Finasteride

Product NDC: 68071-3993
11-digit product format: 680713993
Labeler code: 68071
Product ID: 68071-3993_51287e51-ed53-7fe6-e063-6294a90a93a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA203687
Marketing category: ANDA
Marketing start: 2013-11-05
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203687-001	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
A203687-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203687-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203687-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203687-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203687-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203687-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203687-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203687-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203687-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203687-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203687-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203687-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203687-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203687-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203687-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203687-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203687-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203687-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203687-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203687-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203687-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203687-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203687-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203687-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203687-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203687-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203687-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203687-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203687-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203687-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203687-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203687-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203687-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203687-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203687-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203687-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203687-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203687-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203687-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203687-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203687-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Finasteride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FINASTERIDE	1 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
200172	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
51286a03-c29c-2c0b-e063-6394a90af33c	Available on FDA.report

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.	03429cec-c6b5-47fe-bb11-6b42f977df7e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	51286a03-c29c-2c0b-e063-6394a90af33c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687 ndc (product): 68071-3993
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	74b90430-8ce1-470c-939c-685ca9dfd74f	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	8488cd17-365c-701c-e053-2991aa0af5f9	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Burel Pharmaceuticals, LLC	c8516eaa-98d0-4eb1-bc65-aa765baea5db	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Rising Pharma Holdings, Inc.	01b88593-99d3-4dd6-a7b6-5438c15bd7b7	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Aurobindo Pharma Limited	7d140366-2388-488e-bd86-67e6edf44345	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Asclemed USA, Inc.	b2cac9e5-ea52-44b7-ae88-78e11a732904	2022-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687

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	Sample	Exclude flag	Status
68071-3993-3	68071399303	30 TABLET, FILM COATED in 1 BOTTLE (68071-3993-3)	2026-05-06	No	No	Current