Bicalutamide

Product NDC: 71335-0765
11-digit product format: 713350765
Labeler code: 71335
Product ID: 71335-0765_3e1622b3-c323-44ac-ba08-2ef16997f5c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bicalutamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076932
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: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0765		D	Discontinued by firm	2026-08-17
excluded package	package	71335-0765	71335-0765-1	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0765	71335-0765-2	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0765	71335-0765-3	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 · 56 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0765-2	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0765-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0765-3	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0765-2	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0765-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0765-3	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0765-2	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0765-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0765-3	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0765-2	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0765-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0765-3	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0765-2	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0765-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0765-3	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0765-2	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0765-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0765-3	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0765-2	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0765-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-0765-3	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0765-2	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0765-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71335-0765-3	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0765-2	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0765-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71335-0765-3	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0765-2	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0765-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71335-0765-3	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-0765-2	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-0765-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71335-0765-3	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0765-2	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0765-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71335-0765-3	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0765-2	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0765-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	71335-0765-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0765-2	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0765-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	71335-0765-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A076932-001	BICALUTAMIDE	BICALUTAMIDE	50MG	TABLET / ORAL			2009-07-06

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	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076932-001	BICALUTAMIDE	50MG	TABLET / ORAL		2009-07-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A076932-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076932-001	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-0765-1	2021-04-29	These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE tablets, for oral use Initial U.S. Approval: 1995
71335-0765-2	2021-04-29	These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE tablets, for oral use Initial U.S. Approval: 1995
71335-0765-3	2021-04-29	These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE tablets, for oral use Initial U.S. Approval: 1995
71335-0765-1	2020-01-31	These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE tablets, for oral use Initial U.S. Approval: 1995
71335-0765-2	2020-01-31	These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE tablets, for oral use Initial U.S. Approval: 1995
71335-0765-3	2020-01-31	These highlights do not include all the information needed to use BICALUTAMIDE TABLETS safely and effectively. See full prescribing information for BICALUTAMIDE TABLETS. BICALUTAMIDE tablets, for oral use Initial U.S. Approval: 1995