Home NDC 68462-135 abiraterone acetate
Product NDC 68462-135
11-digit product format 684620135
Labeler code 68462
Product ID 68462-135_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 2019-10-16
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 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.
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 · 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 68462-135-08 abiraterone acetate 120 in 1 BOTTLE TABLET 120 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-135 ABIRATERONE ACETATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 6 Current NDC, Legacy NDC, 1 package rows 20240103_ba32c453-a231-452a-a6d9-b3e57afb2e75.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 68462-135-08 68462013508 120 TABLET in 1 BOTTLE (68462-135-08) 120 tablet 2019-10-16 0000-00-00 No No Current