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 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
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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210308-001	YONSA	125MG	TABLET / ORAL	AB	RLD, RS	2018-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210308-001	YONSA	125MG	TABLET / ORAL	AB	RLD, RS	2018-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210308-001	YONSA	125MG	TABLET / ORAL	AB	RLD, RS	2018-05-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210308-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210308-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210308-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210308-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`bb7c543d1eb4…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
445e70a1-25bd-8fc1-e063-6394a90a1a43	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e8e8aba9-b811-8b6a-ff1e-1aec10655d95	Product name	8	20240223
8f213b7a-23f6-497c-a54d-8a37f1798781	Product name	1	20231023
fb7d5d26-0d70-42a5-a005-42898b3cfc3f	Product name	1	20180730

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-503-12	EA - Each	51407-503	5ec63675-3360-4ed1-a41d-8cb127c7a841	1	2026-01-08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABIRATERONE ACETATE	ABIRATERONE ACETATE	Golden State Medical Supply, Inc.	445e70a1-25bd-8fc1-e063-6394a90a1a43	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210308 application number: NDA210308 ndc (product): 51407-503
YONSA	ABIRATERONE ACETATE	Sun Pharmaceutical Industries, Inc.	b8967e10-f768-47ce-ac9e-2324c8390132	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210308 application number: NDA210308

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EM5OCB9YJ6	ABIRATERONE ACETATE	154229-18-2	ABIRATERONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2046579	abiraterone acetate 125 MG Oral Tablet	PSN	445e70a1-25bd-8fc1-e063-6394a90a1a43	2
2046579	abiraterone acetate 125 MG Oral Tablet	SCD	445e70a1-25bd-8fc1-e063-6394a90a1a43	2

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