Home NDC 60219-1754 ABIRATERONE ACETATE
Product NDC 60219-1754
11-digit product format 602191754
Labeler code 60219
Product ID 60219-1754_1dfa3ed4-c682-4169-b39c-4415008774dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ABIRATERONE
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA208327
Marketing category ANDA
Marketing start 2023-04-28
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 44 .
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 A208327-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 A208327-002 ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23
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 · 80 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 2026-10-15 13:18:30 2026-09 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208327-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-01-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208327-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2020-12-23 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 A208327-001 PC 2019-04-29 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A208327-001 PC 2019-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208327-001 PC 2019-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208327-001 PC 2019-04-29 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60219-1754-6 ABIRATERONE ACETATE 60 in 1 BOTTLE TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-1754 ABIRATERONE ACETATE (ABIRATERONE) TABLET ABIRATERONE ACETATE (ABIRATERONE) TABLET [AMNEAL PHARMACEUTICALS NY LLC] 2 Current NDC, 1 package rows 20240420_6fda6b92-59ed-4180-af68-94052a5e82cf.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60219-1754-6 60219175406 60 TABLET in 1 BOTTLE (60219-1754-6) 60 tablet 2023-04-28 No No Current