{ "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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"69315-306-30", "69315-306-60", "0121-0868-02", "0121-0868-16", "0121-0868-05", "0121-0868-40", "0121-0868-50", "0121-0868-00", "69315-307-15", "69315-307-30", "0472-0166-15", "0472-0166-30", "33342-469-15", "33342-469-30", "70771-1357-1", "70771-1357-2" ], "nui": [ "N0000175498", "M0017172" ], "pharm_class_epc": [ "Polyene Antifungal [EPC]" ], "pharm_class_cs": [ "Polyenes [CS]" ], "unii": [ "BDF1O1C72E" ] } }, { "drugcharacterization": "1", "medicinalproduct": "REVLIMID", "drugbatchnumb": "A2802A", "drugauthorizationnumb": "021880", "drugstructuredosagenumb": "25", "drugstructuredosageunit": "003", "drugdosagetext": "25 MILLIGRAM", "drugdosageform": "CAPSULES", "drugadministrationroute": "048", "drugindication": "MANTLE CELL LYMPHOMA", "drugstartdateformat": "102", "drugstartdate": "20190531", "actiondrug": "4", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "openfda": { "application_number": [ "NDA021880" ], "brand_name": [ "REVLIMID" ], "generic_name": [ "LENALIDOMIDE" ], "manufacturer_name": [ "Celgene Corporation" ], "product_ndc": [ "59572-402", "59572-405", "59572-410", "59572-415", "59572-420", "59572-425" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LENALIDOMIDE" ], "rxcui": [ "602910", "602912", "616114", "616116", "643712", "643714", "643720", "643722", "1242231", "1242233", "1428947", "1429367" ], "spl_id": [ "9329fd28-b848-4013-92e0-a68270328336" ], "spl_set_id": [ "5fa97bf5-28a2-48f1-8955-f56012d296be" ], "package_ndc": [ "59572-402-28", "59572-402-00", "59572-405-28", "59572-405-00", "59572-410-28", "59572-410-00", "59572-415-21", "59572-415-00", "59572-420-21", "59572-420-00", "59572-425-21", "59572-425-00" ], "nui": [ "N0000184014" ], "pharm_class_epc": [ "Thalidomide Analog [EPC]" ], "unii": [ "F0P408N6V4" ] } }, { "drugcharacterization": "2", "medicinalproduct": "XARELTO", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "RIVAROXABAN" }, "openfda": { "application_number": [ "NDA215859", "NDA022406" ], "brand_name": [ "XARELTO" ], "generic_name": [ "RIVAROXABAN" ], "manufacturer_name": [ "Janssen Pharmaceuticals, Inc." ], "product_ndc": [ "50458-575", "50458-577", "50458-580", "50458-578", "50458-579", "50458-584" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RIVAROXABAN" ], "spl_id": [ "5294926b-7812-41da-a0e8-56f492198450" ], "spl_set_id": [ "10db92f9-2300-4a80-836b-673e1ae91610" ], "package_ndc": [ "50458-577-60", "50458-577-18", "50458-577-14", "50458-577-01", "50458-577-10", "50458-580-01", "50458-580-10", "50458-580-30", "50458-580-07", "50458-580-90", "50458-578-01", "50458-578-10", "50458-578-30", "50458-578-90", "50458-578-14", "50458-578-07", "50458-579-01", "50458-579-10", "50458-579-30", "50458-579-90", "50458-579-99", "50458-579-07", "50458-579-89", "50458-584-51", "50458-584-52", "50458-575-01" ], "nui": [ "N0000175635", "N0000175637" ], "pharm_class_moa": [ "Factor Xa Inhibitors [MoA]" ], "pharm_class_epc": [ "Factor Xa Inhibitor [EPC]" ], "unii": [ "9NDF7JZ4M3" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SYNDROS", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "DRONABINOL" }, "openfda": { "application_number": [ "NDA205525" ], "brand_name": [ "SYNDROS" ], "generic_name": [ "DRONABINOL" ], "manufacturer_name": [ "Wellhouse Pharma, LLC", "Benuvia Operations, LLC" ], "product_ndc": [ "85776-201", "78613-201" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DRONABINOL" ], "rxcui": [ "1928948", "1928954" ], "spl_id": [ "dcc02ae3-f1fa-431e-81bb-c52d35b81c66", "3e1cbbb1-291c-41bb-b209-93c1fb08313a" ], "spl_set_id": [ "3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89", "a7801c70-995d-46a2-91ee-141ef427c6b5" ], "package_ndc": [ "85776-201-30", "78613-201-30" ], "nui": [ "N0000175782", "M0003267" ], "pharm_class_epc": [ "Cannabinoid [EPC]" ], "pharm_class_cs": [ "Cannabinoids [CS]" ], "unii": [ "7J8897W37S" ] } }, { "drugcharacterization": "2", "medicinalproduct": "HYDROCODONE-ACETAMINOPHEN", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\HYDROCODONE" } }, { "drugcharacterization": "2", "medicinalproduct": "AMBIEN", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ZOLPIDEM TARTRATE" }, "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": "CLOBETASOL", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "CLOBETASOL" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2019" } } } ] }