{ "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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"drugcharacterization": "2", "medicinalproduct": "CELEBREX", "drugindication": "Product used for unknown indication", "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": "2", "medicinalproduct": "CESAMET", "drugindication": "Product used for unknown indication", "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": "2", "medicinalproduct": "RELISTOR", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "METHYLNALTREXONE BROMIDE" }, "openfda": { "application_number": [ "NDA208271", "NDA021964" ], "brand_name": [ "RELISTOR" ], "generic_name": [ "METHYLNALTREXONE BROMIDE" ], "manufacturer_name": [ "Salix Pharmaceuticals, Inc." ], "product_ndc": [ "65649-150", "65649-552", "65649-551" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "SUBCUTANEOUS" ], "substance_name": [ "METHYLNALTREXONE BROMIDE" ], "rxcui": [ "979113", "979115", "1244060", "1244062", "1244063", "1244064", "1801514", "1801519" ], "spl_id": [ "9db15b8c-2928-4b75-a33b-548416afc8c9" ], "spl_set_id": [ "c488fb7c-0a5b-487c-b452-996809d1cb99" ], "package_ndc": [ "65649-150-90", "65649-150-60", "65649-150-06", "65649-552-04", "65649-551-07", "65649-551-03", "65649-551-02" ], "unii": [ "RFO6IL3D3M" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMINS NOS", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "VITAMINS" } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL", "drugindication": "Product used for unknown indication", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "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" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20200101" } } } ] }