{ "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": 1, "total": 1 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "16755431", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20191005", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20190829", "receiptdateformat": "102", "receiptdate": "20190829", "fulfillexpeditecriteria": "1", "authoritynumb": "E2B-02498571, E2B_02169963", "companynumb": "CA-MERZ NORTH AMERICA, INC.-19MRZ-00337", "duplicate": "1", "reportduplicate": { "duplicatesource": "MERZ", "duplicatenumb": "CA-MERZ NORTH AMERICA, INC.-19MRZ-00337" }, "primarysource": { "reportercountry": "COUNTRY NOT SPECIFIED", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "reaction": [ { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "22.0", "reactionmeddrapt": "Drug dependence", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CODEINE", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "CODEINE" } }, { "drugcharacterization": "1", "medicinalproduct": "OXYCONTIN", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "OXYCODONE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA022272" ], "brand_name": [ "OXYCONTIN" ], "generic_name": [ "OXYCODONE HYDROCHLORIDE" ], "manufacturer_name": [ "Knoa Pharma LLC" ], "product_ndc": [ "59011-410", "59011-415", "59011-420", "59011-430", "59011-440", "59011-460", "59011-480" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OXYCODONE HYDROCHLORIDE" ], "rxcui": [ "1049504", "1049545", "1049565", "1049576", "1049586", "1049595", "1049601", "1860127", "1860129", "1860137", "1860148", "1860151", "1860154", "1860157" ], "spl_id": [ "47b30347-ae1d-4b54-8ccd-594eb7bdbd75" ], "spl_set_id": [ "bfdfe235-d717-4855-a3c8-a13d26dadede" ], "package_ndc": [ "59011-410-10", "59011-410-20", "59011-415-10", "59011-415-20", "59011-420-10", "59011-420-20", "59011-430-10", "59011-430-20", "59011-440-10", "59011-440-20", "59011-460-10", "59011-460-20", "59011-480-20", "59011-480-10" ], "unii": [ "C1ENJ2TE6C" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CAFFEINE.", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "CAFFEINE" }, "openfda": { "application_number": [ "M011", "505G(a)(3)", "M027", "part340" ], "brand_name": [ "STAY AWAKE", "FEELSHION 6% CAFFEINE 1% RETINOL EYE CREAM", "ALERT ALERTNESS AID", "CAFFEINE 1508", "ALERT", "ALERT AID", "JET ALERT REGULAR STRENGTH", "VIVARIN", "UPLIFT CHEWABLE", "CAFFEINE", "AWAKE MAXIMUM STRENGTH", "STAY AWAKE MAXIMUM STRENGTH", "DIUREX ULTIMATE", "DIUREX ULTRA", "TOPCARE STAY AWAKE MAXIMUM STRENGTH", "EARTHMED UPLIFT CHEWABLE ORANGE", "EARTHMED UPLIFT CHEWABLE STRAWBERRY", "EARTHMED UPLIFT CHEWABLE WATERMELON", "EARTHMED UPLIFT CHEWABLE CHERRY" ], "generic_name": [ "CAFFEINE" ], "manufacturer_name": [ "DISCOUNT DRUG MART", "AAA Pharmaceutical, Inc.", "Beijing JUNGE Technology Co., Ltd.", "L.N.K. International, Inc.", "Professional Complementary Health Formulas", "United Natural Foods, Inc. dba UNFI", "DOLGENCORP, LLC", "Strategic Sourcing Services LLC", "Amerisource Bergen", "Bell Pharmaceuticals, Inc", "Vespyr Brands LLC", "Marc Glassman, Inc.", "Geiss, Destin & Dunn