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"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": "CARDIZEM", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "DILTIAZEM HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA018602" ], "brand_name": [ "CARDIZEM" ], "generic_name": [ "DILTIAZEM HYDROCHLORIDE" ], "manufacturer_name": [ "Bausch Health US LLC" ], "product_ndc": [ "0187-0771", "0187-0772", "0187-0791", "0187-0792" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DILTIAZEM HYDROCHLORIDE" ], "rxcui": [ "831054", "831055", "831102", "831103", "831137", "833217", "833219", "834393" ], "spl_id": [ "340462fa-5523-448e-e063-6294a90a4eab" ], "spl_set_id": [ "f3e7ecef-f360-4987-a4f5-933214130ab2" ], "package_ndc": [ "0187-0771-47", "0187-0771-55", "0187-0772-47", "0187-0791-47", "0187-0792-47" ], "unii": [ "OLH94387TE" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20190506" } } } ] }