{ "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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[ "1919507", "1919512", "1919515", "1919516" ], "spl_id": [ "5826517b-d2d2-4636-ad9c-0dc676abad9e" ], "spl_set_id": [ "8baba4ea-2855-42fa-9bd9-5a7548d4cec3" ], "package_ndc": [ "0310-4500-12", "0310-4611-50" ], "nui": [ "N0000193338", "N0000193337", "N0000193336", "M0001357" ], "pharm_class_epc": [ "Programmed Death Ligand-1 Blocker [EPC]" ], "pharm_class_moa": [ "Programmed Death Ligand-1 Antagonists [MoA]", "Programmed Death Ligand-1-directed Antibody Interactions [MoA]" ], "pharm_class_cs": [ "Antibodies, Monoclonal [CS]" ], "unii": [ "28X28X9OKV" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TREMELIMUMAB.", "drugstructuredosagenumb": "75", "drugstructuredosageunit": "003", "drugdosagetext": "75 MILLIGRAM", "drugdosageform": "INJECTION FOR INFUSION", "drugadministrationroute": "041", "drugindication": "PANCREATIC CARCINOMA", "drugstartdateformat": "102", "drugstartdate": "20171027", "actiondrug": "6", "drugrecurreadministration": "3", "activesubstance": { "activesubstancename": "TREMELIMUMAB" }, "openfda": { "application_number": [ "BLA761289" ], "brand_name": [ "IMJUDO" ], "generic_name": [ "TREMELIMUMAB" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0310-4505", "0310-4535" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS" ], "substance_name": [ "TREMELIMUMAB" ], "rxcui": [ "2619317", "2619323", "2619325", "2619326" ], "spl_id": [ "292bb46c-e55a-4acf-9dd1-fbe684ad1363" ], "spl_set_id": [ "6690679c-be2f-4588-a2e4-89fff74dd6be" ], "package_ndc": [ "0310-4505-25", "0310-4535-30" ], "nui": [ "N0000182635", "N0000182634", "N0000182157" ], "pharm_class_epc": [ "CTLA-4-directed Blocking Antibody [EPC]" ], "pharm_class_moa": [ "CTLA-4-directed Antibody Interactions [MoA]" ], "pharm_class_pe": [ "Increased T Lymphocyte Activation [PE]" ], "unii": [ "QEN1X95CIX" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZOLPIDEM", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "INSOMNIA", "drugstartdateformat": "102", "drugstartdate": "20181122", "activesubstance": { "activesubstancename": "ZOLPIDEM TARTRATE" }, "openfda": { "application_number": [ "ANDA077214" ], "brand_name": [ "ZOLPIDEM" ], "generic_name": [ "ZOLPIDEM TARTRATE" ], "manufacturer_name": [ "ACI Healthcare USA, Inc" ], "product_ndc": [ "71093-155", "71093-156" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ZOLPIDEM TARTRATE" ], "rxcui": [ "854873", "854876" ], "spl_id": [ "69a3d187-578f-4e49-b8b3-109219a7bdf6" ], "spl_set_id": [ "021153ce-fe27-4ed1-8d88-b4157b0ed734" ], "package_ndc": [ "71093-155-06", "71093-155-04", "71093-156-04", "71093-156-06" ], "unii": [ "WY6W63843K" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20200126" } } } ] }