Abiraterone

Product NDC: 69539-049
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	69539-049		D	Discontinued by firm		2026-08-03
excluded package	package	69539-049	69539-049-92	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

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

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

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 product	product	69539-049		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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