Abiraterone Acetate

Product NDC: 16714-963
Requested package NDC: 16714-963-01
11-digit product format: 167140963
Labeler code: 16714
Product ID: 16714-963_564a91be-2efd-3ec5-1996-1491749f271e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abiraterone Acetate
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA208416
Marketing category: ANDA
Marketing start: 2020-05-19
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

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
A208416-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2020-05-18
A208416-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2023-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208416-001	AB
A208416-002	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 · 61 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	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`8869cabd3fbd…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 61 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	A208416-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208416-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208416-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208416-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208416-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208416-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208416-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208416-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208416-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208416-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208416-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208416-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208416-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208416-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208416-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208416-001	AB	1	`8869cabd3fbd…`

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: 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
39434b24-bf64-f5c9-fbb6-b0d225099424	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
16714-963-01	Abiraterone Acetate	120 in 1 BOTTLE	TABLET	120		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-963	ABIRATERONE ACETATE TABLET [NORTHSTAR RX LLC]	4	Current NDC, Legacy NDC, 1 package rows	20231227_39434b24-bf64-f5c9-fbb6-b0d225099424.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abiraterone Acetate	ABIRATERONE ACETATE	AvPAK	5108c2fe-9706-c976-e063-6294a90a796d	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416
Abiraterone Acetate	ABIRATERONE ACETATE	Dr. Reddys Laboratories Inc	0c91aa38-3b0a-232c-8eb1-55f08e8e6644	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416
Abiraterone Acetate	ABIRATERONE ACETATE	NorthStar Rx LLC	39434b24-bf64-f5c9-fbb6-b0d225099424	2023-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416 ndc (package): 16714-963-01 ndc (product): 16714-963 ndc11 (package): 16714096301
Abiraterone Acetate	ABIRATERONE ACETATE	Dr. Reddys Laboratories Inc	7eda0d98-c2ba-c117-b757-1f566292e789	2023-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416

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	39434b24-bf64-f5c9-fbb6-b0d225099424	4
1100075	abiraterone acetate 250 MG Oral Tablet	SCD	39434b24-bf64-f5c9-fbb6-b0d225099424	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-963-01	16714096301	120 TABLET in 1 BOTTLE (16714-963-01)	120 tablet	2020-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Abiraterone Acetate	NorthStar Rx LLC \| Dr.Reddy's Laboratories Limited FTO-7	2023-12-26	HUMAN PRESCRIPTION DRUG LABEL	4