Finasteride

Product NDC: 68071-2620
11-digit product format: 680712620
Labeler code: 68071
Product ID: 68071-2620_d5e408f7-7008-1db8-e053-2a95a90af95f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA207750
Marketing category: ANDA
Marketing start: 2017-01-06
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	68071-2620		D	Discontinued by firm		2026-08-11
excluded package	package	68071-2620	68071-2620-9	D	Discontinued by firm		2026-08-11

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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2620-9	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2620-9	D	Discontinued by firm	`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	68071-2620-9	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	68071-2620-9	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	68071-2620-9	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	68071-2620-9	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	68071-2620-9	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	68071-2620-9	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	68071-2620-9	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
A207750-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL	AB		2017-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207750-001	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	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207750-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2017-01-06	`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	A207750-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207750-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207750-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207750-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207750-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207750-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207750-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207750-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207750-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207750-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207750-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207750-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207750-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207750-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207750-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207750-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207750-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207750-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207750-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207750-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207750-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207750-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207750-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207750-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207750-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207750-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207750-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207750-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207750-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207750-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207750-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207750-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207750-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207750-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207750-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207750-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207750-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207750-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207750-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207750-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2620-9	2025-05-02	C162847	48780-1	2cef2736-7237-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
68071-2620-9	2025-01-30	C162847	48780-1	2cef2736-7237-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

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	REMEDYREPACK INC.	90cc0d22-fa5c-4fe4-b0bf-554b715a05ac	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	A-S Medication Solutions	49eb3a1e-d7e6-4652-aa6d-6abf21af34a6	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	b84a67d6-695e-4a7c-9b60-95e9ad18a501	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	Ascend Laboratories, LLC	ecd2fbb2-a4bd-44f2-831d-179e7dbf0741	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	291a2037-2b4f-a2fe-e063-6294a90a1e9a	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	Bryant Ranch Prepack	3e955ce4-d44e-4b4d-b763-ab141cb3f06d	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	Proficient Rx LP	196f7d23-ed90-46c2-ae34-615e6ec1650b	2023-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750
Finasteride	FINASTERIDE	Thirty Madison Inc	3fe7bdaa-b027-4da9-94ee-550bf28c63e1	2021-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207750 application number: ANDA207750

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2620-9	68071262009	90 TABLET, COATED in 1 BOTTLE (68071-2620-9)	2022-01-18	0000-00-00	No	No	Current