Package 57894-050-60

{"route": ["ORAL"], "spl_id": "463bff67-d7cf-a132-e063-6394a90abe1d", "openfda": {"unii": ["195Q483UZD", "EM5OCB9YJ6"], "rxcui": ["2645244", "2645250", "2645251", "2645253"], "spl_set_id": ["8245a990-3268-4613-b5c5-9537858a1eb9"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (57894-050-60)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "57894-050-60", "marketing_start_date": "20230811"}], "brand_name": "AKEEGA", "product_id": "57894-050_463bff67-d7cf-a132-e063-6394a90abe1d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 17A1 Inhibitor [EPC]", "Cytochrome P450 17A1 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Poly(ADP-Ribose) Polymerase Inhibitor [EPC]", "Poly(ADP-Ribose) Polymerase Inhibitors [MoA]"], "product_ndc": "57894-050", "generic_name": "NIRAPARIB TOSYLATE MONOHYDRATE and ABIRATERONE ACETATE", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AKEEGA", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}, {"name": "NIRAPARIB TOSYLATE MONOHYDRATE", "strength": "50 mg/1"}], "application_number": "NDA216793", "marketing_category": "NDA", "marketing_start_date": "20230811", "listing_expiration_date": "20261231"}