", "medicinalproduct": "GABAPENTIN.", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "GABAPENTIN" }, "openfda": { "application_number": [ "ANDA207099", "ANDA207057", "ANDA206402", "ANDA090858", "NDA020235", "NDA021129", "ANDA205101", "ANDA217995", "ANDA214956", "ANDA078787", "ANDA077662", "ANDA075360", "ANDA078974", "ANDA076403", "ANDA200651", "ANDA219319", "ANDA090007", "ANDA078926", "ANDA090705", "ANDA204989", "ANDA218075", "ANDA216252", "ANDA077661", "ANDA217116", "ANDA219814", "ANDA075477", "NDA020882", "ANDA203244", "ANDA211314", "ANDA211330", "ANDA091286", "ANDA203934", "ANDA202764", "NDA022544", "ANDA078428", "ANDA217682", "ANDA214957", "ANDA213603", "ANDA218491", "ANDA075350", "ANDA211313", "ANDA206943", "ANDA216492", "ANDA077242", "ANDA077525", "ANDA217546", "ANDA217965", "ANDA202024" ], "brand_name": [ "GABAPENTIN", "NEURONTIN", "RELGAABI", "GRALISE", "GABA 300-EZS", "GABARONE" ], "generic_name": [ "GABAPENTIN" ], "manufacturer_name": [ "Rising Pharma Holdings, Inc.", "Precision Dose, Inc.", "Ascend Laboratories, LLC", "Parke-Davis Div of Pfizer Inc", "Creekwood Pharmaceuticals LLC", "Camber Pharmaceuticals, Inc.", "Aurobindo Pharma Limited", "BluePoint Laboratories", "Granules Pharmaceuticals Inc", "Mullan Pharmaceutical Inc.", "BioComp Pharma, Inc.", "Acella Pharmaceuticals, LLC", "QUALLENT PHARMACEUTICALS HEALTH LLC", "STALLION LABORATORIES PRIVATE LIMITED", "TIME CAP LABORATORIES, INC", "Zydus Pharmaceuticals USA Inc.", "Glenmark Pharmaceuticals Inc., USA", "Exelan Pharmaceuticals, Inc.", "ScieGen Pharmaceuticals, Inc.", "Pangea Pharmaceuticals, LLC", "McKesson Corporation dba Sky Packaging", "Epic Pharma, LLC", "Radha Pharmaceuticals, Inc.", "NorthStar Rx LLC", "Advagen Pharma Ltd", "Zydus Lifesciences Limited", "Granules Pharmaceuticals Inc.", "Solco Healthcare US, LLC", "Method Pharmaceuticals, LLC", "Westminster Pharmaceuticals, LLC", "Viatris Specialty LLC", "ACI Healthcare USA, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "American Health Packaging", "Amici Pharma, Inc.", "Bi-Coastal Pharma International LLC", "Ajenat Pharmaceuticals LLC", "Strides Pharma Science Limited", "Cipla USA Inc.", "Mylan Pharmaceuticals Inc.", "Almatica Pharma LLC", "JVET PHARMACEUTICALS LLC", "PureTek Corporation", "Amneal Pharmaceuticals LLC", "XLCare Pharmaceuticals, Inc.", "Zhejiang Yongtai Pharmaceutical Co., Ltd", "Actavis Pharma, Inc.", "MARKSANS PHARMA LIMITED", "INA Pharmaceutics Inc.", "Major Pharmaceuticals", "TAGI Pharma, Inc.", "Sun Pharmaceutical Industries, Inc.", "PAI Holdings, LLC dba PAI Pharma", "Kesin Pharma Corporation", "Exelan Pharmaceuticals Inc.", "Amneal Pharmaceuticals of New York LLC", "Teva Pharmaceuticals, Inc.", "Laurus Labs Limited" ], "product_ndc": [ "16571-867", "16571-868", "16571-869", "68094-489", "68094-589", "67877-428", "67877-429", "67877-222", "67877-223", "67877-224", "0071-0805", "0071-0803", "0071-0806", "0071-0513", "0071-0401", "0071-2012", "82619-145", "82619-146", "16571-226", "31722-148", "31722-149", "31722-150", "65862-198", "65862-199", "65862-200", "68001-411", "68001-412", "70010-926", "70010-927", "70010-928", "83301-0001", "83301-0002", "44523-120", "42192-608", "82009-071", "82009-072", "72737-005", "72737-006", "72737-007", "49483-605", "49483-606", "49483-607", "68382-204", "68382-205", "68462-126", "68462-127", "76282-321", "76282-627", "76282-323", "50228-179", "50228-180", "50228-181", "81279-126", "31722-091", "31722-092", "63739-902", "63739-903", "63739-904", "16571-117", "16571-116", "42806-656", "42806-657", "77771-177", "77771-178", "16714-661", "16714-662", "16714-663", "72888-131", "72888-132", "65841-705", "65841-706", "70010-227", "70010-228", "43547-479", "43547-480", "43547-481", "58657-231", "58657-234", "58657-233", "50228-177", "50228-178", "69367-343", "69367-344", "69367-345", "58151-281", "58151-282", "58151-283", "58151-284", "58151-285", "58151-290", "71093-111", "71093-112", "23155-866", "23155-867", "23155-868", "60687-919", "69292-640", "69292-641", "69292-642", "65862-523", "65862-524", "42582-114", "42582-115", "42582-116", "82983-423", "42806-509", "42806-510", "42806-511", "68382-355", "68382-608", "68382-607", "68382-356", "68382-357", "64380-867", "64380-868", "64380-869", "69097-811", "69097-812", "70771-1861", "70771-1862", "70771-1916", "70771-1917", "70771-1918", "16714-330", "16714-332", "59762-5050", "82619-142", "82619-143", "82619-144", "52427-803", "52427-804", "52427-806", "52427-850", "52427-890", "52427-815", "86211-112", "59088-725", "65162-101", "65162-102", "65162-103", "31722-069", "69367-346", "69367-347", "72865-255", "72865-256", "69434-042", "69434-043", "69434-044", "50228-523", "50228-524", "72865-252", "72865-253", "72865-254", "45963-555", "45963-556", "45963-557", "25000-103", "25000-104", "25000-105", "74157-013", "74157-111", "83301-0003", "83301-0004", "83301-0005", "71093-120", "71093-121", "71093-122", "0904-7613", "0904-7614", "0904-7615", "64380-727", "64380-728", "51224-021", "51224-121", "69097-813", "69097-814", "69097-943", "69097-815", "31722-166", "31722-167", "72888-104", "62756-137", "62756-138", "62756-139", "62756-202", "62756-204", "0121-1067", "0121-4067", "0121-2134", "76282-706", "76282-707", "81033-123", "76282-405", "76282-406", "70010-108", "70010-109", "70010-118", "69367-131", "69367-133", "69367-132", "53746-101", "53746-102", "53746-103", "0480-3494", "0480-3495", "0480-3496", "42385-972", "42385-973", "42385-974", "42385-979", "42385-980", "65162-698", "64380-731", "64380-753", "64380-754" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "GABAPENTIN" ], "rxcui": [ "310430", "310431", "310432", "310433", "310434", "105028", "105029", "105030", "261280", "261281", "283523", "351973", "2739001", "1806380", "1806382", "2739007", "2740839", "2740841", "2634743", "2634747", "2634751", "1115012", "1115013", "2398511", "2398512", "2634745", "2634749", "2634753", "476673", "476679", "602399", "602407" ], "spl_id": [ "2e493243-47c0-460e-bea9-4ed0261adf90", "471ad25b-0c63-489c-9df3-44ea7fdcd256", "b21e5d1f-cac9-4727-bbe4-48335103aef3", "f1432ab9-9c63-4880-8c9b-b851c16dc765", "e730d5df-d47b-4d7f-ae3b-bd449f6b1213", "26ce27e6-34a6-70d2-e063-6394a90a7c96", "e4b713f1-a833-4fc7-8a0f-696077ddc280", "2a2c08de-b06c-4926-e063-6394a90a2eb0", "7a45ad84-02a4-442d-8401-1a1495d084fa", "5033e422-4653-7be9-e063-6294a90a1400", "54726620-c2ef-2c6f-e063-6394a90a063f", "423fc29b-e05c-0d6b-e063-6294a90abf30", "462c7cf4-92a8-cf81-e063-6294a90a43c3", "42b42328-c02f-5413-e063-6394a90ace67", "f3eaa220-daf6-41ed-a5a2-4656c4a389d9", "30d4f239-f37b-4b6e-b25e-043a33489011", "57cd7abd-de87-d483-e063-6394a90a90d3", "e85a763f-472b-492b-bf25-a30251b9b50b", "4da1bae0-701b-4b65-a01e-f4bcedfad849", "5e0a57d7-9068-43d3-be26-96f646720fde", "572a8a5c-e362-a22e-e063-6294a90a5eb7", "526cf9ed-8502-fed9-e063-6394a90adf42", "360950f4-eef0-54cb-e063-6394a90aa5d6", "159496fe-700e-4c94-a766-7809a7ce1839", "20c65bad-52d5-462e-aa17-5b7320f92b76", "c48c3c6d-4407-4312-8e81-46db64698cb7", "39ed0291-41ed-48d4-b11b-6deae3269f32", "2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e", "4b9217ba-8356-aab1-e063-6294a90a2dce", "e9f9a5e6-0454-4601-90e4-b170bb325eb6", "3513f676-25fe-02db-e063-6294a90a1f9d", "2d83d237-09b6-4784-ab1e-eb1609ed2ca3", "4ef62c9f-cf61-6ad7-e063-6394a90a2774", "176515ec-fdba-417a-b849-86aea6fd7857", "e369733c-4898-4f60-9499-db7c27a2f3c1", "2d43f32d-2d96-4011-84ac-507c3307dc27", "c5f1ec3b-405e-4128-882b-43559d5083e5", "5cc5ceff-77b9-40d2-bba6-0d4af992e3f8", "4c0c82ce-f685-61fd-e063-6294a90a2cff", "49d67ffb-5d4f-486e-8766-cf56faf70ede", "700d09f5-99cc-492d-ab49-442f674d9c5d", "2623362f-c5cd-4880-bb49-2d64bedf7be0", "1e85899c-edf0-49d0-a007-06f8e6655a43", "20f2898a-4fc1-450c-a7e8-36e3d8219ee0", "898c1710-d86c-4fbe-9a53-34661fcdb63a", "dcbeb06d-b93e-41c0-91e6-152e2ea6c32d", "69887d93-de9a-4397-a629-a0ce8e62c69a", "ba40713a-2f22-4276-a664-355e7442cda4", "e1bc9060-641c-4196-acfd-676a3d263fed", "f5c6e992-4771-4c56-ac1f-00ccfb88bef5", "26aae270-f035-5159-e063-6394a90a5376", "44a61305-2313-59c4-8a44-98c827461735", "63a5fc6d-ca57-4726-b70d-805ac023d959", "b43e4780-f902-89d9-e053-2a95a90a6792", "385f01e9-5b50-41d8-a2d5-748f5f84c027", "45c076af-c121-6962-e063-6394a90aaad1", "3855844f-e123-4574-8d9b-76397d602744", "96acc27b-7400-480e-b79a-baa8ac3ab801", "50180dbb-2297-4ddd-bf6a-a2084827f1cf", "3f2e32c6-5993-0189-e063-6294a90a0ff6", "702f8307-681f-440d-9f1d-3d26141a914b", "6928cff7-f264-464c-bd54-baf27f13ab18", "a09d9505-f432-4ed6-b274-3885faffb02a", "47d9ab92-3736-01a7-e063-6394a90a7c55", "3ce59317-9cf6-5ae5-e063-6394a90aba6c", "a916797c-381c-4008-b778-19221233ef45", "999f3685-2eac-467e-bed2-1d0c36aaf0ed", "a4928566-6bc9-4a2a-a368-c68afc402368", "fff63005-89eb-4aa5-8220-ecb9c7c02af1", "fdeea2da-e306-45d8-a27a-e8be090319ea", "8796e28d-fb63-4438-bec3-aac2dd9decf5", "4b921bb1-ab2e-af6a-e063-6294a90a0694", "ca2658ac-c659-4217-8625-a1043d211cd5", "01ef9bd4-78c9-4ec7-8633-c4e0260ad2de", "96999ce4-193e-4817-939c-900ab87fc88f", "4470a571-3213-9849-e063-6394a90a39b2", "20a38b18-352b-47a6-b640-091b42db10aa", "44f3f3fb-7803-2bc9-e063-6394a90acefe", "b779d072-7cc4-4fa2-9421-0e8ea96334cd", "10e5f9be-7920-4775-801b-e1c32b996410", "d473138f-50d6-4c93-a162-8cd38c479d40", "5fd82a02-46ac-4312-a008-fa17e5cd3ffd", "bcc054b1-a2fa-40b7-b150-b937763fcf7f", "4dcf85f4-ed27-4fba-a2e3-95a3b8a89b86" ], "spl_set_id": [ "969cccfc-e56a-49da-9d36-47c0c3fad7f8", "86c93d8b-6286-44e2-93dd-f1b10a5d83da", "4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a", "722de2a9-38b3-4518-b262-ba0d1346d0ba", "ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388", "266ef369-0a56-f225-e063-6294a90a495e", "8215da86-d7af-4980-b6d6-4bd46f6bfeaf", "e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b", "1a619a14-0b63-4cba-80e7-474c9a1c90b9", "3368bf70-d466-4765-b2b7-7fe967a8c2b7", "c681c804-c6f3-d63b-e053-2995a90a6b8f", "47a22de2-ec66-45be-8648-89ed3ab6e67e", "0b3a4009-42f3-c84f-e063-6294a90a8068", "3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2", "472bb279-bb4e-4246-b2a3-172483ba356b", "b26fd0c6-6aab-4957-8a32-cc7adb9b5fc9", "08880902-bd44-41b6-866b-2cbad4c3f2b1", "310ce005-5a24-489a-b23c-d42ab6a3bfed", "3865a6e3-112c-490c-82ac-35401336b16e", "41d1ead3-046e-4abf-ae0a-cb126a1f5848", "16542ee6-0e0e-4d3c-8b32-60ff6ef48846", "5eff7ad8-0d31-4372-82a2-ac9f549d8796", "0ce53f62-1738-43f4-9a2e-c5dc42a91d09", "23eb133e-2f74-4219-9892-0a8e770ec032", "b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1", "d592d828-8df1-480d-b179-bb9260a9c824", "1045db4e-4c76-4a0d-bf12-019bd96a8f59", "f7c1fd34-d615-43a2-8989-898fe11f90df", "401b30fc-e143-4906-aae1-e5b5c190d4a8", "b033c169-4943-4ad9-ace0-7e4a1f0dc100", "e847bcfa-f3de-404a-8a57-d8a414691e6a", "360d953b-4313-45ae-b933-296547d4577d", "4cc6615b-5447-9c0e-e063-6394a90a2883", "5ab9c18b-9568-4dcb-90b0-252aef8f8dc2", "3ad96553-73a4-4a9b-8a89-10a29b794ed3", "97935fd9-1d4a-43b6-a5d9-de994591187b", "d7646d5e-ca25-4ec5-9e4b-931edcb15a0e", "d8daa30f-1cb3-46aa-9b68-d9aa5b0a2105", "e00f5048-1a06-44f4-b244-aa2755f4be22", "1ea83c18-7107-41f4-8305-62725c1c45c8", "25cf6c40-a239-4dd0-9cad-28da84d285db", "e0cd96d1-b1ef-46ec-a5a3-9505b0811b8b", "02304deb-7b4a-452f-9b1a-64ca0aedbcc2", "030e656a-e384-49ac-830f-32140c18112d", "3cfd04ab-e421-441f-a10e-e4dd1412974d", "43b67ae3-ac6f-48f5-8788-9ead08376864", "7c3ac86f-b8f7-42bf-942a-db854d946e54", "8c0eeefc-ef5b-49f4-8411-ddbae312ed05", "9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a", "cff7de45-148b-4e96-88fd-6052bf75b5f7", "26aac429-a5cd-33cc-e063-6394a90aecc0", "466273b1-c9fc-3930-c94b-aa11394d5140", "63a5fc6d-ca57-4726-b70d-805ac023d959", "bb29692e-1546-4d05-a46a-93baf4172c7d", "507bf6d0-e7a2-413d-9848-cd2445a1411d", "b86c81d9-9a4a-4847-be18-520e5cc5dc4b", "2eec52a1-9016-46dd-8b4c-8dab1d0aeece", "707ed63a-67ca-4a62-9cbe-cdeb5c4ab506", "f1eda6cc-d9b2-4df4-a09b-20eebded760f", "3f2e3ac5-5233-fd57-e063-6294a90a849e", "618c948d-deee-44e2-98f0-e5232171dd50", "5969871e-6c71-4c37-9d63-370718ccc80c", "98bb408d-c402-4da6-8f9d-5de4833dedc4", "0f350a4b-f294-4b98-b69f-3cc789e930ba", "74474aa4-4859-42d2-92d8-f23f18b34e04", "7538e255-95df-4991-aae0-a90d709f1e95", "999f3685-2eac-467e-bed2-1d0c36aaf0ed", "bec31452-b52b-4698-ba4c-0b614780ee84", "725878fa-1e2f-4fee-a9e1-a6e102c79625", "9e4eca9c-6a2c-4ede-a252-1a27094bf594", "9ead7825-d11b-4e00-8533-328d097b8f83", "bfee67dc-d2b1-4a00-92d9-a42be3189c74", "c9a05f0c-b5f0-422c-9d67-6d0efc921a74", "6d3fd1f9-c831-4262-af10-291838a53541", "a88edb00-2189-4c8d-9dd7-9fe1571775cc", "4470a567-93a6-a293-e063-6394a90affc1", "323dad14-ded9-4432-a265-c957e46cc6db", "b20ee34a-7f2d-4d62-a161-898565f74547", "2f70c496-b58c-30f5-e054-00144ff8d46c", "b11dbff5-ceee-4a63-a093-f6efebdc2f6f", "c7f21eaa-68ee-420c-9c98-e997cc73a297", "07aa1bcc-df05-44fa-92d4-63894e0e6cd6", "772d9e7a-3811-455a-99e6-f2a3d0769b9b", "798575b9-ddfa-4915-9574-626abbaf025f" ], "package_ndc": [ "16571-867-03", "16571-867-01", "16571-867-50", "16571-867-10", "16571-868-03", "16571-868-01", "16571-868-50", "16571-868-10", "16571-869-03", "16571-869-01", "16571-869-50", "16571-869-10", "68094-589-50", "68094-589-60", "68094-489-50", "68094-489-60", "67877-428-01", "67877-428-38", "67877-428-05", "67877-428-10", "67877-429-01", "67877-429-38", "67877-429-05", "67877-429-10", "67877-222-01", "67877-222-05", "67877-222-10", "67877-222-38", "67877-223-01", "67877-223-05", "67877-223-10", "67877-223-38", "67877-224-01", "67877-224-05", "67877-224-10", "67877-224-38", "0071-0803-24", "0071-0803-40", "0071-0805-24", "0071-0805-40", "0071-0806-24", "0071-0806-40", "0071-0513-24", "0071-0401-24", "0071-2012-23", "0071-2012-44", "0071-2012-47", "82619-145-01", "82619-145-02", "82619-146-01", "82619-146-02", "16571-226-01", "16571-226-50", "31722-148-01", "31722-148-05", "31722-148-10", "31722-149-01", "31722-149-05", "31722-150-01", "31722-150-05", "65862-198-01", "65862-198-05", "65862-198-99", "65862-198-10", "65862-198-90", "65862-198-18", "65862-198-27", "65862-199-01", "65862-199-05", "65862-199-99", "65862-199-10", "65862-199-30", "65862-199-60", "65862-199-90", "65862-199-18", "65862-199-27", "65862-200-01", "65862-200-05", "65862-200-10", "65862-200-90", "65862-200-27", "68001-411-00", "68001-411-03", "68001-412-00", "68001-412-03", "70010-927-10", "70010-927-05", "70010-927-01", "70010-926-10", "70010-926-01", "70010-926-05", "70010-928-10", "70010-928-01", "70010-928-05", "83301-0001-1", "83301-0001-2", "83301-0002-1", "83301-0002-2", "44523-120-16", "42192-608-16", "42192-608-05", "42192-608-45", "42192-608-06", "42192-608-40", "82009-071-05", "82009-072-05", "72737-005-01", "72737-005-03", "72737-005-02", "72737-005-04", "72737-006-01", "72737-006-02", "72737-006-03", "72737-006-04", "72737-007-03", "72737-007-04", "72737-007-01", "72737-007-02", "49483-605-50", "49483-605-10", "49483-605-01", "49483-606-01", "49483-606-50", "49483-606-10", "49483-607-01", "49483-607-50", "49483-607-10", "68382-204-01", "68382-204-05", "68382-204-10", "68382-205-01", "68382-205-05", "68382-205-10", "68382-205-30", "68382-205-77", "68462-126-01", "68462-126-05", "68462-127-01", "68462-127-05", "76282-321-90", "76282-321-01", "76282-321-18", "76282-321-27", "76282-321-05", "76282-627-30", "76282-627-60", "76282-627-90", "76282-627-01", "76282-627-18", "76282-627-27", "76282-627-05", "76282-323-90", "76282-323-01", "76282-323-27", "76282-323-05", "50228-179-30", "50228-179-01", "50228-179-05", "50228-179-10", "50228-180-30", "50228-180-01", "50228-180-05", "50228-180-10", "50228-181-30", "50228-181-01", "50228-181-05", "81279-126-60", "31722-091-90", "31722-092-90", "63739-902-10", "63739-903-10", "63739-904-10", "16571-116-01", "16571-116-50", "16571-117-01", "16571-117-50", "42806-656-09", "42806-657-09", "77771-177-90", "77771-177-05", "77771-178-90", "77771-178-05", "16714-661-01", "16714-661-02", "16714-661-03", "16714-662-01", "16714-662-02", "16714-662-03", "16714-663-01", "16714-663-02", "72888-131-30", "72888-131-01", "72888-131-05", "72888-131-00", "72888-132-30", "72888-132-01", "72888-132-05", "72888-132-00", "65841-705-01", "65841-705-05", "65841-705-10", "65841-706-01", "65841-706-05", "65841-706-10", "65841-706-77", "70010-227-01", "70010-227-05", "70010-228-01", "70010-228-05", "43547-479-10", "43547-479-50", "43547-479-11", "43547-480-10", "43547-480-50", "43547-480-11", "43547-481-10", "43547-481-50", "58657-234-01", "58657-233-01", "58657-231-01", "50228-177-30", "50228-177-01", "50228-177-05", "50228-178-30", "50228-178-01", "50228-178-05", "69367-343-05", "69367-344-05", "69367-345-05", "58151-281-01", "58151-282-01", "58151-283-01", "58151-284-01", "58151-285-01", "58151-290-35", "71093-111-04", "71093-111-05", "71093-112-04", "71093-112-05", "23155-866-01", "23155-866-05", "23155-866-10", "23155-867-01", "23155-867-05", "23155-867-10", "23155-868-01", "23155-868-05", "23155-868-10", "60687-919-41", "60687-919-47", "60687-919-87", "69292-640-01", "69292-640-10", "69292-640-50", "69292-641-01", "69292-641-50", "69292-641-10", "69292-642-01", "69292-642-50", "69292-642-10", "65