Bicalutamide

Product NDC: 63629-8308
Requested package NDC: 63629-8308-2
11-digit product format: 636298308
Labeler code: 63629
Product ID: 63629-8308_01c32f48-8661-4d25-8e50-c6c97180cc42
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bicalutamide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078917
Marketing category: ANDA
Marketing start: 2009-07-06
Substance: BICALUTAMIDE
Active strength: 50 mg/1
Pharmacologic classes: Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-8308	63629-8308-2	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A078917-001	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
A078917-001	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	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078917-001	BICALUTAMIDE	50MG	TABLET / ORAL	AB	2009-07-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078917-001	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	A078917-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078917-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078917-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078917-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078917-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078917-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078917-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078917-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078917-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078917-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078917-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078917-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078917-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078917-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078917-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078917-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078917-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078917-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078917-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078917-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078917-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078917-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078917-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078917-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078917-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078917-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078917-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078917-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078917-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078917-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078917-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078917-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078917-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078917-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078917-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078917-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078917-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078917-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078917-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078917-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bicalutamide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BICALUTAMIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
A0Z3NAU9DP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199123	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
6d27f9b0-6b93-42fa-807e-fc819c0da14f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
18edadb0-25ee-467f-798d-437ee65ee754	Product name	3	20150616

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-8308-1	2024-05-10	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
63629-8308-2	2024-05-10	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
63629-8308-1	2024-01-30	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
63629-8308-2	2024-01-30	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8308-1	Bicalutamide	30 in 1 BOTTLE	TABLET	30		3
63629-8308-2	Bicalutamide	100 in 1 BOTTLE	TABLET	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8308	BICALUTAMIDE TABLET [BRYANT RANCH PREPACK]	3	Current NDC, Legacy NDC, 2 package rows	20240511_6d27f9b0-6b93-42fa-807e-fc819c0da14f.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
Bicalutamide	BICALUTAMIDE	Golden State Medical Supply, Inc.	7c9a8877-7364-4a3c-9345-78279fa282eb	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078917 application number: ANDA078917
Bicalutamide	BICALUTAMIDE	Bryant Ranch Prepack	6d27f9b0-6b93-42fa-807e-fc819c0da14f	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078917 application number: ANDA078917 ndc (package): 63629-8308-2 ndc (product): 63629-8308 ndc11 (package): 63629830802
Bicalutamide	BICALUTAMIDE	Accord Healthcare Inc.	7c295b64-ec39-42ec-9f02-da5b42e775e1	2024-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078917 application number: ANDA078917
Bicalutamide	BICALUTAMIDE	Proficient Rx LP	c5c04006-0078-4fd7-9ecd-c50d8d9fa5d6	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078917 application number: ANDA078917

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199123	bicalutamide 50 MG Oral Tablet	PSN	6d27f9b0-6b93-42fa-807e-fc819c0da14f	3
199123	bicalutamide 50 MG Oral Tablet	SCD	6d27f9b0-6b93-42fa-807e-fc819c0da14f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8308-2	63629830802	100 TABLET in 1 BOTTLE (63629-8308-2)	100 tablet	2020-03-16	0000-00-00	No	No	Current