ABIRATERONE ACETATE

Product NDC: 42291-073
Requested package NDC: 42291-073-60
11-digit product format: 422910073
Labeler code: 42291
Product ID: 42291-073_ec19a5c9-a06e-4082-e053-2995a90aba71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ABIRATERONE
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA208327
Marketing category: ANDA
Marketing start: 2021-04-29
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A208327-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2019-01-07
A208327-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2020-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208327-001	AB
A208327-002	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 · 76 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
2026-08-18 06:07:40	2026-07	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208327-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208327-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208327-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208327-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208327-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208327-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208327-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208327-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208327-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208327-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208327-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208327-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208327-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208327-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208327-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208327-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208327-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208327-001	AB	1	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208327-001	PC	2019-04-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A208327-001	PC	2019-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208327-001	PC	2019-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208327-001	PC	2019-04-29	`ea99ee380514…`

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
c1200e4e-c4f7-9067-e053-2a95a90af509	Available on FDA.report

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-073-60	EA - Each	42291-073	1f0dbb44-9fee-4dd9-98ef-6fba68a4546b	1	2021-06-02

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABIRATERONE ACETATE	ABIRATERONE	AvKARE	c1200e4e-c4f7-9067-e053-2a95a90af509	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327 ndc (package): 42291-073-60 ndc (product): 42291-073 ndc11 (package): 42291007360
Abiraterone Acetate	ABIRATERONE	AvKARE	7f82d549-6654-1efd-e053-2991aa0aa28d	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327
Abiraterone Acetate	ABIRATERONE	American Health Packaging	b36bff33-595e-4827-9a73-85c6954c314c	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327
Abiraterone Acetate	ABIRATERONE	Amneal Pharmaceuticals NY LLC	6fda6b92-59ed-4180-af68-94052a5e82cf	2023-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327
Abiraterone Acetate	ABIRATERONE	Amneal Pharmaceuticals NY LLC	c9eb9b46-f847-40a8-802c-a51b40406d5a	2023-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EM5OCB9YJ6	ABIRATERONE ACETATE	154229-18-2	ABIRATERONE ACETATE
G819A456D0	ABIRATERONE	154229-19-3	ABIRATERONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-073-60	42291007360	60 TABLET in 1 BOTTLE (42291-073-60)	60 tablet	2021-04-29	0000-00-00	No	No	Current