Finasteride

Product NDC: 68071-2999
11-digit product format: 680712999
Labeler code: 68071
Product ID: 68071-2999_2d53f0d0-c914-0b79-e063-6294a90a6bb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA204304
Marketing category: ANDA
Marketing start: 2017-01-05
Substance: FINASTERIDE
Active strength: 5 mg/1
Pharmacologic classes: 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
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 · 6 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
2025-02-02 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	68071-2999-9	`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	68071-2999-9	`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	68071-2999-9	`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
A204304-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2017-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204304-001	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	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204304-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2017-01-05	`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	A204304-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204304-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204304-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204304-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204304-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204304-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204304-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204304-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204304-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204304-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204304-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204304-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204304-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204304-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204304-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204304-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204304-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204304-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204304-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204304-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204304-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204304-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204304-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204304-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204304-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204304-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204304-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204304-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204304-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204304-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204304-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204304-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204304-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204304-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204304-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204304-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204304-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204304-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204304-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204304-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FINASTERIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57GNO57U7G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310346	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
fe7e6ea7-583e-22d4-e053-6394a90a2526	Available on FDA.report

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
68071-2999-9	2025-02-04	C162847	48780-1	2cef2736-6a00-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
68071-2999-9	2025-01-30	C162847	48780-1	2cef2736-6a00-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
68071-2999-9	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2999	FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250206_fe7e6ea7-583e-22d4-e053-6394a90a2526.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Ascend Laboratories, LLC	9b38c8c7-01e4-45d0-b4ee-3546d9ad849c	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	REMEDYREPACK INC.	aa3fcd1a-02a1-49db-b40e-75e623d730e1	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Direct_Rx	13673a09-8a50-5cd0-e063-6294a90a3d5b	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	33295dce-1e81-4187-bce1-d9b332ea062e	2025-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	fe7e6ea7-583e-22d4-e053-6394a90a2526	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304 ndc (product): 68071-2999
Finasteride	FINASTERIDE	Bryant Ranch Prepack	a7a3af01-de3f-4cd4-ba05-a41ca0544ac2	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	A-S Medication Solutions	e6ee2f07-63a6-4fde-88de-654bf633529e	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	A-S Medication Solutions	5e69ea84-dc5a-4aac-9353-4920c6f7b3aa	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Proficient Rx LP	e31a5901-ef04-4515-bca4-79118a3f3797	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304
Finasteride	FINASTERIDE	Aphena Pharma Solutions - Tennessee, LLC	845cad9c-c50d-4c98-8df8-893d1241836a	2022-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204304 application number: ANDA204304

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
310346	finasteride 5 MG Oral Tablet	PSN	fe7e6ea7-583e-22d4-e053-6394a90a2526	2
310346	finasteride 5 MG Oral Tablet	SCD	fe7e6ea7-583e-22d4-e053-6394a90a2526	2
310346	FIN5C 5 MG Oral Tablet	SY	fe7e6ea7-583e-22d4-e053-6394a90a2526	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-2999-9	68071299909	90 TABLET, FILM COATED in 1 BOTTLE (68071-2999-9)	2023-06-19	No	No	Current