Home NDC 63629-9429-1 Abiraterone Acetate
Product NDC 63629-9429
Requested package NDC 63629-9429-1
11-digit product format 636299429
Labeler code 63629
Product ID 63629-9429_e170bba1-a152-43fb-a566-296819ae50f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abiraterone acetate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA215947
Marketing category ANDA
Marketing start 2022-01-05
Marketing end 0000-00-00
Substance ABIRATERONE ACETATE
Active strength 250 mg/1
Pharmacologic classes Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A215947-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 A215947-002 ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05
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 · 68 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 2026-09-14 22:38:34 2026-08 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215947-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2022-01-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215947-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-01-05 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-9429-1 63629942901 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9429-1) 2022-08-23 0000-00-00 No No Current