862-523-90", "65862-523-01", "65862-523-05", "65862-523-26", "65862-524-90", "65862-524-01", "65862-524-05", "65862-524-31", "42582-114-10", "42582-114-18", "42582-115-10", "42582-115-18", "42582-116-10", "42582-116-18", "82983-423-47", "42806-509-30", "42806-509-01", "42806-509-10", "42806-510-30", "42806-510-01", "42806-510-10", "42806-511-30", "42806-511-01", "42806-511-10", "68382-608-16", "68382-608-05", "68382-608-30", "68382-608-77", "68382-607-16", "68382-607-05", "68382-607-30", "68382-607-77", "68382-355-14", "68382-355-01", "68382-356-14", "68382-356-01", "68382-357-01", "68382-357-14", "64380-867-06", "64380-867-07", "64380-867-08", "64380-868-06", "64380-868-07", "64380-868-08", "64380-869-06", "64380-869-07", "64380-869-08", "69097-812-02", "69097-812-07", "69097-812-12", "69097-811-02", "69097-811-07", "69097-811-12", "70771-1861-9", "70771-1861-5", "70771-1861-2", "70771-1862-9", "70771-1862-5", "70771-1862-2", "70771-1862-4", "70771-1916-6", "70771-1916-1", "70771-1917-6", "70771-1917-1", "70771-1918-6", "70771-1918-1", "16714-330-01", "16714-330-02", "16714-332-01", "16714-332-02", "59762-5050-7", "82619-142-01", "82619-142-02", "82619-142-03", "82619-143-01", "82619-143-02", "82619-143-03", "82619-144-01", "82619-144-02", "52427-803-90", "52427-804-60", "52427-806-90", "52427-850-60", "52427-890-60", "52427-815-99", "86211-112-01", "59088-725-00", "45963-556-11", "65162-101-03", "65162-101-10", "65162-101-50", "65162-101-11", "65162-102-03", "65162-102-10", "65162-102-50", "65162-102-11", "65162-103-03", "65162-103-10", "65162-103-50", "65162-103-11", "31722-069-47", "69367-346-05", "69367-347-05", "72865-255-90", "72865-255-05", "72865-256-90", "72865-256-05", "69434-042-04", "69434-042-03", "69434-043-04", "69434-043-03", "69434-044-04", "69434-044-03", "50228-523-30", "50228-523-05", "50228-523-90", "50228-524-30", "50228-524-05", "50228-524-90", "72865-252-90", "72865-252-18", "72865-252-27", "72865-252-05", "72865-253-30", "72865-253-60", "72865-253-90", "72865-253-18", "72865-253-27", "72865-253-05", "72865-254-90", "72865-254-27", "72865-254-05", "45963-555-11", "45963-555-50", "45963-556-50", "45963-557-11", "45963-557-50", "25000-103-03", "25000-103-12", "25000-103-98", "25000-103-14", "25000-104-03", "25000-104-12", "25000-104-14", "25000-105-03", "25000-105-12", "25000-105-14", "74157-013-90", "74157-111-90", "83301-0003-1", "83301-0003-2", "83301-0003-3", "83301-0004-1", "83301-0004-2", "83301-0004-3", "83301-0005-1", "83301-0005-2", "83301-0005-3", "71093-120-04", "71093-120-05", "71093-121-04", "71093-121-05", "71093-122-04", "71093-122-05", "0904-7613-61", "0904-7614-61", "0904-7615-61", "64380-727-01", "64380-727-02", "64380-728-01", "64380-728-02", "51224-021-50", "51224-021-60", "51224-121-50", "51224-121-60", "69097-813-07", "69097-813-12", "69097-814-12", "69097-814-07", "69097-943-12", "69097-943-07", "69097-815-07", "69097-815-12", "31722-166-01", "31722-166-05", "31722-167-01", "31722-167-05", "72888-104-25", "62756-137-02", "62756-137-03", "62756-137-05", "62756-137-04", "62756-137-01", "62756-138-02", "62756-138-03", "62756-138-05", "62756-138-04", "62756-138-01", "62756-139-02", "62756-139-03", "62756-139-05", "62756-139-04", "62756-139-01", "62756-202-01", "62756-202-03", "62756-204-01", "62756-204-03", "0121-1067-16", "0121-4067-05", "0121-4067-40", "0121-2134-06", "0121-2134-40", "76282-706-90", "76282-706-05", "76282-707-90", "76282-707-05", "81033-123-16", "76282-405-30", "76282-405-90", "76282-405-01", "76282-405-05", "76282-406-30", "76282-406-90", "76282-406-01", "76282-406-05", "70010-108-01", "70010-108-05", "70010-108-10", "70010-109-01", "70010-109-05", "70010-109-10", "70010-118-01", "70010-118-05", "70010-118-10", "69367-131-04", "69367-131-06", "69367-133-04", "69367-133-06", "69367-132-04", "69367-132-06", "53746-101-30", "53746-101-01", "53746-101-05", "53746-101-10", "53746-102-30", "53746-102-01", "53746-102-05", "53746-102-10", "53746-103-30", "53746-103-01", "53746-103-05", "53746-103-10", "0480-3494-05", "0480-3495-01", "0480-3495-05", "0480-3496-05", "42385-972-30", "42385-972-90", "42385-972-01", "42385-972-05", "42385-972-11", "42385-972-72", "42385-973-30", "42385-973-90", "42385-973-01", "42385-973-05", "42385-973-11", "42385-973-72", "42385-974-30", "42385-974-90", "42385-974-01", "42385-974-05", "42385-974-11", "42385-974-72", "42385-979-30", "42385-979-90", "42385-979-01", "42385-979-05", "42385-979-11", "42385-979-72", "42385-980-30", "42385-980-90", "42385-980-01", "42385-980-05", "42385-980-11", "42385-980-72", "65162-698-90", "65162-698-39", "65162-698-54", "64380-753-01", "64380-753-02", "64380-753-03", "64380-754-01", "64380-754-02", "64380-754-03", "64380-731-01", "64380-731-02", "64380-731-03" ], "nui": [ "N0000008486" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "unii": [ "6CW7F3G59X" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DRONABINOL.", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "DRONABINOL" }, "openfda": { "application_number": [ "NDA205525", "NDA018651", "ANDA207421" ], "brand_name": [ "DRONABINOL", "SYNDROS", "MARINOL" ], "generic_name": [ "DRONABINOL" ], "manufacturer_name": [ "Wellhouse Pharma, LLC", "Chartwell RX, LLC", "Ascend Laboratories, LLC", "Benuvia Operations, LLC", "ThePharmaNetwork, LLC", "Camber Pharmaceuticals Inc" ], "product_ndc": [ "85776-202", "62135-033", "67877-753", "67877-754", "67877-755", "85776-201", "78613-201", "53097-568", "53097-569", "53097-570", "53097-571", "53097-572", "53097-573", "31722-960", "31722-961", "31722-962" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DRONABINOL" ], "rxcui": [ "1928948", "197634", "197635", "197636", "1928954", "205641", "205642", "205645" ], "spl_id": [ "818b1821-a561-4dda-87ff-a0311ef7d11a", "4954c560-9d61-5d0f-e063-6394a90a7c5b", "97b6c4dc-59b5-4ee6-b296-26ccdf9ef853", "dcc02ae3-f1fa-431e-81bb-c52d35b81c66", "3e1cbbb1-291c-41bb-b209-93c1fb08313a", "628f9609-6583-49be-be77-b64cfbc46fd7", "5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48", "dd59cbf6-b383-4c39-ae06-2c7ea4de966a" ], "spl_set_id": [ "495aabae-3597-49dc-a5af-e328bcd937b7", "44205ae6-b86a-485c-baf6-233a2c878640", "adb1801c-0fb5-4e16-b969-1db91230e0b9", "3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89", "a7801c70-995d-46a2-91ee-141ef427c6b5", "628f9609-6583-49be-be77-b64cfbc46fd7", "d0efeeec-640d-43c3-8f0a-d31324a11c68", "66f36fe0-9808-4b73-a99a-794d86ff0c1c" ], "package_ndc": [ "85776-202-30", "62135-033-43", "67877-753-60", "67877-754-60", "67877-755-60", "85776-201-30", "78613-201-30", "53097-568-60", "53097-569-60", "53097-570-60", "53097-571-60", "53097-572-60", "53097-573-60", "31722-960-60", "31722-961-60", "31722-962-60" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D2", "drugdosagetext": "50000 UNITS", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ERGOCALCIFEROL" }, "openfda": { "application_number": [ "ANDA090455" ], "brand_name": [ "VITAMIN D" ], "generic_name": [ "ERGOCALCIFEROL" ], "manufacturer_name": [ "Strides Pharma Science Limited" ], "product_ndc": [ "64380-737" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ERGOCALCIFEROL" ], "rxcui": [ "1367410" ], "spl_id": [ "1cc589f7-cd6d-40a6-8fce-c965e8945eae" ], "spl_set_id": [ "2c4c0a36-12cf-444d-9d57-de983eef4d36" ], "package_ndc": [ "64380-737-06", "64380-737-25" ], "nui": [ "M0007651", "N0000175909" ], "pharm_class_cs": [ "Ergocalciferols [CS]" ], "pharm_class_epc": [ "Provitamin D2 Compound [EPC]" ], "unii": [ "VS041H42XC" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FLUCONAZOLE.", "drugstructuredosagenumb": "200", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "FLUCONAZOLE" }, "openfda": { "application_number": [ "ANDA208963", "ANDA076658", "ANDA076665", "ANDA079104", "ANDA077731", "ANDA077253", "ANDA215738", "ANDA076766", "ANDA076736", "ANDA078764", "ANDA078698", "ANDA079150", "NDA020090", "ANDA078423" ], "brand_name": [ "FLUCONAZOLE", "DIFLUCAN" ], "generic_name": [ "FLUCONAZOLE" ], "manufacturer_name": [ "Zydus Lifesciences Limited", "Dr. Reddy's Laboratories Limited", "Chartwell RX, LLC", "Hospira, Inc", "Rising Pharma Holdings, Inc.", "Glenmark Pharmaceuticals Inc., USA", "Zhejiang Poly Pharm. Co., Ltd.", "Baxter Healthcare Company", "Hikma Pharmaceuticals USA Inc.", "NorthStar Rx LLC", "Sagent Pharmaceuticals", "BluePoint Laboratories", "Roerig", "Slate Run Pharmaceuticals", "Radha Pharmaceuticals Inc", "ANI Pharmaceuticals, Inc.", "Zydus Pharmaceuticals (USA) Inc.", "Mylan Pharmaceuticals