{ "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": 145481 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10047029", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140328", "receiptdateformat": "102", "receiptdate": "20140328", "fulfillexpeditecriteria": "2", "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "73", "patientonsetageunit": "801", "patientweight": "62.14", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Chest discomfort" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Palpitations" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blood pressure increased" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "APREMILAST", "drugbatchnumb": "12R0049", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "048", "drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20140130", "drugenddateformat": "102", "drugenddate": "20140325", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } }, { "drugcharacterization": "1", "medicinalproduct": "PLACEBO", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "048", "drugindication": "RHEUMATOID ARTHRITIS", "drugstartdateformat": "102", "drugstartdate": "20140130", "drugenddateformat": "102", "drugenddate": "20140325" }, { "drugcharacterization": "2", "medicinalproduct": "COREG", "openfda": { "application_number": [ "NDA020297" ], "brand_name": [ "COREG" ], "generic_name": [ "CARVEDILOL" ], "manufacturer_name": [ "Waylis Therapeutics LLC" ], "product_ndc": [ "80725-139", "80725-140", "80725-141", "80725-142" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CARVEDILOL" ], "rxcui": [ "200031", "200032", "200033", "212388", "212389", "212390", "686924", "686926" ], "spl_id": [ "514a36dd-5646-48b3-99cc-1457af6cb7d8" ], "spl_set_id": [ "07c619c6-4a0c-445e-94fa-664a54f68a39" ], "package_ndc": [ "80725-139-20", "80725-140-20", "80725-141-20", "80725-142-20" ], "nui": [ "N0000000099", "N0000009923", "N0000009924", "N0000175553", "N0000175556" ], "pharm_class_moa": [ "Adrenergic alpha-Antagonists [MoA]", "Adrenergic beta1-Antagonists [MoA]", "Adrenergic beta2-Antagonists [MoA]" ], "pharm_class_epc": [ "alpha-Adrenergic Blocker [EPC]", "beta-Adrenergic Blocker [EPC]" ], "unii": [ "0K47UL67F2" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TORESEMIDE" }, { "drugcharacterization": "2", "medicinalproduct": "FEXOFENADINE", "openfda": { "application_number": [ "ANDA219032" ], "brand_name": [ "FEXOFENADINE" ], "generic_name": [ "FEXOFENADINE" ], "manufacturer_name": [ "YYBA Corp" ], "product_ndc": [ "73581-012" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "FEXOFENADINE HYDROCHLORIDE" ], "rxcui": [ "997501" ], "spl_id": [ "579c7ff9-0c45-1d46-e063-6294a90aef34" ], "spl_set_id": [ "579c7ff9-0c44-1d46-e063-6294a90aef34" ], "package_ndc": [ "73581-012-01", "73581-012-06", "73581-012-02" ], "unii": [ "2S068B75ZU" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PLAQUENIL", "openfda": { "application_number": [ "NDA009768" ], "brand_name": [ "PLAQUENIL" ], "generic_name": [ "HYDROXYCHLOROQUINE SULFATE" ], "manufacturer_name": [ "Advanz Pharma (US) Corp." ], "product_ndc": [ "59212-562" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "HYDROXYCHLOROQUINE SULFATE" ], "rxcui": [ "979092", "979094" ], "spl_id": [ "1138fd4e-dfba-4c96-a5ec-60f8bc1ba746" ], "spl_set_id": [ "34496b43-05a2-45fb-a769-52b12e099341" ], "package_ndc": [ "59212-562-10", "59212-562-60", "59212-562-11" ], "unii": [ "8Q2869CNVH" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE", "openfda": { "application_number": [ "ANDA215246", "ANDA080292", "ANDA088832", "ANDA083677", "ANDA040584", "ANDA040581", "ANDA040256", "ANDA040392", "ANDA210785", "ANDA080352", "ANDA211495", "ANDA215671", "ANDA219477", "ANDA088703", "ANDA084275", "ANDA208412", "ANDA211496", "ANDA213385", "ANDA215672", "ANDA212629", "ANDA213386", "ANDA211575", "ANDA080356", "ANDA085162", "ANDA085161" ], "brand_name": [ "PREDNISONE", "PREDNISONE DELAYED RELEASE", "PREDNISONE TABLETS, USP, 5 MG", "PREDNISONE TABLETS, USP, 10 MG", "PREDNISONE TABLETS, USP, 20 MG" ], "generic_name": [ "PREDNISONE" ], "manufacturer_name": [ "ANI Pharmaceuticals, Inc.", "Mylan Pharmaceuticals Inc.", "Par Health USA, LLC", "Strides Pharma Science Limited", "Hikma Pharmaceuticals USA Inc.", "Chartwell RX, LLC", "Aurobindo Pharma Limited", "INA Pharmaceutics Inc", "Amneal Pharmaceuticals NY LLC", "Dr. Reddys Laboratories Inc.", "Granulation Technology, Inc.", "Actavis Pharma, Inc." ], "product_ndc": [ "70954-056", "0378-0640", "0378-0641", "0378-0642", "0603-5335", "0603-5336", "0603-5337", "0603-5338", "0603-5339", "64380-782", "0054-9817", "0054-9828", "0054-9818", "62135-471", "59651-484", "74157-010", "74157-019", "0054-0017", "0054-4741", "0054-4742", "0054-4728", "0054-0018", "0054-0019", "0054-3722", "0054-3721", "0054-8739", "0054-8740", "0054-8724", "62135-553", "64380-783", "64380-835", "62135-470", "60219-1705", "60219-1706", "59651-485", "59651-486", "59651-487", "59651-488", "59651-489", "43598-886", "43598-887", "64380-784", "64380-785", "64380-949", "63561-0120", "63561-0121", "63561-0122", "60219-1707", "60219-1708", "70954-057", "70954-058", "70954-059", "70954-060", "70954-061", "0591-5052", "0591-5442", "0591-5443" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISONE" ], "rxcui": [ "198144", "198145", "312615", "312617", "198146", "763179", "763181", "763183", "763185", "1303125", "1303132", "198148", "205301", "315187" ], "spl_id": [ "08d9d724-eebf-4785-a0ac-95c049bc9488", "f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "0433f6e3-8d0e-41c4-a3e2-5ff3c555d57e", "675efef2-fa13-42d1-9460-d1e334f78a48", "249c4c6d-a058-489a-8f84-928c14bfd3f9", "45ae68aa-b969-3d1b-e063-6394a90a0a02", "6f9a9020-efd5-4f7d-90c7-11af33e93793", "463c5b39-7eb2-d396-e063-6394a90aa451", "523ad364-8d95-4679-9290-446d61f36eb5", "04b754a5-5740-f71c-e063-6294a90aef67", "c389b525-c68a-43dc-bacc-c75707b391b5", "45ae6dea-506e-55d8-e063-6394a90a0a4c", "abdf7308-9460-4e7f-a68a-2fe647e82602", "d957f055-4838-49e6-ae32-604fb3056bc4", "a9e0d98c-c1bf-62b0-67b3-3b8f8313b408", "bdf0b63b-7d6e-4799-be31-cdbf94e02145", "3c696af0-7946-dd78-e063-6394a90a71cc", "34381f6f-1b15-42c8-a8e6-af8302eb6c1e", "f662b658-7133-468c-b35a-ed6083cbff91", "6e6cf2e7-c839-4c9f-a58a-fea5023fb432" ], "spl_set_id": [ "7335a293-992b-490c-ab8a-66a7ca1eea30", "fec09050-5ac2-451b-a2b9-5a21b2def212", "10fe5a3b-84dc-4600-87c2-b80c97ce18cf", "a2c2e8ee-d222-47c5-93c2-8b44160a7e48", "263ed4fa-3c29-4abb-9cb1-bc016bd34a05", "36631112-3abb-4003-886b-9fe6d9cbe2cc", "7b33767f-a520-4470-8f3f-4e86b38d615a", "463c7cd2-c973-5c6c-e063-6394a90a09a0", "3115aef0-fd50-4ec8-a064-3effb695f3f2", "92483276-d55c-42c6-8bbc-27137ff25296", "52010a34-aadb-4561-ac4a-3ee53f5e3566", "f532c919-765d-407a-9e01-db2dc0c006f5", "0740ef68-7641-432e-bd46-4710687fc9d7", "b1ac4c92-e1fd-4015-b172-0932790ae019", "01bdc479-1f1f-af94-837c-12e7e861321a", "2ef05381-faad-4e0f-b58d-9f2236a04a2c", "a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "03228706-92b9-43c9-8d73-c73aa124c58d", "f05eb734-07e7-491c-b2e9-aae340e03750", "aa0b1582-6ef3-4697-9ea6-5391e6e57853" ], "package_ndc": [ "70954-056-10", "70954-056-20", "0378-0640-01", "0378-0640-10", "0378-0641-01", "0378-0641-10", "0378-0642-01", "0378-0642-05", "0378-0642-10", "0603-5335-21", "0603-5335-32", "0603-5336-21", "0603-5337-21", "0603-5337-32", "0603-5337-15", "0603-5337-31", "0603-5338-21", "0603-5338-28", "0603-5338-32", "0603-5338-15", "0603-5338-31", "0603-5339-21", "0603-5339-28", "0603-5339-32", "64380-782-06", "0054-9828-25", "0054-9828-31", "0054-9817-25", "0054-9817-29", "0054-9818-25", "0054-9818-29", "62135-471-90", "62135-471-18", "59651-484-01", "59651-484-99", "59651-484-78", "74157-010-30", "74157-019-30", "0054-4741-25", "0054-4741-31", "0054-4742-25", "0054-4728-25", "0054-4728-31", "0054-0017-25", "0054-0017-29", "0054-0017-20", "0054-0018-25", "0054-0018-29", "0054-0018-20", "0054-0019-20", "0054-0019-25", "0054-3722-63", "0054-3722-50", "0054-3721-44", "0054-8739-25", "0054-8740-25", "0054-8724-25", "62135-553-30", "62135-553-90", "64380-835-01", "64380-835-06", "64380-783-06", "64380-783-08", "64380-783-01", "62135-470-90", "62135-470-18", "60219-1705-1", "60219-1706-1", "60219-1706-7", "60219-1706-2", "60219-1706-3", "59651-485-01", "59651-485-78", "59651-486-01", "59651-486-99", "59651-486-78", "59651-487-01", "59651-487-05", "59651-487-78", "59651-488-01", "59651-488-05", "59651-488-78", "59651-489-01", "59651-489-78", "43598-886-01", "43598-886-30", "43598-887-01", "43598-887-30", "64380-784-01", "64380-784-07", "64380-784-08", "64380-784-06", "64380-785-06", "64380-785-07", "64380-785-08", "64380-785-01", "64380-949-06", "64380-949-01", "63561-0120-1", "63561-0120-2", "63561-0120-5", "63561-0121-1", "63561-0121-2", "63561-0121-5", "63561-0122-1", "63561-0122-2", "63561-0122-5", "60219-1707-1", "60219-1707-5", "60219-1707-2", "60219-1707-3", "60219-1708-1", "60219-1708-5", "70954-057-10", "70954-058-10", "70954-058-20", "70954-058-30", "70954-058-40", "70954-059-10", "70954-059-20", "70954-059-30", "70954-059-40", "70954-060-10", "70954-060-20", "70954-060-30", "70954-061-10", "0591-5052-01", "0591-5052-10", "0591-5052-21", "0591-5052-43", "0591-5442-01", "0591-5442-05", "0591-5442-10", "0591-5442-21", "0591-5442-43", "0591-5443-01", "0591-5443-05", "0591-5443-10" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "VB0R961HZT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SIMVASTATIN", "openfda": { "application_number": [ "ANDA078155", "ANDA077691", "ANDA078103", "ANDA200895", "ANDA078034", "ANDA211394", "NDA019766" ], "brand_name": [ "SIMVASTATIN", "ZOCOR" ], "generic_name": [ "SIMVASTATIN" ], "manufacturer_name": [ "Accord Healthcare, Inc.", "NorthStar Rx LLC", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Biocon Pharma Inc,", "Aurobindo Pharma Limited", "Westminster Pharmaceuticals, LLC", "Quallent Pharmaceuticals Health LLC", "Organon LLC", "Camber Pharmaceuticals, Inc." ], "product_ndc": [ "16729-004", "16729-005", "16729-006", "16729-007", "16729-156", "16714-681", "16714-682", "16714-683", "16714-684", "16714-685", "68180-464", "68180-482", "68180-478", "68180-479", "68180-480", "68180-481", "68180-465", "72865-305", "72865-306", "72865-307", "72865-308", "72865-309", "70377-001", "70377-002", "70377-003", "70377-004", "70377-005", "65862-050", "65862-051", "65862-052", "65862-053", "65862-054", "69367-374", "69367-375", "69367-376", "69367-377", "82009-012", "82009-013", "82009-014", "82009-015", "82009-016", "78206-180", "78206-182", "78206-181", "31722-510", "31722-511", "31722-512", "31722-513", "31722-514" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SIMVASTATIN" ], "rxcui": [ "198211", "200345", "312961", "312962", "314231", "104490", "104491", "152923" ], "spl_id": [ "43910ff2-6a21-bf9e-e063-6294a90a3f5c", "6c353eba-27f3-43cc-b954-ec659881872f", "b78d4e8a-2261-43c6-9321-ac2539bdfd2f", "48bd010d-6429-906e-e063-6394a90ae8b7", "4d832ba0-8b5c-de5a-246a-a5f30e884bb4", "854ac8f7-cca5-434c-a611-9c1752260d4a", "5bcccfd7-0ae8-4fad-a535-5efa7b327550", "1de47781-9000-0fc1-e063-6294a90a8139", "11256523-425c-48e8-afe1-e3a4e28c892e", "1553d57f-414d-2c66-e063-6294a90af8e0" ], "spl_set_id": [ "871251c0-36a1-4a32-9eab-ff6c1e925ca9", "0376351b-f1a0-43e5-a0b4-533072c49f39", "3e48217f-8175-4e9b-9fd0-909be4bbba95", "433f8a86-5ad3-43db-8e62-c0812dd3d723", "7b325108-6940-50a7-96b4-822a5206e568", "4724dbb4-3613-4e6a-948f-a43d34f97f06", "acaaab63-c9ff-44c9-8fde-9a4ea6454dd7", "2b4255a7-f9f5-4235-8dbb-b0f03acbd624", "8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "751b79c6-bba8-4d29-b69c-a2ac6453fec8" ], "package_ndc": [ "16729-005-10", "16729-005-12", "16729-005-15", "16729-005-17", "16729-006-10", "16729-006-12", "16729-006-15", "16729-006-17", "16729-007-10", "16729-007-12", "16729-007-15", "16729-007-17", "16729-156-10", "16729-156-15", "16729-156-17", "16729-004-10", "16729-004-12", "16729-004-15", "16729-004-17", "16714-681-01", "16714-681-02", "16714-682-01", "16714-682-02", "16714-682-03", "16714-683-01", "16714-683-02", "16714-683-03", "16714-684-01", "16714-684-02", "16714-684-03", "16714-685-01", "16714-685-02", "16714-685-03", "68180-482-09", "68180-482-06", "68180-482-03", "68180-482-11", "68180-478-02", "68180-478-03", "68180-478-01", "68180-479-02", "68180-479-03", "68180-479-01", "68180-480-01", "68180-480-02", "68180-480-03", "68180-481-01", "68180-481-03", "68180-481-02", "68180-464-06", "68180-464-09", "68180-464-03", "68180-465-06", "68180-465-09", "68180-465-03", "72865-305-30", "72865-305-01", "72865-305-10", "72865-305-90", "72865-306-30", "72865-306-01", "72865-306-10", "72865-306-90", "72865-307-30", "72865-307-01", "72865-307-10", "72865-307-90", "72865-307-45", "72865-308-30", "72865-308-01", "72865-308-10", "72865-308-90", "72865-308-45", "72865-309-30", "72865-309-01", "72865-309-05", "72865-309-90", "72865-309-45", "72865-309-10", "70377-001-13", "70377-001-14", "70377-001-15", "70377-001-12", "70377-002-12", "70377-002-13", "70377-002-14", "70377-002-15", "70377-003-12", "70377-003-13", "70377-003-14", "70377-003-15", "70377-004-12", "70377-004-13", "70377-004-14", "70377-004-15", "70377-005-12", "70377-005-13", "70377-005-14", "70377-005-15", "65862-050-30", "65862-050-45", "65862-050-90", "65862-050-01", "65862-050-00", "65862-050-99", "65862-050-26", "65862-051-30", "65862-051-45", "65862-051-90", "65862-051-01", "65862-051-00", "65862-051-99", "65862-051-26", "65862-052-30", "65862-052-45", "65862-052-90", "65862-052-01", "65862-052-00", "65862-052-99", "65862-052-26", "65862-053-30", "65862-053-45", "65862-053-90", "65862-053-01", "65862-053-00", "65862-053-99", "65862-053-22", "65862-054-30", "65862-054-45", "65862-054-90", "65862-054-00", "65862-054-99", "65862-054-39", "69367-374-09", "69367-374-10", "69367-375-09", "69367-375-10", "69367-376-09", "69367-376-10", "69367-377-09", "69367-377-10", "82009-013-10", "82009-012-10", "82009-014-10", "82009-015-10", "82009-016-05", "78206-182-01", "78206-182-02", "78206-181-02", "78206-181-01", "78206-180-01", "78206-180-02", "31722-510-30", "31722-510-01", "31722-510-10", "31722-510-90", "31722-511-30", "31722-511-01", "31722-511-10", "31722-511-90", "31722-512-30", "31722-512-01", "31722-512-10", "31722-512-90", "31722-513-30", "31722-513-01", "31722-513-10", "31722-513-90", "31722-514-30", "31722-514-01", "31722-514-05", "31722-514-90" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "unii": [ "AGG2FN16EV" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CELEBREX", "openfda": { "application_number": [ "NDA020998" ], "brand_name": [ "CELEBREX" ], "generic_name": [ "CELECOXIB" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-082", "58151-083", "58151-084", "58151-085" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CELECOXIB" ], "rxcui": [ "205322", "205323", "213468", "213469", "349514", "352314", "686379", "686381" ], "spl_id": [ "0c321a7b-89e4-48cc-ab0b-1bd7620d7799" ], "spl_set_id": [ "2d6675e4-5859-4be2-8037-a20ce9f707aa" ], "package_ndc": [ "58151-082-91", "58151-083-01", "58151-083-05", "58151-083-32", "58151-083-88", "58151-084-01", "58151-084-05", "58151-084-32", "58151-084-88", "58151-085-91", "58151-085-32", "58151-085-88" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "JCX84Q7J1L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "WARFARIN", "openfda": { "application_number": [ "ANDA090935", "ANDA202202" ], "brand_name": [ "WARFARIN SODIUM" ], "generic_name": [ "WARFARIN" ], "manufacturer_name": [ "Exelan Pharmaceuticals Inc.", "Amneal Pharmaceuticals LLC" ], "product_ndc": [ "76282-327", "76282-328", "76282-329", "76282-330", "76282-331", "76282-332", "76282-333", "76282-334", "76282-335", "65162-761", "65162-762", "65162-763", "65162-764", "65162-765", "65162-766", "65162-767", "65162-768", "65162-769" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "WARFARIN SODIUM" ], "rxcui": [ "855288", "855296", "855302", "855312", "855318", "855324", "855332", "855338", "855344" ], "spl_id": [ "45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5", "caa13d7d-5a78-412c-8e5e-e03a51164e96" ], "spl_set_id": [ "c0cc4511-e656-4b6d-96cd-e02e76173b9d", "558b7a0d-5490-4c1b-802e-3ab3f1efe760" ], "package_ndc": [ "76282-327-01", "76282-327-10", "76282-328-01", "76282-328-10", "76282-329-01", "76282-329-10", "76282-330-01", "76282-330-10", "76282-331-01", "76282-331-10", "76282-332-01", "76282-332-10", "76282-333-01", "76282-333-10", "76282-334-01", "76282-335-01", "65162-761-10", "65162-761-50", "65162-761-11", "65162-762-10", "65162-762-50", "65162-762-11", "65162-763-10", "65162-763-50", "65162-763-11", "65162-764-10", "65162-764-50", "65162-764-11", "65162-765-10", "65162-765-50", "65162-765-11", "65162-766-10", "65162-766-50", "65162-766-11", "65162-767-10", "65162-767-50", "65162-767-11", "65162-768-10", "65162-768-50", "65162-768-11", "65162-769-10", "65162-769-50", "65162-769-11" ], "unii": [ "6153CWM0CL" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ERGOCALCIFEROL", "openfda": { "application_number": [ "ANDA040833", "ANDA090455", "ANDA080704", "NDA003444" ], "brand_name": [ "ERGOCALCIFEROL", "VITAMIN D" ], "generic_name": [ "ERGOCALCIFEROL" ], "manufacturer_name": [ "Chartwell RX, LLC", "Strides Pharma Science Limited", "Bionpharma Inc.", "Torrent Pharmaceuticals Limited" ], "product_ndc": [ "62135-439", "64380-737", "69452-151", "13668-757" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ERGOCALCIFEROL" ], "rxcui": [ "1367410" ], "spl_id": [ "f409a4d6-5e02-18ee-e053-2a95a90a090c", "1cc589f7-cd6d-40a6-8fce-c965e8945eae", "44ea5b7f-37c7-ed1d-e063-6294a90ab33f", "3f87aa9c-6076-4e63-bea1-afa004686c43" ], "spl_set_id": [ "6490770b-82ef-4e7c-be93-999174d4ee59", "2c4c0a36-12cf-444d-9d57-de983eef4d36", "2a8d73d6-9991-401b-ab8b-81f22e5a0695", "4ae38744-020d-4c37-a6f1-88f55c2f1047" ], "package_ndc": [ "62135-439-90", "64380-737-06", "64380-737-25", "69452-151-20", "13668-757-01" ], "nui": [ "M0007651", "N0000175909" ], "pharm_class_cs": [ "Ergocalciferols [CS]" ], "pharm_class_epc": [ "Provitamin D2 Compound [EPC]" ], "unii": [ "VS041H42XC" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NEXIUM", "openfda": { "application_number": [ "NDA022101", "NDA021957", "NDA021153" ], "brand_name": [ "NEXIUM" ], "generic_name": [ "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-4010", "0186-5020", "0186-4020", "0186-4040", "0186-5040", "0186-4025", "0186-4050" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE" ], "rxcui": [ "606726", "606728", "606730", "606731", "692576", "692578", "861568", "861570", "861576", "861583", "1297658", "1297660", "1297761", "1297763" ], "spl_id": [ "26f66e74-b652-4b1d-bfff-62a3cc87d590" ], "spl_set_id": [ "f4853677-1622-4037-688b-fdf533a11d96" ], "package_ndc": [ "0186-5020-31", "0186-5020-54", "0186-5020-82", "0186-4010-01", "0186-4010-02", "0186-4020-01", "0186-4040-01", "0186-4040-02", "0186-5040-31", "0186-5040-35", "0186-5040-55", "0186-5040-85", "0186-5040-54", "0186-5040-82", "0186-5040-05", "0186-4025-01", "0186-4025-02", "0186-4050-01" ], "unii": [ "R6DXU4WAY9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL", "openfda": { "application_number": [ "M012", "M013" ], "brand_name": [ "TYLENOL COLD PLUS HEAD CONGESTION SEVERE", "TYLENOL REGULAR STRENGTH", "TYLENOL EXTRA STRENGTH" ], "generic_name": [ "ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE", "ACETAMINOPHEN" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-566", "50580-495", "50580-458", "50580-496", "50580-475", "50580-451", "50580-590", "50580-692", "50580-488" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "GUAIFENESIN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1243679", "209387", "313782", "198440", "209459" ], "spl_id": [ "21aceda5-2c34-23df-e063-6394a90acb09", "25b09044-067e-eb90-e063-6394a90a6d21", "49576408-6940-93c6-e063-6394a90a6fa8", "52cd19e4-a4b4-ecee-e063-6394a90ac33b", "398d8996-b523-a3cd-e063-6394a90ac2c8", "2d87c8e1-e743-56cc-e063-6394a90aac79", "22d94fd9-9488-a812-e063-6394a90a7ffc", "21c193b9-6b79-f35c-e063-6394a90adbfe", "4eda2608-4d48-1af0-e063-6294a90a2c72" ], "spl_set_id": [ "ce43e5c2-fe96-4462-882c-d7479318b33d", "de5c6654-56c5-40d3-a286-f04ed47ac7c8", "01f41fae-4abb-4b96-ab09-a7d3dfc286cd", "1622f694-4d63-4c56-8737-fae31f0ecfb7", "398d8996-b522-a3cd-e063-6394a90ac2c8", "bb6533e5-e6a9-488c-b8ab-a6a06e87ede9", "015a6179-bacb-452d-b594-4de628ddc11d", "dd87e342-b0cb-4111-9f15-415dbcda4b77", "1b164780-ec84-4187-8afa-6f8a0da550fc" ], "package_ndc": [ "50580-566-25", "50580-495-01", "50580-458-11", "50580-458-50", "50580-458-10", "50580-496-60", "50580-496-98", "50580-475-11", "50580-475-50", "50580-475-10", "50580-451-03", "50580-451-10", "50580-451-50", "50580-451-70", "50580-590-01", "50580-590-02", "50580-590-03", "50580-590-04", "50580-590-05", "50580-590-06", "50580-692-01", "50580-692-02", "50580-692-03", "50580-488-10", "50580-488-24", "50580-488-25", "50580-488-28", "50580-488-01", "50580-488-52", "50580-488-02", "50580-488-50", "50580-488-22" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "362O9ITL9D", "495W7451VQ", "04JA59TNSJ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "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": "2", "medicinalproduct": "FOLIC ACID", "openfda": { "brand_name": [ "VENTRIXYL", "FOLIC ACID", "QUIOFIC", "VENEXA", "VITRAMYN", "MULTITAM", "VITREXYL", "VITREXATE", "VITRANOL" ], "generic_name": [ "FOLIC ACID" ], "manufacturer_name": [ "PureTek Corporation", "Leading Pharma, LLC", "Amneal Pharmaceuticals of New York LLC", "Solubiomix, LLC", "Cadila Pharmaceuticals Limited", "Ayurax, LLC", "SUNRISE PHARMACEUTICAL, INC.", "Modavar Pharmaceuticals LLC", "Method Pharmaceuticals, LLC", "XGen Pharmaceuticals DJB, Inc.", "QUAGEN PHARMACEUTICALS LLC", "Rising Pharma Holdings, Inc.", "Amneal Pharmaceuticals LLC", "Fresenius Kabi USA, LLC", "Chartwell RX, LLC." ], "product_ndc": [ "59088-186", "69315-127", "53746-361", "69499-501", "59088-176", "71209-007", "73308-501", "11534-165", "72241-050", "58657-151", "59088-193", "39822-1100", "70752-231", "16571-881", "65162-361", "59088-525", "59088-164", "59088-167", "59088-171", "63323-184", "62135-210" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "CHOLECALCIFEROL", "RIBOFLAVIN", "NIACINAMIDE", "ASCORBIC ACID", "FOLIC ACID", "CYANOCOBALAMIN", "CALCIUM CARBONATE", "SELENIUM", "VITAMIN A ACETATE", "THIAMINE MONONITRATE", "ZINC OXIDE", "MANGANESE SULFATE", ".ALPHA.-TOCOPHEROL ACETATE, DL-", "MAGNESIUM OXIDE", "CHROMIUM NICOTINATE", "PYRIDOXINE HYDROCHLORIDE", "MOLYBDENUM" ], "spl_id": [ "286669b9-5e8e-a446-e063-6394a90a2287", "92322e52-3179-4738-8c8a-14fef62311d4", "299a16c1-9627-45e2-a30c-e0f07ae9399a", "c0176981-bd6e-480f-9167-80555050b025", "f204b6b0-92af-3c22-e053-2995a90ad0aa", "fdcdd5ea-a352-4b01-a972-2ed5a82e3a61", "f6a753c1-e141-42a5-b758-7faad81c9427", "5250e701-9f7a-42a8-bae9-95c4779f06aa", "f1dbb47b-a3bd-472b-b565-053e5db411eb", "41b4d71d-2dc2-36bd-e063-6294a90af1e1", "548ee394-41b9-d346-e063-6394a90a0773", "48eb23cf-7425-a5cc-e063-6294a90a5021", "067af2c9-3769-40d4-a991-217390ece384", "a5219f26-2238-4666-9aae-9c98b3003079", "e5ed5369-340d-40ad-b863-c02fd63d5911", "4f5f0e70-672d-571b-e063-6394a90ad1da", "f2048b24-433c-98ba-e053-2995a90a5e85", "f204b4b3-176f-8839-e053-2a95a90a7115", "2445290b-6803-4364-ab42-65e6c550fdcd", "2589605c-12b7-ed10-e063-6294a90ab52b" ], "spl_set_id": [ "c29dc729-93be-2a20-e053-2a95a90a8ca3", "1ba8c407-9613-4319-ac40-0a429cb0f3f4", "fd85395e-6a0b-4072-a80b-36095c0c6dd6", "b868b314-591d-458b-be82-2bcd0b73cce1", "ba130779-cdfd-086d-e053-2a95a90a2590", "103c2cdd-5822-48ba-b62a-e2b11aa444ef", "96618bf8-6c03-4df3-9896-b7ef27ca392a", "6854412b-7ecb-4107-85eb-730f14e23f06", "0eea15e4-7e5d-44e9-818b-a0bdf5271c78", "b9c315ff-cecb-8b75-e053-2995a90aa204", "c8af7616-5178-6df0-e053-2a95a90a334d", "c5b2b84d-9f5e-4b81-ba10-9f2854e5dce9", "354366ea-3702-4706-9fc0-0244b7278bd8", "0baa10dd-6d1d-4946-8236-566451132da3", "c8fe09f0-b32b-43e3-8de7-ed38593b33b4", "cee15842-4a9e-c6ba-e053-2a95a90aebc5", "ae064a9e-daba-fa86-e053-2a95a90a16a7", "b34fee43-bea9-45b7-e053-2a95a90aad4d", "e215318c-4f8b-4711-ae76-f370d1da0f3b", "9a533666-8906-438e-adf7-11bb162ecb63" ], "package_ndc": [ "59088-186-54", "69315-127-01", "69315-127-10", "53746-361-01", "53746-361-10", "69499-501-75", "59088-176-54", "71209-007-05", "71209-007-11", "73308-501-75", "11534-165-01", "11534-165-03", "11534-165-90", "72241-050-05", "72241-050-11", "58657-151-10", "58657-151-01", "59088-193-54", "39822-1100-1", "70752-231-10", "70752-231-11", "16571-881-10", "16571-881-01", "65162-361-01", "65162-361-10", "65162-361-50", "65162-361-11", "59088-525-54", "59088-164-54", "59088-171-54", "59088-167-54", "63323-184-10", "62135-210-90", "62135-210-01", "62135-210-05", "62135-210-10", "62135-210-72", "62135-210-97" ], "nui": [ "M0022797", "N0000175952", "N0000193618", "M0001797", "M0022794", "N0000175951" ], "pharm_class_cs": [ "Vitamin D [CS]", "Ascorbic Acid [CS]", "Vitamin B 12 [CS]" ], "pharm_class_epc": [ "Vitamin D [EPC]", "Vitamin C [EPC]", "Vitamin B12 [EPC]" ], "unii": [ "1C6V77QF41", "TLM2976OFR", "25X51I8RD4", "PQ6CK8PD0R", "935E97BOY8", "P6YC3EG204", "H0G9379FGK", "H6241UJ22B", "3LE3D9D6OY", "8K0I04919X", "SOI2LOH54Z", "W00LYS4T26", "WR1WPI7EW8", "3A3U0GI71G", "A150AY412V", "68Y4CF58BV", "81AH48963U" ], "application_number": [ "ANDA040796", "ANDA040625", "NDA216395", "ANDA202437", "ANDA204418", "ANDA211064", "ANDA202522", "ANDA091145", "ANDA089202", "ANDA090035" ], "rxcui": [ "310410", "2707361", "2733998", "237786" ] } }, { "drugcharacterization": "2", "medicinalproduct": "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" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10090638", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140421", "receiptdateformat": "102", "receiptdate": "20140421", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-10004-14042640", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-10004-14042640" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Tremor", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugauthorizationnumb": "205437", "drugdosageform": "TABLETS", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10154933", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140505", "receiptdateformat": "102", "receiptdate": "20140505", "fulfillexpeditecriteria": "2", "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "74", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nausea" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Diarrhoea" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugdosagetext": "TITRATION, TITRATION, ORAL", "drugadministrationroute": "048", "drugindication": "PSORIATIC ARTHROPATHY", "drugtreatmentduration": "3", "drugtreatmentdurationunit": "803", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10155195", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140505", "receiptdateformat": "102", "receiptdate": "20140505", "fulfillexpeditecriteria": "2", "primarysource": { "reportercountry": "US" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "62", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nausea" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Diarrhoea" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Rectal haemorrhage" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugstructuredosagenumb": "10-20", "drugstructuredosageunit": "003", "drugdosagetext": "QD TO BID", "drugadministrationroute": "048", "drugindication": "PSORIATIC ARTHROPATHY", "drugstartdateformat": "102", "drugstartdate": "20140428", "drugenddateformat": "102", "drugenddate": "20140501", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } } ] } }, { "safetyreportversion": "8", "safetyreportid": "10161711", "primarysourcecountry": "FR", "occurcountry": "FR", "transmissiondateformat": "102", "transmissiondate": "20190417", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140509", "receiptdateformat": "102", "receiptdate": "20190207", "fulfillexpeditecriteria": "1", "companynumb": "FR-AMGEN-FRACT2014033670", "duplicate": "1", "reportduplicate": { "duplicatesource": "AMGEN", "duplicatenumb": "FR-AMGEN-FRACT2014033670" }, "primarysource": { "reportercountry": "FR", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "39", "patientonsetageunit": "801", "patientagegroup": "5", "patientweight": "100", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Dermo-hypodermitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Chondritis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "21.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "ETANERCEPT", "drugauthorizationnumb": "103795", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "50 MG, QWK", "drugdosageform": "SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE", "drugadministrationroute": "058", "drugstartdateformat": "610", "drugstartdate": "201302", "drugenddateformat": "102", "drugenddate": "20140101", "actiondrug": "1", "drugrecurreadministration": "3", "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": "2", "medicinalproduct": "ABILIFY", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "ARIPIPRAZOLE" }, "openfda": { "application_number": [ "NDA021436" ], "brand_name": [ "ABILIFY" ], "generic_name": [ "ARIPIPRAZOLE" ], "manufacturer_name": [ "Otsuka America Pharmaceutical, Inc." ], "product_ndc": [ "59148-006", "59148-007", "59148-008", "59148-009", "59148-010", "59148-011" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ARIPIPRAZOLE" ], "rxcui": [ "349490", "349545", "349547", "349553", "352307", "352308", "352309", "352310", "402131", "404602", "602964", "615172" ], "spl_id": [ "1b189d15-798d-4bed-a93d-a543ed7abd81" ], "spl_set_id": [ "c040bd1d-45b7-49f2-93ea-aed7220b30ac" ], "package_ndc": [ "59148-006-13", "59148-006-92", "59148-007-13", "59148-007-35", "59148-007-94", "59148-008-13", "59148-008-35", "59148-008-95", "59148-009-13", "59148-009-35", "59148-009-95", "59148-010-13", "59148-010-35", "59148-011-13", "59148-011-35" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "82VFR53I78" ] } }, { "drugcharacterization": "2", "medicinalproduct": "RISPERDAL", "drugdosagetext": "2 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "activesubstance": { "activesubstancename": "RISPERIDONE" }, "openfda": { "application_number": [ "NDA020272", "NDA020588" ], "brand_name": [ "RISPERDAL" ], "generic_name": [ "RISPERIDONE" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-300", "50458-302", "50458-320", "50458-330", "50458-350", "50458-395", "50458-315", "50458-325", "50458-335", "50458-355", "50458-305" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RISPERIDONE" ], "rxcui": [ "104781", "104782", "104783", "104784", "199387", "211489", "262222", "312829", "312830", "312831", "312832", "314211", "401953", "401954", "403825", "616698", "616705", "630890", "630974", "806297", "806298", "806299" ], "spl_id": [ "408e48a3-35fc-49e1-8e01-44305d9083a4" ], "spl_set_id": [ "7e117c7e-02fc-4343-92a1-230061dfc5e0" ], "package_ndc": [ "50458-302-06", "50458-302-50", "50458-302-01", "50458-300-06", "50458-300-50", "50458-300-01", "50458-320-06", "50458-320-50", "50458-320-01", "50458-330-06", "50458-330-50", "50458-330-01", "50458-350-06", "50458-350-01", "50458-395-28", "50458-395-30", "50458-315-28", "50458-315-30", "50458-325-28", "50458-335-28", "50458-355-28", "50458-305-03" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "L6UH7ZF8HC" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ETANERCEPT", "drugauthorizationnumb": "103795", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "50 MG, QWK", "drugdosageform": "SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE", "drugadministrationroute": "058", "drugstartdateformat": "610", "drugstartdate": "201409", "drugenddateformat": "610", "drugenddate": "201703", "actiondrug": "1", "drugrecurreadministration": "3", "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": "2", "medicinalproduct": "MIANSERIN HYDROCHLORIDE", "drugstructuredosagenumb": "60", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "60 MG, 1X/DAY", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "MIANSERIN HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "PARKINANE", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "5 MG, 1X/DAY", "drugdosageform": "PROLONGED-RELEASE CAPSULE", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "TRIHEXYPHENIDYL HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "SEBIPROX", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "UNK, 3 TIMES/WK", "activesubstance": { "activesubstancename": "CICLOPIROX OLAMINE" } }, { "drugcharacterization": "2", "medicinalproduct": "AUGMENTIN", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugseparatedosagenumb": "3", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "1 DF, 3X/DAY", "drugadministrationroute": "048", "drugenddateformat": "610", "drugenddate": "201401", "activesubstance": { "activesubstancename": "AMOXICILLIN\\CLAVULANATE POTASSIUM" }, "openfda": { "application_number": [ "NDA050575" ], "brand_name": [ "AUGMENTIN" ], "generic_name": [ "AMOXICILLIN AND CLAVULANATE POTASSIUM" ], "manufacturer_name": [ "Allegis Holdings, LLC" ], "product_ndc": [ "71297-240" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMOXICILLIN", "CLAVULANATE POTASSIUM" ], "rxcui": [ "617302", "617333" ], "spl_id": [ "18975386-c292-a0cb-e063-6294a90aed18" ], "spl_set_id": [ "04a31a42-d79e-bbb4-e063-6394a90a63ee" ], "package_ndc": [ "71297-240-35", "71297-240-36", "71297-240-34" ], "unii": [ "804826J2HU", "Q42OMW3AT8" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SIMVASTATIN.", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, 1X/DAY", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "SIMVASTATIN" }, "openfda": { "application_number": [ "ANDA078155", "ANDA077691", "ANDA078103", "ANDA200895", "ANDA078034", "ANDA211394", "NDA019766" ], "brand_name": [ "SIMVASTATIN", "ZOCOR" ], "generic_name": [ "SIMVASTATIN" ], "manufacturer_name": [ "Accord Healthcare, Inc.", "NorthStar Rx LLC", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Biocon Pharma Inc,", "Aurobindo Pharma Limited", "Westminster Pharmaceuticals, LLC", "Quallent Pharmaceuticals Health LLC", "Organon LLC", "Camber Pharmaceuticals, Inc." ], "product_ndc": [ "16729-004", "16729-005", "16729-006", "16729-007", "16729-156", "16714-681", "16714-682", "16714-683", "16714-684", "16714-685", "68180-464", "68180-482", "68180-478", "68180-479", "68180-480", "68180-481", "68180-465", "72865-305", "72865-306", "72865-307", "72865-308", "72865-309", "70377-001", "70377-002", "70377-003", "70377-004", "70377-005", "65862-050", "65862-051", "65862-052", "65862-053", "65862-054", "69367-374", "69367-375", "69367-376", "69367-377", "82009-012", "82009-013", "82009-014", "82009-015", "82009-016", "78206-180", "78206-182", "78206-181", "31722-510", "31722-511", "31722-512", "31722-513", "31722-514" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SIMVASTATIN" ], "rxcui": [ "198211", "200345", "312961", "312962", "314231", "104490", "104491", "152923" ], "spl_id": [ "43910ff2-6a21-bf9e-e063-6294a90a3f5c", "6c353eba-27f3-43cc-b954-ec659881872f", "b78d4e8a-2261-43c6-9321-ac2539bdfd2f", "48bd010d-6429-906e-e063-6394a90ae8b7", "4d832ba0-8b5c-de5a-246a-a5f30e884bb4", "854ac8f7-cca5-434c-a611-9c1752260d4a", "5bcccfd7-0ae8-4fad-a535-5efa7b327550", "1de47781-9000-0fc1-e063-6294a90a8139", "11256523-425c-48e8-afe1-e3a4e28c892e", "1553d57f-414d-2c66-e063-6294a90af8e0" ], "spl_set_id": [ "871251c0-36a1-4a32-9eab-ff6c1e925ca9", "0376351b-f1a0-43e5-a0b4-533072c49f39", "3e48217f-8175-4e9b-9fd0-909be4bbba95", "433f8a86-5ad3-43db-8e62-c0812dd3d723", "7b325108-6940-50a7-96b4-822a5206e568", "4724dbb4-3613-4e6a-948f-a43d34f97f06", "acaaab63-c9ff-44c9-8fde-9a4ea6454dd7", "2b4255a7-f9f5-4235-8dbb-b0f03acbd624", "8f55d5de-5a4f-4a39-8c84-c53976dd6af9", "751b79c6-bba8-4d29-b69c-a2ac6453fec8" ], "package_ndc": [ "16729-005-10", "16729-005-12", "16729-005-15", "16729-005-17", "16729-006-10", "16729-006-12", "16729-006-15", "16729-006-17", "16729-007-10", "16729-007-12", "16729-007-15", "16729-007-17", "16729-156-10", "16729-156-15", "16729-156-17", "16729-004-10", "16729-004-12", "16729-004-15", "16729-004-17", "16714-681-01", "16714-681-02", "16714-682-01", "16714-682-02", "16714-682-03", "16714-683-01", "16714-683-02", "16714-683-03", "16714-684-01", "16714-684-02", "16714-684-03", "16714-685-01", "16714-685-02", "16714-685-03", "68180-482-09", "68180-482-06", "68180-482-03", "68180-482-11", "68180-478-02", "68180-478-03", "68180-478-01", "68180-479-02", "68180-479-03", "68180-479-01", "68180-480-01", "68180-480-02", "68180-480-03", "68180-481-01", "68180-481-03", "68180-481-02", "68180-464-06", "68180-464-09", "68180-464-03", "68180-465-06", "68180-465-09", "68180-465-03", "72865-305-30", "72865-305-01", "72865-305-10", "72865-305-90", "72865-306-30", "72865-306-01", "72865-306-10", "72865-306-90", "72865-307-30", "72865-307-01", "72865-307-10", "72865-307-90", "72865-307-45", "72865-308-30", "72865-308-01", "72865-308-10", "72865-308-90", "72865-308-45", "72865-309-30", "72865-309-01", "72865-309-05", "72865-309-90", "72865-309-45", "72865-309-10", "70377-001-13", "70377-001-14", "70377-001-15", "70377-001-12", "70377-002-12", "70377-002-13", "70377-002-14", "70377-002-15", "70377-003-12", "70377-003-13", "70377-003-14", "70377-003-15", "70377-004-12", "70377-004-13", "70377-004-14", "70377-004-15", "70377-005-12", "70377-005-13", "70377-005-14", "70377-005-15", "65862-050-30", "65862-050-45", "65862-050-90", "65862-050-01", "65862-050-00", "65862-050-99", "65862-050-26", "65862-051-30", "65862-051-45", "65862-051-90", "65862-051-01", "65862-051-00", "65862-051-99", "65862-051-26", "65862-052-30", "65862-052-45", "65862-052-90", "65862-052-01", "65862-052-00", "65862-052-99", "65862-052-26", "65862-053-30", "65862-053-45", "65862-053-90", "65862-053-01", "65862-053-00", "65862-053-99", "65862-053-22", "65862-054-30", "65862-054-45", "65862-054-90", "65862-054-00", "65862-054-99", "65862-054-39", "69367-374-09", "69367-374-10", "69367-375-09", "69367-375-10", "69367-376-09", "69367-376-10", "69367-377-09", "69367-377-10", "82009-013-10", "82009-012-10", "82009-014-10", "82009-015-10", "82009-016-05", "78206-182-01", "78206-182-02", "78206-181-02", "78206-181-01", "78206-180-01", "78206-180-02", "31722-510-30", "31722-510-01", "31722-510-10", "31722-510-90", "31722-511-30", "31722-511-01", "31722-511-10", "31722-511-90", "31722-512-30", "31722-512-01", "31722-512-10", "31722-512-90", "31722-513-30", "31722-513-01", "31722-513-10", "31722-513-90", "31722-514-30", "31722-514-01", "31722-514-05", "31722-514-90" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "unii": [ "AGG2FN16EV" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PRAVASTATIN.", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "PRAVASTATIN" } }, { "drugcharacterization": "2", "medicinalproduct": "PRAVASTATIN.", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "PRAVASTATIN" } }, { "drugcharacterization": "2", "medicinalproduct": "AMOXICILLIN.", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DF, 3X/WEEK", "drugadministrationroute": "048", "drugstartdateformat": "610", "drugstartdate": "201401", "drugenddateformat": "610", "drugenddate": "201401", "activesubstance": { "activesubstancename": "AMOXICILLIN" }, "openfda": { "application_number": [ "ANDA065255", "ANDA062216", "ANDA065271", "ANDA065256", "ANDA065322", "ANDA065319", "ANDA061926", "ANDA065056", "ANDA064013", "ANDA065119", "ANDA061931", "ANDA065291", "ANDA064076", "ANDA065228", "ANDA065387", "ANDA065378", "ANDA207471", "ANDA065334", "NDA050760", "ANDA062058", "ANDA204030", "ANDA062059", "ANDA065325" ], "brand_name": [ "AMOXICILLIN" ], "generic_name": [ "AMOXICILLIN" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc.", "USAntibiotics, LLC", "American Health Packaging", "NorthStar Rx LLC", "Rising Pharma Holdings, Inc.", "Chartwell RX, LLC", "Teva Pharmaceuticals USA, Inc.", "Aurobindo Pharma Limited", "Sandoz Inc", "Micro Labs Limited", "Chartwell Governmental & Specialty RX, LLC" ], "product_ndc": [ "0143-9285", "81964-205", "81964-225", "81964-350", "60687-776", "60687-787", "16714-298", "16714-299", "57237-028", "57237-029", "0143-9888", "0143-9889", "62135-815", "62135-082", "62135-084", "62135-085", "62135-088", "62135-089", "62135-090", "62135-086", "62135-087", "62135-083", "0093-2263", "0093-2264", "0093-4160", "0093-4155", "0093-4161", "0093-2267", "0093-2268", "0093-3107", "0093-3109", "65862-014", "65862-015", "0143-9939", "0781-2020", "0781-2613", "0781-5060", "0781-5061", "0781-6039", "0781-6156", "0781-6041", "0781-6157", "57237-030", "57237-031", "42571-233", "42571-234", "57237-032", "57237-033", "65862-016", "65862-017", "81964-207", "62135-824", "62135-825", "65862-070", "65862-071", "60687-798", "60687-809", "68999-824", "68999-825", "65862-706", "65862-707", "68999-083", "62135-776", "62135-777", "0143-9886", "0143-9887" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMOXICILLIN" ], "rxcui": [ "308194", "308182", "308191", "308192", "239191", "313797", "308189", "308177", "313850", "598025" ], "spl_id": [ "a4cd19b3-f938-4afe-9409-3bdea10deb63", "5253eb61-6d82-8057-e063-6294a90a5c84", "2f75b1e8-87b4-bd7d-e063-6294a90a0587", "3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0", "679691e2-bbbf-4ed0-a31b-e538b3df75c0", "c2fa2c99-c735-4834-a8a5-04a30da8a002", "4690e611-3a29-35ce-e063-6294a90a5e9e", "575bc388-3782-3521-e063-6394a90aa532", "31223839-1653-4906-826a-f9d6af179334", "ee0e12cd-e881-4048-a0fb-74bd771cb9aa", "ed305c7b-0cf6-4dc6-b584-a68b7bd3245b", "f4681ad2-fcc2-41f6-9100-90fb4524cd28", "4e6f21c7-0e2a-4361-9549-ab42efd08d5b", "238f9a44-0678-eb7c-e063-6394a90a4c73", "62bfc65c-04fe-43b5-b659-d37067b280c0", "4dc94f3c-990d-476f-a88e-df9967570eec", "52498bbe-c0d7-4bea-e063-6394a90aafd0", "4690ed91-8da8-2e62-e063-6294a90a0ab2", "3e3ca279-1838-4348-a01c-df10a8bcb8b9", "4ee4fb77-9fd6-ea5e-e063-6394a90a0d9c", "46911108-ba5e-8cba-e063-6294a90adccc", "f4a410c9-3a78-48f9-8195-915896a974ff", "57d3f80c-e734-335f-e063-6294a90aeb3c", "4690a5fd-79cc-e1fd-e063-6294a90a009c", "606474e1-adba-4ffa-83d5-6565fc12c892" ], "spl_set_id": [ "c8591c2a-92ef-4432-b19a-bb46063047ee", "110ba6b1-f175-48a1-8e30-616c02212538", "ecb439f7-434a-4e4c-b899-943d83346f09", "843f6053-63d9-47d2-81f1-b6aa78a7c20c", "bb7733f8-6aad-4273-84a0-ef472630203f", "077f4a65-3cfb-4cb1-99f2-e27ffc5939c0", "1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f", "b07b5ac4-253e-4c83-91c3-3fdc46e91a0f", "4c0f348a-a65d-409c-8668-207c82a5e3cb", "99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e", "4fb7837e-964c-4d38-a3a5-b384b1bd6e08", "13bd4214-9b7f-425b-af5f-fc1ddc678230", "bbe590a0-4196-4885-b679-cc1833af567f", "42f935ca-45ba-4b3e-8b40-9b2d4eb56281", "554239db-69fe-405a-910a-d9f9e3f8b6ed", "7e3a4517-1934-4e03-b96b-4ad65ab076c5", "06e5c07d-d95c-4955-8d35-a4703ca2359e", "5002cce4-0abc-4446-888c-47396549d4da", "3cacd754-73f4-496e-a529-9ca39fa6692d", "d339ea0f-8797-460f-a3b7-b8455c250366", "f9062321-ffb3-42e8-8f98-453cd30f5282", "234d0dfc-cb24-413f-b798-129c73eb848e", "809393b7-6271-4715-ae84-13fd8f901772", "9ce26893-c7a1-47e9-98f9-f5d998cac418", "d46f1091-33dc-4f8f-9c34-75dcfedb4b4c" ], "package_ndc": [ "0143-9285-01", "0143-9285-20", "81964-225-01", "81964-225-05", "81964-205-01", "81964-205-05", "81964-205-10", "81964-205-60", "81964-350-98", "81964-350-10", "81964-350-60", "60687-776-11", "60687-776-01", "60687-787-11", "60687-787-01", "16714-298-01", "16714-298-02", "16714-299-01", "16714-299-02", "16714-299-03", "16714-299-04", "57237-028-20", "57237-028-01", "57237-029-20", "57237-029-01", "0143-9888-80", "0143-9888-01", "0143-9888-15", "0143-9889-80", "0143-9889-01", "0143-9889-15", "62135-815-42", "62135-084-60", "62135-084-01", "62135-085-20", "62135-085-60", "62135-085-01", "62135-088-50", "62135-088-75", "62135-088-01", "62135-089-80", "62135-089-01", "62135-089-51", "62135-090-50", "62135-090-75", "62135-090-01", "62135-086-60", "62135-086-01", "62135-087-60", "62135-087-01", "62135-082-30", "62135-082-01", "62135-082-31", "62135-083-20", "62135-083-60", "62135-083-01", "62135-083-05", "0093-2263-01", "0093-2264-01", "0093-4160-76", "0093-4160-78", "0093-4160-73", "0093-4155-79", "0093-4155-73", "0093-4155-80", "0093-4161-76", "0093-4161-78", "0093-4161-73", "0093-2267-01", "0093-2268-01", "0093-3107-01", "0093-3107-05", "0093-3109-53", "0093-3109-05", "65862-014-20", "65862-014-01", "65862-014-05", "65862-015-20", "65862-015-01", "65862-015-05", "0143-9939-05", "0143-9939-28", "0781-2020-31", "0781-2020-76", "0781-2020-01", "0781-2020-05", "0781-2613-31", "0781-2613-76", "0781-2613-01", "0781-2613-05", "0781-5060-20", "0781-5060-01", "0781-5061-20", "0781-5061-01", "0781-6039-58", "0781-6039-46", "0781-6039-55", "0781-6156-52", "0781-6156-57", "0781-6156-46", "0781-6041-58", "0781-6041-46", "0781-6041-55", "0781-6157-52", "0781-6157-57", "0781-6157-46", "57237-030-01", "57237-030-05", "57237-031-01", "57237-031-05", "42571-233-30", "42571-233-01", "42571-233-05", "42571-233-10", "42571-234-30", "42571-234-01", "42571-234-05", "42571-234-10", "57237-032-50", "57237-032-75", "57237-032-01", "57237-033-50", "57237-033-75", "57237-033-01", "65862-016-20", "65862-016-30", "65862-016-50", "65862-016-01", "65862-016-05", "65862-017-20", "65862-017-30", "65862-017-50", "65862-017-01", "65862-017-05", "81964-207-50", "81964-207-51", "81964-207-52", "62135-824-01", "62135-824-05", "62135-825-60", "62135-825-05", "65862-070-50", "65862-070-75", "65862-070-01", "65862-071-50", "65862-071-75", "65862-071-01", "60687-798-95", "60687-798-25", "60687-809-18", "60687-809-28", "68999-824-01", "68999-825-60", "68999-825-01", "65862-706-80", "65862-706-01", "65862-706-55", "65862-707-80", "65862-707-01", "65862-707-55", "68999-083-20", "68999-083-60", "68999-083-01", "62135-777-68", "62135-777-42", "62135-777-38", "62135-776-68", "62135-776-42", "62135-776-38", "0143-9886-01", "0143-9886-50", "0143-9886-75", "0143-9887-01", "0143-9887-50", "0143-9887-75" ], "unii": [ "804826J2HU" ] } }, { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "30 MG, 2X/DAY", "drugadministrationroute": "048", "drugindication": "PSORIASIS", "drugstartdateformat": "610", "drugstartdate": "201703", "drugenddateformat": "602", "drugenddate": "2017", "activesubstance": { "activesubstancename": "APREMILAST" }, "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "JANUMET", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE\\SITAGLIPTIN PHOSPHATE" }, "openfda": { "application_number": [ "NDA022044", "NDA202270" ], "brand_name": [ "JANUMET", "JANUMET XR" ], "generic_name": [ "SITAGLIPTIN AND METFORMIN HYDROCHLORIDE" ], "manufacturer_name": [ "Merck Sharp & Dohme LLC" ], "product_ndc": [ "0006-0575", "0006-0577", "0006-0078", "0006-0080", "0006-0081" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SITAGLIPTIN PHOSPHATE", "METFORMIN HYDROCHLORIDE" ], "rxcui": [ "861771", "861821", "2709488", "2709491", "1243833", "1243843", "1243848", "2709470", "2709477", "2709482" ], "spl_id": [ "601dfad8-02f7-4696-9fe2-548610338dc9", "4323fb1c-54a7-4648-bfe0-28fb4cb65f50" ], "spl_set_id": [ "d19c7ed0-ad5c-426e-b2df-722508f97d67", "64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50" ], "package_ndc": [ "0006-0575-82", "0006-0575-61", "0006-0575-62", "0006-0575-01", "0006-0575-52", "0006-0575-56", "0006-0575-02", "0006-0575-03", "0006-0577-61", "0006-0577-62", "0006-0577-82", "0006-0577-01", "0006-0577-52", "0006-0577-56", "0006-0577-02", "0006-0577-03", "0006-0078-61", "0006-0078-62", "0006-0078-82", "0006-0078-14", "0006-0078-28", "0006-0080-61", "0006-0080-62", "0006-0080-82", "0006-0080-14", "0006-0080-28", "0006-0081-31", "0006-0081-54", "0006-0081-82", "0006-0081-07", "0006-0081-14" ], "unii": [ "786Z46389E", "TS63EW8X6F" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ETANERCEPT", "drugauthorizationnumb": "103795", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "50 MG, 2 TIMES/WK", "drugdosageform": "SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE", "drugadministrationroute": "058", "drugindication": "PSORIASIS", "drugstartdateformat": "610", "drugstartdate": "201211", "drugenddateformat": "610", "drugenddate": "201302", "actiondrug": "1", "drugrecurreadministration": "3", "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": "2", "medicinalproduct": "RISPERDAL", "drugstructuredosagenumb": "2", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "2 MG, 1X/DAY", "drugdosageform": "FILM-COATED TABLET", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "RISPERIDONE" }, "openfda": { "application_number": [ "NDA020272", "NDA020588" ], "brand_name": [ "RISPERDAL" ], "generic_name": [ "RISPERIDONE" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-300", "50458-302", "50458-320", "50458-330", "50458-350", "50458-395", "50458-315", "50458-325", "50458-335", "50458-355", "50458-305" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RISPERIDONE" ], "rxcui": [ "104781", "104782", "104783", "104784", "199387", "211489", "262222", "312829", "312830", "312831", "312832", "314211", "401953", "401954", "403825", "616698", "616705", "630890", "630974", "806297", "806298", "806299" ], "spl_id": [ "408e48a3-35fc-49e1-8e01-44305d9083a4" ], "spl_set_id": [ "7e117c7e-02fc-4343-92a1-230061dfc5e0" ], "package_ndc": [ "50458-302-06", "50458-302-50", "50458-302-01", "50458-300-06", "50458-300-50", "50458-300-01", "50458-320-06", "50458-320-50", "50458-320-01", "50458-330-06", "50458-330-50", "50458-330-01", "50458-350-06", "50458-350-01", "50458-395-28", "50458-395-30", "50458-315-28", "50458-315-30", "50458-325-28", "50458-335-28", "50458-355-28", "50458-305-03" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "L6UH7ZF8HC" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ETANERCEPT", "drugauthorizationnumb": "103795", "drugstructuredosagenumb": "50", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "50 MG, 2 TIMES/WK", "drugdosageform": "SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE", "drugadministrationroute": "058", "drugstartdateformat": "102", "drugstartdate": "20170723", "actiondrug": "1", "drugrecurreadministration": "3", "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": "2", "medicinalproduct": "MYCOSTER [CICLOPIROX]", "drugdosagetext": "UNK" } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140101" } } }, { "safetyreportversion": "2", "safetyreportid": "10166678", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140512", "receiptdateformat": "102", "receiptdate": "20140610", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-10004-14050131", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-10004-14050131" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Osteoarthritis", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "205437", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "60 MILLIGRAM", "drugdosageform": "TABLETS", "drugadministrationroute": "048", "drugindication": "PSORIATIC ARTHROPATHY", "drugstartdateformat": "102", "drugstartdate": "20140415", "actiondrug": "1", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CELEBREX", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA020998" ], "brand_name": [ "CELEBREX" ], "generic_name": [ "CELECOXIB" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-082", "58151-083", "58151-084", "58151-085" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CELECOXIB" ], "rxcui": [ "205322", "205323", "213468", "213469", "349514", "352314", "686379", "686381" ], "spl_id": [ "0c321a7b-89e4-48cc-ab0b-1bd7620d7799" ], "spl_set_id": [ "2d6675e4-5859-4be2-8037-a20ce9f707aa" ], "package_ndc": [ "58151-082-91", "58151-083-01", "58151-083-05", "58151-083-32", "58151-083-88", "58151-084-01", "58151-084-05", "58151-084-32", "58151-084-88", "58151-085-91", "58151-085-32", "58151-085-88" ], "nui": [ "N0000000160", "M0001335", "N0000175722" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "JCX84Q7J1L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "NDA209400", "ANDA206582", "ANDA075576", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", "ANDA076048", "ANDA211732", "ANDA204012", "ANDA218829", "ANDA091672", "ANDA213201", "ANDA078490", "ANDA212977", "ANDA203270" ], "brand_name": [ "GOOD NEIGHBOR PHARMACY OMEPRAZOLE", "OMEPRAZOLE/SODIUM BICARBONATE", "KIRKLAND SIGNATURE OMEPRAZOLE", "OMEPRAZOLE", "FOSTER AND THRIVE OMEPRAZOLE", "ACID REDUCER", "BERKLEY AND JENSEN OMEPRAZOLE", "GOOD NOW OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE", "BASIC CARE OMEPRAZOLE", "UP AND UP OMEPRAZOLE", "EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER", "DG HEALTH OMEPRAZOLE", "TOPCARE OMEPRAZOLE", "CAREONE OMEPRAZOLE", "EQUALINE OMEPRAZOLE", "LEADER OMEPRAZOLE", "EQUATE OMEPRAZOLE", "DG HEALTH OMPERAZOLE", "OMEPRAZOLE DELAYED-RELEASE", "SIGNATURE CARE OMEPRAZOLE", "MEMBERS MARK OMEPRAZOLE", "AMAZON BASIC CARE OMEPRAZOLE", "RUGBY OMEPRAZOLE", "TOPCARE OMEPRAZOLE DELAYED RELEASE", "24 HR OMEPRAZOLE", "CARE ONE OMEPRAZOLE", "EXCHANGE SELECT OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE DELAYED RELEASE" ], "generic_name": [ "OMEPRAZOLE", "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Amerisource Bergen", "Strides Pharma Science Limited", "Costco Wholesale Company", "INNOVUS PHARMACEUTICALS, INC.", "OHM LABORATORIES INC.", "Strategic Sourcing Services LLC", "STRATEGIC SOURCING SERVICES LLC", "GERI-CARE PHARMACEUTICALS, CORP", "Lannett Company, Inc.", "WALGREEN CO.", "Sandoz Inc", "Cardinal Health", "Chartwell RX, LLC", "BJWC", "CVS Pharmacy, Inc.", "HARRIS TEETER", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. Perrigo Company", "WinCo Foods, LLC", "Aurohealth LLC", "Amazon.com Services LLC", "Meijer Distribution Inc.", "Meijer Distribution Inc", "CVS Pharmacy", "H E B", "Quallent Pharmaceuticals Health LLC", "Target Corporation", "Fred's, Inc.", "Wal-Mart Stores Inc", "THE KROGER COMPANY", "HyVee Inc", "Meijer, Inc.", "Dolgencorp, LLC", "Topco Associates LLC", "Dolgencorp Inc", "Zydus Lifesciences Limited", "NORTHEAST PHARMA", "P & L Development, LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Retail Business Services, LLC", "Walgreen Company", "United Natural Foods, Inc. dba UNFI", "Little Pharma, Inc.", "American Sales Company", "Golden State Medical Supply, Inc.", "Padagis Israel Pharmaceuticals Ltd", "AMERISOURCE BERGEN", "BluePoint Laboratories", "Cardinal Health 110, LLC. dba Leader", "Twin Med LLC", "Sun Pharmaceutical Industries, Inc.", "Zydus Pharmaceuticals USA Inc.", "Walmart Inc.", "Apotex Corp", "Strategic Sourcing Services", "Rite Aid", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Rite Aid Corporation", "Rugby Laboratories", "VALU MERCHANDISERS COMPANY", "WALMART INC. (see also Equate)", "Camber Pharmaceuticals, Inc.", "H-E-B", "KROGER COMPANY", "Living Better Brands LLC", "Safeway", "Publix Super Markets Inc", "Sam's West Inc", "Camber Consumer Care Inc", "Glenmark Pharmaceuticals Inc., USA", "Family Dollar (FAMILY WELLNESS)", "Allegiant Health", "Dr. Reddy's Laboratories Limited", "Kroger Company", "NorthStar Rx