Home NDC 57894-155-12 Abiraterone acetate
Product NDC 57894-155
Requested package NDC 57894-155-12
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 Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 8 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57894-155 57894-155-12 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202379-002 ZYTIGA 500MG TABLET / ORAL RLD, RS 2017-04-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202379-001 ZYTIGA 250MG TABLET / ORAL AB RLD 2011-04-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202379-002 ZYTIGA 500MG TABLET / ORAL AB RLD, RS 2017-04-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202379-002 8822438 2027-08-24 U-2235 Delist requested 2017-08-02 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1580 Delist requested 2017-08-02 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N202379-002 8822438 2027-08-24 U-1579 Delist requested 2017-08-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202379-001 8822438 2027-08-24 U-1580 2014-10-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-001 8822438 2027-08-24 U-2235 2014-10-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-001 8822438 2027-08-24 U-1579 2014-10-01 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-002 8822438 2027-08-24 U-2235 2017-08-02 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-002 8822438 2027-08-24 U-1580 2017-08-02 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N202379-002 8822438 2027-08-24 U-1579 2017-08-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202379-001 8822438 2027-08-24 U-1579 2014-10-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-001 8822438 2027-08-24 U-1580 2014-10-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-001 8822438 2027-08-24 U-2235 2014-10-01 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-002 8822438 2027-08-24 U-2235 2017-08-02 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-002 8822438 2027-08-24 U-1580 2017-08-02 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N202379-002 8822438 2027-08-24 U-1579 2017-08-02 ea99ee380514…
Observed Orange Book exclusivity history# 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