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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 2026-08-01 22:54:32 2026-06 A215086-001 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2023-03-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A215086-001 AB 1 a50c72e98297…
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 · 1 matching rows.
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
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