Home NDC 57894-155 Abiraterone acetate
Product NDC 57894-155
11-digit product format 578940155
Labeler code 57894
Product ID 57894-155_85c1da76-b9c5-4e17-bc0d-7814f644cd4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abiraterone acetate
Dosage form TABLET
Route ORAL
Labeler Janssen Biotech, Inc.
Application NDA202379
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-02-09
Marketing end 0000-00-00
Substance ABIRATERONE ACETATE
Active strength 250 mg/1
Pharmacologic classes Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202379-001 ZYTIGA ABIRATERONE ACETATE 250MG TABLET / ORAL AB RLD 2011-04-28 N202379-002 ZYTIGA ABIRATERONE ACETATE 500MG TABLET / ORAL AB RLD, RS 2017-04-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 a50c72e98297…2026-08-01 22:54:32 2026-06 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N202379-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 N202379-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zytiga ABIRATERONE ACETATE Janssen Biotech, Inc. 4e338e89-3cf2-48eb-b6e2-a06c608c6513 2025-03-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 202379 application number: NDA202379
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57894-155-12 57894015512 120 TABLET in 1 BOTTLE (57894-155-12) 120 tablet 2018-02-09 0000-00-00 No No Current