Home NDC 71921-177 Abiraterone acetate
Product NDC 71921-177
11-digit product format 719210177
Labeler code 71921
Product ID 71921-177_2b8d3621-3b8b-286c-e063-6294a90a7ac2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abiraterone acetate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Florida Pharmaceutical Products, LLC
Application ANDA215086
Marketing category ANDA
Marketing start 2023-04-10
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 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 71921-177 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 71921-177 71921-177-06 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A215086-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215086-001 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.
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 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Abiraterone acetate
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 71921-177-06 Abiraterone acetate 60 in 1 BOTTLE TABLET, FILM COATED 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71921-177 ABIRATERONE ACETATE TABLET, FILM COATED [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] 3 Current NDC, 1 package rows 20250114_68121a71-5024-4f9e-bd9c-2d412f6a6355.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71921-177-06 71921017706 60 TABLET, FILM COATED in 1 BOTTLE (71921-177-06) 2023-04-10 No No Current