Inc.", "Carolina Cannabis Creations LLC", "Aurohealth LLC", "Allegiant Health", "Walgreen Company", "LEADER/ Cardinal Health 110, Inc.", "Better Living Brands, LLC", "Harris Teeter", "Kroger Company", "PUBLIX SUPER MARKETS INC", "ARMY AND AIR FORCE EXCHANGE SERVICE", "CVS Pharmacy, Inc.", "Kobayashi Healthcare International, Inc.", "VALU MERCHANDISERS COMPANY", "Wal-Mart Stores Inc", "Topco Associates, LLC", "Time Cap Labs, Inc", "Rite Aid Corporation", "Salado Sales, Inc.", "RETAIL BUSINESS SERVICES , LLC.", "Shield Pharmaceuticals Corp", "TopCo Associates, LLC", "KROGER COMPANY", "Earthmed LLC", "CHAIN DRUG MARKETING ASSOCIATION INC" ], "product_ndc": [ "53943-320", "57344-220", "85212-0021", "50844-226", "63083-1508", "41163-226", "55910-226", "70677-1126", "46122-457", "15579-201", "71179-018", "68998-076", "50804-262", "82876-833", "58602-747", "69168-076", "0363-3440", "70000-0409", "21130-226", "72036-020", "82876-831", "30142-726", "56062-030", "21130-944", "55301-226", "69842-500", "52389-656", "52389-155", "63941-020", "0363-5009", "49035-226", "36800-844", "82876-832", "49483-343", "11822-2260", "57243-226", "72476-102", "41163-434", "83059-0097", "76162-002", "30142-284", "69842-509", "82876-977", "82876-978", "82876-980", "82876-979", "82876-830", "63868-114" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL", "EXTRACORPOREAL" ], "substance_name": [ "CAFFEINE" ], "rxcui": [ "198520", "308853", "1595393", "209754" ], "spl_id": [ "249d8323-64c9-0a0a-e063-6394a90a1d70", "1acb92f2-304e-30bb-e063-6394a90ac9e1", "2f6a1684-c7ba-9298-e063-6294a90adf13", "7cfe988f-eb9c-4ad9-b601-da533ac80e4f", "4d47dca4-36cb-459e-b812-8454079ca871", "b437cc48-0b5c-4d6d-a5bc-e8c980868eca", "7b0804c8-0e96-47e5-9060-4d5bc717799b", "66ecf57a-99be-4ee6-807c-6ae27d5e1f0f", "ef1f727a-99af-4322-9faf-6fd985531c4d", "0c86777f-3cf7-5e1d-e063-6294a90a2369", "51434ef1-f498-b938-e063-6294a90aa262", "d7ab9f11-858d-41fb-b64f-614a194703c2", "c53e2f19-7447-4370-b9dc-8c261d087f96", "2bcaad44-2492-020e-e063-6294a90a955b", "2dbf82e7-8f3a-47fb-8045-9136f4b9ae49", "548c1927-d2e5-460c-bb6e-3315f97d2d5f", "c0167c00-8424-4232-b459-306dee8bb91a", "497945c6-ed39-4111-e063-6394a90a3cf3", "8ea1326b-c73b-414c-9e92-7146585de29b", "251277d1-53b9-e2da-e063-6394a90ad513", "2bca3c4b-7fc5-7ded-e063-6294a90ae46d", "4aaef558-2517-4e1a-b15e-2fb47859eb48", "253da9fc-016c-4c4a-e063-6294a90ab864", "726d6827-f32d-447a-b61b-37e9ab4c9550", "1b3a82f6-8682-4ff0-994d-25a3866d86df", "414cc89c-3d0a-1162-e063-6294a90a6902", "53c43c3f-7dd9-4887-e063-6294a90a0db4", "32c05c2a-5010-0362-e063-6394a90af7cf", "45b0aad8-2c51-0298-e063-6394a90a1e45", "289e6ff9-4f6f-ed2a-e063-6394a90a8cd1", "3700aa04-b831-409f-828b-2ee62a219558", "40e82efd-a4c9-4b38-965a-0178f507503d", "2bcab022-6b18-2e20-e063-6294a90ad527", "7d3e5e3c-3199-5637-e053-2991aa0a0d27", "86541d08-a427-4d20-b203-9b97f555c2f3", "51685540-d721-4c16-a810-66ff7151b2c6", "24892182-997a-5f67-e063-6394a90ac5e4", "ca7154ee-94cf-4299-9c6b-0c42a504ea96", "521f2fa3-8120-45ab-e063-6294a90a73dd", "64df3a52-8279-458b-9d0d-4f600dc8b879", "8f7569c7-8007-469d-b6b0-0a9e8e6fbb38", "4b987a78-00ba-74d6-e063-6394a90abcde", "43958e94-2a12-c342-e063-6294a90a7717", "2bca63e0-b51c-0d2e-e063-6394a90aa1d3", "de2c7249-8ef8-433f-bcf6-ae651bee42bc" ], "spl_set_id": [ "c264a28b-424b-44f0-ac80-62849dbaf0ed", "14967dc9-d223-d954-e063-6394a90aa676", "2f6a1684-c7b9-9298-e063-6294a90adf13", "4bd13171-78a7-44bb-a6d6-94c6de1f945d", "970ce7be-a373-45db-b35f-f150a49d1fba", "15e4d040-ed21-46e7-98c6-56267f388f57", "9e47eed8-4d0f-4a26-b761-578fb593f025", "49f408a8-b182-4172-84aa-390bff31d5d5", "7f80346e-fe30-4a22-aa42-193c5fad93a2", "cd7366f9-6ee9-4f1d-bfd2-3ce067f59b2d", "4537a56b-e875-4961-9fff-3f778746f126", "fda5b0a8-2c85-4a8b-97ab-777682c816e2", "a4c796a8-6685-4214-bf08-10ee2735ea12", "04a71dd1-19ae-d1cd-e063-6294a90a4fc0", "2dbf82e7-8f3a-47fb-8045-9136f4b9ae49", "959b50a1-3037-4f94-8bc5-651501815092", "899acc4f-4d50-41d0-bcf2-9937d58aa923", "7c4d61f7-9c6a-61ac-e053-2991aa0a9533", "976780f9-228c-44cb-b1f4-8027280fc7cb", "b30a226a-790f-46a7-a418-623d5ee30247", "04a72aec-0e60-5d16-e063-6294a90a3c49", "00cc94fa-23b7-4148-87a3-669111267522", "aaf84add-6afd-f1d9-e053-2995a90a6075", "ce4da457-805f-4d2a-8667-6516eea85221", "44d60bfb-4320-4f5b-8a22-9a984805ddaf", "6de63f21-c3b4-0c2f-e053-2991aa0a7886", "c6debbfe-6061-463f-8f17-fb240c6f1bab", "9a035265-40c6-43f5-8de6-6bece8449840", "b2ae7941-5711-4046-b715-bc77cc04becb", "c2c7768a-6f9d-d8fe-e053-2995a90a491c", "5f5b65a2-4db7-4c8e-a954-95611a087217", "e8961b01-d692-40e7-a52f-2d81a21f06c5", "04a75f6a-a68e-8a0f-e063-6294a90a68c3", "d221f66d-06bb-44e8-a01b-f5919f5c52d2", "e33e353c-3af4-4e91-bd76-fa09860fee43", "2bb2176f-baae-4314-af6a-9150da7017a5", "9f953ea7-2e15-2d67-e053-2a95a90a96ba", "1357eade-f1d3-4df2-8a8a-4c318aab1141", "82c582ce-1360-4c4f-b9a7-a5a43cf5fd2c", "2223cf52-c172-462d-aacc-b069849b7441", "167374f6-747b-cd6f-e063-6294a90a06f2", "6d9b3926-7198-5e00-e053-2a91aa0a9580", "43958b2a-c2cd-bbf9-e063-6294a90a66d9", "01e352a7-24f3-d380-e063-6394a90acc5e", "5a75ff5b-78d5-4ab4-b648-f1a9511efd30" ], "package_ndc": [ "53943-320-02", "57344-220-02", "85212-0021-1", "50844-226-12", "50844-226-21", "63083-1508-1", "41163-226-10", "55910-226-21", "55910-226-31", "70677-1126-1", "46122-457-73", "15579-201-20", "15579-201-09", "15579-201-35", "71179-018-16", "71179-018-40", "71179-018-60", "71179-018-24", "68998-076-84", "50804-262-21", "50804-262-10", "82876-833-20", "58602-747-47", "69168-076-84", "69168-076-40", "0363-3440-11", "70000-0409-1", "21130-226-10", "72036-020-02", "82876-831-20", "30142-726-10", "56062-030-01", "21130-944-11", "55301-226-10", "69842-500-11", "52389-656-01", "52389-656-60", "52389-155-80", "52389-155-90", "52389-155-02", "63941-020-01", "0363-5009-01", "49035-226-31", "36800-844-11", "82876-832-20", "49483-343-44", "11822-2260-2", "11822-2260-1", "57243-226-21", "72476-102-01", "41163-434-11", "83059-0097-3", "76162-002-84", "76162-002-58", "30142-284-40", "69842-509-10", "69842-509-21", "69842-509-31", "82876-977-20", "82876-978-20", "82876-980-20", "82876-979-20", "82876-830-20", "63868-114-16", "63868-114-40" ], "nui": [ "N0000175739", "N0000175729", "N0000175790", "M0023046" ], "pharm_class_epc": [ "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]" ], "pharm_class_pe": [ "Central Nervous System Stimulation [PE]" ], "pharm_class_cs": [ "Xanthines [CS]" ], "unii": [ "3G6A5W338E" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CELEBREX", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "CELECOXIB" }, "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": "1", "medicinalproduct": "CESAMET", "drugdosagetext": "2 CAPSULES DAILY", "drugdosageform": "CAPSULES", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "NABILONE" }, "openfda": { "application_number": [ "NDA018677" ], "brand_name": [ "CESAMET" ], "generic_name": [ "NABILONE" ], "manufacturer_name": [ "Bausch Health US LLC" ], "product_ndc": [ "0187-1231" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NABILONE" ], "rxcui": [ "104885", "311891" ], "spl_id": [ "c8ba6520-445a-4934-85f4-6f706cb21585" ], "spl_set_id": [ "83c7ac15-ece9-47de-b83c-d575544fa449" ], "package_ndc": [ "0187-1231-50" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "2N4O9L084N" ] } }, { "drugcharacterization": "1", "medicinalproduct": "XEOMIN", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "125360", "drugdosagetext": "UNKNOWN", "drugdosageform": "INJECTION", "drugindication": "PAIN", "actiondrug": "6", "activesubstance": { "activesubstancename": "INCOBOTULINUMTOXINA" }, "openfda": { "application_number": [ "BLA125360" ], "brand_name": [ "XEOMIN" ], "generic_name": [ "INCOBOTULINUMTOXINA" ], "manufacturer_name": [ "Merz Pharmaceuticals, LLC", "Merz North America, Inc." ], "product_ndc": [ "0259-1605", "0259-1610", "0259-4150", "0259-4110", "0259-1620", "46783-160", "46783-161", "46783-165" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR" ], "substance_name": [ "BOTULINUM TOXIN TYPE A" ], "rxcui": [ "1000107", "1009456", "1009459", "1732157", "1732161", "1732165" ], "spl_id": [ "75c52aa4-0780-4e18-bac3-ba1440a74dee", "8b2d961a-6bb4-4bef-ac07-7dcc2bbfacc7" ], "spl_set_id": [ "ccdc3aae-6e2d-4cd0-a51c-8375bfee9458", "3f35d6e0-3450-4abc-a0da-cc7b277e7c6e" ], "package_ndc": [ "0259-1605-01", "0259-1610-01", "0259-4150-01", "0259-4110-01", "0259-1620-01", "0259-1620-10", "46783-161-01", "46783-160-01", "46783-160-10", "46783-165-01" ], "nui": [ "N0000175771", "N0000193962", "N0000175731", "N0000175770" ], "pharm_class_epc": [ "Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]" ], "pharm_class_pe": [ "Neuromuscular Blockade [PE]" ], "pharm_class_moa": [ "Acetylcholine Release Inhibitors [MoA]" ], "unii": [ "E211KPY694" ] } }, { "drugcharacterization": "1", "medicinalproduct": "AMITRIPTYLINE", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "AMITRIPTYLINE" } }, { "drugcharacterization": "1", "medicinalproduct": "TEGRETOL", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "CARBAMAZEPINE" }, "openfda": { "application_number": [ "NDA018927", "NDA016608", "NDA020234" ], "brand_name": [ "TEGRETOL", "TEGRETOL XR" ], "generic_name": [ "CARBAMAZEPINE" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0508", "0078-0509", "0078-0510", "0078-0511", "0078-0512" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CARBAMAZEPINE" ], "rxcui": [ "199378", "308971", "308972", "308976", "308979", "402505", "402506", "866303", "866305", "866307" ], "spl_id": [ "ac037b7c-7ff9-415e-9870-963f9bbf79a7" ], "spl_set_id": [ "8d409411-aa9f-4f3a-a52c-fbcb0c3ec053" ], "package_ndc": [ "0078-0508-83", "0078-0509-05", "0078-0509-20", "0078-0510-05", "0078-0511-05", "0078-0512-05" ], "nui": [ "N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "pharm_class_epc": [ "Mood Stabilizer [EPC]" ], "pharm_class_moa": [ "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]" ], "unii": [ "33CM23913M" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TORADOLIN", "drugindication": "PAIN", "actiondrug": "6", "activesubstance": { "activesubstancename": "KETOROLAC TROMETHAMINE" } }, { "drugcharacterization": "1", "medicinalproduct": "FENTANYL.", "drugdosageform": "CUTANEOUS LIQUID", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "FENTANYL" }, "openfda": { "application_number": [ "ANDA077449", "ANDA202097", "ANDA076258" ], "brand_name": [ "FENTANYL", "FENTANYL SYSTEM" ], "generic_name": [ "FENTANYL" ], "manufacturer_name": [ "Aveva Drug Delivery Systems Inc.", "INGENUS PHARMACEUTICALS, LLC", "ALVOGEN", "Mylan Pharmaceuticals Inc." ], "product_ndc": [ "3215-7701", "3215-7702", "3215-7703", "3215-7704", "3215-7705", "3215-7706", "3215-7707", "3215-7708", "50742-549", "50742-550", "50742-551", "50742-552", "50742-553", "50742-554", "50742-555", "50742-556", "47781-423", "47781-424", "47781-426", "47781-427", "47781-428", "0378-9119", "0378-9121", "0378-9125", "0378-9122", "0378-9126", "0378-9123", "0378-9127", "0378-9124" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "TRANSDERMAL" ], "substance_name": [ "FENTANYL" ], "rxcui": [ "197696", "245134", "245135", "245136", "577057", "1603495", "1603498", "1603501" ], "spl_id": [ "4edfc77d-dee4-611b-e063-6294a90a47f8", "4edfd739-fc61-0f08-e063-6394a90ae646", "4b8493ea-0ce4-6949-e063-6294a90a8861", "a6e21c86-57e5-4be5-b1bb-c894893991b2" ], "spl_set_id": [ "73897c38-e4ec-40bc-9f41-3359ee23a5a8", "bf02ffd0-cc5d-446b-b648-378f6885052f", "242759ef-cb6d-4e3e-9f8d-5e31efa1f289", "2a2238e9-4b5d-c56d-8663-dd354ff9ae0c" ], "package_ndc": [ "3215-7701-01", "3215-7701-05", "3215-7702-01", "3215-7702-05", "3215-7703-01", "3215-7703-05", "3215-7704-01", "3215-7704-05", "3215-7705-01", "3215-7705-05", "3215-7706-01", "3215-7706-05", "3215-7707-01", "3215-7707-05", "3215-7708-01", "3215-7708-05", "50742-549-01", "50742-549-05", "50742-550-01", "50742-550-05", "50742-551-01", "50742-551-05", "50742-552-01", "50742-552-05", "50742-553-01", "50742-553-05", "50742-554-01", "50742-554-05", "50742-555-01", "50742-555-05", "50742-556-01", "50742-556-05", "47781-423-11", "47781-423-47", "47781-424-11", "47781-424-47", "47781-426-11", "47781-426-47", "47781-427-11", "47781-427-47", "47781-428-11", "47781-428-47", "0378-9119-16", "0378-9119-98", "0378-9121-16", "0378-9121-98", "0378-9125-16", "0378-9125-98", "0378-9122-16", "0378-9122-98", "0378-9126-16", "0378-9126-98", "0378-9123-16", "0378-9123-98", "0378-9127-16", "0378-9127-98", "0378-9124-16", "0378-9124-98" ], "nui": [ "N0000175684", "N0000175690" ], "pharm_class_moa": [ "Full Opioid Agonists [MoA]" ], "pharm_class_epc": [ "Opioid Agonist [EPC]" ], "unii": [ "UF599785JZ" ] } }, { "drugcharacterization": "1", "medicinalproduct": "HYDROMORPHONE HYDROCHLORIDE.", "drugindication": "PAIN", "activesubstance": { "activesubstancename": "HYDROMORPHONE HYDROCHLORIDE" }, "openfda": { "application_number": [ "ANDA202159", "ANDA076855", "ANDA212133", "ANDA205629", "ANDA205814", "NDA019034", "ANDA074653", "NDA019892", "NDA019891", "NDA200403", "NDA217812", "ANDA216899", "ANDA078591", "ANDA210506", "ANDA204278", "ANDA210176" ], "brand_name": [ "HYDROMORPHONE HYDROCHLORIDE", "DILAUDID" ], "generic_name": [ "HYDROMORPHONE HYDROCHLORIDE" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc.", "SpecGx LLC", "Camber Pharmaceuticals, Inc.", "Trigen Laboratories, LLC", "Aurolife Pharma, LLC", "Fresenius Kabi USA, LLC", "Rhodes Pharmaceuticals LLC", "Hospira, Inc.", "XLCare Pharmaceuticals, Inc.", "Ascent Pharmaceuticals Inc", "Padagis US LLC", "Teva Parenteral Medicines, Inc." ], "product_ndc": [ "0641-6151", "0406-3243", "0406-3244", "0406-3249", "31722-119", "31722-120", "31722-121", "31722-122", "13811-701", "13811-703", "13811-702", "13811-704", "13811-720", "13107-107", "13107-108", "13107-109", "63323-851", "63323-852", "63323-853", "63323-854", "0054-0386", "0054-0264", "0054-0265", "76045-009", "76045-010", "76045-121", "42858-122", "42858-234", "42858-338", "42858-416", "0409-1283", "0409-1312", "0409-4264", "0409-1805", "72865-168", "72865-169", "72865-170", "72865-171", "0641-6254", "0641-6169", "0641-6170", "0641-6206", "0641-6259", "0409-2634", "43602-002", "43602-003", "43602-004", "0574-0293", "0574-0294", "0574-0295", "0574-0297", "0703-0018", "0703-0110", "0703-0113", "43602-001", "0409-2552", "0409-3356", "0409-2540", "0409-3365", "0409-1304", "0641-2341", "0641-0121", "0574-7224", "42858-301", "42858-302", "42858-303", "42858-304" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS", "ORAL", "RECTAL" ], "substance_name": [ "HYDROMORPHONE HYDROCHLORIDE" ], "rxcui": [ "1724276", "897696", "897702", "897710", "902729", "902736", "902741", "1306898", "2706360", "897653", "897753", "1724338", "1724340", "1724341", "897657", "897756", "897757", "1433251", "1872265", "1872269", "1872752", "2277368", "2277370", "897658", "897698", "897704", "897712", "1724383", "1724644", "2675350", "897745", "897758", "897749" ], "spl_id": [ "cd9429e0-ad70-458b-b5dc-14598dc77120", "914c9f88-d1ae-4b14-a18a-e1767ebb5c40", "8b32d26f-fcb6-43f3-bfd3-8769e9ca6138", "e22a1e07-ff84-4ef1-b154-804b49dcd52f", "1c45740c-5fb6-4cf7-81b9-0865717334e5", "2cfa0a3e-eb57-4dea-ae2c-0b91176f0f67", "4c3c8198-731d-4136-9222-01063f3364cb", "002d5650-24df-4b60-a5ce-e7adc091026f", "3348b431-907c-4f1d-8a18-e4be2a04df23", "766e302a-2d03-4d93-b237-2348b57ee517", "55fb6272-5677-43cf-b92d-5a6a6f484b6e", "68e84ae8-2bd5-4f57-abef-4d0cde3c4775", "2c21b807-cef3-4127-a395-37fae2a435c6", "50886ad5-eeca-4fe7-beb0-01305f92c65d", "b492adee-8ae4-476e-8047-c13fb2136b58", "8b576b81-17fc-4251-acc3-6e1b9e18030c", "540b835a-db66-417c-8507-0c1ed05c95bf", "c5abd799-51be-4368-b788-b6b6c30b90af", "a3ebafac-648e-47b1-a6f5-1e3bff1e3e08", "29e3211f-1115-45e9-8416-c3dfe01a9916", "8c369b50-cf2a-4e30-a31c-ccf5f49ab920", "b786b01b-46f9-4a00-a667-699e813a741b" ], "spl_set_id": [ "67e79859-4efc-4ea7-8211-cadf746bc864", "4c5c1cc8-c42b-46e3-ad68-8e22f57101f2", "c33e6320-4206-4b69-8cac-ebfc2351b8f2", "8bb81796-6990-40e9-bee4-1f292f91ae99", "f778dfab-e109-428e-b1b7-4dfb1b8293e4", "e034eb96-03e0-46e1-8b92-5e1f94555e7b", "cc574063-6ede-4da7-82c4-7450c92b229b", "9eebd88a-5632-460f-b7b6-26c8a180540d", "d6b40e39-a57e-402c-b4f6-7041e832f837", "f9ca2ef5-46d8-475a-a26e-f7c8becd6db7", "90bda45c-9dbe-4ed5-91d0-df8446ad7026", "c729424e-e483-4bf8-b86c-ce56636dcffa", "31d5a37a-0e90-4e88-be14-75c877be9de2", "3832ede8-d3fc-455d-ecab-3b77be5869f5", "4de15afe-d676-4faa-a34d-9b9cb20dbf54", "780a2616-0392-4715-bc50-71799bea1957", "f0b78db9-a38c-41bb-8233-5e93f7f18c5c", "e8fd7b0e-22b9-4f8a-8eb2-41d5031779af", "e9c9ef18-7dfc-4322-b2fc-29b934c30f8b", "b325028e-0722-4c8c-9fdb-ab6fb0dc460c", "1bfbba46-1979-4797-a29e-d67718131686", "37565441-0d95-4743-a695-d7b3326f58a1" ], "package_ndc": [ "0641-6151-01", "0641-6151-25", "0406-3243-01", "0406-3244-01", "0406-3249-01", "31722-119-01", "31722-120-01", "31722-121-01", "31722-122-01", "13811-703-10", "13811-701-10", "13811-702-10", "13811-704-10", "13811-720-10", "13107-107-20", "13107-107-01", "13107-107-05", "13107-107-99", "13107-108-20", "13107-108-01", "13107-108-05", "13107-108-99", "13107-109-20", "13107-109-01", "13107-109-05", "13107-109-99", "63323-851-03", "63323-851-10", "63323-851-07", "63323-851-15", "63323-851-50", "63323-852-03", "63323-852-25", "63323-853-03", "63323-853-25", "63323-854-03", "63323-854-10", "0054-0264-24", "0054-0264-25", "0054-0265-25", "0054-0386-63", "76045-009-96", "76045-009-06", "76045-009-01", "76045-009-11", "76045-010-01", "76045-010-11", "76045-121-01", "76045-121-11", "42858-122-01", "42858-234-01", "42858-234-50", "42858-338-01", "42858-416-16", "0409-1283-17", "0409-1283-37", "0409-1312-16", "0409-1312-36", "0409-4264-11", "0409-4264-01", "0409-1805-10", "0409-1805-01", "72865-168-01", "72865-169-01", "72865-170-01", "72865-171-01", "0641-6254-01", "0641-6170-01", "0641-6170-10", "0641-6206-01", "0641-6206-10", "0641-6169-01", "0641-6169-10", "0641-6259-01", "0641-6259-10", "0409-2634-10", "0409-2634-01", "0409-2634-25", "0409-2634-05", "0409-2634-50", "43602-002-30", "43602-002-05", "43602-003-30", "43602-003-05", "43602-004-30", "43602-004-05", "0574-0293-01", "0574-0294-01", "0574-0295-01", "0574-0297-01", "0703-0110-01", "0703-0110-03", "0703-0113-01", "0703-0113-03", "0703-0018-01", "43602-001-47", "0409-2552-11", "0409-2552-01", "0409-3356-11", "0409-3356-01", "0409-2540-11", "0409-2540-01", "0409-3365-11", "0409-3365-01", "0409-3365-10", "0409-1283-03", "0409-1283-31", "0409-1312-03", "0409-1312-30", "0409-1304-03", "0409-1304-31", "0641-0121-21", "0641-0121-25", "0641-2341-39", "0641-2341-41", "0574-7224-06", "42858-301-01", "42858-301-25", "42858-302-01", "42858-302-25", "42858-302-50", "42858-303-01", "42858-304-16" ], "unii": [ "L960UP2KRW" ] } } ] } } ] }