Home NDC 72606-566 Abiraterone acetate
Product NDC 72606-566
11-digit product format 726060566
Labeler code 72606
Product ID 72606-566_2765ab03-f2d2-4e68-a704-c1c45505b50a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abiraterone acetate
Dosage form TABLET
Route ORAL
Labeler CELLTRION USA, INC.
Application ANDA212462
Marketing category ANDA
Marketing start 2020-01-07
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# 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72606-566-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72606-566-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 72606-566-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 72606-566-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 72606-566-01 cfe11265f3b6…090c488252e2…
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 A212462-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 A212462-002 ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25
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 · 72 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 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A212462-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2021-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212462-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-09-27 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
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 · 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 72606-566-01 72606056601 120 TABLET in 1 BOTTLE (72606-566-01) 120 tablet 2020-01-07 0000-00-00 No No Current