Home NDC 68462-882 abiraterone acetate
Product NDC 68462-882
11-digit product format 684620882
Labeler code 68462
Product ID 68462-882_ccb0d191-e233-4e8c-9485-044cbbdba4aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abiraterone acetate
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA209227
Marketing category ANDA
Marketing start 2022-05-19
Substance ABIRATERONE ACETATE
Active strength 500 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 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 A209227-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 A209227-002 ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19
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 2026-02-19 14:30 UTC 2026-02 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209227-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2022-05-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209227-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-10-16 3f01610625f2…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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.
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 500 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1100075 Internal RxNorm lookup 1918042 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 68462-882-60 abiraterone acetate 60 in 1 BOTTLE TABLET 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-882 ABIRATERONE ACETATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 Current NDC, Legacy NDC, 1 package rows 20240103_ba32c453-a231-452a-a6d9-b3e57afb2e75.zip
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 68462-882-60 68462088260 60 TABLET in 1 BOTTLE (68462-882-60) 60 tablet 2022-05-19 0000-00-00 No No Current