LLC", "BI-MART", "Family Dollar Stores, LLC", "Chain Drug Marketing Association INC", "AMERISOURCEBERGEN DRUG CORPORATION", "CVS Pharamacy, Inc", "Bi-Mart", "Dr. Reddys Laboratories Inc", "Aurobindo Pharma Limited", "UP & UP", "Winco Foods, LLC.", "Xiromed, LLC", "WALMART INC.", "7-Eleven", "Army & Air Force Exchange Service", "Best Choice", "Rising Pharma Holdings, Inc.", "Walgreens", "Wal-Mart Stores, Inc." ], "product_ndc": [ "46122-281", "64380-182", "64380-183", "63981-915", "57483-740", "51660-029", "70677-1275", "70677-1098", "57896-659", "62175-114", "62175-118", "62175-136", "0363-1008", "0781-2785", "0781-2790", "70000-0521", "62135-559", "62135-530", "68391-103", "69842-941", "72036-981", "63548-8040", "69618-054", "53943-016", "82501-0915", "0113-0915", "67091-464", "58602-850", "57483-840", "72288-047", "79481-0061", "41250-915", "68391-915", "59779-503", "37808-401", "59640-047", "82009-022", "11673-346", "55315-996", "49035-915", "30142-992", "42507-164", "79481-0281", "55910-915", "36800-915", "55910-712", "65841-759", "65841-760", "65841-761", "80136-852", "59726-744", "51316-271", "63548-2970", "72476-473", "0363-1819", "58602-826", "41163-915", "72559-014", "0113-1723", "41520-939", "41163-634", "51407-664", "51407-814", "0363-9980", "45802-888", "69842-791", "46122-686", "37808-915", "63548-4080", "68001-441", "70000-0723", "55681-306", "62756-377", "68382-411", "68382-412", "68382-500", "49035-119", "79903-305", "0781-2234", "0363-6101", "55910-713", "57483-120", "60505-0065", "60505-0145", "60505-3952", "60505-0146", "41250-349", "70677-0148", "0363-0915", "11822-0061", "83324-011", "11822-0453", "0536-1322", "63941-997", "59726-740", "0113-6010", "79903-377", "0113-0520", "31722-527", "31722-528", "37808-569", "0363-0007", "30142-077", "21130-991", "59726-298", "51316-843", "21130-128", "56062-401", "70677-1104", "68196-700", "69230-318", "68462-395", "68462-396", "68462-397", "56062-915", "55319-219", "68196-915", "58602-837", "59779-580", "69168-476", "79481-3023", "55111-643", "55111-644", "55111-645", "30142-474", "72288-409", "0536-1448", "36800-121", "16714-714", "16714-715", "37835-001", "42507-414", "11673-018", "30142-394", "30142-593", "36800-601", "0781-2859", "0781-2868", "55319-037", "83324-141", "82009-023", "82009-183", "21130-783", "0363-6089", "46122-029", "46122-739", "41250-401", "63548-7370", "55111-157", "55111-158", "55111-159", "0363-4099", "11822-1190", "21130-528", "51407-641", "51407-943", "51407-813", "30142-557", "51316-061", "79481-0075", "37835-189", "43598-286", "46122-616", "72288-401", "72288-123", "59651-001", "59651-002", "59651-003", "11673-948", "41520-915", "67091-316", "70700-149", "70700-150", "70700-151", "55910-215", "16714-123", "16714-630", "16714-634", "72288-915", "72288-606", "21130-401", "79903-113", "10202-722", "69842-661", "11673-212", "42507-915", "43598-841", "55301-915", "63941-006", "57237-160", "57237-161", "57237-162", "0363-9510", "11673-915", "37808-354", "76162-470", "49035-983", "0113-1803", "21130-137", "41520-802", "70000-0381", "58602-729" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OMEPRAZOLE", "SODIUM BICARBONATE", "OMEPRAZOLE MAGNESIUM" ], "rxcui": [ "402014", "753557", "753562", "198051", "199119", "200329", "2003656" ], "spl_id": [ "b734d645-be14-4398-b7e2-9017c771fff1", "2ac68a93-2f3b-46aa-a874-c109ad1bfefe", "633c827b-bb87-4c7f-9865-633006a60e21", "ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "e9ea61cb-d280-42b0-8819-34117270c618", "07de4a08-07e5-444b-8d1b-7f259b32936e", "252eeb77-6319-49df-9259-fcf2f917b2b5", "df05ccee-e8d0-43b2-a266-86afc1ce741c", "e786b865-dc62-4018-9cb1-7056b7ca2cde", "f3c6b5e7-49d3-4c89-907f-782953c31b90", "24a57c2e-eda8-4c3f-9c81-a28a5b9a9229", "a54de89f-8710-4fc7-97c3-8607e5974263", "2df74daf-da0f-36e2-e063-6294a90abc9d", "46879e67-0bb9-93a7-e063-6294a90af37d", "c7b50625-4920-4bb2-8eff-943670438248", "94a59c53-72bd-4d37-9ea9-c73f51ea1031", "ca9797c6-5708-4d45-bd1a-c670077e1a0b", "4e880f49-93d0-436b-a072-c3286d358e45", "ba632dd1-c85a-49c0-88a6-6d10ddbff1af", "0029ee94-3c34-42fb-982f-9baefdfe0b3b", "fa4938ea-ffb5-466e-8fce-4fdfdc97989e", "1d135e1c-1e90-4e42-a2c7-2ef3b3fc6545", "5c220251-3504-4c65-a385-85920515c499", "492b45bf-5734-4a64-8907-feaebadbb41a", "3fc301fe-e89b-488b-8437-c48b59cec420", "e00843ad-85f1-458c-9f2c-c1c4b41947a7", "77a11f0a-d2ce-40b7-8c19-011d6665d18b", "88bf3550-4633-47fe-88ec-e9ca94f7f752", "74157f10-5953-44de-abf5-b6793f13e70d", "2d9d60cd-6c79-4da7-9c48-ac1b73df9832", "9cb203e7-86d0-4757-9a32-afd2038898a3", "5d5df90d-3535-4337-99d8-e7e0309b433e", "17380ad5-9506-8e44-aa84-b6ce52ac7b9b", "dc644613-1131-499d-9c16-7ee241a10c26", "5df31fd8-49c4-4a00-aadc-3f02860ab01f", "03d865a0-ac92-49d5-82e2-2276292add17", "759b705a-526e-47e2-97f9-a78ab21a2c5d", "c1ec28a1-d0e5-4878-8295-eb06ff5e1fd6", "edbe9a75-73ef-4b53-8f08-10e775091e23", "4900f1e8-5133-4ef9-a871-4d88507d56eb", "e1557259-5889-4677-981e-ebd3970162c8", "72620a9f-63f1-421d-825a-ac73e891cd08", "691b64ae-e6ff-4a10-9973-886901529db0", "29498c01-1121-44bf-9a93-d5c5438bb83c", "141dd771-bc04-40b1-a80e-95ce0a471d6c", "6fe0d098-2eb4-49b6-881f-fbe7e102bfcb", "2bd05b96-ec80-440b-9e49-53c375ce9f8c", "965c30c2-5455-4f16-8fbf-2c57329806d5", "d56182bb-d424-4890-93c6-bca29194af8c", "d4d5397d-41ee-4c3c-bf0f-a923b1731d0b", "9cf01d8d-1fe8-4350-a23b-065f4d126547", "4d29deee-4362-9457-e063-6394a90a87eb", "c0f585e4-bc50-4364-9864-63ef2c3c9467", "7a2142d9-ea48-4cd8-bb1a-aed470b43852", "d806739f-7f7b-42ae-af48-d1b0b22d3eef", "4f745e3f-7028-51ec-e063-6294a90af7af", "8add376a-81a3-41e0-ba8d-037f7f56165a", "390ed372-f284-46b1-92bd-c2432fe6920b", "21aa099b-aabb-40ee-bbea-9db44c62e1e8", "47dce86f-d184-44cf-8ee3-18dad7f401b8", "0623c22d-32db-42d7-8a2b-d50e96baae5b", "6039daeb-5242-4b4e-80c9-45cb90249eba", "0486dc89-1bf1-8e37-e063-6394a90a9aa7", "01e166d4-7ac5-421f-87d2-7b647631bf8d", "c9a11bc6-0680-4030-871e-599417fccf57", "676e2f39-d83e-485a-9366-ed14c382e466", "d0074baa-52cb-4039-9bd8-966a36ff70da", "65ea67fd-2018-49ce-bccf-3d4ccf4f235b", "cd2683cb-42a1-cb9f-6dd4-a1464ddb3afd", "fe6aa833-89e6-4679-a7b8-6600e92c1bed", "ef7892f0-4389-4c7a-bc74-dabebce4b128", "d1d7bb64-1c13-4d36-b761-01ac075da14a", "72b23ff2-70a3-412c-9a9c-902927598e2f", "8619e520-d106-4778-e92a-09b919b55c70", "e3d7b200-cb51-46f2-aebf-b95ddac1b664", "b4a9538c-049e-45d3-8b28-581c68a36ed6", "364bb6a8-58c8-460d-92db-c25b9eed8d2b", "67c3cfe2-ab40-4c32-b386-ad3c740e3f6f", "164b1d0f-ad03-40dd-e063-6394a90a6771", "b518a17f-c0c9-4f15-884f-e2b193115a96", "6616864c-9739-4e69-86a1-29c07441f9ba", "9c033207-ae1c-4212-aeef-3bb5bfef6fca", "e9703fb1-76b2-42e6-9ceb-51aaa62bca31", "b840439b-540b-465a-8faa-f7b1024c628e", "1fabf3d4-e22f-474e-8812-679544cc48aa", "5e2cb7f9-93ec-4919-9648-0ecb1c5fe086", "2b439e93-9a24-e64a-e063-6394a90a634f", "50962214-2053-1974-e063-6394a90a0fc0", "8e923ce5-8ec6-464d-9772-55a9b1213cdf", "f5f26771-fb6e-4fc5-8ad9-92c64a9d7b81", "1a05a724-635a-49fa-a890-85363fd43a27", "1ef5cd55-c1c3-40a9-9486-91ad26c24a1c", "2480bbfc-d4fe-4d52-b9a6-48c9f4fe9698", "eb0dd73c-7d2d-424f-a939-dcdb18ee21f1", "8137007b-8ac1-4c7e-bc89-d9d9bb66a8ea", "4bb8b63d-4f46-4d58-a069-c88a969e960a", "7292128d-5bd2-4239-b53d-22ec365a835e", "ee873df8-2b35-9bc7-e053-2a95a90a0f83", "69b1e229-f845-4608-be48-f97e8d3e2273", "23f9d37a-deb7-4e56-90bc-13099e0d1e8f", "5ab86c77-4f33-46e4-84dc-57c96b8fc490", "ec7763a5-521c-486b-8215-2d66c97c3977", "0c2600f3-e9de-4e73-8ee1-9aeb94d228e4", "e5387742-f011-4d3c-b3ed-44e0251b053f", "37309c28-8650-401e-9a39-6b52112e0baf", "d9659b73-1336-4777-8ce9-926b851e1616", "8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d", "90aa0006-a47e-4058-bff3-5fb2d7bef8f1", "0e2645ca-76b7-4f38-9513-cba86dfa20a3", "bc786388-cb4d-4210-9124-39a4bcbb7d38", "f384bca8-e266-489a-8d87-3df17e7d0a56", "9ced381c-99a7-a9c4-211a-82326fb17900", "31dbc48a-ec90-e368-e063-6294a90a6c96", "c7e11072-2333-4846-a37b-2b2c3a59a6d0", "a8a64ea9-0d2c-45d5-a81d-da0d8ce60044", "46b01c78-c491-4087-a980-a43add76537d", "97fc5b6e-8e86-4774-933d-c85dfe71825d", "0edd49e4-cf9e-42db-8bbb-78ce370ac480", "b182f298-e28f-434b-b6f1-ecfac29d495e", "c1eee169-a04a-485d-9c17-2229cdca1fd1", "c8061435-ef48-b29f-b9bc-3fdda780ecc4", "8aee798c-2e69-76b9-85b5-3a4e0a0c7a94", "ba9d8915-89e0-4a90-a8e3-03784b496950", "cc051c20-36b7-4eb6-95e5-65734ef65458", "9517ab3c-69eb-4c6b-b65a-b3411b6373a9", "0c214fe9-7d95-39e0-0526-2d257f47695e", "9215653a-ae65-423a-9eb6-c94f21fe4413", "2cb02338-e348-4b60-aae0-e7806e03f5bf", "0dc50704-e0d5-1fcc-b0b5-6e5556db65e8", "4565e652-447a-484b-b8d2-adde9454111c", "e00e0544-dee7-4322-aa62-e1b912f2e6cf", "e018508f-372e-4b81-9979-15dbd798b271", "3ba5e1e5-159d-2492-e063-6294a90a6c8b", "ca200f16-7b7e-4b33-964b-e2ccfc62f0f4", "a3b8b93d-6725-4c5c-8b80-dcc27e408501", "9dee9797-6b74-498a-9237-53ac64642d27", "cd7c9c63-7126-43f0-bca2-f0d263415e36", "ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4", "99568183-6575-488b-a829-414bb8cf34a6", "02dbc562-2299-4c4d-a107-944a2b342d1a", "3d759662-06ea-46b7-b26e-33f376b7e262", "4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a", "ef059a98-451b-4590-93b4-937b855d6595", "5248b065-e6de-4bc6-af17-ee5e7ecdc45f", "cdedc06f-c813-421a-b613-0768f17d8633", "49528611-b139-6768-e43e-bc6f26715fa3", "fe39c1c0-3f79-418f-88c7-e4f40619b77e", "fe36a9a7-13d0-f4f1-1e31-b35cf651b79d", "617f2b9c-d13b-4128-af41-af5abd3e7bfe", "0cb73d40-2e1f-4197-a2bd-038b2295738f", "fd87b124-5abc-4db7-9125-350ac1699a1d", "a9fc2493-e10b-4d7a-9708-18ecdc757ef4", "d9c2719b-9650-41da-8ad4-085852934eeb", "20b6b69a-3bd9-42a4-a225-7efbf97a99eb", "1713a351-8a7a-405c-b37d-e01c2de0c246", "926d7c5a-14db-4560-ac64-898166bf2241", "bf20de45-af46-d037-efd5-6efe069d0569", "8adc4bc1-677f-4ad1-b301-bb5f25ce0205", "3a3a6029-3c1c-4c22-863d-1bf12733c39f", "aec12e35-60fb-416c-a2d0-a87cfdcb30a6", "6c1e8126-e1ab-4087-a25e-872bcace2a60", "cd15d39d-8e0a-4c39-806a-ff9951f33434", "51d6a6ce-e096-4152-876e-472f6b47e5bb", "255def35-0ba3-44c0-af0c-e5aa99806996", "b0339709-5175-4501-a96b-67ae8b88e153", "bffe358a-cc5a-4ff6-9a04-b0fbca4444e7", "fe806f67-4a8c-40ae-9750-d0c7a4a33aa6", "704e2091-bd15-4fd1-892e-425dffd01656", "867caf67-b128-4c09-9e35-352f8c04bcbe", "81d45120-49d4-4de8-8477-79312e2c1d56" ], "spl_set_id": [ "5ee3cb79-5c0c-456f-b5d5-d5a008bbd118", "cf6d293e-d70d-443e-8292-d693e93aab55", "48a44d0c-3502-430b-8b75-188a49d14da2", "ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "35a95bec-51b9-465b-aa93-ad26afb87be8", "51bcc19d-acfc-487b-870b-251c8953741f", "56380ccc-6fc2-4e1b-bd87-da24c9aa31cd", "8a77aea7-912e-43a3-bce3-f666b9b9c9bc", "92201fb1-4570-42db-8da3-3b8c0e291d32", "b9561780-e358-b610-e053-2a95a90af020", "e4562da8-9d94-4417-9f80-c1ffd4247259", "230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8", "4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e", "10f5502a-2e63-4f2a-a3ba-ddc5bd403051", "1729c60d-3475-45cd-b192-f88438403d1a", "3349ee88-e53b-4586-8d28-20ecf8fcb1a5", "c618964f-4b16-448e-851b-e6b2a816c660", "e67bf2c6-0618-48e0-aa08-705501d86431", "f6b13640-6c71-4c3d-8eb5-c36fca201aee", "ff2c8446-9d8b-4300-b157-884b48e98bb7", "0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f", "11dfbf6c-59bf-4a30-b627-f49ccd31c0d0", "2782b98b-50e4-4a4e-8626-d34ebfd71bfb", "287ceb12-e4d8-43c7-8cec-c4d23aa8fb12", "7535a309-1a67-4f50-911b-7cf570322931", "76b941f0-a02f-43e8-821e-09ccf675d944", "8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573", "925399c7-dcbc-4546-9111-2a98a11ba538", "f74752a8-a686-4c7d-91ad-8c87c4596a7a", "fb3b1c3b-d486-4fa6-9ebf-ee1812ed2512", "491e3710-9a15-4b07-ae22-923bd1152ecc", "501d80c0-68ee-4fd9-bc56-0b214dbf72b5", "665e9877-85ac-fdb6-54ac-1c47941ceab8", "7dc339da-e90b-452b-b25e-8d7f3aa8bc18", "7f00d0ed-4b7e-7011-e053-2a91aa0a2454", "9a0f2d8a-eaad-403b-90c3-0fd275abe4dc", "f55cedc7-e0bc-4d30-af52-bfa881f6adde", "fd22d4df-9679-4c2d-9bc4-3619288fb4cc", "0340ef94-d2b4-47af-a045-d0d031293984", "326bf21c-fad4-473e-9e7f-797319d4353a", "4d98665d-38db-4c08-8406-cc0e45f7ab7c", "6d19783d-2856-4a86-9f5c-6cc26b4ca33e", "2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2", "35ceccb5-dc3d-4ee1-bdac-35cb52c22f59", "883e428a-e157-4bbf-8657-e7a93dc99e8c", "8edfcc08-a14e-4579-bd44-045267de5b79", "d9c8a242-bdba-4f92-8629-692b47ebba21", "063cfad8-3ca6-4b72-a4c9-512b8047bae3", "064f048c-eddd-4370-9ee4-706f9f00c8d2", "3eb70031-6439-44cf-8056-3e2e1e4a7fa9", "b6c87a6a-253a-4455-9b7d-62f506da592e", "d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f", "db333c49-2c3e-4ade-a202-7d4499205fc4", "5b88717a-e90c-4e74-ae2a-29270e14a3cc", "78743f3b-257e-49df-98cd-6cc0e1b4e370", "f27b3518-d5c1-1229-e053-2a95a90ab56f", "537b9a46-ecc8-4537-9657-c9ff7821dd4b", "cb47354c-297b-4dc2-85af-242acc967b56", "01bde9ca-0114-426d-8188-c55aefaa0961", "47dce86f-d184-44cf-8ee3-18dad7f401b8", "5ceaec04-3ca3-4c7c-9184-51a42686a595", "6a1aeb95-5760-4363-816a-fa8305979c50", "a86d52a5-15e2-012d-e053-2a95a90ac912", "19beab17-ca25-4be3-bada-20a2e9aa26b5", "346141b5-b49d-489a-84eb-18df8b940460", "51c3ef34-b7c1-419e-a784-ae82540c7a22", "9c22ceb2-2c34-43c3-9a35-2589c9078741", "504b8282-d93f-454f-9f93-84cb8a9105d7", "5168ccd9-31b4-3a49-85b9-4f202cd99f6b", "5a09ce48-7139-4fc7-9b6e-439459c8e866", "87cee50d-4c1e-473d-9d70-b1622f84aee1", "99fdfeed-6828-4bf6-bb81-cd29a4ec610b", "a4e92bd2-8f75-4acc-9b75-df8332bd4cc4", "b83329ac-a65e-b3af-a3fb-c5a6c740e5e7", "d54e1097-bd56-4371-8e59-8ceab1a5e824", "dfa91081-3917-4dfc-9789-76800f57bb31", "30a893d2-198a-4184-81b4-02399324ff29", "b1ba65d1-8f68-4bae-bb9d-776bba348346", "da09aac6-8fce-448b-98ba-1fc9bce42075", "ee853401-b641-4dab-b708-29424c2d0b79", "33990795-e994-4307-a570-9e8e8b44c473", "7b2d41b6-3e36-4973-b5f6-adf9b828f40d", "911a08c4-ba73-4600-a5f2-7f26ba8c8604", "b840439b-540b-465a-8faa-f7b1024c628e", "d3c1ba08-680d-4e39-875c-1f1d42ae787c", "dcd93796-8904-415d-a379-c4ea590cf544", "0c6e00a2-31e8-4e84-928d-80e69a5fc634", "448ba584-6a6e-3d85-e063-6294a90a5579", "b7972f17-4a63-4d78-a181-01ea6d7d3963", "eb5d02a8-4112-2066-e053-2a95a90abba3", "1d500e2d-395b-437e-a95c-3922a71a0956", "44a92926-1941-4fe8-9b2a-31a45289456f", "6479415a-ffb0-4d20-ad00-f091c8aaaadb", "c76c4235-92d4-4384-8ddc-ceed0b928c48", "05fae639-ba68-4c05-8ca7-7c5cc2d50584", "836efc63-b633-497c-ab56-76bb495bd723", "907e9974-46b8-4dae-be92-518c076cb98f", "9c856d3a-e38f-4006-a43a-ec1a9fa0f057", "c6c22be1-659d-4e71-b292-701e27da201b", "e4a68b0a-a550-4416-8911-1defe014ad89", "f2195d73-1fd5-4de2-aa5c-18741d11f4fc", "0edfa800-fb14-44dd-9c31-de930b864ef9", "19097902-a5e6-423a-8569-31c569cd3cdb", "19b5b960-cc4d-42d0-8c8a-04a355a4db92", "3344c589-c4ac-4f2d-8d32-828db4e825a6", "47c41c68-cb20-40f0-9d85-ea8db3328478", "603d2d06-c5e8-4378-a422-8dca1a410af7", "da18d91c-5fe9-44d4-9d6f-602900af3f08", "10efef7c-bdf4-36cf-e063-6394a90a8c0f", "61952807-f38d-4e7a-8646-a8ec85d7fb37", "8ed57521-e69a-4563-9ce2-4f6d667f065d", "c5af5f4b-17be-7245-b281-f27c87831242", "fb089d15-daa4-477a-be83-ecd55c3283d4", "cf9919e6-a839-4bad-a007-80d5bf6f81db", "d664c45d-564a-4692-ae8f-8dd980ffcd87", "083841e8-482d-4e5b-90ab-1139b576d691", "236a9447-23ec-44c7-a241-20f9ddc83ab8", "436c5ea1-c5ee-481f-803d-439f65873b1c", "516170d4-4913-4577-a2d2-f5c52d1e79c6", "6d8daf78-1672-4bbf-a022-514bf0a5ac9a", "77d4f6c7-87ca-78bb-3310-2304a68f9f9b", "8090d4c3-3184-7812-53d7-aa30e14b79d1", "b3ec4a44-5643-4438-b41b-e04946436719", "f56ff74d-116d-4a75-87dc-41c309f03918", "f9aab207-d309-49b5-b941-c2912b186583", "0521c51b-d113-7e35-f1a6-c4495a2bcfcc", "4e849a58-ad34-4d6e-a065-d1e5a1ac8218", "71add294-ff24-4bbf-9067-7c56ed7c9f1a", "72fb11b6-b08c-2f02-d82b-f60f52394903", "97eaf0dc-380b-4039-aeb7-dde39942a9d6", "28a0b4c8-3ad3-451c-a957-28aef5e3d8b5", "7ae4d70f-08f1-4586-965f-5a32fbe21591", "ded71262-d17f-3799-e053-2995a90a5427", "015b1c8f-9d5b-4afc-a55c-1a731b5fc72a", "0769e47f-f8f1-4b1c-a8cc-7c8385c74070", "36adb053-3189-4c91-87dd-e122a2c8e812", "419659f9-098a-4a18-8bba-cd45157bfa50", "4b3b389d-a151-d851-cb05-64eb49979e5e", "54fd9f84-9c67-4846-b79d-eb9e6720a315", "73c36634-a70f-4641-910f-6cdda7fbcd36", "87a2aa9b-c681-41c7-8a59-b359efd443cb", "934601b6-fbba-43c4-a8ef-7a7dfe9f9a51", "ac10cf46-1dcc-483a-83d6-2fcb9896cc19", "db2d75ea-5924-4b7f-a92d-d4847a010d52", "0cb2949a-baf2-4276-a27b-8f3cc4b9a658", "38bd8e13-591e-f11b-7d8a-11717c56493c", "3c34fa4b-be9f-4aa6-ab6b-775b528a8949", "40a75dc7-49b7-5c9d-6c5f-d4682ec6922e", "548629d3-8d93-465d-b6ac-2a42bc0baebf", "7e0d319c-6917-45c4-b7e1-e870fc3fcea5", "85ece978-3cfb-4c09-bf0f-3217fda8e7d4", "dcfe8e94-9c88-464e-9a80-3baa9c4755d9", "61206416-e0c1-44d7-ad35-feb629361ba9", "64a62f09-19a9-4281-a55d-451fd33711c1", "8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56", "a5df7dac-00f4-4d97-9586-cde3055890ac", "b377cb0b-14b2-04bb-f276-fd69a257f9ca", "22b4492d-7afe-410f-97bf-57e4a57b1c27", "43ea758b-6cea-44a2-b4d6-8f99211c8826", "a1b1c61b-d4fe-433d-ad31-0b11758976fa", "b9683a94-fd44-4364-be0e-477ca1a29aba", "2f2b26fe-dbc2-4185-8a27-6b166dd49ba2", "344b5548-e5c0-45bf-bc3f-73af50bd5913", "ec9d8dab-480c-49bc-bdbb-bebcc7676d01", "1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c", "38082e59-c509-4be5-b29c-33a97565df1c", "6361a492-782f-4608-a20f-1bd86afbd864", "a5ec923a-dbc7-43e0-b3b8-f61dcaa6765d", "b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a", "fde12bf8-3e3b-4813-a8c4-4385e7de8204" ], "package_ndc": [ "46122-281-04", "46122-281-74", "64380-183-01", "64380-183-02", "64380-182-01", "64380-182-02", "63981-915-55", "57483-740-01", "57483-740-42", "51660-029-44", "51660-029-14", "51660-029-27", "70677-1275-2", "70677-1275-1", "70677-1098-1", "57896-659-14", "57896-659-42", "62175-114-37", "62175-114-32", "62175-114-46", "62175-114-49", "62175-118-49", "62175-118-32", "62175-118-46", "62175-118-37", "62175-118-43", "62175-136-32", "62175-136-46", "62175-136-37", "62175-136-43", "62175-136-49", "0363-1008-05", "0363-1008-61", "0363-1008-62", "0781-2785-31", "0781-2785-01", "0781-2785-10", "0781-2790-10", "0781-2790-01", "0781-2790-92", "0781-2790-31", "70000-0521-1", "70000-0521-3", "70000-0521-4", "70000-0521-2", "62135-559-30", "62135-530-30", "62135-530-90", "68391-103-55", "69842-941-05", "69842-941-61", "69842-941-62", "69842-941-01", "69842-941-03", "72036-981-14", "72036-981-42", "63548-8040-4", "63548-8040-8", "63548-8040-2", "69618-054-42", "53943-016-05", "53943-016-62", "82501-0915-0", "0113-0915-74", "0113-0915-30", "0113-0915-55", "0113-0915-01", "0113-0915-03", "67091-464-14", "58602-850-05", "58602-850-62", "57483-840-01", "57483-840-42", "72288-047-01", "72288-047-03", "79481-0061-1", "79481-0061-3", "41250-915-74", "41250-915-30", "41250-915-55", "41250-915-01", "41250-915-02", "41250-915-03", "68391-915-55", "59779-503-30", "59779-503-55", "59779-503-74", "59779-503-02", "59779-503-01", "59779-503-03", "37808-401-03", "37808-401-01", "59640-047-01", "59640-047-03", "82009-022-10", "11673-346-03", "55315-996-74", "55315-996-04", "49035-915-30", "49035-915-55", "49035-915-74", "49035-915-01", "49035-915-03", "30142-992-14", "30142-992-28", "42507-164-42", "79481-0281-0", "79481-0281-1", "55910-915-30", "55910-915-74", "55910-915-02", "55910-915-01", "55910-915-03", "36800-915-74", "36800-915-30", "36800-915-55", "36800-915-03", "36800-915-01", "55910-712-01", "55910-712-03", "65841-759-06", "65841-759-16", "65841-759-01", "65841-759-05", "65841-759-10", "65841-760-06", "65841-760-16", "65841-760-01", "65841-760-05", "65841-760-10", "65841-761-06", "65841-761-16", "65841-761-01", "65841-761-05", "65841-761-10", "80136-852-03", "80136-852-42", "59726-744-42", "59726-744-14", "51316-271-01", "51316-271-03", "63548-2970-4", "63548-2970-8", "63548-2970-2", "72476-473-01", "72476-473-03", "0363-1819-55", "0363-1819-74", "58602-826-05", "58602-826-61", "58602-826-62", "41163-915-74", "41163-915-30", "41163-915-55", "41163-915-01", "72559-014-06", "72559-014-07", "72559-014-36", "72559-014-09", "0113-1723-03", "0113-1723-01", "41520-939-74", "41520-939-55", "41163-634-74", "51407-814-01", "51407-814-05", "51407-814-30", "51407-814-90", "51407-664-01", "51407-664-05", "51407-664-00", "0363-9980-42", "0363-9980-28", "0363-9980-14", "45802-888-55", "45802-888-30", "69842-791-55", "69842-791-74", "46122-686-74", "46122-686-03", "37808-915-55", "37808-915-30", "37808-915-74", "37808-915-01", "37808-915-03", "63548-4080-4", "63548-4080-8", "63548-4080-2", "68001-441-55", "68001-441-98", "68001-441-39", "68001-441-40", "70000-0723-1", "70000-0723-3", "70000-0723-2", "55681-306-14", "55681-306-42", "62756-377-21", "62756-377-11", "62756-377-12", "62756-377-70", "62756-377-96", "62756-377-79", "68382-411-06", "68382-411-16", "68382-411-01", "68382-411-05", "68382-411-10", "68382-412-06", "68382-412-16", "68382-412-01", "68382-412-05", "68382-412-10", "68382-500-06", "68382-500-16", "68382-500-01", "68382-500-05", "68382-500-10", "49035-119-01", "49035-119-03", "79903-305-14", "79903-305-28", "79903-305-41", "0781-2234-10", "0781-2234-01", "0781-2234-31", "0363-6101-01", "0363-6101-03", "55910-713-74", "55910-713-30", "55910-713-55", "57483-120-42", "57483-120-14", "60505-0145-0", "60505-0145-2", "60505-0145-1", "60505-0145-3", "60505-0145-7", "60505-0065-0", "60505-0065-2", "60505-0065-5", "60505-0065-1", "60505-0065-8", "60505-0065-3", "60505-0065-7", "60505-3952-3", "60505-3952-8", "60505-0146-0", "60505-0146-9", "60505-0146-2", "60505-0146-1", "41250-349-74", "41250-349-55", "70677-0148-1", "0363-0915-30", "0363-0915-55", "0363-0915-74", "0363-0915-01", "0363-0915-03", "11822-0061-1", "11822-0061-4", "83324-011-14", "83324-011-42", "11822-0453-1", "11822-0453-2", "11822-0453-3", "0536-1322-88", "0536-1322-71", "0536-1322-13", "63941-997-42", "63941-997-14", "59726-740-42", "0113-6010-00", "0113-6010-03", "79903-377-14", "79903-377-42", "0113-0520-55", "0113-0520-74", "31722-528-30", "31722-528-01", "31722-527-30", "31722-527-01", "37808-569-45", "37808-569-82", "37808-569-41", "0363-0007-03", "0363-0007-01", "30142-077-01", "30142-077-05", "21130-991-44", "21130-991-28", "59726-298-14", "51316-843-01", "51316-843-03", "21130-128-55", "21130-128-74", "56062-401-01", "56062-401-03", "70677-1104-1", "70677-1104-2", "68196-700-01", "68196-700-03", "69230-318-35", "69230-318-36", "69230-318-37", "69230-318-32", "69230-318-33", "69230-318-34", "69230-318-05", "69230-318-10", "68462-395-30", "68462-395-90", "68462-395-01", "68462-395-10", "68462-396-30", "68462-396-90", "68462-396-01", "68462-396-10", "68462-397-30", "68462-397-90", "68462-397-01", "68462-397-10", "56062-915-55", "56062-915-74", "56062-915-30", "55319-219-14", "68196-915-55", "68196-915-74", "68196-915-03", "68196-915-01", "58602-837-05", "59779-580-01", "59779-580-03", "69168-476-14", "69168-476-42", "69168-476-61", "69168-476-15", "79481-3023-0", "79481-3023-1", "55111-643-30", "55111-643-01", "55111-643-05", "55111-643-79", "55111-643-78", "55111-644-30", "55111-644-01", "55111-644-05", "55111-644-10", "55111-644-77", "55111-645-30", "55111-645-34", "55111-645-01", "55111-645-05", "55111-645-10", "55111-645-79", "55111-645-78", "30142-474-01", "72288-409-05", "72288-409-01", "72288-409-61", "72288-409-03", "0536-1448-88", "0536-1448-13", "36800-121-01", "36800-121-03", "16714-714-01", "16714-715-01", "16714-715-02", "16714-715-03", "37835-001-42", "37835-001-14", "42507-414-00", "42507-414-01", "42507-414-42", "11673-018-03", "11673-018-01", "30142-394-74", "30142-394-55", "30142-593-03", "30142-593-01", "36800-601-74", "36800-601-55", "0781-2859-10", "0781-2859-01", "0781-2859-92", "0781-2859-31", "0781-2868-10", "0781-2868-01", "0781-2868-92", "0781-2868-31", "55319-037-05", "55319-037-62", "83324-141-42", "83324-141-14", "82009-183-10", "82009-023-05", "21130-783-03", "21130-783-01", "0363-6089-03", "0363-6089-01", "46122-029-74", "46122-029-03", "46122-029-04", "46122-029-99", "46122-739-74", "46122-739-03", "46122-739-04", "41250-401-03", "41250-401-01", "63548-7370-4", "63548-7370-8", "63548-7370-2", "55111-157-30", "55111-157-01", "55111-157-10", "55111-157-79", "55111-157-78", "55111-158-30", "55111-158-34", "55111-158-01", "55111-158-10", "55111-158-79", "55111-158-78", "55111-159-30", "55111-159-01", "55111-159-05", "55111-159-10", "55111-159-79", "55111-159-78", "0363-4099-01", "0363-4099-03", "11822-1190-0", "11822-1190-1", "21130-528-01", "21130-528-03", "51407-641-10", "51407-641-01", "51407-641-00", "51407-641-90", "51407-943-00", "51407-943-01", "51407-943-05", "51407-943-90", "51407-813-10", "51407-813-01", "51407-813-30", "51407-813-90", "30142-557-55", "30142-557-30", "30142-557-74", "30142-557-01", "30142-557-02", "30142-557-03", "51316-061-28", "79481-0075-3", "79481-0075-1", "37835-189-14", "37835-189-42", "43598-286-52", "43598-286-27", "43598-286-33", "43598-286-74", "43598-286-25", "43598-286-37", "43598-286-70", "43598-286-32", "46122-616-04", "72288-401-03", "72288-401-01", "72288-123-74", "72288-123-55", "59651-001-30", "59651-001-01", "59651-001-99", "59651-001-10", "59651-001-03", "59651-001-78", "59651-002-30", "59651-002-90", "59651-002-01", "59651-002-05", "59651-002-99", "59651-002-10", "59651-002-03", "59651-002-78", "59651-003-30", "59651-003-90", "59651-003-01", "59651-003-05", "59651-003-99", "59651-003-10", "59651-003-03", "59651-003-78", "11673-948-14", "11673-948-42", "41520-915-74", "41520-915-30", "41520-915-55", "41520-915-03", "67091-316-14", "70700-149-30", "70700-149-05", "70700-149-01", "70700-150-10", "70700-150-30", "70700-150-01", "70700-150-00", "70700-151-10", "70700-151-00", "55910-215-01", "55910-215-02", "55910-215-03", "16714-630-01", "16714-634-01", "16714-634-02", "16714-634-03", "16714-123-01", "16714-123-02", "16714-123-03", "72288-915-01", "72288-915-30", "72288-915-03", "72288-915-55", "72288-606-01", "72288-606-03", "21130-401-01", "21130-401-03", "79903-113-14", "79903-113-42", "10202-722-05", "69842-661-01", "69842-661-03", "11673-212-74", "11673-212-55", "42507-915-00", "42507-915-01", "42507-915-74", "42507-915-30", "42507-915-55", "42507-915-03", "43598-841-52", "43598-841-42", "55301-915-74", "55301-915-55", "63941-006-05", "63941-006-62", "57237-160-30", "57237-160-01", "57237-161-30", "57237-161-90", "57237-161-01", "57237-161-99", "57237-161-50", "57237-162-30", "57237-162-90", "57237-162-01", "57237-162-50", "57237-162-10", "0363-9510-14", "11673-915-55", "11673-915-30", "11673-915-01", "11673-915-02", "11673-915-03", "11673-915-74", "37808-354-74", "37808-354-55", "76162-470-03", "76162-470-01", "49035-983-05", "49035-983-62", "0113-1803-01", "0113-1803-03", "21130-137-55", "21130-137-30", "21130-137-74", "41520-802-01", "41520-802-03", "70000-0381-2", "70000-0381-1", "58602-729-05", "58602-729-61", "58602-729-62", "58602-729-64", "58602-729-65", "58602-729-01", "58602-729-02", "58602-729-03" ], "nui": [ "N0000175525", "N0000000147", "N0000182140" ], "pharm_class_epc": [ "Proton Pump Inhibitor [EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OXYCODONE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA203638", "NDA208090" ], "brand_name": [ "OXYCODONE HYDROCHLORIDE", "XTAMPZA ER" ], "generic_name": [ "OXYCODONE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Collegium Pharmaceutical, Inc." ], "product_ndc": [ "65162-047", "65162-048", "65162-049", "65162-050", "65162-051", "24510-110", "24510-115", "24510-120", "24510-130", "24510-140" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OXYCODONE HYDROCHLORIDE", "OXYCODONE" ], "rxcui": [ "1049611", "1049618", "1049621", "1049683", "1049686", "1790527", "1790533", "1791558", "1791560", "1791567", "1791569", "1791574", "1791576", "1791580", "1791582" ], "spl_id": [ "4fb6c994-cbd3-4d0d-bdae-505cb8082e61", "fda0989d-9319-4e35-af83-fca1ec66878e" ], "spl_set_id": [ "094b64b3-cd32-4de5-afb6-ea00d9caad74", "b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c" ], "package_ndc": [ "65162-047-03", "65162-047-10", "65162-047-25", "65162-047-50", "65162-048-03", "65162-048-10", "65162-048-25", "65162-049-03", "65162-049-10", "65162-049-25", "65162-049-50", "65162-050-03", "65162-050-10", "65162-050-25", "65162-051-03", "65162-051-10", "65162-051-25", "65162-051-50", "24510-110-10", "24510-110-20", "24510-115-10", "24510-115-20", "24510-120-10", "24510-120-20", "24510-130-10", "24510-130-20", "24510-140-10", "24510-140-20" ], "unii": [ "C1ENJ2TE6C", "CD35PMG570" ], "nui": [ "N0000175684", "N0000175690" ], "pharm_class_moa": [ "Full Opioid Agonists [MoA]" ], "pharm_class_epc": [ "Opioid Agonist [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PROMETHAZINE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": {} } ] } }, { "safetyreportversion": "1", "safetyreportid": "10168957", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140513", "receiptdateformat": "102", "receiptdate": "20140513", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-10004-14051019", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-10004-14051019" }, "primarysource": { "reportercountry": "US", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "0", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pericarditis", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugauthorizationnumb": "205437", "drugdosageform": "TABLETS", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } } ] } }, { "safetyreportversion": "1", "safetyreportid": "10185806", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140521", "receiptdateformat": "102", "receiptdate": "20140521", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-10004-14052577", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-10004-14052577" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "63", "patientonsetageunit": "801", "patientweight": "77.72", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Haematochezia", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Abdominal pain upper", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nausea", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Headache", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugauthorizationnumb": "205437", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "60 MILLIGRAM", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PSORIATIC ARTHROPATHY", "drugstartdateformat": "102", "drugstartdate": "20140506", "actiondrug": "4", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DYAZIDE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "LOTENSIN", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA019851" ], "brand_name": [ "LOTENSIN" ], "generic_name": [ "BENAZEPRIL HYDROCHLORIDE" ], "manufacturer_name": [ "Validus Pharmaceuticals LLC" ], "product_ndc": [ "30698-448", "30698-449", "30698-450" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BENAZEPRIL HYDROCHLORIDE" ], "rxcui": [ "898687", "898689", "898690", "898692", "898719", "898721" ], "spl_id": [ "40029d07-adfa-0cc3-e063-6294a90a4cd5" ], "spl_set_id": [ "2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e" ], "package_ndc": [ "30698-449-01", "30698-450-01", "30698-448-01" ], "unii": [ "N1SN99T69T" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NIFEDIPINE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA075269", "ANDA210184", "ANDA212016", "ANDA216896", "ANDA075289", "ANDA202644", "ANDA077127", "ANDA203126", "ANDA213361", "ANDA210012", "ANDA216067", "NDA019684", "ANDA076070", "ANDA202987", "ANDA210614" ], "brand_name": [ "NIFEDIPINE", "PROCARDIA XL" ], "generic_name": [ "NIFEDIPINE" ], "manufacturer_name": [ "Oceanside Pharmaceuticals", "Zydus Lifesciences Limited", "Elite Pharmaceutical Solution, Inc.", "Alembic Pharmaceuticals Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "Chartwell RX, LLC", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited", "Lannett Company, Inc.", "Ascend Laboratories, LLC", "Alembic Pharmaceuticals Limited", "Zydus Pharmaceuticals (USA) Inc.", "Pfizer Laboratories Div Pfizer Inc", "Ingenus Pharmaceuticals, LLC" ], "product_ndc": [ "68682-105", "70771-1365", "70771-1366", "70771-1367", "68682-106", "70807-503", "62332-732", "62332-733", "62332-734", "68682-108", "68682-109", "23155-194", "23155-195", "62135-521", "62135-522", "62135-523", "24979-009", "24979-011", "24979-010", "59651-295", "59651-296", "59651-297", "70771-1190", "70771-1191", "70771-1192", "62175-260", "62175-261", "62175-262", "67877-756", "67877-757", "67877-758", "46708-732", "46708-733", "46708-734", "68382-685", "68382-686", "68382-687", "0069-2650", "0069-2660", "0069-2670", "62135-739", "62135-740", "68682-107", "68382-688", "68382-689", "68382-690", "50742-620", "50742-621", "50742-622", "50742-260", "50742-261", "50742-262" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NIFEDIPINE" ], "rxcui": [ "198034", "198035", "198036", "1812015", "1812011", "1812013", "198032", "198033", "207772", "207773", "207774" ], "spl_id": [ "ed2ab44d-7e6a-4c65-8bb0-9d3a4d9bf618", "b4ac4791-5cb1-4199-b56f-4171fd16fc33", "2c9ac184-8e21-479c-a1e8-4abeadfb54a1", "3816123b-e06c-4abf-aead-2bed62b89c15", "69114afa-390f-4134-9055-d0b539d45c96", "68cca98c-658a-48b4-9630-478b62b1471e", "b9bbf7c7-2447-4cb1-a0c2-662a9d01d6d9", "462a6c34-db5b-8d31-e063-6294a90ae196", "9987d031-2d2a-4a43-a185-f29e28617e31", "4d72a04e-43a6-4fa4-bd1c-1360c4539d71", "58c4c95e-4db0-47e2-afb9-36472e6fcefc", "b8c99bfa-b2c5-4436-8e84-54348a032311", "2b91b384-4c20-4162-a717-9dc53ea834cc", "2833cb85-4017-41e2-aa4a-c19371ba85e8", "1486f187-0ec6-4c70-8991-02c1493912b4", "c0025ef1-99d7-4b31-9d99-4be010b2b9fb", "c24a0478-46d4-413a-8d48-c21af0bc10e4", "462a6e34-b07c-965d-e063-6294a90ab52b", "8e94acd8-b4bb-4b2f-be6f-9783fd5e1d04", "18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45", "182d5c87-db57-4042-a1e8-d2c78b07789b", "2d798366-5fb6-4ea5-b1cc-663a0c3290b0" ], "spl_set_id": [ "cb051508-60f3-4b89-9da0-5261024bd7f4", "925e2ea9-f51a-4b89-ab5d-ce590b6c4d85", "fb6d8f32-198e-4ccf-bf25-069c03d624fd", "1df07edb-630d-4c70-a68c-bdbc607ce850", "63f062f6-5669-434c-8ded-9801d8486dbf", "c7874606-c71e-424c-b881-38697988e0d0", "b8b8cfee-ea71-44c2-81af-675efecfdf15", "0a8e3090-7733-4914-bacb-01bbdc8deb30", "3bf4282f-b063-4d35-8ef0-6f48b98e9deb", "eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46", "160271a8-7922-2107-e054-00144ff88e88", "ac3f68b2-29b5-45c1-b6a2-54704dc3143e", "331db003-cc8e-4509-9415-20e48c5cc5b2", "f661c1d9-f0f6-4595-82dd-f656bff974f1", "1486f187-0ec6-4c70-8991-02c1493912b4", "657221d5-9eb8-42f9-8cdc-39cefc386f51", "8ebcb33c-f43b-4b36-9f94-9774b2a59e06", "5014847e-389d-48c1-8350-b9b24ca8d2a4", "ca5b0178-4e5f-4077-ada5-7058b0a03858", "1c857df2-9cce-40de-95c3-b1274ed1e1bc", "4d02eba2-e964-4fa7-aaae-25949b5f0316", "4d3e11d2-d320-45d3-96c8-48322202b504" ], "package_ndc": [ "68682-105-10", "68682-105-30", "70771-1365-9", "70771-1365-1", "70771-1365-7", "70771-1365-5", "70771-1365-0", "70771-1365-4", "70771-1366-9", "70771-1366-1", "70771-1366-7", "70771-1366-0", "70771-1366-4", "70771-1367-9", "70771-1367-1", "70771-1367-7", "70771-1367-0", "70771-1367-4", "68682-106-10", "68682-106-30", "70807-503-12", "70807-503-13", "62332-732-31", "62332-732-63", "62332-732-91", "62332-733-31", "62332-733-63", "62332-734-31", "68682-108-10", "68682-108-30", "68682-109-10", "68682-109-30", "23155-194-13", "23155-194-01", "23155-195-01", "62135-521-90", "62135-522-90", "62135-523-90", "24979-011-01", "24979-009-01", "24979-010-01", "59651-295-01", "59651-296-01", "59651-297-01", "24979-011-12", "24979-010-12", "24979-009-12", "70771-1190-1", "70771-1190-3", "70771-1190-0", "70771-1191-1", "70771-1191-3", "70771-1191-0", "70771-1192-1", "70771-1192-3", "70771-1192-0", "62175-260-46", "62175-260-37", "62175-260-55", "62175-261-46", "62175-261-37", "62175-261-55", "62175-262-32", "62175-262-46", "62175-262-37", "67877-757-01", "67877-757-58", "67877-757-05", "67877-757-90", "67877-758-01", "67877-758-58", "67877-758-05", "67877-758-90", "67877-756-01", "67877-756-05", "67877-756-90", "67877-756-58", "46708-732-31", "46708-732-63", "46708-732-91", "46708-733-31", "46708-733-63", "46708-734-31", "68382-685-01", "68382-685-95", "68382-685-10", "68382-686-01", "68382-686-95", "68382-686-10", "68382-687-01", "68382-687-95", "68382-687-10", "0069-2650-66", "0069-2650-72", "0069-2650-41", "0069-2660-66", "0069-2660-72", "0069-2660-41", "0069-2670-66", "62135-740-90", "62135-739-90", "68682-107-10", "68382-688-16", "68382-688-01", "68382-688-95", "68382-688-05", "68382-688-10", "68382-688-77", "68382-689-16", "68382-689-01", "68382-689-95", "68382-689-10", "68382-689-77", "68382-690-16", "68382-690-01", "68382-690-95", "68382-690-10", "68382-690-77", "50742-620-01", "50742-621-01", "50742-622-01", "50742-260-30", "50742-260-01", "50742-260-03", "50742-261-30", "50742-261-01", "50742-261-03", "50742-262-30", "50742-262-01", "50742-262-03" ], "nui": [ "N0000000069", "N0000175421", "M0006414" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ], "unii": [ "I9ZF7L6G2L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CYMBALTA", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA021427" ], "brand_name": [ "CYMBALTA" ], "generic_name": [ "DULOXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-3235", "0002-3240", "0002-3270" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DULOXETINE HYDROCHLORIDE" ], "rxcui": [ "596926", "596928", "596930", "596932", "596934", "615186" ], "spl_id": [ "aa5061b1-f237-425a-9d05-575c333dfd37" ], "spl_set_id": [ "2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba" ], "package_ndc": [ "0002-3235-60", "0002-3240-30", "0002-3240-90", "0002-3270-30" ], "unii": [ "9044SC542W" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMBIEN", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA019908", "NDA021774" ], "brand_name": [ "AMBIEN", "AMBIEN CR" ], "generic_name": [ "ZOLPIDEM TARTRATE" ], "manufacturer_name": [ "Cosette Pharmaceuticals, Inc.", "Sanofi-Aventis U.S. LLC" ], "product_ndc": [ "0713-5401", "0713-5421", "0713-5501", "0713-5521", "0024-5401", "0024-5421" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ZOLPIDEM TARTRATE" ], "rxcui": [ "854873", "854875", "854876", "854878", "854880", "854882", "854894", "854896" ], "spl_id": [ "2d934208-e709-2948-e063-6294a90aa9b6", "2d9350bd-56ea-7273-e063-6394a90a0e61", "3d6feaca-4f30-4ca9-a9c8-d9038744fa2f" ], "spl_set_id": [ "747949c5-2c91-4909-8a07-71b6826f8e97", "2d934da3-bd77-4470-e063-6294a90a64f5", "c36cadf4-65a4-4466-b409-c82020b42452" ], "package_ndc": [ "0713-5401-01", "0713-5421-01", "0713-5521-01", "0713-5501-01", "0024-5401-31", "0024-5421-31", "0024-5421-50" ], "unii": [ "WY6W63843K" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OMEPRAZOLE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA022032", "ANDA079182", "ANDA210593", "ANDA207891", "ANDA075410", "ANDA206877", "ANDA075757", "NDA209400", "ANDA206582", "ANDA075576", "ANDA216096", "ANDA091352", "ANDA203481", "ANDA207740", "ANDA076515", "ANDA076048", "ANDA211732", "ANDA204012", "ANDA218829", "ANDA091672", "ANDA213201", "ANDA078490", "ANDA212977", "ANDA203270" ], "brand_name": [ "GOOD NEIGHBOR PHARMACY OMEPRAZOLE", "OMEPRAZOLE/SODIUM BICARBONATE", "KIRKLAND SIGNATURE OMEPRAZOLE", "OMEPRAZOLE", "FOSTER AND THRIVE OMEPRAZOLE", "ACID REDUCER", "BERKLEY AND JENSEN OMEPRAZOLE", "GOOD NOW OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE", "BASIC CARE OMEPRAZOLE", "UP AND UP OMEPRAZOLE", "EQUATE OMEPRAZOLE DELAYED RELEASE ACID REDUCER", "DG HEALTH OMEPRAZOLE", "TOPCARE OMEPRAZOLE", "CAREONE OMEPRAZOLE", "EQUALINE OMEPRAZOLE", "LEADER OMEPRAZOLE", "EQUATE OMEPRAZOLE", "DG HEALTH OMPERAZOLE", "OMEPRAZOLE DELAYED-RELEASE", "SIGNATURE CARE OMEPRAZOLE", "MEMBERS MARK OMEPRAZOLE", "AMAZON BASIC CARE OMEPRAZOLE", "RUGBY OMEPRAZOLE", "TOPCARE OMEPRAZOLE DELAYED RELEASE", "24 HR OMEPRAZOLE", "CARE ONE OMEPRAZOLE", "EXCHANGE SELECT OMEPRAZOLE", "GOOD SENSE OMEPRAZOLE DELAYED RELEASE" ], "generic_name": [ "OMEPRAZOLE", "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Amerisource Bergen", "Strides Pharma Science Limited", "Costco Wholesale Company", "INNOVUS PHARMACEUTICALS, INC.", "OHM LABORATORIES INC.", "Strategic Sourcing Services LLC", "STRATEGIC SOURCING SERVICES LLC", "GERI-CARE PHARMACEUTICALS, CORP", "Lannett Company, Inc.", "WALGREEN CO.", "Sandoz Inc", "Cardinal Health", "Chartwell RX, LLC", "BJWC", "CVS Pharmacy, Inc.", "HARRIS TEETER", "PLD Acquisitions LLC DBA Avma Pharma Solutions", "RELIABLE 1 LABORATORIES LLC", "DISCOUNT DRUG MART", "Gobrands, Inc", "L. Perrigo Company", "WinCo Foods, LLC", "Aurohealth LLC", "Amazon.com Services LLC", "Meijer Distribution Inc.", "Meijer Distribution Inc", "CVS Pharmacy", "H E B", "Quallent Pharmaceuticals Health LLC", "Target Corporation", "Fred's, Inc.", "Wal-Mart Stores Inc", "THE KROGER COMPANY", "HyVee Inc", "Meijer, Inc.", "Dolgencorp, LLC", "Topco Associates LLC", "Dolgencorp Inc", "Zydus Lifesciences Limited", "NORTHEAST PHARMA", "P & L Development, LLC", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Retail Business Services, LLC", "Walgreen Company", "United Natural Foods, Inc. dba UNFI", "Little Pharma, Inc.", "American Sales Company", "Golden State Medical Supply, Inc.", "Padagis Israel Pharmaceuticals Ltd", "AMERISOURCE BERGEN", "BluePoint Laboratories", "Cardinal Health 110, LLC. dba Leader", "Twin Med LLC", "Sun Pharmaceutical Industries, Inc.", "Zydus Pharmaceuticals USA Inc.", "Walmart Inc.", "Apotex Corp", "Strategic Sourcing Services", "Rite Aid", "CHAIN DRUG MARKETING ASSOCIATION, INC.", "Rite Aid Corporation", "Rugby Laboratories", "VALU MERCHANDISERS COMPANY", "WALMART INC. (see also Equate)", "Camber Pharmaceuticals, Inc.", "H-E-B", "KROGER COMPANY", "Living Better Brands LLC", "Safeway", "Publix Super Markets Inc", "Sam's West Inc", "Camber Consumer Care Inc", "Glenmark Pharmaceuticals Inc., USA", "Family Dollar (FAMILY WELLNESS)", "Allegiant Health", "Dr. Reddy's Laboratories Limited", "Kroger Company", "NorthStar Rx LLC", "BI-MART", "Family Dollar Stores, LLC", "Chain Drug Marketing Association INC", "AMERISOURCEBERGEN DRUG CORPORATION", "CVS Pharamacy, Inc", "Bi-Mart", "Dr. Reddys Laboratories Inc", "Aurobindo Pharma Limited", "UP & UP", "Winco Foods, LLC.", "Xiromed, LLC", "WALMART INC.", "7-Eleven", "Army & Air Force Exchange Service", "Best Choice", "Rising Pharma Holdings, Inc.", "Walgreens", "Wal-Mart Stores, Inc." ], "product_ndc": [ "46122-281", "64380-182", "64380-183", "63981-915", "57483-740", "51660-029", "70677-1275", "70677-1098", "57896-659", "62175-114", "62175-118", "62175-136", "0363-1008", "0781-2785", "0781-2790", "70000-0521", "62135-559", "62135-530", "68391-103", "69842-941", "72036-981", "63548-8040", "69618-054", "53943-016", "82501-0915", "0113-0915", "67091-464", "58602-850", "57483-840", "72288-047", "79481-0061", "41250-915", "68391-915", "59779-503", "37808-401", "59640-047", "82009-022", "11673-346", "55315-996", "49035-915", "30142-992", "42507-164", "79481-0281", "55910-915", "36800-915", "55910-712", "65841-759", "65841-760", "65841-761", "80136-852", "59726-744", "51316-271", "63548-2970", "72476-473", "0363-1819", "58602-826", "41163-915", "72559-014", "0113-1723", "41520-939", "41163-634", "51407-664", "51407-814", "0363-9980", "45802-888", "69842-791", "46122-686", "37808-915", "63548-4080", "68001-441", "70000-0723", "55681-306", "62756-377", "68382-411", "68382-412", "68382-500", "49035-119", "79903-305", "0781-2234", "0363-6101", "55910-713", "57483-120", "60505-0065", "60505-0145", "60505-3952", "60505-0146", "41250-349", "70677-0148", "0363-0915", "11822-0061", "83324-011", "11822-0453", "0536-1322", "63941-997", "59726-740", "0113-6010", "79903-377", "0113-0520", "31722-527", "31722-528", "37808-569", "0363-0007", "30142-077", "21130-991", "59726-298", "51316-843", "21130-128", "56062-401", "70677-1104", "68196-700", "69230-318", "68462-395", "68462-396", "68462-397", "56062-915", "55319-219", "68196-915", "58602-837", "59779-580", "69168-476", "79481-3023", "55111-643", "55111-644", "55111-645", "30142-474", "72288-409", "0536-1448", "36800-121", "16714-714", "16714-715", "37835-001", "42507-414", "11673-018", "30142-394", "30142-593", "36800-601", "0781-2859", "0781-2868", "55319-037", "83324-141", "82009-023", "82009-183", "21130-783", "0363-6089", "46122-029", "46122-739", "41250-401", "63548-7370", "55111-157", "55111-158", "55111-159", "0363-4099", "11822-1190", "21130-528", "51407-641", "51407-943", "51407-813", "30142-557", "51316-061", "79481-0075", "37835-189", "43598-286", "46122-616", "72288-401", "72288-123", "59651-001", "59651-002", "59651-003", "11673-948", "41520-915", "67091-316", "70700-149", "70700-150", "70700-151", "55910-215", "16714-123", "16714-630", "16714-634", "72288-915", "72288-606", "21130-401", "79903-113", "10202-722", "69842-661", "11673-212", "42507-915", "43598-841", "55301-915", "63941-006", "57237-160", "57237-161", "57237-162", "0363-9510", "11673-915", "37808-354", "76162-470", "49035-983", "0113-1803", "21130-137", "41520-802", "70000-0381", "58602-729" ], "product_type": [ "HUMAN OTC DRUG", "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OMEPRAZOLE", "SODIUM BICARBONATE", "OMEPRAZOLE MAGNESIUM" ], "rxcui": [ "402014", "753557", "753562", "198051", "199119", "200329", "2003656" ], "spl_id": [ "b734d645-be14-4398-b7e2-9017c771fff1", "2ac68a93-2f3b-46aa-a874-c109ad1bfefe", "633c827b-bb87-4c7f-9865-633006a60e21", "ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "e9ea61cb-d280-42b0-8819-34117270c618", "07de4a08-07e5-444b-8d1b-7f259b32936e", "252eeb77-6319-49df-9259-fcf2f917b2b5", "df05ccee-e8d0-43b2-a266-86afc1ce741c", "e786b865-dc62-4018-9cb1-7056b7ca2cde", "f3c6b5e7-49d3-4c89-907f-782953c31b90", "24a57c2e-eda8-4c3f-9c81-a28a5b9a9229", "a54de89f-8710-4fc7-97c3-8607e5974263", "2df74daf-da0f-36e2-e063-6294a90abc9d", "46879e67-0bb9-93a7-e063-6294a90af37d", "c7b50625-4920-4bb2-8eff-943670438248", "94a59c53-72bd-4d37-9ea9-c73f51ea1031", "ca9797c6-5708-4d45-bd1a-c670077e1a0b", "4e880f49-93d0-436b-a072-c3286d358e45", "ba632dd1-c85a-49c0-88a6-6d10ddbff1af", "0029ee94-3c34-42fb-982f-9baefdfe0b3b", "fa4938ea-ffb5-466e-8fce-4fdfdc97989e", "1d135e1c-1e90-4e42-a2c7-2ef3b3fc6545", "5c220251-3504-4c65-a385-85920515c499", "492b45bf-5734-4a64-8907-feaebadbb41a", "3fc301fe-e89b-488b-8437-c48b59cec420", "e00843ad-85f1-458c-9f2c-c1c4b41947a7", "77a11f0a-d2ce-40b7-8c19-011d6665d18b", "88bf3550-4633-47fe-88ec-e9ca94f7f752", "74157f10-5953-44de-abf5-b6793f13e70d", "2d9d60cd-6c79-4da7-9c48-ac1b73df9832", "9cb203e7-86d0-4757-9a32-afd2038898a3", "5d5df90d-3535-4337-99d8-e7e0309b433e", "17380ad5-9506-8e44-aa84-b6ce52ac7b9b", "dc644613-1131-499d-9c16-7ee241a10c26", "5df31fd8-49c4-4a00-aadc-3f02860ab01f", "03d865a0-ac92-49d5-82e2-2276292add17", "759b705a-526e-47e2-97f9-a78ab21a2c5d", "c1ec28a1-d0e5-4878-8295-eb06ff5e1fd6", "edbe9a75-73ef-4b53-8f08-10e775091e23", "4900f1e8-5133-4ef9-a871-4d88507d56eb", "e1557259-5889-4677-981e-ebd3970162c8", "72620a9f-63f1-421d-825a-ac73e891cd08", "691b64ae-e6ff-4a10-9973-886901529db0", "29498c01-1121-44bf-9a93-d5c5438bb83c", "141dd771-bc04-40b1-a80e-95ce0a471d6c", "6fe0d098-2eb4-49b6-881f-fbe7e102bfcb", "2bd05b96-ec80-440b-9e49-53c375ce9f8c", "965c30c2-5455-4f16-8fbf-2c57329806d5", "d56182bb-d424-4890-93c6-bca29194af8c", "d4d5397d-41ee-4c3c-bf0f-a923b1731d0b", "9cf01d8d-1fe8-4350-a23b-065f4d126547", "4d29deee-4362-9457-e063-6394a90a87eb", "c0f585e4-bc50-4364-9864-63ef2c3c9467", "7a2142d9-ea48-4cd8-bb1a-aed470b43852", "d806739f-7f7b-42ae-af48-d1b0b22d3eef", "4f745e3f-7028-51ec-e063-6294a90af7af", "8add376a-81a3-41e0-ba8d-037f7f56165a", "390ed372-f284-46b1-92bd-c2432fe6920b", "21aa099b-aabb-40ee-bbea-9db44c62e1e8", "47dce86f-d184-44cf-8ee3-18dad7f401b8", "0623c22d-32db-42d7-8a2b-d50e96baae5b", "6039daeb-5242-4b4e-80c9-45cb90249eba", "0486dc89-1bf1-8e37-e063-6394a90a9aa7", "01e166d4-7ac5-421f-87d2-7b647631bf8d", "c9a11bc6-0680-4030-871e-599417fccf57", "676e2f39-d83e-485a-9366-ed14c382e466", "d0074baa-52cb-4039-9bd8-966a36ff70da", "65ea67fd-2018-49ce-bccf-3d4ccf4f235b", "cd2683cb-42a1-cb9f-6dd4-a1464ddb3afd", "fe6aa833-89e6-4679-a7b8-6600e92c1bed", "ef7892f0-4389-4c7a-bc74-dabebce4b128", "d1d7bb64-1c13-4d36-b761-01ac075da14a", "72b23ff2-70a3-412c-9a9c-902927598e2f", "8619e520-d106-4778-e92a-09b919b55c70", "e3d7b200-cb51-46f2-aebf-b95ddac1b664", "b4a9538c-049e-45d3-8b28-581c68a36ed6", "364bb6a8-58c8-460d-92db-c25b9eed8d2b", "67c3cfe2-ab40-4c32-b386-ad3c740e3f6f", "164b1d0f-ad03-40dd-e063-6394a90a6771", "b518a17f-c0c9-4f15-884f-e2b193115a96", "6616864c-9739-4e69-86a1-29c07441f9ba", "9c033207-ae1c-4212-aeef-3bb5bfef6fca", "e9703fb1-76b2-42e6-9ceb-51aaa62bca31", "b840439b-540b-465a-8faa-f7b1024c628e", "1fabf3d4-e22f-474e-8812-679544cc48aa", "5e2cb7f9-93ec-4919-9648-0ecb1c5fe086", "2b439e93-9a24-e64a-e063-6394a90a634f", "50962214-2053-1974-e063-6394a90a0fc0", "8e923ce5-8ec6-464d-9772-55a9b1213cdf", "f5f26771-fb6e-4fc5-8ad9-92c64a9d7b81", "1a05a724-635a-49fa-a890-85363fd43a27", "1ef5cd55-c1c3-40a9-9486-91ad26c24a1c", "2480bbfc-d4fe-4d52-b9a6-48c9f4fe9698", "eb0dd73c-7d2d-424f-a939-dcdb18ee21f1", "8137007b-8ac1-4c7e-bc89-d9d9bb66a8ea", "4bb8b63d-4f46-4d58-a069-c88a969e960a", "7292128d-5bd2-4239-b53d-22ec365a835e", "ee873df8-2b35-9bc7-e053-2a95a90a0f83", "69b1e229-f845-4608-be48-f97e8d3e2273", "23f9d37a-deb7-4e56-90bc-13099e0d1e8f", "5ab86c77-4f33-46e4-84dc-57c96b8fc490", "ec7763a5-521c-486b-8215-2d66c97c3977", "0c2600f3-e9de-4e73-8ee1-9aeb94d228e4", "e5387742-f011-4d3c-b3ed-44e0251b053f", "37309c28-8650-401e-9a39-6b52112e0baf", "d9659b73-1336-4777-8ce9-926b851e1616", "8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d", "90aa0006-a47e-4058-bff3-5fb2d7bef8f1", "0e2645ca-76b7-4f38-9513-cba86dfa20a3", "bc786388-cb4d-4210-9124-39a4bcbb7d38", "f384bca8-e266-489a-8d87-3df17e7d0a56", "9ced381c-99a7-a9c4-211a-82326fb17900", "31dbc48a-ec90-e368-e063-6294a90a6c96", "c7e11072-2333-4846-a37b-2b2c3a59a6d0", "a8a64ea9-0d2c-45d5-a81d-da0d8ce60044", "46b01c78-c491-4087-a980-a43add76537d", "97fc5b6e-8e86-4774-933d-c85dfe71825d", "0edd49e4-cf9e-42db-8bbb-78ce370ac480", "b182f298-e28f-434b-b6f1-ecfac29d495e", "c1eee169-a04a-485d-9c17-2229cdca1fd1", "c8061435-ef48-b29f-b9bc-3fdda780ecc4", "8aee798c-2e69-76b9-85b5-3a4e0a0c7a94", "ba9d8915-89e0-4a90-a8e3-03784b496950", "cc051c20-36b7-4eb6-95e5-65734ef65458", "9517ab3c-69eb-4c6b-b65a-b3411b6373a9", "0c214fe9-7d95-39e0-0526-2d257f47695e", "9215653a-ae65-423a-9eb6-c94f21fe4413", "2cb02338-e348-4b60-aae0-e7806e03f5bf", "0dc50704-e0d5-1fcc-b0b5-6e5556db65e8", "4565e652-447a-484b-b8d2-adde9454111c", "e00e0544-dee7-4322-aa62-e1b912f2e6cf", "e018508f-372e-4b81-9979-15dbd798b271", "3ba5e1e5-159d-2492-e063-6294a90a6c8b", "ca200f16-7b7e-4b33-964b-e2ccfc62f0f4", "a3b8b93d-6725-4c5c-8b80-dcc27e408501", "9dee9797-6b74-498a-9237-53ac64642d27", "cd7c9c63-7126-43f0-bca2-f0d263415e36", "ccd2bf38-c7b2-b12e-14a6-ca3631d9dfd4", "99568183-6575-488b-a829-414bb8cf34a6", "02dbc562-2299-4c4d-a107-944a2b342d1a", "3d759662-06ea-46b7-b26e-33f376b7e262", "4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a", "ef059a98-451b-4590-93b4-937b855d6595", "5248b065-e6de-4bc6-af17-ee5e7ecdc45f", "cdedc06f-c813-421a-b613-0768f17d8633", "49528611-b139-6768-e43e-bc6f26715fa3", "fe39c1c0-3f79-418f-88c7-e4f40619b77e", "fe36a9a7-13d0-f4f1-1e31-b35cf651b79d", "617f2b9c-d13b-4128-af41-af5abd3e7bfe", "0cb73d40-2e1f-4197-a2bd-038b2295738f", "fd87b124-5abc-4db7-9125-350ac1699a1d", "a9fc2493-e10b-4d7a-9708-18ecdc757ef4", "d9c2719b-9650-41da-8ad4-085852934eeb", "20b6b69a-3bd9-42a4-a225-7efbf97a99eb", "1713a351-8a7a-405c-b37d-e01c2de0c246", "926d7c5a-14db-4560-ac64-898166bf2241", "bf20de45-af46-d037-efd5-6efe069d0569", "8adc4bc1-677f-4ad1-b301-bb5f25ce0205", "3a3a6029-3c1c-4c22-863d-1bf12733c39f", "aec12e35-60fb-416c-a2d0-a87cfdcb30a6", "6c1e8126-e1ab-4087-a25e-872bcace2a60", "cd15d39d-8e0a-4c39-806a-ff9951f33434", "51d6a6ce-e096-4152-876e-472f6b47e5bb", "255def35-0ba3-44c0-af0c-e5aa99806996", "b0339709-5175-4501-a96b-67ae8b88e153", "bffe358a-cc5a-4ff6-9a04-b0fbca4444e7", "fe806f67-4a8c-40ae-9750-d0c7a4a33aa6", "704e2091-bd15-4fd1-892e-425dffd01656", "867caf67-b128-4c09-9e35-352f8c04bcbe", "81d45120-49d4-4de8-8477-79312e2c1d56" ], "spl_set_id": [ "5ee3cb79-5c0c-456f-b5d5-d5a008bbd118", "cf6d293e-d70d-443e-8292-d693e93aab55", "48a44d0c-3502-430b-8b75-188a49d14da2", "ce5c9fdc-0c50-4315-8f11-e00c9810abd0", "35a95bec-51b9-465b-aa93-ad26afb87be8", "51bcc19d-acfc-487b-870b-251c8953741f", "56380ccc-6fc2-4e1b-bd87-da24c9aa31cd", "8a77aea7-912e-43a3-bce3-f666b9b9c9bc", "92201fb1-4570-42db-8da3-3b8c0e291d32", "b9561780-e358-b610-e053-2a95a90af020", "e4562da8-9d94-4417-9f80-c1ffd4247259", "230e1aca-6644-4e6d-a6e1-9ba04cdcc8a8", "4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e", "10f5502a-2e63-4f2a-a3ba-ddc5bd403051", "1729c60d-3475-45cd-b192-f88438403d1a", "3349ee88-e53b-4586-8d28-20ecf8fcb1a5", "c618964f-4b16-448e-851b-e6b2a816c660", "e67bf2c6-0618-48e0-aa08-705501d86431", "f6b13640-6c71-4c3d-8eb5-c36fca201aee", "ff2c8446-9d8b-4300-b157-884b48e98bb7", "0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f", "11dfbf6c-59bf-4a30-b627-f49ccd31c0d0", "2782b98b-50e4-4a4e-8626-d34ebfd71bfb", "287ceb12-e4d8-43c7-8cec-c4d23aa8fb12", "7535a309-1a67-4f50-911b-7cf570322931", "76b941f0-a02f-43e8-821e-09ccf675d944", "8f5f9bbb-48d2-4fb1-81a2-3cbf070ed573", "925399c7-dcbc-4546-9111-2a98a11ba538", "f74752a8-a686-4c7d-91ad-8c87c4596a7a", "fb3b1c3b-d486-4fa6-9ebf-ee1812ed2512", "491e3710-9a15-4b07-ae22-923bd1152ecc", "501d80c0-68ee-4fd9-bc56-0b214dbf72b5", "665e9877-85ac-fdb6-54ac-1c47941ceab8", "7dc339da-e90b-452b-b25e-8d7f3aa8bc18", "7f00d0ed-4b7e-7011-e053-2a91aa0a2454", "9a0f2d8a-eaad-403b-90c3-0fd275abe4dc", "f55cedc7-e0bc-4d30-af52-bfa881f6adde", "fd22d4df-9679-4c2d-9bc4-3619288fb4cc", "0340ef94-d2b4-47af-a045-d0d031293984", "326bf21c-fad4-473e-9e7f-797319d4353a", "4d98665d-38db-4c08-8406-cc0e45f7ab7c", "6d19783d-2856-4a86-9f5c-6cc26b4ca33e", "2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2", "35ceccb5-dc3d-4ee1-bdac-35cb52c22f59", "883e428a-e157-4bbf-8657-e7a93dc99e8c", "8edfcc08-a14e-4579-bd44-045267de5b79", "d9c8a242-bdba-4f92-8629-692b47ebba21", "063cfad8-3ca6-4b72-a4c9-512b8047bae3", "064f048c-eddd-4370-9ee4-706f9f00c8d2", "3eb70031-6439-44cf-8056-3e2e1e4a7fa9", "b6c87a6a-253a-4455-9b7d-62f506da592e", "d4f86bbe-fe4d-41e2-96cc-4b4bbe2f1f7f", "db333c49-2c3e-4ade-a202-7d4499205fc4", "5b88717a-e90c-4e74-ae2a-29270e14a3cc", "78743f3b-257e-49df-98cd-6cc0e1b4e370", "f27b3518-d5c1-1229-e053-2a95a90ab56f", "537b9a46-ecc8-4537-9657-c9ff7821dd4b", "cb47354c-297b-4dc2-85af-242acc967b56", "01bde9ca-0114-426d-8188-c55aefaa0961", "47dce86f-d184-44cf-8ee3-18dad7f401b8", "5ceaec04-3ca3-4c7c-9184-51a42686a595", "6a1aeb95-5760-4363-816a-fa8305979c50", "a86d52a5-15e2-012d-e053-2a95a90ac912", "19beab17-ca25-4be3-bada-20a2e9aa26b5", "346141b5-b49d-489a-84eb-18df8b940460", "51c3ef34-b7c1-419e-a784-ae82540c7a22", "9c22ceb2-2c34-43c3-9a35-2589c9078741", "504b8282-d93f-454f-9f93-84cb8a9105d7", "5168ccd9-31b4-3a49-85b9-4f202cd99f6b", "5a09ce48-7139-4fc7-9b6e-439459c8e866", "87cee50d-4c1e-473d-9d70-b1622f84aee1", "99fdfeed-6828-4bf6-bb81-cd29a4ec610b", "a4e92bd2-8f75-4acc-9b75-df8332bd4cc4", "b83329ac-a65e-b3af-a3fb-c5a6c740e5e7", "d54e1097-bd56-4371-8e59-8ceab1a5e824", "dfa91081-3917-4dfc-9789-76800f57bb31", "30a893d2-198a-4184-81b4-02399324ff29", "b1ba65d1-8f68-4bae-bb9d-776bba348346", "da09aac6-8fce-448b-98ba-1fc9bce42075", "ee853401-b641-4dab-b708-29424c2d0b79", "33990795