Finasteride

Product NDC: 50090-3942
11-digit product format: 500903942
Labeler code: 50090
Product ID: 50090-3942_64923e45-53a4-4447-8479-12f212ea13a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA091643
Marketing category: ANDA
Marketing start: 2013-11-08
Marketing end: 0000-00-00
Substance: FINASTERIDE
Active strength: 1 mg/1
Pharmacologic classes: 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	50090-3942		I	Inactivated by FDA		2026-08-07
excluded package	package	50090-3942	50090-3942-0	I	Inactivated by FDA		2026-08-07

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-3942-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3942-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3942-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3942-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3942-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3942-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3942-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3942-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3942-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3942-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3942-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3942-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-3942-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-3942-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-3942-0	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091643-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL	AB		2013-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091643-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091643-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091643-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091643-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091643-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091643-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091643-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091643-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091643-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091643-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091643-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091643-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091643-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091643-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091643-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091643-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091643-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091643-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091643-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091643-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091643-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091643-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091643-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091643-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091643-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091643-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091643-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091643-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091643-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091643-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091643-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091643-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091643-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091643-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091643-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091643-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091643-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091643-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091643-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091643-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091643-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091643-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
928d249c-35c3-4d88-a9ef-cf2f2e31b96f	Product name	1	20220706
d00474ae-23eb-a8eb-bf56-520e590cc6db	Product name	2	20170406
0f90664c-9d0e-f046-dc6a-73563cd8347e	Product name	2	20170405

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3942-0	2023-01-30	C162847	48780-1	f386c64a-2d10-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3942-0	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3942	FINASTERIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 1 package rows	20200121_976be3a0-71a7-40eb-a70c-e07968f15b55.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Accord Healthcare, Inc.	e3728709-e805-4b46-9954-2c433a865987	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091643 application number: ANDA091643
Finasteride	FINASTERIDE	Proficient Rx LP	870ab7fe-fff9-4348-b900-213c1cf05f8e	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091643 application number: ANDA091643

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57GNO57U7G	FINASTERIDE	98319-26-7	FINASTERIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200172	finasteride 1 MG Oral Tablet	PSN	976be3a0-71a7-40eb-a70c-e07968f15b55	3
200172	finasteride 1 MG Oral Tablet	SCD	976be3a0-71a7-40eb-a70c-e07968f15b55	3
200172	FIN5C 1 MG Oral Tablet	SY	976be3a0-71a7-40eb-a70c-e07968f15b55	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3942-0	50090394200	90 TABLET, FILM COATED in 1 BOTTLE (50090-3942-0)	2018-12-10	0000-00-00	No	No	Current