ABIRATERONE ACETATE

Product NDC: 60219-1754
11-digit product format: 602191754
Labeler code: 60219
Product ID: 60219-1754_7bb0d9aa-97d5-483c-9ab8-2f2fff30cbcd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ABIRATERONE
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA208327
Marketing category: ANDA
Marketing start: 2023-04-28
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
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 · 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
2026-09-14 22:38:34	2026-08	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`84e616aacf4f…`
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…`

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
2026-09-14 22:38:34	2026-08	A208327-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208327-002	AB	1	`84e616aacf4f…`
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…`

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…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1100075	Internal RxNorm lookup
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
6fda6b92-59ed-4180-af68-94052a5e82cf	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
60219-1754-6	ABIRATERONE ACETATE	60 in 1 BOTTLE	TABLET	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1754	ABIRATERONE ACETATE (ABIRATERONE) TABLET ABIRATERONE ACETATE (ABIRATERONE) TABLET [AMNEAL PHARMACEUTICALS NY LLC]	2	Current NDC, 1 package rows	20240420_6fda6b92-59ed-4180-af68-94052a5e82cf.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abiraterone Acetate	ABIRATERONE	Amneal Pharmaceuticals LLC	6fda6b92-59ed-4180-af68-94052a5e82cf	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327 ndc (product): 60219-1754
ABIRATERONE ACETATE	ABIRATERONE	AvKARE	c1200e4e-c4f7-9067-e053-2a95a90af509	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327
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	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1100075	abiraterone acetate 250 MG Oral Tablet	PSN	6fda6b92-59ed-4180-af68-94052a5e82cf	2
1918042	abiraterone acetate 500 MG Oral Tablet	PSN	6fda6b92-59ed-4180-af68-94052a5e82cf	2
1100075	abiraterone acetate 250 MG Oral Tablet	SCD	6fda6b92-59ed-4180-af68-94052a5e82cf	2
1918042	abiraterone acetate 500 MG Oral Tablet	SCD	6fda6b92-59ed-4180-af68-94052a5e82cf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60219-1754-6	60219175406	60 TABLET in 1 BOTTLE (60219-1754-6)	60 tablet	2023-04-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Abiraterone Acetate	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2026-10-05	HUMAN PRESCRIPTION DRUG LABEL	4