-e994-4307-a570-9e8e8b44c473", "7b2d41b6-3e36-4973-b5f6-adf9b828f40d", "911a08c4-ba73-4600-a5f2-7f26ba8c8604", "b840439b-540b-465a-8faa-f7b1024c628e", "d3c1ba08-680d-4e39-875c-1f1d42ae787c", "dcd93796-8904-415d-a379-c4ea590cf544", "0c6e00a2-31e8-4e84-928d-80e69a5fc634", "448ba584-6a6e-3d85-e063-6294a90a5579", "b7972f17-4a63-4d78-a181-01ea6d7d3963", "eb5d02a8-4112-2066-e053-2a95a90abba3", "1d500e2d-395b-437e-a95c-3922a71a0956", "44a92926-1941-4fe8-9b2a-31a45289456f", "6479415a-ffb0-4d20-ad00-f091c8aaaadb", "c76c4235-92d4-4384-8ddc-ceed0b928c48", "05fae639-ba68-4c05-8ca7-7c5cc2d50584", "836efc63-b633-497c-ab56-76bb495bd723", "907e9974-46b8-4dae-be92-518c076cb98f", "9c856d3a-e38f-4006-a43a-ec1a9fa0f057", "c6c22be1-659d-4e71-b292-701e27da201b", "e4a68b0a-a550-4416-8911-1defe014ad89", "f2195d73-1fd5-4de2-aa5c-18741d11f4fc", "0edfa800-fb14-44dd-9c31-de930b864ef9", "19097902-a5e6-423a-8569-31c569cd3cdb", "19b5b960-cc4d-42d0-8c8a-04a355a4db92", "3344c589-c4ac-4f2d-8d32-828db4e825a6", "47c41c68-cb20-40f0-9d85-ea8db3328478", "603d2d06-c5e8-4378-a422-8dca1a410af7", "da18d91c-5fe9-44d4-9d6f-602900af3f08", "10efef7c-bdf4-36cf-e063-6394a90a8c0f", "61952807-f38d-4e7a-8646-a8ec85d7fb37", "8ed57521-e69a-4563-9ce2-4f6d667f065d", "c5af5f4b-17be-7245-b281-f27c87831242", "fb089d15-daa4-477a-be83-ecd55c3283d4", "cf9919e6-a839-4bad-a007-80d5bf6f81db", "d664c45d-564a-4692-ae8f-8dd980ffcd87", "083841e8-482d-4e5b-90ab-1139b576d691", "236a9447-23ec-44c7-a241-20f9ddc83ab8", "436c5ea1-c5ee-481f-803d-439f65873b1c", "516170d4-4913-4577-a2d2-f5c52d1e79c6", "6d8daf78-1672-4bbf-a022-514bf0a5ac9a", "77d4f6c7-87ca-78bb-3310-2304a68f9f9b", "8090d4c3-3184-7812-53d7-aa30e14b79d1", "b3ec4a44-5643-4438-b41b-e04946436719", "f56ff74d-116d-4a75-87dc-41c309f03918", "f9aab207-d309-49b5-b941-c2912b186583", "0521c51b-d113-7e35-f1a6-c4495a2bcfcc", "4e849a58-ad34-4d6e-a065-d1e5a1ac8218", "71add294-ff24-4bbf-9067-7c56ed7c9f1a", "72fb11b6-b08c-2f02-d82b-f60f52394903", "97eaf0dc-380b-4039-aeb7-dde39942a9d6", "28a0b4c8-3ad3-451c-a957-28aef5e3d8b5", "7ae4d70f-08f1-4586-965f-5a32fbe21591", "ded71262-d17f-3799-e053-2995a90a5427", "015b1c8f-9d5b-4afc-a55c-1a731b5fc72a", "0769e47f-f8f1-4b1c-a8cc-7c8385c74070", "36adb053-3189-4c91-87dd-e122a2c8e812", "419659f9-098a-4a18-8bba-cd45157bfa50", "4b3b389d-a151-d851-cb05-64eb49979e5e", "54fd9f84-9c67-4846-b79d-eb9e6720a315", "73c36634-a70f-4641-910f-6cdda7fbcd36", "87a2aa9b-c681-41c7-8a59-b359efd443cb", "934601b6-fbba-43c4-a8ef-7a7dfe9f9a51", "ac10cf46-1dcc-483a-83d6-2fcb9896cc19", "db2d75ea-5924-4b7f-a92d-d4847a010d52", "0cb2949a-baf2-4276-a27b-8f3cc4b9a658", "38bd8e13-591e-f11b-7d8a-11717c56493c", "3c34fa4b-be9f-4aa6-ab6b-775b528a8949", "40a75dc7-49b7-5c9d-6c5f-d4682ec6922e", "548629d3-8d93-465d-b6ac-2a42bc0baebf", "7e0d319c-6917-45c4-b7e1-e870fc3fcea5", "85ece978-3cfb-4c09-bf0f-3217fda8e7d4", "dcfe8e94-9c88-464e-9a80-3baa9c4755d9", "61206416-e0c1-44d7-ad35-feb629361ba9", "64a62f09-19a9-4281-a55d-451fd33711c1", "8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c56", "a5df7dac-00f4-4d97-9586-cde3055890ac", "b377cb0b-14b2-04bb-f276-fd69a257f9ca", "22b4492d-7afe-410f-97bf-57e4a57b1c27", "43ea758b-6cea-44a2-b4d6-8f99211c8826", "a1b1c61b-d4fe-433d-ad31-0b11758976fa", "b9683a94-fd44-4364-be0e-477ca1a29aba", "2f2b26fe-dbc2-4185-8a27-6b166dd49ba2", "344b5548-e5c0-45bf-bc3f-73af50bd5913", "ec9d8dab-480c-49bc-bdbb-bebcc7676d01", "1b4e75bf-0dcb-4fec-aca4-fc0132a79f5c", "38082e59-c509-4be5-b29c-33a97565df1c", "6361a492-782f-4608-a20f-1bd86afbd864", "a5ec923a-dbc7-43e0-b3b8-f61dcaa6765d", "b2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a", "fde12bf8-3e3b-4813-a8c4-4385e7de8204" ], "package_ndc": [ "46122-281-04", "46122-281-74", "64380-183-01", "64380-183-02", "64380-182-01", "64380-182-02", "63981-915-55", "57483-740-01", "57483-740-42", "51660-029-44", "51660-029-14", "51660-029-27", "70677-1275-2", "70677-1275-1", "70677-1098-1", "57896-659-14", "57896-659-42", "62175-114-37", "62175-114-32", "62175-114-46", "62175-114-49", "62175-118-49", "62175-118-32", "62175-118-46", "62175-118-37", "62175-118-43", "62175-136-32", "62175-136-46", "62175-136-37", "62175-136-43", "62175-136-49", "0363-1008-05", "0363-1008-61", "0363-1008-62", "0781-2785-31", "0781-2785-01", "0781-2785-10", "0781-2790-10", "0781-2790-01", "0781-2790-92", "0781-2790-31", "70000-0521-1", "70000-0521-3", "70000-0521-4", "70000-0521-2", "62135-559-30", "62135-530-30", "62135-530-90", "68391-103-55", "69842-941-05", "69842-941-61", "69842-941-62", "69842-941-01", "69842-941-03", "72036-981-14", "72036-981-42", "63548-8040-4", "63548-8040-8", "63548-8040-2", "69618-054-42", "53943-016-05", "53943-016-62", "82501-0915-0", "0113-0915-74", "0113-0915-30", "0113-0915-55", "0113-0915-01", "0113-0915-03", "67091-464-14", "58602-850-05", "58602-850-62", "57483-840-01", "57483-840-42", "72288-047-01", "72288-047-03", "79481-0061-1", "79481-0061-3", "41250-915-74", "41250-915-30", "41250-915-55", "41250-915-01", "41250-915-02", "41250-915-03", "68391-915-55", "59779-503-30", "59779-503-55", "59779-503-74", "59779-503-02", "59779-503-01", "59779-503-03", "37808-401-03", "37808-401-01", "59640-047-01", "59640-047-03", "82009-022-10", "11673-346-03", "55315-996-74", "55315-996-04", "49035-915-30", "49035-915-55", "49035-915-74", "49035-915-01", "49035-915-03", "30142-992-14", "30142-992-28", "42507-164-42", "79481-0281-0", "79481-0281-1", "55910-915-30", "55910-915-74", "55910-915-02", "55910-915-01", "55910-915-03", "36800-915-74", "36800-915-30", "36800-915-55", "36800-915-03", "36800-915-01", "55910-712-01", "55910-712-03", "65841-759-06", "65841-759-16", "65841-759-01", "65841-759-05", "65841-759-10", "65841-760-06", "65841-760-16", "65841-760-01", "65841-760-05", "65841-760-10", "65841-761-06", "65841-761-16", "65841-761-01", "65841-761-05", "65841-761-10", "80136-852-03", "80136-852-42", "59726-744-42", "59726-744-14", "51316-271-01", "51316-271-03", "63548-2970-4", "63548-2970-8", "63548-2970-2", "72476-473-01", "72476-473-03", "0363-1819-55", "0363-1819-74", "58602-826-05", "58602-826-61", "58602-826-62", "41163-915-74", "41163-915-30", "41163-915-55", "41163-915-01", "72559-014-06", "72559-014-07", "72559-014-36", "72559-014-09", "0113-1723-03", "0113-1723-01", "41520-939-74", "41520-939-55", "41163-634-74", "51407-814-01", "51407-814-05", "51407-814-30", "51407-814-90", "51407-664-01", "51407-664-05", "51407-664-00", "0363-9980-42", "0363-9980-28", "0363-9980-14", "45802-888-55", "45802-888-30", "69842-791-55", "69842-791-74", "46122-686-74", "46122-686-03", "37808-915-55", "37808-915-30", "37808-915-74", "37808-915-01", "37808-915-03", "63548-4080-4", "63548-4080-8", "63548-4080-2", "68001-441-55", "68001-441-98", "68001-441-39", "68001-441-40", "70000-0723-1", "70000-0723-3", "70000-0723-2", "55681-306-14", "55681-306-42", "62756-377-21", "62756-377-11", "62756-377-12", "62756-377-70", "62756-377-96", "62756-377-79", "68382-411-06", "68382-411-16", "68382-411-01", "68382-411-05", "68382-411-10", "68382-412-06", "68382-412-16", "68382-412-01", "68382-412-05", "68382-412-10", "68382-500-06", "68382-500-16", "68382-500-01", "68382-500-05", "68382-500-10", "49035-119-01", "49035-119-03", "79903-305-14", "79903-305-28", "79903-305-41", "0781-2234-10", "0781-2234-01", "0781-2234-31", "0363-6101-01", "0363-6101-03", "55910-713-74", "55910-713-30", "55910-713-55", "57483-120-42", "57483-120-14", "60505-0145-0", "60505-0145-2", "60505-0145-1", "60505-0145-3", "60505-0145-7", "60505-0065-0", "60505-0065-2", "60505-0065-5", "60505-0065-1", "60505-0065-8", "60505-0065-3", "60505-0065-7", "60505-3952-3", "60505-3952-8", "60505-0146-0", "60505-0146-9", "60505-0146-2", "60505-0146-1", "41250-349-74", "41250-349-55", "70677-0148-1", "0363-0915-30", "0363-0915-55", "0363-0915-74", "0363-0915-01", "0363-0915-03", "11822-0061-1", "11822-0061-4", "83324-011-14", "83324-011-42", "11822-0453-1", "11822-0453-2", "11822-0453-3", "0536-1322-88", "0536-1322-71", "0536-1322-13", "63941-997-42", "63941-997-14", "59726-740-42", "0113-6010-00", "0113-6010-03", "79903-377-14", "79903-377-42", "0113-0520-55", "0113-0520-74", "31722-528-30", "31722-528-01", "31722-527-30", "31722-527-01", "37808-569-45", "37808-569-82", "37808-569-41", "0363-0007-03", "0363-0007-01", "30142-077-01", "30142-077-05", "21130-991-44", "21130-991-28", "59726-298-14", "51316-843-01", "51316-843-03", "21130-128-55", "21130-128-74", "56062-401-01", "56062-401-03", "70677-1104-1", "70677-1104-2", "68196-700-01", "68196-700-03", "69230-318-35", "69230-318-36", "69230-318-37", "69230-318-32", "69230-318-33", "69230-318-34", "69230-318-05", "69230-318-10", "68462-395-30", "68462-395-90", "68462-395-01", "68462-395-10", "68462-396-30", "68462-396-90", "68462-396-01", "68462-396-10", "68462-397-30", "68462-397-90", "68462-397-01", "68462-397-10", "56062-915-55", "56062-915-74", "56062-915-30", "55319-219-14", "68196-915-55", "68196-915-74", "68196-915-03", "68196-915-01", "58602-837-05", "59779-580-01", "59779-580-03", "69168-476-14", "69168-476-42", "69168-476-61", "69168-476-15", "79481-3023-0", "79481-3023-1", "55111-643-30", "55111-643-01", "55111-643-05", "55111-643-79", "55111-643-78", "55111-644-30", "55111-644-01", "55111-644-05", "55111-644-10", "55111-644-77", "55111-645-30", "55111-645-34", "55111-645-01", "55111-645-05", "55111-645-10", "55111-645-79", "55111-645-78", "30142-474-01", "72288-409-05", "72288-409-01", "72288-409-61", "72288-409-03", "0536-1448-88", "0536-1448-13", "36800-121-01", "36800-121-03", "16714-714-01", "16714-715-01", "16714-715-02", "16714-715-03", "37835-001-42", "37835-001-14", "42507-414-00", "42507-414-01", "42507-414-42", "11673-018-03", "11673-018-01", "30142-394-74", "30142-394-55", "30142-593-03", "30142-593-01", "36800-601-74", "36800-601-55", "0781-2859-10", "0781-2859-01", "0781-2859-92", "0781-2859-31", "0781-2868-10", "0781-2868-01", "0781-2868-92", "0781-2868-31", "55319-037-05", "55319-037-62", "83324-141-42", "83324-141-14", "82009-183-10", "82009-023-05", "21130-783-03", "21130-783-01", "0363-6089-03", "0363-6089-01", "46122-029-74", "46122-029-03", "46122-029-04", "46122-029-99", "46122-739-74", "46122-739-03", "46122-739-04", "41250-401-03", "41250-401-01", "63548-7370-4", "63548-7370-8", "63548-7370-2", "55111-157-30", "55111-157-01", "55111-157-10", "55111-157-79", "55111-157-78", "55111-158-30", "55111-158-34", "55111-158-01", "55111-158-10", "55111-158-79", "55111-158-78", "55111-159-30", "55111-159-01", "55111-159-05", "55111-159-10", "55111-159-79", "55111-159-78", "0363-4099-01", "0363-4099-03", "11822-1190-0", "11822-1190-1", "21130-528-01", "21130-528-03", "51407-641-10", "51407-641-01", "51407-641-00", "51407-641-90", "51407-943-00", "51407-943-01", "51407-943-05", "51407-943-90", "51407-813-10", "51407-813-01", "51407-813-30", "51407-813-90", "30142-557-55", "30142-557-30", "30142-557-74", "30142-557-01", "30142-557-02", "30142-557-03", "51316-061-28", "79481-0075-3", "79481-0075-1", "37835-189-14", "37835-189-42", "43598-286-52", "43598-286-27", "43598-286-33", "43598-286-74", "43598-286-25", "43598-286-37", "43598-286-70", "43598-286-32", "46122-616-04", "72288-401-03", "72288-401-01", "72288-123-74", "72288-123-55", "59651-001-30", "59651-001-01", "59651-001-99", "59651-001-10", "59651-001-03", "59651-001-78", "59651-002-30", "59651-002-90", "59651-002-01", "59651-002-05", "59651-002-99", "59651-002-10", "59651-002-03", "59651-002-78", "59651-003-30", "59651-003-90", "59651-003-01", "59651-003-05", "59651-003-99", "59651-003-10", "59651-003-03", "59651-003-78", "11673-948-14", "11673-948-42", "41520-915-74", "41520-915-30", "41520-915-55", "41520-915-03", "67091-316-14", "70700-149-30", "70700-149-05", "70700-149-01", "70700-150-10", "70700-150-30", "70700-150-01", "70700-150-00", "70700-151-10", "70700-151-00", "55910-215-01", "55910-215-02", "55910-215-03", "16714-630-01", "16714-634-01", "16714-634-02", "16714-634-03", "16714-123-01", "16714-123-02", "16714-123-03", "72288-915-01", "72288-915-30", "72288-915-03", "72288-915-55", "72288-606-01", "72288-606-03", "21130-401-01", "21130-401-03", "79903-113-14", "79903-113-42", "10202-722-05", "69842-661-01", "69842-661-03", "11673-212-74", "11673-212-55", "42507-915-00", "42507-915-01", "42507-915-74", "42507-915-30", "42507-915-55", "42507-915-03", "43598-841-52", "43598-841-42", "55301-915-74", "55301-915-55", "63941-006-05", "63941-006-62", "57237-160-30", "57237-160-01", "57237-161-30", "57237-161-90", "57237-161-01", "57237-161-99", "57237-161-50", "57237-162-30", "57237-162-90", "57237-162-01", "57237-162-50", "57237-162-10", "0363-9510-14", "11673-915-55", "11673-915-30", "11673-915-01", "11673-915-02", "11673-915-03", "11673-915-74", "37808-354-74", "37808-354-55", "76162-470-03", "76162-470-01", "49035-983-05", "49035-983-62", "0113-1803-01", "0113-1803-03", "21130-137-55", "21130-137-30", "21130-137-74", "41520-802-01", "41520-802-03", "70000-0381-2", "70000-0381-1", "58602-729-05", "58602-729-61", "58602-729-62", "58602-729-64", "58602-729-65", "58602-729-01", "58602-729-02", "58602-729-03" ], "nui": [ "N0000175525", "N0000000147", "N0000182140" ], "pharm_class_epc": [ "Proton Pump Inhibitor [EPC]" ], "pharm_class_moa": [ "Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "KG60484QX9", "8MDF5V39QO", "426QFE7XLK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FLEXERIL", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "SALSALATE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "brand_name": [ "SALSALATE" ], "generic_name": [ "SALSALATE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Westminster Pharmaceuticals, LLC" ], "product_ndc": [ "65162-512", "65162-513", "69367-615", "69367-616" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SALSALATE" ], "rxcui": [ "312899", "583170" ], "spl_id": [ "6b990a95-3932-4771-adb1-84bfe4c456de", "56747829-5049-405d-8d69-83c34d70002b" ], "spl_set_id": [ "213f0930-4a4a-4894-90b9-70c12daaa093", "24815546-658b-4b01-ac11-de7fbd0ebd16" ], "package_ndc": [ "65162-512-10", "65162-512-50", "65162-512-11", "65162-513-10", "65162-513-50", "65162-513-11", "69367-615-01", "69367-616-01" ], "unii": [ "V9MO595C9I" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMIN D", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "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": "MULTIVITAMINS", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "CLORAZEPATE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" } ] } }, { "safetyreportversion": "1", "safetyreportid": "10189545", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141212", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140522", "receiptdateformat": "102", "receiptdate": "20140522", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-10004-14053409", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-10004-14053409" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "72", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Tremor", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dizziness", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nausea", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugauthorizationnumb": "205437", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "60 MILLIGRAM", "drugdosageform": "Capsules", "drugadministrationroute": "048", "drugindication": "PSORIATIC ARTHROPATHY", "drugstartdateformat": "102", "drugstartdate": "20140427", "actiondrug": "4", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LYRICA", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "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": "2", "medicinalproduct": "CYMBALTA", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "NDA021427" ], "brand_name": [ "CYMBALTA" ], "generic_name": [ "DULOXETINE HYDROCHLORIDE" ], "manufacturer_name": [ "Eli Lilly and Company" ], "product_ndc": [ "0002-3235", "0002-3240", "0002-3270" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DULOXETINE HYDROCHLORIDE" ], "rxcui": [ "596926", "596928", "596930", "596932", "596934", "615186" ], "spl_id": [ "aa5061b1-f237-425a-9d05-575c333dfd37" ], "spl_set_id": [ "2f7d4d67-10c1-4bf4-a7f2-c185fbad64ba" ], "package_ndc": [ "0002-3235-60", "0002-3240-30", "0002-3240-90", "0002-3270-30" ], "unii": [ "9044SC542W" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PREDNISONE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA215246", "ANDA080292", "ANDA088832", "ANDA083677", "ANDA040584", "ANDA040581", "ANDA040256", "ANDA040392", "ANDA210785", "ANDA080352", "ANDA211495", "ANDA215671", "ANDA219477", "ANDA088703", "ANDA084275", "ANDA208412", "ANDA211496", "ANDA213385", "ANDA215672", "ANDA212629", "ANDA213386", "ANDA211575", "ANDA080356", "ANDA085162", "ANDA085161" ], "brand_name": [ "PREDNISONE", "PREDNISONE DELAYED RELEASE", "PREDNISONE TABLETS, USP, 5 MG", "PREDNISONE TABLETS, USP, 10 MG", "PREDNISONE TABLETS, USP, 20 MG" ], "generic_name": [ "PREDNISONE" ], "manufacturer_name": [ "ANI Pharmaceuticals, Inc.", "Mylan Pharmaceuticals Inc.", "Par Health USA, LLC", "Strides Pharma Science Limited", "Hikma Pharmaceuticals USA Inc.", "Chartwell RX, LLC", "Aurobindo Pharma Limited", "INA Pharmaceutics Inc", "Amneal Pharmaceuticals NY LLC", "Dr. Reddys Laboratories Inc.", "Granulation Technology, Inc.", "Actavis Pharma, Inc." ], "product_ndc": [ "70954-056", "0378-0640", "0378-0641", "0378-0642", "0603-5335", "0603-5336", "0603-5337", "0603-5338", "0603-5339", "64380-782", "0054-9817", "0054-9828", "0054-9818", "62135-471", "59651-484", "74157-010", "74157-019", "0054-0017", "0054-4741", "0054-4742", "0054-4728", "0054-0018", "0054-0019", "0054-3722", "0054-3721", "0054-8739", "0054-8740", "0054-8724", "62135-553", "64380-783", "64380-835", "62135-470", "60219-1705", "60219-1706", "59651-485", "59651-486", "59651-487", "59651-488", "59651-489", "43598-886", "43598-887", "64380-784", "64380-785", "64380-949", "63561-0120", "63561-0121", "63561-0122", "60219-1707", "60219-1708", "70954-057", "70954-058", "70954-059", "70954-060", "70954-061", "0591-5052", "0591-5442", "0591-5443" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PREDNISONE" ], "rxcui": [ "198144", "198145", "312615", "312617", "198146", "763179", "763181", "763183", "763185", "1303125", "1303132", "198148", "205301", "315187" ], "spl_id": [ "08d9d724-eebf-4785-a0ac-95c049bc9488", "f7cba7fb-7b9f-4464-a702-5c4f818aeb5f", "0433f6e3-8d0e-41c4-a3e2-5ff3c555d57e", "675efef2-fa13-42d1-9460-d1e334f78a48", "249c4c6d-a058-489a-8f84-928c14bfd3f9", "45ae68aa-b969-3d1b-e063-6394a90a0a02", "6f9a9020-efd5-4f7d-90c7-11af33e93793", "463c5b39-7eb2-d396-e063-6394a90aa451", "523ad364-8d95-4679-9290-446d61f36eb5", "04b754a5-5740-f71c-e063-6294a90aef67", "c389b525-c68a-43dc-bacc-c75707b391b5", "45ae6dea-506e-55d8-e063-6394a90a0a4c", "abdf7308-9460-4e7f-a68a-2fe647e82602", "d957f055-4838-49e6-ae32-604fb3056bc4", "a9e0d98c-c1bf-62b0-67b3-3b8f8313b408", "bdf0b63b-7d6e-4799-be31-cdbf94e02145", "3c696af0-7946-dd78-e063-6394a90a71cc", "34381f6f-1b15-42c8-a8e6-af8302eb6c1e", "f662b658-7133-468c-b35a-ed6083cbff91", "6e6cf2e7-c839-4c9f-a58a-fea5023fb432" ], "spl_set_id": [ "7335a293-992b-490c-ab8a-66a7ca1eea30", "fec09050-5ac2-451b-a2b9-5a21b2def212", "10fe5a3b-84dc-4600-87c2-b80c97ce18cf", "a2c2e8ee-d222-47c5-93c2-8b44160a7e48", "263ed4fa-3c29-4abb-9cb1-bc016bd34a05", "36631112-3abb-4003-886b-9fe6d9cbe2cc", "7b33767f-a520-4470-8f3f-4e86b38d615a", "463c7cd2-c973-5c6c-e063-6394a90a09a0", "3115aef0-fd50-4ec8-a064-3effb695f3f2", "92483276-d55c-42c6-8bbc-27137ff25296", "52010a34-aadb-4561-ac4a-3ee53f5e3566", "f532c919-765d-407a-9e01-db2dc0c006f5", "0740ef68-7641-432e-bd46-4710687fc9d7", "b1ac4c92-e1fd-4015-b172-0932790ae019", "01bdc479-1f1f-af94-837c-12e7e861321a", "2ef05381-faad-4e0f-b58d-9f2236a04a2c", "a173fcbb-99be-4b3e-a3a4-4e9ae04ad83f", "03228706-92b9-43c9-8d73-c73aa124c58d", "f05eb734-07e7-491c-b2e9-aae340e03750", "aa0b1582-6ef3-4697-9ea6-5391e6e57853" ], "package_ndc": [ "70954-056-10", "70954-056-20", "0378-0640-01", "0378-0640-10", "0378-0641-01", "0378-0641-10", "0378-0642-01", "0378-0642-05", "0378-0642-10", "0603-5335-21", "0603-5335-32", "0603-5336-21", "0603-5337-21", "0603-5337-32", "0603-5337-15", "0603-5337-31", "0603-5338-21", "0603-5338-28", "0603-5338-32", "0603-5338-15", "0603-5338-31", "0603-5339-21", "0603-5339-28", "0603-5339-32", "64380-782-06", "0054-9828-25", "0054-9828-31", "0054-9817-25", "0054-9817-29", "0054-9818-25", "0054-9818-29", "62135-471-90", "62135-471-18", "59651-484-01", "59651-484-99", "59651-484-78", "74157-010-30", "74157-019-30", "0054-4741-25", "0054-4741-31", "0054-4742-25", "0054-4728-25", "0054-4728-31", "0054-0017-25", "0054-0017-29", "0054-0017-20", "0054-0018-25", "0054-0018-29", "0054-0018-20", "0054-0019-20", "0054-0019-25", "0054-3722-63", "0054-3722-50", "0054-3721-44", "0054-8739-25", "0054-8740-25", "0054-8724-25", "62135-553-30", "62135-553-90", "64380-835-01", "64380-835-06", "64380-783-06", "64380-783-08", "64380-783-01", "62135-470-90", "62135-470-18", "60219-1705-1", "60219-1706-1", "60219-1706-7", "60219-1706-2", "60219-1706-3", "59651-485-01", "59651-485-78", "59651-486-01", "59651-486-99", "59651-486-78", "59651-487-01", "59651-487-05", "59651-487-78", "59651-488-01", "59651-488-05", "59651-488-78", "59651-489-01", "59651-489-78", "43598-886-01", "43598-886-30", "43598-887-01", "43598-887-30", "64380-784-01", "64380-784-07", "64380-784-08", "64380-784-06", "64380-785-06", "64380-785-07", "64380-785-08", "64380-785-01", "64380-949-06", "64380-949-01", "63561-0120-1", "63561-0120-2", "63561-0120-5", "63561-0121-1", "63561-0121-2", "63561-0121-5", "63561-0122-1", "63561-0122-2", "63561-0122-5", "60219-1707-1", "60219-1707-5", "60219-1707-2", "60219-1707-3", "60219-1708-1", "60219-1708-5", "70954-057-10", "70954-058-10", "70954-058-20", "70954-058-30", "70954-058-40", "70954-059-10", "70954-059-20", "70954-059-30", "70954-059-40", "70954-060-10", "70954-060-20", "70954-060-30", "70954-061-10", "0591-5052-01", "0591-5052-10", "0591-5052-21", "0591-5052-43", "0591-5442-01", "0591-5442-05", "0591-5442-10", "0591-5442-21", "0591-5442-43", "0591-5443-01", "0591-5443-05", "0591-5443-10" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "VB0R961HZT" ] } }, { "drugcharacterization": "2", "medicinalproduct": "FLOMAX", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" }, { "drugcharacterization": "2", "medicinalproduct": "WARFARIN", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA090935", "ANDA202202" ], "brand_name": [ "WARFARIN SODIUM" ], "generic_name": [ "WARFARIN" ], "manufacturer_name": [ "Exelan Pharmaceuticals Inc.", "Amneal Pharmaceuticals LLC" ], "product_ndc": [ "76282-327", "76282-328", "76282-329", "76282-330", "76282-331", "76282-332", "76282-333", "76282-334", "76282-335", "65162-761", "65162-762", "65162-763", "65162-764", "65162-765", "65162-766", "65162-767", "65162-768", "65162-769" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "WARFARIN SODIUM" ], "rxcui": [ "855288", "855296", "855302", "855312", "855318", "855324", "855332", "855338", "855344" ], "spl_id": [ "45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5", "caa13d7d-5a78-412c-8e5e-e03a51164e96" ], "spl_set_id": [ "c0cc4511-e656-4b6d-96cd-e02e76173b9d", "558b7a0d-5490-4c1b-802e-3ab3f1efe760" ], "package_ndc": [ "76282-327-01", "76282-327-10", "76282-328-01", "76282-328-10", "76282-329-01", "76282-329-10", "76282-330-01", "76282-330-10", "76282-331-01", "76282-331-10", "76282-332-01", "76282-332-10", "76282-333-01", "76282-333-10", "76282-334-01", "76282-335-01", "65162-761-10", "65162-761-50", "65162-761-11", "65162-762-10", "65162-762-50", "65162-762-11", "65162-763-10", "65162-763-50", "65162-763-11", "65162-764-10", "65162-764-50", "65162-764-11", "65162-765-10", "65162-765-50", "65162-765-11", "65162-766-10", "65162-766-50", "65162-766-11", "65162-767-10", "65162-767-50", "65162-767-11", "65162-768-10", "65162-768-50", "65162-768-11", "65162-769-10", "65162-769-50", "65162-769-11" ], "unii": [ "6153CWM0CL" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LISINOPRIL", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA212041", "ANDA208920", "ANDA077321", "NDA208401", "ANDA076102", "ANDA076164", "ANDA075903", "ANDA076059", "ANDA075743", "ANDA203508", "NDA019777", "ANDA077622" ], "brand_name": [ "LISINOPRIL", "QBRELIS", "ZESTRIL" ], "generic_name": [ "LISINOPRIL" ], "manufacturer_name": [ "Chartwell RX, LLC", "Quallent Pharmaceuticals Health LLC", "Azurity Pharmaceuticals, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)", "Solco healthcare U.S., LLC", "Camber Pharmaceuticals, Inc.", "Actavis Pharma, Inc.", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Exelan Pharmaceuticals, Inc", "BluePoint Laboratories", "Exelan Pharmaceuticals Inc.", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited" ], "product_ndc": [ "62135-640", "62135-641", "62135-642", "62135-643", "62135-644", "62135-645", "82009-062", "82009-063", "82009-064", "82009-065", "82009-066", "52652-3001", "23155-876", "23155-877", "23155-878", "23155-879", "23155-880", "23155-881", "43547-351", "43547-352", "43547-353", "43547-354", "43547-355", "43547-356", "31722-172", "31722-176", "31722-177", "31722-178", "31722-179", "31722-180", "0591-0409", "0591-0405", "0591-0406", "0591-0407", "0591-0408", "0591-0885", "68180-512", "68180-513", "68180-517", "68180-980", "68180-981", "68180-982", "68180-979", "68180-514", "68180-515", "68180-516", "72865-208", "72865-209", "72865-210", "72865-211", "72865-212", "72865-213", "76282-728", "76282-729", "76282-730", "76282-731", "76282-732", "76282-733", "68001-332", "68001-337", "68001-333", "68001-486", "68001-334", "68001-335", "68001-336", "43547-414", "43547-415", "43547-416", "43547-417", "43547-418", "43547-419", "76282-417", "76282-418", "76282-419", "76282-420", "76282-421", "76282-422", "24979-238", "24979-239", "24979-240", "24979-241", "24979-242", "24979-243", "65862-037", "65862-038", "65862-039", "65862-040", "65862-041", "65862-042" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LISINOPRIL" ], "rxcui": [ "197884", "205326", "311353", "311354", "314076", "314077", "1806884", "1806890", "104375", "104376", "104377", "104378", "206771", "213482" ], "spl_id": [ "462a5023-e5a0-692a-e063-6294a90a7236", "d2b42923-6e5f-47a1-9b31-4d019142a102", "461e97d5-c8b3-75a7-e063-6394a90a6ec6", "cb748971-2531-4478-8dff-e01cd87dec09", "61b942b0-3ad3-49d4-8321-c3b01f0d7ce1", "cfe12692-404c-ae05-e053-2995a90aa182", "01764c1d-aebe-4a46-920c-4b5f8cca8acb", "6723a96d-02f8-40c2-95ec-89a7053a7117", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "c3c02066-1571-4291-ae9a-fd50a43486ad", "c5fac2c4-de1f-49d3-e053-2a95a90a5285", "1ed80b02-cb3b-41c5-ab33-ff0106b8792d", "3e79fbc7-ef6e-4f2f-99a3-7ae3c1e1eec7", "7875efff-59e3-4f68-84c5-e3c9c16d6a3c", "99502ee9-cea6-473a-91c1-e4b4ded719e2", "337644b9-adae-41c1-9a9c-8d879ab355d2" ], "spl_set_id": [ "8824e5e5-ed35-4a95-bfd6-98a2e7c4bbce", "f2e09150-22f2-4028-b214-917d686200ad", "9f6e4e57-a489-4b36-b093-b93865d3717c", "c6c55efa-36bd-4613-98ca-2eb589a31e53", "e299d477-a612-4af4-b6aa-f5addc8a736d", "8f20acd7-2635-4a9b-b732-2a84ea93dea7", "43e2c8d1-3704-4323-bcaf-f582572b81f7", "7d6c31e2-b5a4-4279-8013-a8dad37ea73b", "c008ecb6-970d-4ac9-9402-e21e8d9d76b2", "4aad4d30-3e18-489c-80ad-ccf7532bb933", "34ebeea1-6812-4697-84c4-b2ae4f39e55f", "f8d16c85-50e2-4d99-afae-6fb902734e42", "1bc69836-a659-4e3b-84a7-a00b7c4dc268", "838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8", "0e6364a4-6d66-4151-8197-d45e2a762895", "387068e7-7fb9-44f3-ae1c-e45ebc755a3e" ], "package_ndc": [ "62135-640-31", "62135-640-90", "62135-641-31", "62135-641-90", "62135-642-31", "62135-642-90", "62135-643-31", "62135-643-90", "62135-644-31", "62135-644-90", "62135-645-31", "62135-645-90", "82009-062-05", "82009-063-10", "82009-064-10", "82009-065-10", "82009-066-10", "52652-3001-1", "23155-876-01", "23155-876-05", "23155-877-01", "23155-877-10", "23155-878-01", "23155-878-10", "23155-879-01", "23155-879-10", "23155-880-01", "23155-880-05", "23155-881-01", "23155-881-10", "43547-351-50", "43547-351-10", "43547-351-03", "43547-352-11", "43547-352-10", "43547-353-11", "43547-353-10", "43547-353-03", "43547-354-11", "43547-354-10", "43547-354-03", "43547-355-11", "43547-355-10", "43547-355-03", "43547-355-50", "43547-356-11", "43547-356-10", "31722-172-01", "31722-172-05", "31722-176-01", "31722-176-10", "31722-177-01", "31722-177-10", "31722-178-01", "31722-178-10", "31722-179-01", "31722-179-05", "31722-180-01", "31722-180-10", "0591-0405-01", "0591-0405-05", "0591-0406-01", "0591-0406-10", "0591-0407-01", "0591-0407-10", "0591-0408-01", "0591-0408-10", "0591-0885-01", "0591-0409-01", "0591-0409-05", "68180-512-02", "68180-512-30", "68180-512-09", "68180-512-01", "68180-512-03", "68180-513-30", "68180-513-03", "68180-513-01", "68180-513-09", "68180-513-02", "68180-513-05", "68180-517-03", "68180-517-01", "68180-517-30", "68180-517-09", "68180-517-04", "68180-517-02", "68180-980-03", "68180-980-30", "68180-980-01", "68180-980-09", "68180-980-05", "68180-980-02", "68180-981-01", "68180-981-03", "68180-981-30", "68180-981-09", "68180-981-02", "68180-981-05", "68180-982-01", "68180-982-02", "68180-982-30", "68180-982-03", "68180-982-09", "68180-979-01", "68180-979-03", "68180-979-30", "68180-979-09", "68180-514-01", "68180-514-02", "68180-514-03", "68180-514-09", "68180-514-30", "68180-514-05", "68180-515-01", "68180-515-02", "68180-515-03", "68180-515-09", "68180-515-30", "68180-515-05", "68180-516-01", "68180-516-02", "68180-516-03", "68180-516-09", "68180-516-30", "72865-208-01", "72865-208-05", "72865-209-45", "72865-209-90", "72865-209-01", "72865-209-10", "72865-210-45", "72865-210-90", "72865-210-01", "72865-210-10", "72865-210-50", "72865-211-45", "72865-211-90", "72865-211-01", "72865-211-18", "72865-211-10", "72865-211-50", "72865-212-01", "72865-212-05", "72865-213-45", "72865-213-90", "72865-213-01", "72865-213-18", "72865-213-10", "76282-728-30", "76282-728-45", "76282-728-90", "76282-728-01", "76282-728-18", "76282-728-05", "76282-728-10", "76282-729-30", "76282-729-45", "76282-729-90", "76282-729-01", "76282-729-18", "76282-729-05", "76282-729-10", "76282-730-30", "76282-730-45", "76282-730-90", "76282-730-01", "76282-730-18", "76282-730-05", "76282-730-10", "76282-730-50", "76282-731-30", "76282-731-45", "76282-731-90", "76282-731-01", "76282-731-18", "76282-731-05", "76282-731-10", "76282-731-50", "76282-732-30", "76282-732-45", "76282-732-90", "76282-732-01", "76282-732-18", "76282-732-05", "76282-732-10", "76282-733-30", "76282-733-45", "76282-733-90", "76282-733-01", "76282-733-18", "76282-733-05", "76282-733-10", "68001-337-00", "68001-337-08", "68001-332-00", "68001-332-03", "68001-333-00", "68001-333-08", "68001-486-00", "68001-486-08", "68001-334-00", "68001-334-08", "68001-335-00", "68001-335-08", "68001-336-00", "43547-414-10", "43547-414-50", "43547-415-03", "43547-415-04", "43547-415-09", "43547-415-10", "43547-415-50", "43547-415-11", "43547-415-25", "43547-416-04", "43547-416-09", "43547-416-10", "43547-416-50", "43547-416-11", "43547-416-15", "43547-417-04", "43547-417-09", "43547-417-10", "43547-417-50", "43547-417-11", "43547-417-15", "43547-418-10", "43547-418-50", "43547-419-04", "43547-419-09", "43547-419-10", "43547-419-18", "43547-419-50", "43547-419-11", "43547-419-15", "43547-419-25", "76282-417-30", "76282-417-45", "76282-417-90", "76282-417-01", "76282-417-18", "76282-417-05", "76282-417-10", "76282-418-30", "76282-418-45", "76282-418-90", "76282-418-01", "76282-418-18", "76282-418-05", "76282-418-10", "76282-419-30", "76282-419-45", "76282-419-90", "76282-419-01", "76282-419-18", "76282-419-05", "76282-419-10", "76282-419-50", "76282-420-30", "76282-420-45", "76282-420-90", "76282-420-01", "76282-420-18", "76282-420-05", "76282-420-10", "76282-420-50", "76282-421-30", "76282-421-45", "76282-421-90", "76282-421-01", "76282-421-18", "76282-421-05", "76282-421-10", "76282-422-30", "76282-422-45", "76282-422-90", "76282-422-01", "76282-422-18", "76282-422-05", "76282-422-10", "24979-238-07", "24979-239-07", "24979-240-07", "24979-241-07", "24979-242-07", "24979-243-07", "65862-037-30", "65862-037-01", "65862-037-00", "65862-037-05", "65862-037-99", "65862-038-30", "65862-038-01", "65862-038-00", "65862-038-05", "65862-038-99", "65862-039-30", "65862-039-01", "65862-039-00", "65862-039-05", "65862-039-99", "65862-040-30", "65862-040-01", "65862-040-00", "65862-040-05", "65862-040-99", "65862-041-30", "65862-041-01", "65862-041-00", "65862-041-05", "65862-041-99", "65862-042-30", "65862-042-01", "65862-042-00", "65862-042-05", "65862-042-99", "31722-172-31", "31722-176-31", "31722-177-31", "31722-178-31", "31722-179-31", "31722-180-31" ], "unii": [ "E7199S1YWR" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OXYCODONE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "openfda": { "application_number": [ "ANDA203638", "NDA208090" ], "brand_name": [ "OXYCODONE HYDROCHLORIDE", "XTAMPZA ER" ], "generic_name": [ "OXYCODONE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC", "Collegium Pharmaceutical, Inc." ], "product_ndc": [ "65162-047", "65162-048", "65162-049", "65162-050", "65162-051", "24510-110", "24510-115", "24510-120", "24510-130", "24510-140" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OXYCODONE HYDROCHLORIDE", "OXYCODONE" ], "rxcui": [ "1049611", "1049618", "1049621", "1049683", "1049686", "1790527", "1790533", "1791558", "1791560", "1791567", "1791569", "1791574", "1791576", "1791580", "1791582" ], "spl_id": [ "4fb6c994-cbd3-4d0d-bdae-505cb8082e61", "fda0989d-9319-4e35-af83-fca1ec66878e" ], "spl_set_id": [ "094b64b3-cd32-4de5-afb6-ea00d9caad74", "b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c" ], "package_ndc": [ "65162-047-03", "65162-047-10", "65162-047-25", "65162-047-50", "65162-048-03", "65162-048-10", "65162-048-25", "65162-049-03", "65162-049-10", "65162-049-25", "65162-049-50", "65162-050-03", "65162-050-10", "65162-050-25", "65162-051-03", "65162-051-10", "65162-051-25", "65162-051-50", "24510-110-10", "24510-110-20", "24510-115-10", "24510-115-20", "24510-120-10", "24510-120-20", "24510-130-10", "24510-130-20", "24510-140-10", "24510-140-20" ], "unii": [ "C1ENJ2TE6C", "CD35PMG570" ], "nui": [ "N0000175684", "N0000175690" ], "pharm_class_moa": [ "Full Opioid Agonists [MoA]" ], "pharm_class_epc": [ "Opioid Agonist [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "IMMUNE GLOBULIN", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION" } ] } }, { "safetyreportversion": "2", "safetyreportid": "10196182", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140527", "receiptdateformat": "102", "receiptdate": "20140715", "fulfillexpeditecriteria": "1", "companynumb": "US-CELGENEUS-163-10004-14053415", "duplicate": "1", "reportduplicate": { "duplicatesource": "CELGENE", "duplicatenumb": "US-CELGENEUS-163-10004-14053415" }, "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "67", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Lethargy", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Headache", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OTEZLA", "drugbatchnumb": "NSCN", "drugauthorizationnumb": "205437", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "60 MILLIGRAM", "drugdosageform": "Capsules", "drugadministrationroute": "048", "drugindication": "PSORIATIC ARTHROPATHY", "drugstartdateformat": "102", "drugstartdate": "20140513", "drugenddateformat": "102", "drugenddate": "20140707", "actiondrug": "5", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "APREMILAST" }, "openfda": { "application_number": [ "NDA205437" ], "brand_name": [ "OTEZLA" ], "generic_name": [ "APREMILAST" ], "manufacturer_name": [ "Amgen, Inc" ], "product_ndc": [ "55513-137", "55513-369", "55513-485", "55513-497", "55513-508", "55513-996", "55513-519", "55513-516" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APREMILAST" ], "rxcui": [ "1492732", "1492738", "1492740", "1492742", "1492744", "1492746", "1492747", "1492748", "1605454", "1605455", "2682429", "2682430", "2682431", "2682432", "2723448", "2723452", "2724366", "2724367" ], "spl_id": [ "d869faaf-a5ad-4b12-b427-06587d17787e" ], "spl_set_id": [ "f6b1f516-4972-4d82-bced-113e47b41cc5" ], "package_ndc": [ "55513-137-60", "55513-137-95", "55513-369-55", "55513-485-95", "55513-485-96", "55513-497-60", "55513-508-55", "55513-518-04", "55513-497-51", "55513-996-96", "55513-996-95", "55513-497-23", "55513-519-30", "55513-516-41" ], "nui": [ "N0000182961", "N0000182960" ], "pharm_class_epc": [ "Phosphodiesterase 4 Inhibitor [EPC]" ], "pharm_class_moa": [ "Phosphodiesterase 4 Inhibitors [MoA]" ], "unii": [ "UP7QBP99PN" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2014" } } } ] }