Home NDC 42292-057 Abiraterone Acetate
Product NDC 42292-057
11-digit product format 422920057
Labeler code 42292
Product ID 42292-057_d3aef164-ffc6-d7a6-e053-2a95a90a5711
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abiraterone acetate
Dosage form TABLET
Route ORAL
Labeler Mylan Institutional Inc.
Application ANDA208446
Marketing category ANDA
Marketing start 2020-06-03
Marketing end 2022-02-28
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 0000-00-00
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 · 2 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 42292-057 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42292-057 42292-057-03 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 A208446-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 A208446-002 ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14
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 2 · 76 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 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208446-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208446-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42292-057-03 42292005703 30 BLISTER PACK in 1 CARTON (42292-057-03) > 1 TABLET in 1 BLISTER PACK (42292-057-01) 30 blister pack 2020-06-03 0000-00-00 No No Current