zytiga

Generic: abiraterone acetate

Labeler: janssen biotech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zytiga
Generic Name abiraterone acetate
Labeler janssen biotech, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

abiraterone acetate 500 mg/1

Manufacturer
Janssen Biotech, Inc.

Identifiers & Regulatory

Product NDC 57894-195
Product ID 57894-195_316974bf-2b6d-9d66-e063-6294a90a33a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202379
Listing Expiration 2026-12-31
Marketing Start 2017-04-17

Pharmacologic Class

Classes
cytochrome p450 17a1 inhibitor [epc] cytochrome p450 17a1 inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57894195
Hyphenated Format 57894-195

Supplemental Identifiers

RxCUI
1100075 1100079 1918042 1918044
UPC
0357894195061 0357894150121
UNII
EM5OCB9YJ6

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zytiga (source: ndc)
Generic Name abiraterone acetate (source: ndc)
Application Number NDA202379 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06)
  • 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15)
source: ndc

Packages (2)

57894-195-06 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06) 57894-195-15 60 TABLET, FILM COATED in 1 BOTTLE (57894-195-15)

Ingredients (1)

abiraterone acetate (500 mg/1)

Linked Drug Pages (1)

Zytiga ndc-match (0.9)

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"}