Inc.", "Aurobindo Pharma Limited" ], "product_ndc": [ "70771-1063", "70771-1064", "70771-1065", "70771-1066", "55111-143", "55111-144", "55111-145", "55111-146", "62135-130", "62135-131", "62135-132", "62135-133", "0409-3435", "0409-4321", "57237-003", "57237-004", "57237-005", "57237-006", "68462-101", "68462-102", "68462-103", "68462-119", "68462-104", "72673-091", "0338-6045", "0338-6046", "0143-9899", "0143-9669", "0143-9668", "0143-9667", "0143-9666", "16714-691", "16714-694", "16714-692", "16714-693", "25021-184", "57237-149", "57237-150", "16714-695", "16714-696", "68001-251", "68001-253", "68001-254", "68001-252", "0049-3450", "0049-3410", "0049-3420", "0049-3500", "0049-3430", "0049-3440", "70436-227", "77771-396", "77771-397", "77771-398", "77771-399", "62559-990", "62559-991", "62559-992", "62559-993", "70710-1137", "70710-1138", "70710-1139", "70710-1140", "59762-5029", "59762-5015", "59762-5016", "59762-5017", "59762-5018", "59762-5030", "65862-299", "65862-300", "65862-058", "65862-059", "65862-060", "65862-061" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "FLUCONAZOLE" ], "rxcui": [ "197698", "197699", "197700", "197701", "1721314", "1721315", "310353", "310352", "201900", "201901", "207106", "207107", "207108", "207112" ], "spl_id": [ "4813fe26-a1f0-4782-a210-c669ae1ad899", "69e67aa4-a859-7ab0-79df-d9bf8489998d", "25892746-5194-5955-e063-6294a90a3b7f", "f49a2c6f-6b6f-43a4-8faf-d21b97ccbbf5", "1018b9ad-7145-49b4-903a-b483797d7c86", "639b832d-b798-4efb-8db0-e64b8ba81574", "47d8769c-b294-65ab-e063-6394a90a8bff", "36e35cdf-c4a0-428a-879e-1d65e2b66f64", "a90257a3-d842-4990-81a5-614293e23119", "06bbf63a-4457-4206-af05-246be0ddb301", "c643b54a-3aea-4b5a-afb9-fbb2917243fb", "8c4429e6-5542-4bec-9d50-1021ea548c01", "95e12350-efed-4dad-8ec3-6aa48fdc1512", "472a93c7-fd2a-f837-e063-6294a90aed1b", "c835d7dd-af65-4b2c-a92c-42d1986f902d", "2c3342fa-abe7-d6b0-e063-6394a90ad1c0", "bd560fcb-5efc-48d3-8d2c-e21f2d072215", "4616cc03-ba84-a659-e063-6294a90a7dcb", "eec2c521-a32a-482b-afb4-057860a109cf", "538304da-3971-4e3d-9ad3-af8b3dc186c3", "5a926244-1653-4a4e-9a60-9713a91d2485", "5305f9a9-119f-43e6-a48a-1598094d6c8f", "d017859b-48a2-4b16-9f5a-84316c6e7f4b" ], "spl_set_id": [ "0adb2f88-8a6f-4f33-9e2d-73f537e05313", "d7fa1d79-4cd3-4a55-b74b-b31e82e616a3", "f86ea347-78f5-43b8-9574-a52569a4237b", "22ebc3fb-ee81-44bd-a6e3-5e759ee724a8", "2ca7efcd-4a8d-4139-a3eb-930afd18b13f", "3da5f41d-5200-45ac-b89d-00881237ec85", "2a3ba181-5baa-5942-e063-6294a90a82b2", "cd24a261-9c15-42b4-8040-89d2dbda174e", "d3ca59bd-ae00-48ab-89aa-87c7f56e9989", "d2acccda-8068-46c1-8562-950d7f70ee06", "02f74fe7-0649-46c5-a06a-0700cd265773", "ccbe0991-27a1-4ddb-bfc7-1b3422e53390", "afde17e7-b95b-4cd5-97eb-e361724014bd", "83bcb8fc-53f1-4d7b-b083-0905b52c6c7e", "f694c617-3383-416c-91b6-b94fda371204", "13804efd-7cb3-431f-a6a7-bd6d1da5889e", "c041227b-dab6-4c29-ab59-d31993d524b2", "4616c7ad-be61-7ac0-e063-6394a90ab9ed", "8f90f169-6a72-4c33-a2af-0bc943602bc2", "d1364455-1537-46d4-b093-38cca3be778f", "737e0fac-a2d2-4053-a0d7-edbfb6248f69", "bf588f7e-89de-4b4e-8d33-c1ff2be1b34e", "6ebf24fd-41cd-4b3c-8176-a1436253ba2d" ], "package_ndc": [ "70771-1063-3", "70771-1063-1", "70771-1063-5", "70771-1063-4", "70771-1064-3", "70771-1064-1", "70771-1064-5", "70771-1064-4", "70771-1065-3", "70771-1065-1", "70771-1065-5", "70771-1065-7", "70771-1065-8", "70771-1066-3", "70771-1066-1", "70771-1066-5", "70771-1066-4", "55111-143-30", "55111-143-01", "55111-143-05", "55111-143-79", "55111-143-78", "55111-144-30", "55111-144-01", "55111-144-05", "55111-144-79", "55111-144-78", "55111-145-71", "55111-145-12", "55111-146-30", "55111-146-01", "55111-146-05", "55111-146-79", "55111-146-78", "62135-130-30", "62135-131-30", "62135-132-77", "62135-133-30", "0409-3435-01", "0409-3435-24", "0409-4321-01", "0409-4321-24", "57237-003-30", "57237-004-30", "57237-005-11", "57237-006-30", "57237-006-01", "68462-101-30", "68462-101-10", "68462-102-30", "68462-102-10", "68462-103-40", "68462-119-40", "68462-119-44", "68462-104-30", "68462-104-10", "72673-091-14", "0338-6046-48", "0338-6045-37", "0143-9899-01", "0143-9899-91", "0143-9669-01", "0143-9669-10", "0143-9668-01", "0143-9668-10", "0143-9667-01", "0143-9667-06", "0143-9666-01", "0143-9666-06", "16714-694-01", "16714-691-01", "16714-691-02", "16714-692-10", "16714-692-11", "16714-693-01", "16714-693-02", "25021-184-82", "25021-184-87", "57237-149-35", "57237-150-35", "16714-695-01", "16714-696-01", "68001-253-21", "68001-253-20", "68001-253-44", "68001-253-17", "68001-254-04", "68001-251-04", "68001-252-04", "0049-3410-30", "0049-3420-30", "0049-3420-41", "0049-3500-79", "0049-3430-30", "0049-3430-41", "0049-3440-19", "0049-3450-19", "70436-227-48", "25021-184-66", "25021-184-67", "77771-396-30", "77771-397-30", "77771-397-01", "77771-398-13", "77771-398-11", "77771-399-30", "77771-399-01", "62559-990-30", "62559-991-30", "62559-992-12", "62559-993-30", "70710-1137-1", "70710-1137-5", "70710-1137-4", "70710-1137-3", "70710-1138-3", "70710-1138-1", "70710-1138-5", "70710-1138-4", "70710-1139-3", "70710-1139-1", "70710-1139-5", "70710-1139-7", "70710-1139-8", "70710-1140-3", "70710-1140-1", "70710-1140-5", "70710-1140-4", "59762-5015-1", "59762-5016-1", "59762-5017-1", "59762-5018-1", "59762-5029-1", "59762-5030-1", "65862-299-35", "65862-300-35", "65862-058-30", "65862-059-30", "65862-059-01", "65862-059-05", "65862-060-11", "65862-061-30", "65862-061-01", "65862-061-05" ], "nui": [ "N0000175487", "M0002083", "N0000182140", "N0000182141", "N0000185504" ], "pharm_class_epc": [ "Azole Antifungal [EPC]" ], "pharm_class_cs": [ "Azoles [CS]" ], "pharm_class_moa": [ "Cytochrome P450 2C19 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]" ], "unii": [ "8VZV102JFY" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ALPRAZOLAM.", "drugstructuredosagenumb": ".5", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ALPRAZOLAM" }, "openfda": { "application_number": [ "ANDA074342", "ANDA203346", "ANDA090871", "NDA018276", "ANDA074174", "ANDA078088", "ANDA078561", "ANDA078387", "ANDA200739", "NDA021434", "ANDA074312", "ANDA074112", "ANDA074909" ], "brand_name": [ "ALPRAZOLAM", "XANAX", "XANAX XR", "ALPRAZOLAM XR" ], "generic_name": [ "ALPRAZOLAM" ], "manufacturer_name": [ "Actavis Pharma, Inc.", "Aurobindo Pharma Limited", "Mylan Pharmaceuticals Inc.", "ANI Pharmaceuticals, Inc.", "Par Health USA, LLC", "Amneal Pharmaceuticals LLC", "Natco Pharma USA LLC", "PHARMACIA & UPJOHN COMPANY LLC", "Viatris Specialty LLC", "Hikma Pharmaceuticals USA Inc.", "Sandoz Inc" ], "product_ndc": [ "0228-2027", "0228-2029", "0228-2031", "0228-2039", "65862-676", "65862-677", "65862-678", "65862-679", "65862-454", "65862-455", "65862-456", "65862-457", "59762-3719", "59762-3720", "59762-3721", "59762-3722", "70954-508", "70954-509", "70954-510", "70954-511", "49884-110", "49884-111", "49884-213", "49884-214", "0228-4019", "0228-4022", "0228-4024", "0228-4025", "65162-809", "65162-810", "65162-812", "65162-813", "69339-199", "69339-200", "69339-201", "69339-202", "0009-0090", "0009-0029", "0009-0055", "0009-0094", "58151-503", "58151-504", "58151-505", "58151-506", "59762-0057", "59762-0059", "59762-0066", "59762-0068", "58151-452", "58151-453", "58151-454", "58151-455", "0054-3068", "0781-1061", "0781-1077", "0781-1079", "0781-1089" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ALPRAZOLAM" ], "rxcui": [ "197321", "197322", "308047", "308048", "433798", "433799", "433800", "433801", "485413", "485414", "485415", "485416", "141927", "141928", "214003", "214004", "687022", "687023", "687024", "687025", "308050" ], "spl_id": [ "9cf12473-8eb9-4248-bfce-76eef6b82bfd", "7527aeb7-8912-404d-afb7-8c692c84422b", "f2273fea-bd3b-4ef5-b698-73ba677722e3", "0deddc26-2764-4879-a0e4-a29fff246244", "18a6f29f-7eb8-4aa2-8121-d554c59da191", "38e94d5e-f7e2-4349-94f2-2fba605f5ae6", "38c5b407-25a1-48f5-960e-87ef637b644c", "4b2e21bc-ca1c-4ff5-a996-32f1e94d2a91", "885d0fec-f1a6-42f4-8617-1d048cb15ee9", "f5323eac-81d0-4096-ac15-2f25220c5c28", "7ceb0a8d-f766-4806-a289-652080edf4a3", "70f0098e-50b5-4e61-b4e0-141a55d92267", "27062ff4-9ce3-4d8a-aeae-f4468efb623a", "d7b8cdff-1337-4ef6-a5fb-654f1d655bfe", "4c8c7366-aa3b-4124-9d64-67fb0ead6e15" ], "spl_set_id": [ "a23063c0-099a-4256-b95f-3a857bbf704b", "d2fd0b3e-9b78-44d0-82a6-96d6c6238750", "326fa31a-5420-429b-9f7f-170cb38f64bd", "13930c94-d83a-414f-be35-b1fef35f738d", "38428a1b-718c-49cc-94ae-2e3644ba6256", "ff1630b4-2044-433c-96bc-0bb4ae8d42a0", "5ceed721-2e65-4c81-bd84-f110b1ac9d2e", "259387c1-e374-4bc2-9510-5f7f2c60d1a5", "b3c55877-2538-4892-bdb1-d618c643d29c", "388e249d-b9b6-44c3-9f8f-880eced0239f", "c8990714-c2f5-4b0c-9f1c-91d77156d962", "1338d1c9-7c75-42ed-95f3-9eb1b6fc51d3", "bb5cf72e-3a41-41a8-9a38-80f974eca33f", "b945ac6f-796e-41ef-85e9-61007e4a4e9a", "d9b0e228-17cf-40d7-b62e-5050311c571c" ], "package_ndc": [ "0228-2027-10", "0228-2027-50", "0228-2027-96", "0228-2029-10", "0228-2029-50", "0228-2029-96", "0228-2031-10", "0228-2031-50", "0228-2031-96", "0228-2039-10", "65862-676-01", "65862-676-05", "65862-676-99", "65862-677-01", "65862-677-05", "65862-677-99", "65862-678-01", "65862-678-05", "65862-678-99", "65862-679-01", "65862-679-05", "65862-679-99", "65862-454-60", "65862-454-99", "65862-454-71", "65862-455-60", "65862-455-99", "65862-455-71", "65862-456-60", "65862-456-99", "65862-456-71", "65862-457-60", "65862-457-99", "65862-457-71", "59762-3719-1", "59762-3719-3", "59762-3719-4", "59762-3720-1", "59762-3720-3", "59762-3720-4", "59762-3721-1", "59762-3721-3", "59762-3721-4", "59762-3722-1", "59762-3722-3", "70954-508-10", "70954-508-20", "70954-508-30", "70954-509-10", "70954-509-20", "70954-509-30", "70954-510-10", "70954-510-20", "70954-510-30", "70954-511-10", "70954-511-20", "49884-110-74", "49884-111-74", "49884-213-74", "49884-214-74", "0228-4019-11", "0228-4022-11", "0228-4024-11", "0228-4025-11", "65162-809-03", "65162-809-06", "65162-809-50", "65162-810-03", "65162-810-06", "65162-810-50", "65162-812-03", "65162-812-06", "65162-812-50", "65162-813-03", "65162-813-06", "65162-813-50", "69339-199-01", "69339-199-05", "69339-199-10", "69339-200-01", "69339-200-05", "69339-200-10", "69339-201-01", "69339-201-05", "69339-201-10", "69339-202-01", "69339-202-05", "69339-202-10", "0009-0029-01", "0009-0029-46", "0009-0029-02", "0009-0029-14", "0009-0055-01", "0009-0055-46", "0009-0055-03", "0009-0055-15", "0009-0090-01", "0009-0090-04", "0009-0090-13", "0009-0094-01", "0009-0094-03", "58151-503-91", "58151-504-91", "58151-505-91", "58151-506-91", "59762-0057-1", "59762-0059-1", "59762-0066-1", "59762-0068-1", "58151-452-01", "58151-452-05", "58151-453-01", "58151-453-05", "58151-454-01", "58151-454-05", "58151-455-01", "0054-3068-44", "0781-1061-01", "0781-1061-05", "0781-1061-10", "0781-1077-01", "0781-1077-05", "0781-1077-10", "0781-1079-01", "0781-1079-05", "0781-1079-10", "0781-1089-01", "0781-1089-05" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "YU55MQ3IZY" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ANDROGEL", "drugstructuredosagenumb": "1.25", "drugstructuredosageunit": "002", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "TESTOSTERONE" } }, { "drugcharacterization": "2", "medicinalproduct": "FINASTERIDE.", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "FINASTERIDE" }, "openfda": { "application_number": [ "ANDA203687", "ANDA090121", "ANDA091643", "ANDA090061", "ANDA207750", "ANDA090508", "ANDA078341", "ANDA076436", "ANDA090060", "ANDA076511", "ANDA204304", "NDA020180", "ANDA076437", "NDA020788" ], "brand_name": [ "FINASTERIDE", "PROSCAR", "PROPECIA" ], "generic_name": [ "FINASTERIDE" ], "manufacturer_name": [ "Aurobindo Pharma Limited", "Rising Pharma Holdings, Inc.", "Accord Healthcare, Inc.", "Camber Pharmaceuticals, Inc.", "Ascend Laboratories, LLC", "Sun Pharmaceutical Industries, Inc.", "QUALLENT PHARMACEUTICALS HEALTH LLC", "Exelan Pharmaceuticals Inc.", "Dr. Reddy's Laboratories Limited", "Dr Reddys Laboratories Inc", "Teva Pharmaceuticals USA, Inc.", "Thirty Madison Inc", "Organon LLC", "Burel Pharmaceuticals, LLC" ], "product_ndc": [ "65862-927", "65862-686", "57237-061", "16729-090", "16729-089", "31722-525", "67877-455", "47335-714", "65862-149", "82009-061", "76282-412", "55111-171", "43598-390", "0093-7355", "31722-526", "67877-288", "71713-099", "78206-153", "57237-062", "55111-172", "43598-303", "78206-152", "35573-400" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FINASTERIDE" ], "rxcui": [ "200172", "310346", "201961", "213178" ], "spl_id": [ "92ac09b3-d036-4c90-81e6-c13310f0a673", "2afe9ff4-1cd2-4392-8e11-8e6ea24a68af", "23a879ed-37ee-0f94-e063-6394a90a17a0", "2397604d-3fd8-2d97-e063-6394a90a0750", "2c74278f-8221-8804-e063-6394a90a7eaf", "f4ed6589-2062-48b0-8a0c-25b0342342c2", "3fb7fc89-95b5-4c8a-9b1c-dd509cadb4eb", "f415dbd7-7dda-4142-92e0-150c4f4627b7", "7e56c5b9-a7be-4413-83f2-38c0f3c688e3", "6e0d44f6-d0c0-4db5-b0ea-8f52dd2e5613", "f7dbde3b-f358-c073-8516-fc07fa33303a", "47e5c3f0-f718-b400-c5f7-ba0057fdf6b1", "c5126a52-1e69-447d-800f-ba863246b7d7", "0ebbabf3-0681-484d-ab8d-58e670d80a0d", "c706fcdf-4849-45cd-a597-c334896e167a", "3fe7bdaa-b027-4da9-94ee-550bf28c63e1", "979b0a0c-7868-4ec1-8887-f2b7e43f4326", "c44c39d5-9ec1-4714-838b-b03b69494caf", "3e2181d6-f6be-c77e-e3f3-63e26fc35897", "8e1e332b-310c-a528-339a-702c542d14dd", "97f5deb0-a4ab-42c3-afa0-db2170a16297", "6752dcb1-091e-40a9-a6e2-069d543398a7" ], "spl_set_id": [ "7d140366-2388-488e-bd86-67e6edf44345", "01b88593-99d3-4dd6-a7b6-5438c15bd7b7", "adfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad", "e3728709-e805-4b46-9954-2c433a865987", "cc9709ce-2d29-48bd-b46b-3f72114f2527", "ecd2fbb2-a4bd-44f2-831d-179e7dbf0741", "abd87058-923f-4767-986c-278201c0e688", "32266029-c710-44dd-943f-7e31d0afa622", "5efc695c-d9fd-4892-a63f-a35cceb8d3c7", "1c1bf77c-f99a-44e4-b71e-ce766afa99b6", "fa19372d-027d-a91b-f58e-1bdb8fd7e2b6", "9acbe693-8448-b443-9f78-1f9972520798", "77589cc3-c440-4695-800c-82a0e5128a6c", "00e934bb-c15b-490a-a852-839689a1231a", "9b38c8c7-01e4-45d0-b4ee-3546d9ad849c", "3fe7bdaa-b027-4da9-94ee-550bf28c63e1", "6f988153-fc74-4ca4-b29a-111f750c4a4b", "9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d", "a4dd6d6c-c8c7-16a9-aa68-aa46283dfae1", "c8ed59a3-c5b2-3156-b781-5e514b79011b", "6f904709-65aa-44ce-b144-b4c8a0416e36", "c8516eaa-98d0-4eb1-bc65-aa765baea5db" ], "package_ndc": [ "65862-927-30", "65862-927-90", "65862-927-99", "65862-686-30", "65862-686-90", "65862-686-99", "57237-061-30", "57237-061-90", "16729-090-10", "16729-090-15", "16729-090-01", "16729-090-16", "16729-090-17", "16729-089-10", "16729-089-15", "31722-525-30", "31722-525-01", "31722-525-10", "31722-525-90", "31722-525-05", "67877-455-30", "67877-455-90", "67877-455-05", "67877-455-34", "67877-455-94", "47335-714-83", "47335-714-81", "47335-714-88", "47335-714-08", "47335-714-18", "65862-149-30", "65862-149-90", "65862-149-01", "65862-149-05", "82009-061-05", "76282-412-30", "76282-412-90", "76282-412-05", "76282-412-10", "55111-171-30", "55111-171-90", "55111-171-18", "55111-171-05", "43598-390-30", "43598-390-90", "0093-7355-56", "0093-7355-98", "0093-7355-05", "31722-526-30", "31722-526-90", "31722-526-10", "67877-288-90", "67877-288-05", "67877-288-10", "67877-288-01", "67877-288-30", "67877-288-33", "71713-099-90", "78206-153-01", "78206-153-02", "57237-062-30", "57237-062-90", "57237-062-05", "55111-172-30", "55111-172-90", "55111-172-01", "55111-172-05", "55111-172-79", "55111-172-78", "43598-303-30", "43598-303-90", "78206-152-02", "78206-152-01", "35573-400-99" ], "nui": [ "N0000175836", "N0000000126" ], "pharm_class_epc": [ "5-alpha Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "5-alpha Reductase Inhibitors [MoA]" ], "unii": [ "57GNO57U7G" ] } }, { "drugcharacterization": "1", "medicinalproduct": "POMALYST", "drugbatchnumb": "C0021A", "drugauthorizationnumb": "204026", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugdosagetext": "2 MILLIGRAM", "drugdosageform": "Capsules", "drugadministrationroute": "048", "drugindication": "PLASMA CELL MYELOMA", "drugstartdateformat": "102", "drugstartdate": "20140206", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "POMALIDOMIDE" }, "openfda": { "application_number": [ "NDA204026" ], "brand_name": [ "POMALYST" ], "generic_name": [ "POMALIDOMIDE" ], "manufacturer_name": [ "Celgene Corporation" ], "product_ndc": [ "59572-501", "59572-502", "59572-503", "59572-504" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POMALIDOMIDE" ], "rxcui": [ "1369718", "1369724", "1369726", "1369728", "1369730", "1369732", "1369734", "1369736" ], "spl_id": [ "4410582a-a5f3-429f-a7ca-5c17fb5560bf" ], "spl_set_id": [ "2b25ef01-5c9e-11e1-b86c-0800200c9a66" ], "package_ndc": [ "59572-501-21", "59572-501-00", "59572-502-21", "59572-502-00", "59572-503-21", "59572-503-00", "59572-504-21", "59572-504-00" ], "nui": [ "N0000184014" ], "pharm_class_epc": [ "Thalidomide Analog [EPC]" ], "unii": [ "D2UX06XLB5" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PANTOPRAZOLE