Bicalutamide

Product NDC: 16714-816
11-digit product format: 167140816
Labeler code: 16714
Product ID: 16714-816_96d5cdb2-e538-fecd-e053-2995a90aace4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bicalutamide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northstar RxLLC
Application: ANDA078917
Marketing category: ANDA
Marketing start: 2018-06-01
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: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16714-816		D	Discontinued by firm	2026-08-17
excluded package	package	16714-816	16714-816-01	D	Discontinued by firm	2026-08-17
excluded package	package	16714-816	16714-816-02	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 · 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-816	16714-816-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
16714-816-01	EA - Each	16714-816	cbc0d226-982c-4195-a632-ced8065bd8ad	1	2018-10-11
16714-816-02	EA - Each	16714-816	c8ca8cd7-5b1c-432c-993e-29d20b61943a	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-816	BICALUTAMIDE TABLET, FILM COATED [NORTHSTAR RXLLC]	3	Legacy NDC	20240718_ad46d58b-3f81-4bcf-bf5f-de70c8b6c930.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	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-816-01	16714081601	30 TABLET, FILM COATED in 1 BOTTLE (16714-816-01)	2018-06-01	0000-00-00	No	No	Current
16714-816-02	16714081602	100 TABLET, FILM COATED in 1 BOTTLE (16714-816-02)	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bicalutamide	Northstar RxLLC \| Intas Pharmaceuticals Limited	2024-07-17	HUMAN PRESCRIPTION DRUG LABEL	3