Package 57894-195-15
Brand: zytiga
Generic: abiraterone acetatePackage Facts
Identity
Package NDC
57894-195-15
Digits Only
5789419515
Product NDC
57894-195
Description
60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15)
Marketing
Marketing Status
Brand
zytiga
Generic
abiraterone acetate
Sample Package
Yes
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "316974bf-2b6d-9d66-e063-6294a90a33a9", "openfda": {"upc": ["0357894195061", "0357894150121"], "unii": ["EM5OCB9YJ6"], "rxcui": ["1100075", "1100079", "1918042", "1918044"], "spl_set_id": ["4e338e89-3cf2-48eb-b6e2-a06c608c6513"], "manufacturer_name": ["Janssen Biotech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06)", "package_ndc": "57894-195-06", "marketing_start_date": "20170417"}, {"sample": true, "description": "60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15)", "package_ndc": "57894-195-15", "marketing_start_date": "20170417"}], "brand_name": "Zytiga", "product_id": "57894-195_316974bf-2b6d-9d66-e063-6294a90a33a9", "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]"], "product_ndc": "57894-195", "generic_name": "Abiraterone acetate", "labeler_name": "Janssen Biotech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zytiga", "active_ingredients": [{"name": "ABIRATERONE ACETATE", "strength": "500 mg/1"}], "application_number": "NDA202379", "marketing_category": "NDA", "marketing_start_date": "20170417", "listing_expiration_date": "20261231"}