Abiraterone Acetate

Product NDC: 60505-4327
11-digit product format: 605054327
Labeler code: 60505
Product ID: 60505-4327_0eeb49ee-ae24-1cac-cf45-7b6064981875
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abiraterone Acetate
Dosage form: TABLET
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA208453
Marketing category: ANDA
Marketing start: 2018-11-23
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-4327	60505-4327-3	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 · 12 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A208453-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208453-001	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 · 42 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	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208453-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A208453-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208453-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208453-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208453-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208453-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208453-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208453-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208453-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208453-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208453-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208453-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208453-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208453-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208453-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208453-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208453-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208453-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208453-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208453-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208453-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208453-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208453-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208453-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208453-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208453-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208453-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208453-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208453-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208453-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208453-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208453-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208453-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208453-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208453-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208453-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208453-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208453-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208453-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208453-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208453-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Abiraterone Acetate
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1100075	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
2ac063f0-4177-c90f-27c3-e70e29689255	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
60505-4327-1	Abiraterone Acetate	120 in 1 BOTTLE	TABLET	120		10
60505-4327-3	Abiraterone Acetate	360 in 1 BOTTLE	TABLET	360		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4327-1	EA - Each	60505-4327	dab732de-d86a-4c80-b693-e1791eedf6eb	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-4327	ABIRATERONE ACETATE TABLET [APOTEX CORP.]	9	Current NDC, Legacy NDC, 2 package rows	20240919_2ac063f0-4177-c90f-27c3-e70e29689255.zip

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	Major Pharmaceuticals	49809a29-6558-43a3-a347-5027de44aa41	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208453 application number: ANDA208453
Abiraterone Acetate	ABIRATERONE ACETATE	Apotex Corp.	2ac063f0-4177-c90f-27c3-e70e29689255	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208453 application number: ANDA208453 ndc (product): 60505-4327

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
1100075	abiraterone acetate 250 MG Oral Tablet	PSN	2ac063f0-4177-c90f-27c3-e70e29689255	10
1100075	abiraterone acetate 250 MG Oral Tablet	SCD	2ac063f0-4177-c90f-27c3-e70e29689255	10
1100075	abiraterone acetate 250 MG Oral Tablet	PSN	49809a29-6558-43a3-a347-5027de44aa41	5
1100075	abiraterone acetate 250 MG Oral Tablet	SCD	49809a29-6558-43a3-a347-5027de44aa41	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-4327-1	60505432701	120 TABLET in 1 BOTTLE (60505-4327-1)	120 tablet	2018-11-23	0000-00-00	No	No	Current
60505-4327-3	60505432703	360 TABLET in 1 BOTTLE (60505-4327-3)	360 tablet	2018-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Abiraterone Acetate	Major Pharmaceuticals	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	5
Abiraterone Acetate	Apotex Corp. \| Apotex Inc.	2025-09-16	HUMAN PRESCRIPTION DRUG LABEL	10