Bicalutamide

Product NDC: 65841-613
Requested package NDC: 65841-613-10
11-digit product format: 658410613
Labeler code: 65841
Product ID: 65841-613_03a74f00-132e-4a48-ba2e-4adf7c3f3170
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bicalutamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA079089
Marketing category: ANDA
Marketing start: 2009-07-06
Marketing end: 0000-00-00
Substance: BICALUTAMIDE
Active strength: 50 mg/1
Pharmacologic classes: Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	65841-613	65841-613-10	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
A079089-001	BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET / ORAL	AB		2009-07-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079089-001	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	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079089-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`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	A079089-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079089-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079089-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079089-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079089-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079089-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079089-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079089-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079089-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079089-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079089-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079089-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079089-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079089-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079089-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079089-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079089-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079089-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079089-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079089-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079089-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079089-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079089-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079089-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079089-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079089-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079089-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079089-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079089-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079089-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079089-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079089-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079089-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079089-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079089-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079089-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079089-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079089-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079089-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079089-001	AB	1	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BICALUTAMIDE	ACTIVE INGREDIENT	A0Z3NAU9DP	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
BICALUTAMIDE	ACTIVE MOIETY	A0Z3NAU9DP	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BICALUTAMIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2

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
Bicalutamide	BICALUTAMIDE	PINNACLE LIFE SCIENCE PRIVATE LIMITED	8e7747d8-0e4f-4284-9cd1-407d0fe5b946	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079089 application number: ANDA079089
Bicalutamide	BICALUTAMIDE	Viona Pharmaceuticals Inc.	5a7cbe80-f119-4b3d-949a-c7824ea91908	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079089 application number: ANDA079089

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A0Z3NAU9DP	BICALUTAMIDE	90357-06-5	BICALUTAMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-613-10	65841061310	1000 TABLET, FILM COATED in 1 BOTTLE (65841-613-10)	2009-07-06	0000-00-00	No	No	Current