Home NDC 0904-6948 Abiraterone Acetate
Product NDC 0904-6948
11-digit product format 009046948
Labeler code 0904
Product ID 0904-6948_74c86cf4-5313-48ea-89ca-b36abe6f6325
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abiraterone Acetate
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA208453
Marketing category ANDA
Marketing start 2018-11-23
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208453-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208453-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208453-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2018-10-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Abiraterone Acetate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABIRATERONE ACETATE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EM5OCB9YJ6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1100075 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-6948-04 Abiraterone Acetate 30 in 1 CARTON TABLET 30 5 0904-6948-04 Abiraterone Acetate 1 in 1 BLISTER PACK TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6948 ABIRATERONE ACETATE TABLET [MAJOR PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 2 package rows 20250207_49809a29-6558-43a3-a347-5027de44aa41.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6948-04 00904694804 30 BLISTER PACK in 1 CARTON (0904-6948-04) / 1 TABLET in 1 BLISTER PACK 30 blister pack 2018-11-23 0000-00-00 No No Current