Bicalutamide

Product NDC: 0904-6019
11-digit product format: 009046019
Labeler code: 0904
Product ID: 0904-6019_ca1ad8ef-c41f-4ad8-b451-75cd9068bbdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bicalutamide
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA078917
Marketing category: ANDA
Marketing start: 2010-05-11
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-6019		D	Discontinued by firm		2026-08-17
excluded package	package	0904-6019	0904-6019-46	D	Discontinued by firm		2026-08-17

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6019-46	EA - Each	0904-6019	4d0e2c72-278b-4aa7-800e-93e0b12c8d78	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BICALUTAMIDE	ACTIVE INGREDIENT	A0Z3NAU9DP	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
BICALUTAMIDE	ACTIVE MOIETY	A0Z3NAU9DP	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (5 CPS)	INACTIVE INGREDIENT	R75537T0T4	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6019	BICALUTAMIDE TABLET [MAJOR PHARMACEUTICALS]	6	Legacy NDC	20240612_82d4877e-6ebf-4f75-a108-28dc840b07fc.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6019-46	00904601946	30 TABLET in 1 BOTTLE (0904-6019-46)	30 tablet	2010-05-11	0000-00-00	No	No	Current