{ "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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"spl_set_id": [ "628f9609-6583-49be-be77-b64cfbc46fd7", "d0efeeec-640d-43c3-8f0a-d31324a11c68" ], "package_ndc": [ "53097-568-60", "53097-569-60", "53097-570-60", "53097-571-60", "53097-572-60", "53097-573-60" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZOCOR", "drugdosagetext": "UNK", "drugindication": "HYPERLIPIDAEMIA", "activesubstance": { "activesubstancename": "SIMVASTATIN" }, "openfda": { "application_number": [ "NDA019766" ], "brand_name": [ "ZOCOR" ], "generic_name": [ "SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-180", "78206-182", "78206-181" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SIMVASTATIN" ], "rxcui": [ "104490", "104491", "152923", "198211", "312961", "314231" ], "spl_id": [ "11256523-425c-48e8-afe1-e3a4e28c892e" ], "spl_set_id": [ "8f55d5de-5a4f-4a39-8c84-c53976dd6af9" ], "package_ndc": [ "78206-182-01", "78206-182-02", "78206-181-02", "78206-181-01", "78206-180-01", "78206-180-02" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "unii": [ "AGG2FN16EV" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CABOZANTINIB", "drugbatchnumb": "1164654", "drugauthorizationnumb": "208692", "drugstructuredosagenumb": "40", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "40 MG, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "NON-SMALL CELL LUNG CANCER METASTATIC", "drugstartdateformat": "102", "drugstartdate": "20210226", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "CABOZANTINIB" }, "openfda": { "application_number": [ "NDA203756", "NDA208692" ], "brand_name": [ "COMETRIQ", "CABOMETYX" ], "generic_name": [ "CABOZANTINIB" ], "manufacturer_name": [ "Exelixis, Inc." ], "product_ndc": [ "42388-011", "42388-012", "42388-013", "42388-023", "42388-025", "42388-024" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "1363273", "1363279", "1363281", "1363284", "1363312", "1363408", "1363409", "1363410", "1364580", "1364581", "1790161", "1790167", "1790169", "1790171", "1790173", "1790175" ], "spl_id": [ "03fee098-20c7-4a04-81a7-06fb7d8b1470", "e8cdcbdc-d863-4d48-af3e-a8926b9ab017" ], "spl_set_id": [ "1a0c3bea-c87b-4d25-bb44-5f0174da6b34", "3850cce2-6137-42e5-a792-d318c4a4b3b5" ], "package_ndc": [ "42388-011-14", "42388-012-14", "42388-013-14", "42388-023-26", "42388-023-46", "42388-023-36", "42388-023-37", "42388-023-57", "42388-025-26", "42388-025-46", "42388-025-37", "42388-025-57", "42388-024-26", "42388-024-46", "42388-024-37", "42388-024-57" ], "unii": [ "DR7ST46X58" ], "route": [ "ORAL" ], "substance_name": [ "CABOZANTINIB S-MALATE" ] } }, { "drugcharacterization": "1", "medicinalproduct": "ATEZOLIZUMAB.", "drugbatchnumb": "1161080", "drugstructuredosagenumb": "1200", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "3", "drugintervaldosagedefinition": "803", "drugdosagetext": "1200 MG, Q3WEEKS", "drugadministrationroute": "042", "drugindication": "NON-SMALL CELL LUNG CANCER METASTATIC", "drugstartdateformat": "102", "drugstartdate": "20210226", "actiondrug": "5", "drugrecurreadministration": "3", "drugadditional": "3", "activesubstance": { "activesubstancename": "ATEZOLIZUMAB" }, "openfda": { "application_number": [ "BLA761034" ], "brand_name": [ "TECENTRIQ" ], "generic_name": [ "ATEZOLIZUMAB" ], "manufacturer_name": [ "Genentech, Inc." ], "product_ndc": [ "50242-917", "50242-918" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "ATEZOLIZUMAB" ], "rxcui": [ "1792780", "1792785", "2119695", "2119696" ], "spl_id": [ "4b922b35-c401-4189-a8b2-9f9a820878db" ], "spl_set_id": [ "6fa682c9-a312-4932-9831-f286908660ee" ], "package_ndc": [ "50242-917-01", "50242-917-86", "50242-918-01" ], "nui": [ "N0000191260", "N0000191259", "M0556300", "M0001357", "M0001352" ], "pharm_class_epc": [ "Programmed Death Receptor-1 Blocking Antibody [EPC]" ], "pharm_class_moa": [ "Programmed Death Receptor-1-directed Antibody Interactions [MoA]" ], "pharm_class_cs": [ "Antibodies, Monoclonal, Humanized [CS]", "Antibodies, Monoclonal [CS]", "Antibodies [CS]" ], "unii": [ "52CMI0WC3Y" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZOFRAN", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "MSIR", "drugdosagetext": "UNK", "activesubstance": { "activesubstancename": "MORPHINE SULFATE" } }, { "drugcharacterization": "2", "medicinalproduct": "TRIAMCINOLONE", "drugdosagetext": "UNK", "drugindication": "DERMATITIS", "activesubstance": { "activesubstancename": "TRIAMCINOLONE" } }, { "drugcharacterization": "1", "medicinalproduct": "CABOZANTINIB", "drugauthorizationnumb": "208692", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, QD", "drugdosageform": "TABLET", "drugadministrationroute": "048", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "CABOZANTINIB" }, "openfda": { "application_number": [ "NDA203756", "NDA208692" ], "brand_name": [ "COMETRIQ", "CABOMETYX" ], "generic_name": [ "CABOZANTINIB" ], "manufacturer_name": [ "Exelixis, Inc." ], "product_ndc": [ "42388-011", "42388-012", "42388-013", "42388-023", "42388-025", "42388-024" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "1363273", "1363279", "1363281", "1363284", "1363312", "1363408", "1363409", "1363410", "1364580", "1364581", "1790161", "1790167", "1790169", "1790171", "1790173", "1790175" ], "spl_id": [ "03fee098-20c7-4a04-81a7-06fb7d8b1470", "e8cdcbdc-d863-4d48-af3e-a8926b9ab017" ], "spl_set_id": [ "1a0c3bea-c87b-4d25-bb44-5f0174da6b34", "3850cce2-6137-42e5-a792-d318c4a4b3b5" ], "package_ndc": [ "42388-011-14", "42388-012-14", "42388-013-14", "42388-023-26", "42388-023-46", "42388-023-36", "42388-023-37", "42388-023-57", "42388-025-26", "42388-025-46", "42388-025-37", "42388-025-57", "42388-024-26", "42388-024-46", "42388-024-37", "42388-024-57" ], "unii": [ "DR7ST46X58" ], "route": [ "ORAL" ], "substance_name": [ "CABOZANTINIB S-MALATE" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20210511" } } } ] }