Home NDC 51407-503 Abiraterone Acetate
Product NDC 51407-503
11-digit product format 514070503
Labeler code 51407
Product ID 51407-503_48d6c090-b0d3-a69e-e063-6394a90ae49a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abiraterone acetate
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application NDA210308
Marketing category NDA
Marketing start 2018-05-22
Substance ABIRATERONE ACETATE
Active strength 125 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210308-001 YONSA ABIRATERONE ACETATE 125MG TABLET / ORAL RLD, RS 2018-05-22
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210308-001 9889144 2034-03-17 Drug product 2018-07-19 N210308-001 10292990 2034-05-20 U-2535 2019-05-31
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 N210308-001 YONSA 125MG TABLET / ORAL RLD, RS 2018-05-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N210308-001 9889144 2034-03-17 Drug product 2018-07-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N210308-001 10292990 2034-05-20 U-2535 2019-05-31 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 · 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 125 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 2046579 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 51407-503-12 Abiraterone Acetate 120 in 1 BOTTLE, PLASTIC TABLET 120 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51407-503-12 51407050312 120 TABLET in 1 BOTTLE, PLASTIC (51407-503-12) 120 tablet 2025-09-04 No No Current