Home NDC 72205-030 Abiraterone
Product NDC 72205-030
11-digit product format 722050030
Labeler code 72205
Product ID 72205-030_a87a3fa5-28cb-42be-9039-af800a7c482c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Abiraterone acetate
Dosage form TABLET
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA210686
Marketing category ANDA
Marketing start 2019-07-10
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210686-001 ABIRATERONE ACETATE ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 A210686-002 ABIRATERONE ACETATE ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24
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 · 56 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 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210686-002 ABIRATERONE ACETATE 500MG TABLET / ORAL AB 2024-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210686-001 ABIRATERONE ACETATE 250MG TABLET / ORAL AB 2019-07-10 b00525d2431f…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Abiraterone
Listing expiration 2026-12-31 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 72205-030-92 Abiraterone 120 in 1 BOTTLE TABLET 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-030 ABIRATERONE (ABIRATERONE ACETATE) TABLET ABIRATERONE (ABIRATERONE ACETATE) TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240525_88d05db3-8bdc-47f1-bb00-6b4a71f98609.zip
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 72205-030-92 72205003092 120 TABLET in 1 BOTTLE (72205-030-92) 120 tablet 2019-07-10 0000-00-00 No No Current