Abiraterone

Product NDC: 69539-049
Requested package NDC: 69539-049-92
11-digit product format: 695390049
Labeler code: 69539
Product ID: 69539-049_2c63b39b-45a2-48d0-a2c4-c39b2e5e4861
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Abiraterone acetate
Dosage form: TABLET
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA210686
Marketing category: ANDA
Marketing start: 2019-07-10
Marketing end: 0000-00-00
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69539-049	69539-049-92	D	Discontinued by firm		2026-08-03

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-049	69539-049-92	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210686-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2019-07-10
A210686-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2024-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210686-001	AB
A210686-002	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 · 56 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
2026-02-19 14:30 UTC	2026-02	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`b00525d2431f…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210686-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210686-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210686-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210686-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210686-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210686-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210686-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210686-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210686-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210686-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210686-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210686-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210686-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210686-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210686-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210686-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210686-001	AB	1	`b00525d2431f…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-049	ABIRATERONE (ABIRATERONE ACETATE) TABLET ABIRATERONE (ABIRATERONE ACETATE) TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]	10	Legacy NDC	20240525_0a84f388-a8b4-4065-93a6-1c663c99d265.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abiraterone	ABIRATERONE ACETATE	BluePoint Laboratories	32f6b83d-c743-4934-9a20-1b5bf9f4eea3	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210686 application number: ANDA210686
Abiraterone	ABIRATERONE ACETATE	Novadoz Pharmaceuticals LLC	88d05db3-8bdc-47f1-bb00-6b4a71f98609	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210686 application number: ANDA210686
Abiraterone	ABIRATERONE ACETATE	Quallent Pharmaceuticals Health LLC	6f5b628b-69da-4a04-a4d5-623b18d1fd5d	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210686 application number: ANDA210686

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
69539-049-92	69539004992	120 TABLET in 1 BOTTLE (69539-049-92)	120 tablet	2019-07-10	0000-00-00	No	No	Current