{ "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. 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"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": "METHOTREXATE", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "803", "drugdosagetext": "UNK UNK, QW", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "METHOTREXATE" }, "openfda": { "application_number": [ "ANDA210454", "NDA011719", "NDA212479", "ANDA040385", "ANDA040263", "ANDA220225", "ANDA040632", "ANDA201529", "ANDA201749", "ANDA081235", "NDA205776", "NDA208400", "ANDA040266", "ANDA040843", "ANDA207812", "ANDA081099", "ANDA040716", "ANDA089343", "ANDA089342", "ANDA089341", "ANDA089340", "ANDA213343", "ANDA217552", "NDA204824" ], "brand_name": [ "METHOTREXATE", "JYLAMVO", "TREXALL", "RASUVO", "XATMEP", "OTREXUP" ], "generic_name": [ "METHOTREXATE", "METHOTREXATE SODIUM" ], "manufacturer_name": [ "Chartwell RX, LLC", "Hospira, Inc.", "SHORLA ONCOLOGY INC.", "Teva Women's Health LLC", "Fresenius Kabi USA, LLC", "Alembic 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"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]" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20200424" } } } ] }