Abiraterone Acetate

Product NDC: 42292-057
11-digit product format: 422920057
Labeler code: 42292
Product ID: 42292-057_d3aef164-ffc6-d7a6-e053-2a95a90a5711
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: abiraterone acetate
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA208446
Marketing category: ANDA
Marketing start: 2020-06-03
Marketing end: 2022-02-28
Substance: ABIRATERONE ACETATE
Active strength: 250 mg/1
Pharmacologic classes: Cytochrome P450 17A1 Inhibitors [MoA],Cytochrome P450 17A1 Inhibitor [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42292-057		D	Discontinued by firm		2026-08-17
excluded package	package	42292-057	42292-057-03	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42292-057-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42292-057-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42292-057-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42292-057-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42292-057-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42292-057-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42292-057-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42292-057-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42292-057-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42292-057-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42292-057-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42292-057-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 78 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	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…`
2022-03-09 01:35 UTC	2022-03	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	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…`
2022-03-09 01:35 UTC	2022-03	A208446-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208446-001	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42292-057-01	EA - Each	42292-057	2a12e42d-f1c4-4353-8c69-bc76c56844e9	1	2020-07-13
42292-057-03	EA - Each	42292-057	544cba86-c958-4cac-b80d-1c9349f2bd3e	1	2020-07-13

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
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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42292-057-03	42292005703	30 BLISTER PACK in 1 CARTON (42292-057-03) > 1 TABLET in 1 BLISTER PACK (42292-057-01)	30 blister pack	2020-06-03	0000-00-00	No	No	Current