{ "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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"66993-607-04", "66993-608-30", "66993-608-04", "66993-609-30", "66993-609-04", "31722-407-30", "31722-407-05", "31722-408-30", "31722-408-10", "31722-408-05", "31722-409-30", "31722-409-05", "31722-410-30", "31722-410-05" ], "unii": [ "A051Q2099Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JAKAFI", "drugbatchnumb": "NOT AVAILABLE", "drugauthorizationnumb": "202192", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "MYELOFIBROSIS", "drugstartdateformat": "602", "drugstartdate": "2013", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "RUXOLITINIB" }, "openfda": { "application_number": [ "NDA202192" ], "brand_name": [ "JAKAFI" ], "generic_name": [ "RUXOLITINIB" ], "manufacturer_name": [ "Incyte Corporation" ], "product_ndc": [ "50881-005", "50881-010", "50881-015", "50881-020", "50881-025", "50881-011", "50881-022", "50881-033", "50881-044", "50881-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RUXOLITINIB" ], "rxcui": [ "1193331", "1193337", "1193339", "1193341", "1193343", "1193345", "1193347", "1193349", "1193351", "1193353", "2743012", "2743016", "2743019", "2743022", "2743025", "2743028", "2743032", "2743035", "2743041", "2743044" ], "spl_id": [ "baf91401-9bd0-4ce6-a5c4-7ca5c572f106" ], "spl_set_id": [ "f1c82580-87ae-11e0-bc84-0002a5d5c51b" ], "package_ndc": [ "50881-005-60", "50881-010-01", "50881-010-60", "50881-015-60", "50881-020-60", "50881-025-60", "50881-011-08", "50881-022-08", "50881-033-08", "50881-044-08", "50881-055-08" ], "nui": [ "N0000175605", "N0000190858", "N0000190857" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]", "Janus Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Janus Kinase Inhibitors [MoA]" ], "unii": [ "82S8X8XX8H" ] } }, { "drugcharacterization": "1", "medicinalproduct": "JAKAFI", "drugbatchnumb": "AG4910G", "drugauthorizationnumb": "202192", "drugstructuredosagenumb": "15", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "15 MG, BID", "drugdosageform": "TABLET", "drugadministrationroute": "048", "actiondrug": "1", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "RUXOLITINIB" }, "openfda": { "application_number": [ "NDA202192" ], "brand_name": [ "JAKAFI" ], "generic_name": [ "RUXOLITINIB" ], "manufacturer_name": [ "Incyte Corporation" ], "product_ndc": [ "50881-005", "50881-010", "50881-015", "50881-020", "50881-025", "50881-011", "50881-022", "50881-033", "50881-044", "50881-055" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "RUXOLITINIB" ], "rxcui": [ "1193331", "1193337", "1193339", "1193341", "1193343", "1193345", "1193347", "1193349", "1193351", "1193353", "2743012", "2743016", "2743019", "2743022", "2743025", "2743028", "2743032", "2743035", "2743041", "2743044" ], "spl_id": [ "baf91401-9bd0-4ce6-a5c4-7ca5c572f106" ], "spl_set_id": [ "f1c82580-87ae-11e0-bc84-0002a5d5c51b" ], "package_ndc": [ "50881-005-60", "50881-010-01", "50881-010-60", "50881-015-60", "50881-020-60", "50881-025-60", "50881-011-08", "50881-022-08", "50881-033-08", "50881-044-08", "50881-055-08" ], "nui": [ "N0000175605", "N0000190858", "N0000190857" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]", "Janus Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Janus Kinase Inhibitors [MoA]" ], "unii": [ "82S8X8XX8H" ] } }, { "drugcharacterization": "2", "medicinalproduct": "EXJADE", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "DEFERASIROX" }, "openfda": { "application_number": [ "NDA021882" ], "brand_name": [ "EXJADE" ], "generic_name": [ "DEFERASIROX" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-0468", "0078-0469", "0078-0470" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEFERASIROX" ], "rxcui": [ "597768", "597770", "597772", "616159", "616161", "616163" ], "spl_id": [ "17c39217-5502-420d-8d2e-799626756189" ], "spl_set_id": [ "3495a70c-870c-4968-940e-8baea152cf85" ], "package_ndc": [ "0078-0468-15", "0078-0469-15", "0078-0470-15" ], "nui": [ "N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138" ], "pharm_class_moa": [ "Iron Chelating Activity [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]" ], "pharm_class_epc": [ "Iron Chelator [EPC]" ], "unii": [ "V8G4MOF2V9" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NORVASC", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA019787" ], "brand_name": [ "NORVASC" ], "generic_name": [ "AMLODIPINE BESYLATE" ], "manufacturer_name": [ "Viatris Specialty LLC", "PFIZER LABORATORIES DIV PFIZER INC" ], "product_ndc": [ "58151-353", "58151-354", "58151-355", "0069-1520", "0069-1530", "0069-1540" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE" ], "rxcui": [ "197361", "212542", "212549", "212575", "308135", "308136" ], "spl_id": [ "643fa1a0-53d9-4ce8-bc04-44285b006997", "3714a872-b6c6-4d74-88d2-add8a895e311" ], "spl_set_id": [ "7367289c-b0b0-466a-83e2-558e2985c29f", "abd6a2ca-40c2-485c-bc53-db1c652505ed" ], "package_ndc": [ "58151-353-77", "58151-354-77", "58151-354-88", "58151-354-30", "58151-355-77", "58151-355-88", "0069-1520-68", "0069-1530-68", "0069-1530-41", "0069-1530-72", "0069-1540-68", "0069-1540-41" ], "unii": [ "864V2Q084H" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140110" } } } ] }