SODIUM", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "PANTOPRAZOLE SODIUM" }, "openfda": { "application_number": [ "ANDA090970", "ANDA204400", "ANDA216171", "ANDA213725", "ANDA217923", "NDA209463", "NDA020988", "ANDA215860", "ANDA202882", "ANDA216021", "ANDA202038", "ANDA090074", "ANDA213778", "NDA217512", "ANDA219230", "ANDA205119", "ANDA217282", "ANDA214680", "ANDA217416", "ANDA205675", "ANDA216139", "ANDA219087", "ANDA216247", "ANDA078281", "ANDA209524", "ANDA077674", "NDA020987", "NDA022020", "ANDA215074" ], "brand_name": [ "PANTOPRAZOLE SODIUM", "PROTONIX I.V.", "PANTOPRAZOLE SODIUM I.V.", "PROTONIX DELAYED-RELEASE" ], "generic_name": [ "PANTOPRAZOLE SODIUM", "PANTOPRAZOLE", "PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE", "PANTOPRAZOLE SODIUM INJECTION" ], "manufacturer_name": [ "Mylan Pharmaceuticals Inc.", "Sun Pharmaceutical Industries Limited", "Novadoz Pharmaceuticals LLC", "Sun Pharmaceutical Industries, Inc.", "Aurobindo Pharma Limited", "Civica, Inc.", "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "Northstar Rx LLC", "NorthStar RxLLC", "XLCare Pharmaceuticals Inc.", "Fresenius Kabi USA, LLC", "NorthStar Rx LLC", "Quallent Pharmaceuticals Health LLC", "Torrent Pharmaceuticals Limited", "Camber Pharmaceuticals, Inc.", "Sagent Pharmaceuticals", "Baxter Healthcare Company", "Meitheal Pharmaceuticals Inc.", "Alembic Pharmaceuticals Limited", "Amneal Pharmaceuticals LLC", "Granules Pharmaceuticals Inc.", "Piramal Critical Care", "Burel Pharmaceuticals, LLC", "Ajanta Pharma USA Inc.", "Gland Pharma Limited", "Eugia US LLC", "BE Pharmaceuticals Inc.", "Rising Pharma Holdings, Inc.", "Edenbridge Pharmaceuticals LLC.", "Lannett Company, Inc.", "Alembic Pharmaceuticals Inc.", "Hikma Pharmaceuticals USA Inc.", "American Health Packaging", "Sandoz Inc", "Devatis Inc.", "Chartwell RX, LLC" ], "product_ndc": [ "0378-6688", "0378-6689", "70095-024", "72205-180", "62756-071", "59651-671", "72572-553", "0008-0923", "72603-128", "72603-317", "72865-229", "72865-230", "65219-385", "72603-746", "82009-010", "82009-011", "13668-096", "13668-429", "31722-204", "25021-751", "0338-9644", "0338-9646", "0338-9648", "71288-600", "46708-071", "65162-636", "65162-637", "70010-190", "70010-191", "31722-712", "31722-713", "65862-559", "65862-560", "0008-4001", "66794-258", "35573-428", "27241-256", "68083-493", "55150-202", "31722-032", "71839-122", "64980-676", "64980-677", "42799-952", "62175-617", "62175-180", "62175-618", "62332-071", "0143-9300", "60687-767", "0143-9284", "0781-3480", "62756-129", "0008-0841", "0008-0843", "0008-0844", "73043-020", "62135-533", "62135-534" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAVENOUS" ], "substance_name": [ "PANTOPRAZOLE SODIUM" ], "rxcui": [ "251872", "314200", "283669", "763306", "885257", "2675781", "2675784", "2675786", "284400", "352125", "763308" ], "spl_id": [ "38896560-f523-4d0b-8113-5ff7f5f38c81", "b423abbc-01e1-4d07-9c89-a7398c898d2f", "1172bc4e-1700-402f-8262-97f05bac0d09", "d19d65d9-7bab-4a6f-9a79-ed3d32bd83d9", "b3cec41e-e98b-470a-8ba2-c31537023989", "9d6f752f-428f-455d-8f09-3b74c68524fb", "a7e7d657-a748-4234-8dd6-c0e4d0f81a86", "e74d873e-138b-4ba4-ba33-05a0998dc45d", "4494f9d0-a1c8-477f-9b4a-f65d7637d9ec", "f26fc428-a419-1008-e053-2a95a90a83fc", "452b14d4-4fbd-47b1-b4b1-f0b302e8f0d9", "6637d90b-b268-4a5f-ab5b-885f2d5f0d4b", "48430767-cec0-15e0-e063-6394a90ac032", "7d09300f-2078-458c-9328-f83ffd997c9e", "358ef102-b287-cdc7-e063-6394a90aa4a6", "2b04a735-571c-4668-bc78-ac3a611d575c", "d5de6772-699a-46a0-a3c6-b4be83caff14", "48bbc577-3242-4da3-bca3-7a5f89105415", "02ee7ed6-217f-4128-bbbb-b9390475a65b", "940df77d-5373-4196-946e-19271ac91087", "4ec4732c-38ba-bcc3-e063-6294a90a823c", "48f42a12-2eac-e5dd-e063-6294a90aa92d", "4784124c-9df4-42f6-8044-c0480c1a3bbf", "d36cd2fb-517f-44e5-8438-53e563775f86", "941d4274-57b1-4c13-a7e6-cbebfca66343", "390349ed-4093-e0b3-e063-6294a90a474e", "eb46c38e-b217-4295-9569-98c16cad56df", "d0fe5d1b-fb0c-4c7b-af8b-cda49f2c8f7e", "6cd73b63-72e7-4f03-955d-fa897f905c2a", "d5f032bc-da34-4b3a-a337-7d7a594ea7b2", "092a2d03-1a01-a7ac-e063-6394a90a01b4", "bad4fab9-654b-423c-87dc-25ff7a9f29d9", "9fe81197-8014-4967-aa15-7525509d532c", "491a4100-ef0e-4a7e-82cd-6f574f416c26", "cfbf12d8-f656-4b99-bd2e-fb11bab669e5", "db0264f6-5825-49a1-bb86-746ece155660", "673b147b-f117-4f86-b22c-e78ea92fb0e8", "236c62bf-3ddb-0b3e-e063-6394a90ad6c6", "284915b9-082e-4c76-8998-13aff7221045", "38e9f0e0-9691-4c5d-b4aa-d3d314df242c", "ef1bb9ed-b534-4698-abf5-836dcce85f45", "b1adaee5-9353-48ce-bde4-f169a3787e30", "ee61b559-2d9b-4202-b9de-e37ce3733019", "4687aefe-4974-b8d6-e063-6294a90a0522" ], "spl_set_id": [ "56ad5b97-8e5f-48a5-b2ba-a5484b43d018", "eb3f58d4-0c69-4377-be45-c36099c98d33", "1172bc4e-1700-402f-8262-97f05bac0d09", "38353b9e-63bd-47e8-b7cb-b198d1e901f9", "b3cec41e-e98b-470a-8ba2-c31537023989", "c857dc41-7b47-4f26-a9f5-d76eb82b44ee", "51e4144a-489e-436c-609a-39305f8f56ba", "7e0c5dac-6832-4692-b012-ca59d5e88987", "4494f9d0-a1c8-477f-9b4a-f65d7637d9ec", "17468dbf-84b6-4c53-9ad5-341350d2cfab", "340b57c2-bcf8-4f46-b522-886daaf80351", "6637d90b-b268-4a5f-ab5b-885f2d5f0d4b", "643eb498-d916-4fb7-9281-32895575ab36", "9c983da1-a8e0-479e-8816-5d5668ea242e", "1bb94d3c-8bc3-4193-9dd8-e9a22066707c", "c39be14b-e881-4586-b77e-4747db494954", "a476e063-9450-4793-9a22-16b0a0a61cd0", "014f9762-6948-46b7-8659-5c89f35ad8bf", "02ee7ed6-217f-4128-bbbb-b9390475a65b", "f3ded82a-cf0d-4844-944a-75f9f9215ff0", "8f2fb647-15bc-41cb-84a4-02e956e614fc", "9daa1483-5a36-44db-9e0d-904d100da262", "7418f358-f536-4de6-adf0-562b4373f2e3", "f39b3e7d-39d2-4c8a-9974-4ab885241880", "c18aff31-f91e-4b6a-9713-52c9094c6082", "0696b10c-972b-9dcf-e063-6294a90a1034", "3cc5197e-6b39-4415-b963-d4bbeecd7953", "90963a38-f629-45a4-bddd-9e13a55fe0f7", "c1ad8f91-3783-4139-8154-e461a53809c1", "9bed093a-9586-4c82-a2b7-c68f89d0faef", "ee6278c0-d8c0-417c-a65c-b522ff76fe44", "52d5bc28-66df-43aa-bb1a-8ac4a2a7f693", "91a6b13f-457f-4136-9541-c4adb9c3c35c", "a0bb76bc-094a-4d61-9bb2-2226c9da4ae9", "e7705bf6-e473-4b9c-bb5d-57e26ffe7b97", "a9e5fac6-2db6-4311-a98b-eb3f0dde19d6", "1e102c44-232b-4aaf-b457-2a740c47193a", "423dac8b-bb1e-4456-9b6e-913c028b11bc", "b02f3f85-8f9b-4d06-8eae-73e592626f3e", "22b71a1d-87f8-43ba-b53d-53ca3f70c63e", "d9fcf6a2-3788-4955-84d9-3c319b13267c", "08098cb2-c048-4640-f387-6beec4a38936", "13c337e7-1e7b-47bd-9f88-92b0d548ca9c", "42a969c3-1144-4151-9cf3-3e9bace6a380" ], "package_ndc": [ "0378-6688-77", "0378-6688-99", "0378-6689-77", "0378-6689-10", "0378-6689-99", "70095-024-01", "70095-024-02", "70095-024-03", "72205-180-01", "72205-180-09", "72205-180-07", "62756-071-60", "62756-071-64", "59651-671-30", "72572-553-01", "72572-553-10", "0008-0923-51", "0008-0923-60", "0008-0923-55", "72603-128-01", "72603-128-10", "72603-317-01", "72603-317-30", "72865-229-90", "72865-230-90", "72865-230-10", "65219-385-01", "65219-385-10", "72603-746-01", "72603-746-02", "82009-010-90", "82009-011-90", "82009-011-10", "13668-096-90", "13668-429-30", "13668-429-05", "13668-429-90", "13668-429-10", "31722-204-31", "31722-204-10", "31722-204-32", "25021-751-10", "25021-751-11", "0338-9644-01", "0338-9644-12", "0338-9646-01", "0338-9646-24", "0338-9648-01", "0338-9648-12", "71288-600-91", "71288-600-92", "46708-071-01", "46708-071-10", "46708-071-25", "65162-636-03", "65162-636-09", "65162-637-03", "65162-637-09", "65162-637-50", "65162-637-11", "70010-191-09", "70010-191-10", "70010-190-09", "70010-190-10", "31722-712-90", "31722-712-32", "31722-712-31", "31722-713-90", "31722-713-32", "31722-713-31", "31722-713-10", "65862-559-90", "65862-559-99", "65862-559-10", "65862-560-90", "65862-560-05", "65862-560-99", "65862-560-10", "0008-4001-01", "0008-4001-10", "0008-4001-25", "71288-600-10", "71288-600-11", "66794-258-41", "35573-428-80", "27241-256-11", "27241-256-38", "68083-493-01", "68083-493-10", "68083-493-25", "55150-202-00", "55150-202-10", "55150-202-25", "31722-032-32", "71839-122-25", "71839-122-10", "71839-122-01", "64980-676-09", "64980-677-09", "64980-677-10", "42799-952-01", "42799-952-30", "62175-617-46", "62175-617-43", "62175-180-46", "62175-180-43", "62175-618-46", "62175-618-43", "62332-071-01", "62332-071-10", "62332-071-25", "0143-9300-01", "0143-9300-10", "60687-767-99", "60687-767-27", "0143-9284-01", "0143-9284-10", "0781-3480-95", "62756-129-40", "62756-129-44", "62756-129-45", "0008-0843-81", "0008-0841-81", "0008-0844-01", "0008-0844-02", "73043-020-25", "73043-020-10", "73043-020-01", "62135-533-90", "62135-534-90", "62135-534-08" ], "unii": [ "6871619Q5X" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CRESTOR", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ROSUVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA021366" ], "brand_name": [ "CRESTOR" ], "generic_name": [ "ROSUVASTATIN" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0310-7560", "0310-7570", "0310-7580", "0310-7590" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ROSUVASTATIN CALCIUM" ], "rxcui": [ "859419", "859421", "859424", "859426", "859747", "859749", "859751", "859753" ], "spl_id": [ "afc9b415-ee6f-4905-a281-13e74dcf6ce6" ], "spl_set_id": [ "325a5d0e-9a72-4015-9fcd-1655fb504cee" ], "package_ndc": [ "0310-7560-90", "0310-7570-90", "0310-7580-90", "0310-7590-30" ], "unii": [ "83MVU38M7Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "MORPHINE SULFATE.", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "MORPHINE SULFATE" }, "openfda": { "application_number": [ "ANDA202861", "NDA018565", "ANDA074862", "ANDA074769", "NDA204223", "ANDA076412", "ANDA076438", "ANDA211452", "NDA022207", "ANDA205758", "NDA022195", "ANDA203518", "ANDA203602", "NDA202515", "ANDA202348", "ANDA079040", "ANDA203158", "ANDA212451", "ANDA206573", "ANDA073509", "ANDA073510", "ANDA215194", "ANDA202104", "NDA019516", "ANDA204393", "ANDA078761", "ANDA210610", "ANDA200411", "ANDA211454" ], "brand_name": [ "MORPHINE SULFATE", "INFUMORPH 200", "INFUMORPH 500", "MORPHINE SULFATE EXTENDED RELEASE", "MS CONTIN", "MITIGO", "DURAMORPH" ], "generic_name": [ "MORPHINE SULFATE" ], "manufacturer_name": [ "International Medication Systems, Limited", "Hikma Pharmaceuticals USA Inc.", "Rhodes Pharmaceuticals LLC", "Fresenius Kabi, USA LLC", "SpecGx LLC", "Civica, Inc.", "Cranbury Pharmaceuticals, LLC", "Lupin Pharmaceuticals,Inc.", "Padagis US LLC", "Hospira, Inc.", "Actavis Pharma, Inc.", "Nortec Development Associates, Inc.", "Ascend Laboratories, LLC", "PAI Holdings, LLC dba PAI Pharma", "Upsher-Smith Laboratories, LLC", "American Health Packaging", "Piramal Critical Care, Inc.", "Sun Pharmaceutical Industries, Inc.", "Amneal Pharmaceuticals of New York LLC", "Fresenius Kabi USA, LLC", "Winder Laboratories LLC" ], "product_ndc": [ "76329-1912", "0641-6039", "0641-6040", "42858-801", "42858-802", "42858-803", "42858-804", "42858-805", "76045-004", "76045-005", "76045-006", "76045-007", "76045-008", "0406-8315", "0406-8330", "0406-8380", "0406-8390", "0406-8320", "0641-6191", "0641-6192", "0054-0235", "0054-0236", "72572-440", "0054-0237", "0054-0404", "0054-0517", "0054-0238", "27808-082", "27808-084", "43386-540", "43386-541", "43386-542", "43386-543", "43386-544", "0574-7110", "0574-7112", "0574-7114", "0574-7116", "0409-1896", "0409-2022", "0406-8003", "0228-3090", "0228-3116", "0228-3091", "0228-3117", "0228-3092", "0228-3093", "42689-005", "42689-006", "42689-007", "42689-008", "42689-009", "42689-010", "67877-670", "67877-671", "0121-4955", "0409-3814", "0409-3815", "0406-5118", "0406-5119", "0641-6125", "0641-6126", "0641-6127", "0832-0225", "0832-0226", "0832-0227", "0832-0228", "0832-0229", "0832-0230", "0832-0233", "42858-515", "42858-631", "42858-760", "42858-799", "42858-900", "60687-927", "0409-1890", "0409-1891", "0409-1892", "0409-1893", "0409-1894", "66794-160", "66794-162", "63304-450", "63304-451", "63304-758", "63304-452", "63304-453", "0832-0273", "0832-0274", "0115-1277", "0115-1278", "0115-1279", "0115-1280", "0115-1281", "0115-1282", "0115-1479", "0641-6019", "0641-6020", "63323-451", "63323-452", "63323-454", "63323-455", "63323-458", "75826-129", "75826-130", "75826-131" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "EPIDURAL", "INTRATHECAL", "ORAL", "INTRAMUSCULAR", "RECTAL" ], "substance_name": [ "MORPHINE SULFATE" ], "spl_id": [ "99799101-d92b-485b-93ec-f2b5a2e5ca26", "b1c060cb-5c5b-495f-90b5-044e04f2a3f2", "ccb2d4f4-3f19-40cd-9653-cec37213f8a0", "286bce70-23cd-4d5b-989b-230d6cdd5a91", "6873cac9-e7d5-4db2-851d-528268b483e9", "cbc693d6-fa17-4710-b91f-22c4f5d74793", "c89c4f71-eab3-4b74-b098-fcd31d5aa0dd", "af373236-891f-4ea8-adf8-17e6accdfea0", "1bfdbb7c-d06a-4010-82f9-189b59a2f18d", "6c3bd932-ab35-4173-8087-f916e3d688ff", "d4efe614-fe99-4cc7-b3ba-87c4e010efbd", "fa18ac09-a625-47aa-8cde-7051dc4d0c49", "6f2d5741-5543-4bea-8d1d-7e4889b634a0", "c946a19a-39f9-4c54-8715-0918f976b8bc", "d41b3be8-7ef7-4b1d-9692-fffd13baf96d", "863bb977-9d7b-4258-a6ff-3ed2eeefeb81", "2d263950-4148-405d-b582-13857ac88044", "8a1bb0fe-ab24-4c30-b843-d06c61fcf0cb", "0a2ba20b-448f-4412-9899-b82040ebfa7d", "4212f903-83d4-42e3-af2a-55a6d63b5c36", "45b5788e-b745-4835-9311-0ca569d45ebe", "3984af25-b79e-1fe0-e063-6394a90ac936", "8c82ab15-28e5-4c36-b05e-64139e120e2d", "4a17fffd-a5d3-d770-e063-6294a90ace0c", "56671cfe-7548-442e-a2b5-ffebebf65ade", "495a6a51-d35d-2b96-e063-6394a90ac5f3", "4d15b836-54c7-2f40-e063-6294a90a68a2", "46a682fc-0430-5a66-e063-6294a90a6179", "b2330bfc-8b32-421e-ade5-2076ee23cebb", "aa74af85-7068-4254-9a79-c7f3792044a6", "dbf870e7-7bfe-48f0-ba6a-9cc476dfe5cc", "2b0eba4c-7f43-72ef-e063-6294a90afd7e" ], "spl_set_id": [ "1034467f-d436-4b87-a902-c7e8885daa8a", "db9ac9e3-d761-4a99-9f34-4946ebe8f255", "19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804", "1f53de80-efc8-4930-b3e3-fba0d026af05", "533034fd-c8e7-495b-8874-0db41bd1e65a", "69a0d5be-3211-4b7f-962b-e9d9a507321f", "3c847554-3b4b-4d24-a145-2ef7e9b83699", "9362eca1-2bc9-4f72-8895-0b9179bfeb2b", "ca359246-4674-4b32-b8b2-673d32b7112f", "d8598654-94ad-4cfb-81d2-9b68e013a428", "d360a33f-6323-4b10-9e81-07e2813c2dbd", "649d731b-962a-45df-b043-7e0781e8a530", "ee8057d1-ed12-4e18-9efa-d83504abf612", "242c2512-1d49-486b-a9c3-6905f667799e", "2da87bfa-11fd-43e3-8fef-d16ebeb15680", "9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4", "07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a", "9405556c-20e0-4e47-b1b0-7872bcc6517e", "1d181906-f3ec-4222-1883-e61577a3122e", "8b69f67f-30b3-4982-953e-5a4b87ec6ac6", "6023606c-150c-40c5-9175-598efe2a56c3", "97948a8f-7d1b-4614-b11d-e944cf56590b", "c354b3bf-86c0-4bb8-8b1f-be2164942698", "66a3f607-7f48-490f-84dd-b74dd1ee39e5", "be420e8b-bcb0-49b5-bb4d-1df8b9959809", "728f3d83-9a63-0c1f-e053-2a91aa0ac7db", "736c9b80-682c-4cda-bf18-61b18de0bd39", "5ceb3205-2f8d-4ba3-9f27-dc328bab4fa1", "f7e9a4b3-a2ee-4f0a-becd-6ef90867332b", "ebb18761-e5c4-4238-bb84-f9549f500210", "582f42e5-444e-4246-af8c-e7e28097c69a", "e9a7319a-bf1f-48db-a71e-6d4e6ead9555" ], "package_ndc": [ "76329-1912-0", "76329-1912-1", "0641-6039-01", "0641-6040-01", "42858-801-01", "42858-802-01", "42858-803-01", "42858-804-01", "42858-805-01", "76045-004-01", "76045-004-11", "76045-005-01", "76045-005-11", "76045-006-01", "76045-006-11", "76045-007-01", "76045-007-11", "76045-008-01", "76045-008-11", "0406-8315-01", "0406-8315-62", "0406-8315-23", "0406-8330-01", "0406-8330-62", "0406-8330-23", "0406-8380-01", "0406-8380-62", "0406-8380-23", "0406-8390-01", "0406-8390-62", "0406-8390-23", "0406-8320-01", "0641-6191-10", "0641-6192-10", "0054-0235-24", "0054-0235-25", "0054-0236-24", "0054-0236-25", "72572-440-01", "72572-440-25", "0054-0404-44", "0054-0404-50", "0054-0404-41", "0054-0517-44", "0054-0517-50", "0054-0517-41", "0054-0238-63", "0054-0238-49", "0054-0237-55", "0054-0237-49", "0054-0237-63", "0054-0237-41", "27808-084-01", "27808-084-02", "27808-082-01", "27808-082-02", "43386-540-01", "43386-540-05", "43386-541-01", "43386-541-05", "43386-542-01", "43386-542-05", "43386-543-01", "43386-543-05", "43386-544-01", "43386-544-05", "0574-7110-12", "0574-7112-12", "0574-7114-12", "0574-7116-12", "0409-1896-20", "0409-2022-01", "0406-8003-15", "0406-8003-30", "0406-8003-12", "0406-8003-24", "0228-3090-11", "0228-3116-11", "0228-3091-11", "0228-3117-11", "0228-3092-11", "0228-3093-11", "42689-006-01", "42689-005-01", "42689-007-01", "42689-008-01", "42689-009-01", "42689-010-01", "67877-670-01", "67877-671-01", "0121-4955-05", "0121-4955-94", "0409-3814-11", "0409-3814-12", "0409-3815-11", "0409-3815-12", "0406-5118-01", "0406-5118-62", "0406-5119-01", "0406-5119-62", "0641-6126-01", "0641-6126-25", "0641-6127-01", "0641-6127-25", "0641-6125-01", "0641-6125-25", "0832-0225-00", "0832-0225-50", "0832-0226-00", "0832-0226-50", "0832-0227-00", "0832-0227-50", "0832-0228-00", "0832-0228-50", "0832-0229-00", "0832-0229-50", "0832-0230-00", "0832-0230-50", "0832-0233-00", "0832-0233-50", "42858-515-01", "42858-631-01", "42858-760-01", "42858-799-01", "42858-900-01", "60687-927-40", "60687-927-46", "60687-927-86", "0409-1890-03", "0409-1890-01", "0409-1890-13", "0409-1890-23", "0409-1891-03", "0409-1891-01", "0409-1891-13", "0409-1891-23", "0409-1892-03", "0409-1892-01", "0409-1892-13", "0409-1892-23", "0409-1893-03", "0409-1893-01", "0409-1893-13", "0409-1893-23", "0409-1894-03", "0409-1894-01", "66794-160-02", "66794-162-02", "63304-450-03", "63304-450-01", "63304-450-05", "63304-451-03", "63304-451-01", "63304-451-05", "63304-758-03", "63304-758-01", "63304-758-05", "63304-758-50", "63304-452-03", "63304-452-01", "63304-452-05", "63304-453-03", "63304-453-01", "63304-453-05", "0832-0273-11", "0832-0274-11", "0115-1277-08", "0115-1277-01", "0115-1277-03", "0115-1278-08", "0115-1278-01", "0115-1278-03", "0115-1279-08", "0115-1279-01", "0115-1279-03", "0115-1280-08", "0115-1280-01", "0115-1280-03", "0115-1281-08", "0115-1281-01", "0115-1281-03", "0115-1282-08", "0115-1282-01", "0115-1282-03", "0115-1479-01", "0641-6020-01", "0641-6020-10", "0641-6019-01", "0641-6019-10", "63323-452-00", "63323-452-01", "63323-454-00", "63323-454-01", "63323-455-00", "63323-455-01", "63323-458-00", "63323-458-01", "63323-451-00", "63323-451-01", "75826-129-05", "75826-129-17", "75826-130-05", "75826-130-17", "75826-131-15", "75826-131-04", "75826-131-01" ], "unii": [ "X3P646A2J0" ], "rxcui": [ "892652", "1731522", "1731998", "1731999", "891874", "891881", "891888", "891893", "892646", "894912", "894914", "998212", "998213", "1442790", "892582", "892672", "1732006", "892589", "892625", "894780", "892516", "892603", "892678", "894807", "1731537", "1731545", "894970", "892297", "892342", "892349", "892355", "894942", "892345", "892352", "892554", "892596", "894801", "894814", "1728783", "1728800", "1731993", "1732011", "892494", "892560", "892574", "892648", "892660", "894813", "1729197", "1731995", "1732014", "2055307", "2055311", "1303736", "892473", "892489", "1732136", "2003714" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NYSTATIN.", "drugdosagetext": "10000 UNITS", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "NYSTATIN" }, "openfda": { "application_number": [ "ANDA203621", "ANDA065203", "ANDA211838", "ANDA208581", "ANDA065183", "ANDA062512", "ANDA062832", "ANDA064022", "ANDA064118", "ANDA219527", "ANDA209114", "ANDA212557", "ANDA062506", "ANDA213826", "NDA050299", "ANDA214346", "ANDA065148", "ANDA207767", "ANDA062474", "ANDA062225", "ANDA062472", "ANDA061966", "ANDA208838", "ANDA209082", "ANDA062840", "ANDA213566" ], "brand_name": [ "NYSTATIN", "NYAMYC", "NYSTATIN ORAL SUSPENSION", "NYSTOP" ], "generic_name": [ "NYSTATIN", "NYSTATIN OINTMENT", "NYSTATIN CREAM" ], "manufacturer_name": [ "Pharmaceutical Associates, Inc.", "Dr. Reddy's Labratories Inc.", "Torrent Pharmaceuticals Limited", "Zydus Lifesciences Limited", "Upsher-Smith Laboratories, LLC", "Xttrium Laboratories, Inc.", "Kanchan Healthcare Inc", "Sun Pharmaceutical Industries, Inc.", "Padagis US LLC", "Aurobindo Pharma Limited", "Cosette Pharmaceuticals, Inc.", "Kesin Pharma Corporation", "Teva Pharmaceuticals USA, Inc.", "Macleods Pharmaceuticals Limited", "Chartwell Governmental & Specialty RX, LLC", "Leading Pharma, LLC", "Genus Lifesciences Inc.", "Viona Pharmaceuticals Inc", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Zydus Pharmaceuticals USA Inc.", "Padagis Israel Pharmaceuticals Ltd", "Northstar Rx LLC", "Major Pharmaceuticals", "PAI Holdings, LLC dba PAI Pharma", "Chartwell RX, LLC", "Actavis Pharma, Inc." ], "product_ndc": [ "0121-0810", "0121-4810", "75907-060", "13668-534", "70771-1585", "0832-0465", "0116-4026", "85742-013", "51672-1289", "0574-2008", "59651-907", "0713-0686", "81033-015", "13668-595", "0093-0983", "33342-481", "68999-813", "69315-504", "64950-372", "72578-089", "23155-051", "68382-370", "45802-059", "72603-491", "0904-7276", "45802-048", "0121-1045", "62135-813", "62135-741", "0713-0678", "69315-306", "0121-0868", "69315-307", "0472-0166", "33342-469", "70771-1357" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "TOPICAL" ], "substance_name": [ "NYSTATIN" ], "rxcui": [ "312055", "646456", "884308", "584414", "543546", "261178", "312059" ], "spl_id": [ "d57cde69-0eb9-180d-e053-2995a90a33aa", "f635996b-25e1-c80b-32d0-eb75ee46a25f", "b5c975a5-4d7a-4177-b1e2-524bad92a5fb", "ea55d8af-28a2-491e-8aae-aa5102c228aa", "3984f88f-d61f-1fa9-e063-6394a90acb11", "4a2ff89a-52fe-8bf9-e063-6394a90a7f1d", "a7f34e4a-98d2-4cbf-9e62-1a2b5f00bcfd", "3908cf94-b2b6-30a4-e063-6394a90add43", "ef93a977-5107-4b0b-8d58-df221d7777db", "1a24e1d4-b691-4849-822a-9a9a4aed4b27", "0b479d47-d58c-1457-e063-6394a90a1256", "45b08d8c-c755-d45b-e063-6394a90aa4c8", "96bcc133-c446-4fce-a99a-ccd1039ded49", "b55205c3-f0be-44eb-a267-3af07c1639f4", "fe3db8b2-9de4-4f9e-b763-8536a1e4cea8", "4369e33a-8ee4-2c6b-e063-6394a90aabcb", "eb4efca9-e5e8-4509-9437-6ad7c593a9ef", "319a98e0-8009-47c9-9f40-9cd288c26e48", "3d917a6c-4e9a-4c45-9e79-caf91f8b11b0", "d5c4ffad-b502-4226-9ff2-8603aac88dba", "7f7aaf27-0265-40b9-a900-341232347fad", "e2839c50-5b8f-4e7b-9636-d22687038a89", "e7bbfa6e-9723-4309-97d3-76fe9a0cfde6", "764e2a6a-00ef-4340-8810-9537bae3b0be", "d0882d4c-19ef-45d3-99c2-2697b1d213d4", "4901e044-ed1c-4f55-add3-c33e1399f91a", "4c47b825-6b93-307f-e063-6394a90a2b7d", "462a7357-7985-7f48-e063-6294a90ac5c8", "ee0cb97f-1642-0dc0-e053-2995a90a8db3", "408ac13e-825a-44b1-b8cd-d52cbb0185d0", "7d265612-edc5-42bc-8e58-bae7d7ab7918", "520822eb-a9f1-4017-9a73-1979ee53f4e9", "6a5c1ca5-b727-4129-b884-fa7d3eb2cd8f", "d8ebb61a-a326-4f0d-a346-c3db045c3fb0", "f94a3196-9f89-4b93-8b26-bf811b9bbc3f" ], "spl_set_id": [ "31e3da10-5a7b-4bc5-8a4f-3e786b64c13a", "6bde84a1-341d-09ce-58b6-f9a653dc98c5", "4949dea7-d2b9-4e0d-974a-39408fa174ba", "5d593aa9-f2e4-4adf-9f02-37832ffcb5b4", "01b44f91-9b68-464a-9693-b5d3e793bf3c", "4a670371-d373-1ba6-e063-6394a90a13b6", "90a52c3f-3ef7-4f3b-9fe5-40af408e9f2a", "4d845b3f-ca26-4c47-b424-b6d783cc10e5", "e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4f", "7d8a30ab-465e-4804-a06b-afd689e16683", "8f87de59-33f2-32af-ae17-78bf30fb424d", "43817169-bbe8-58ee-e063-6294a90a1250", "559b5bd4-3564-4437-8d0a-fa3a972f8b83", "f03b294d-10cd-4bba-92c8-42ae9b110cd0", "fe3db8b2-9de4-4f9e-b763-8536a1e4cea8", "88a0a22e-8d6b-42aa-b225-2d57fb5b3a97", "954205d8-47ba-4c89-95cd-f0066a514cf9", "b25cbae5-eaf5-4501-b013-02c778ca4a4e", "e135a7d2-adba-48a2-b3e1-07b778cce9b0", "e87b8480-987d-4f82-87bf-cf831d6984a1", "2daf159d-6a12-4b5d-97b3-8069c17e7635", "e630aa3d-11a6-4300-942a-cbdf2d016f77", "9e6d0b0d-a68f-46aa-a707-3110ecb931b4", "17b9e33d-da9c-467a-bbc4-9e257727f19a", "6c091c66-2e4d-4412-b7bf-35315dc8152f", "05a8b8b6-3639-47b8-b7fc-47b105f5e6f9", "9954118e-abe6-4388-98c9-4473d39b2e28", "30175930-f5fa-403d-a3ac-3bdbbe723641", "ec1b52af-d38e-eba1-e63c-dba4341d3af2", "089e6444-2bd1-443e-acf0-dfeaa69faef9", "28b4e26e-206a-4e8a-abfe-774b780e91c3", "8900ba02-2c6a-4dd4-b82f-45620c06e255", "aee7ce4c-8cc6-4446-a4d7-63bc4773066f", "d8ebb61a-a326-4f0d-a346-c3db045c3fb0", "6aa2f67e-9636-45e5-be1b-83e7ab86e436" ], "package_ndc": [ "0121-0810-02", "0121-0810-16", "0121-4810-05", "0121-4810-40", "0121-4810-00", "0121-4810-50", "75907-060-44", "75907-060-30", "75907-060-60", "13668-534-01", "13668-534-02", "70771-1585-1", "70771-1585-3", "70771-1585-2", "0832-0465-15", "0832-0465-30", "0832-0465-60", "0116-4026-16", "0116-4026-05", "0116-4026-50", "0116-4026-11", "85742-013-10", "85742-013-11", "51672-1289-1", "51672-1289-2", "0574-2008-15", "0574-2008-30", "0574-2008-02", "59651-907-14", "59651-907-30", "0713-0686-15", "0713-0686-31", "81033-015-05", "81033-015-01", "81033-015-54", "13668-595-01", "13668-595-02", "0093-0983-01", "33342-481-15", "33342-481-30", "68999-813-05", "68999-813-24", "69315-504-60", "69315-504-47", "64950-372-47", "64950-372-06", "72578-089-01", "72578-089-04", "23155-051-01", "68382-370-01", "68382-370-03", "68382-370-02", "45802-059-35", "45802-059-11", "72603-491-01", "72603-491-02", "72603-491-03", "0904-7276-41", "0904-7276-92", "0904-7276-70", "45802-048-35", "45802-048-11", "0121-1045-16", "62135-813-47", "62135-813-46", "62135-741-90", "0713-0678-15", "0713-0678-31", "69315-306-15", "69315-306-30", "69315-306-60", "0121-0868-02", "0121-0868-16", "0121-0868-05", "0121-0868-40", "0121-0868-50", "0121-0868-00", "69315-307-15", "69315-307-30", "0472-0166-15", "0472-0166-30", "33342-469-15", "33342-469-30", "70771-1357-1", "70771-1357-2" ], "nui": [ "N0000175498", "M0017172" ], "pharm_class_epc": [ "Polyene Antifungal [EPC]" ], "pharm_class_cs": [ "Polyenes [CS]" ], "unii": [ "BDF1O1C72E" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140306" } } } ] }