Abiraterone Acetate

Product NDC: 51407-989
11-digit product format: 514070989
Labeler code: 51407
Product ID: 51407-989_58b88ccb-29f6-b90a-e063-6294a90ac62e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: abiraterone acetate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA208446
Marketing category: ANDA
Marketing start: 2020-12-14
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208446-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2018-10-31
A208446-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2020-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208446-001	AB
A208446-002	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.

Product history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208446-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208446-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208446-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208446-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208446-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208446-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208446-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208446-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208446-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208446-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208446-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208446-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208446-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208446-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208446-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208446-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208446-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208446-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208446-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208446-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208446-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208446-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208446-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208446-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208446-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208446-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208446-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208446-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208446-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208446-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208446-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208446-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208446-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208446-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208446-001	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
58b88e76-eba4-2471-e063-6394a90ad988	Available on FDA.report

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 · 3 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.	58b88e76-eba4-2471-e063-6394a90ad988	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208446 application number: ANDA208446 ndc (product): 51407-989
Abiraterone Acetate	ABIRATERONE ACETATE	Mylan Pharmaceuticals Inc.	fe02db79-fa04-441f-b514-70bd74af6624	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208446 application number: ANDA208446
Abiraterone Acetate	ABIRATERONE ACETATE	Bryant Ranch Prepack	79082b18-adde-4ffb-832a-b8c1d030c413	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208446 application number: ANDA208446

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51407-989-60	51407098960	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-989-60)	2026-06-17	No	No	Current