Finasteride

Product NDC: 71713-096
11-digit product format: 717130096
Labeler code: 71713
Product ID: 71713-096_ecdd4925-db44-f8de-e053-2995a90a83ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Thirty Madison Inc
Application: ANDA091643
Marketing category: ANDA
Marketing start: 2019-06-12
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: 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	71713-096		I	Inactivated by FDA		2026-08-07
excluded package	package	71713-096	71713-096-90	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 · 18 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71713-096-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71713-096-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71713-096-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71713-096-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71713-096-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71713-096-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71713-096-90	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71713-096-90	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71713-096-90	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
71713-096-90	2025-01-30	C162847	48780-1	2cef2736-59ba-d83d-e063-dadaa90ab31f	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
71713-096-90	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71713-096-90	EA - Each	71713-096	4ad6e2ac-bd64-4e82-8f17-146c99bb101e	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71713-096	FINASTERIDE TABLET, FILM COATED [THIRTY MADISON INC]	2	Legacy NDC, 1 package rows	20221108_df82de18-6113-4644-a54d-b57b646956c6.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	df82de18-6113-4644-a54d-b57b646956c6	2
200172	finasteride 1 MG Oral Tablet	SCD	df82de18-6113-4644-a54d-b57b646956c6	2
200172	FIN5C 1 MG Oral Tablet	SY	df82de18-6113-4644-a54d-b57b646956c6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71713-096-90	71713009690	90 TABLET, FILM COATED in 1 BOTTLE (71713-096-90)	2019-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Finasteride	Thirty Madison Inc \| Intas Pharmaceuticals Limited.	2022-11-07	HUMAN PRESCRIPTION DRUG LABEL	2