Finasteride

Product NDC: 68071-3354
Requested package NDC: 68071-3354-9
11-digit product format: 680713354
Labeler code: 68071
Product ID: 68071-3354_1ce8f294-6f83-88c2-e063-6294a90a6d94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090121
Marketing category: ANDA
Marketing start: 2010-05-28
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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A090121-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2010-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090121-001	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	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090121-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-02-23	`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	A090121-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090121-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090121-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090121-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090121-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090121-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090121-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090121-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090121-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090121-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090121-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090121-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090121-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090121-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090121-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090121-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090121-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090121-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090121-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090121-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090121-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090121-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090121-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090121-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090121-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090121-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090121-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090121-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090121-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090121-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090121-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090121-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090121-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090121-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090121-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090121-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090121-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090121-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090121-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090121-001	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
54c73290-bdc1-3453-e054-00144ff88e88	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#

Effective, Related label table
Effective	Related label
2024-07-10	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 5 mg, for oral use Initial U.S. Approval: 1992
2023-01-30	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 5 mg, for oral use Initial U.S. Approval: 1992
2021-02-12	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 5 mg, for oral use Initial U.S. Approval: 1992
2021-01-29	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 5 mg, 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
68071-3354-9	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3354	FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20240711_54c73290-bdc1-3453-e054-00144ff88e88.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Atlantic Biologicals Corps	29e59387-120c-4367-9f87-75cb53b6460d	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121
Finasteride	FINASTERIDE	Bryant Ranch Prepack	ef9c0b23-4736-4fb0-862c-c2a4d644e0d6	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121
Finasteride	FINASTERIDE	Accord Healthcare, Inc.	adfb8f6b-a7bb-4ac2-b2aa-fec6d56630ad	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	54c73290-bdc1-3453-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121 ndc (package): 68071-3354-9 ndc (product): 68071-3354 ndc11 (package): 68071335409
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	549aab5d-819a-1691-e054-00144ff88e88	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121
Finasteride	FINASTERIDE	Proficient Rx LP	e9ea2f77-11c3-4dbf-bdc4-d1b0e7437990	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121
Finasteride	FINASTERIDE	Bryant Ranch Prepack	88511bd5-624e-49d6-b80e-1f1d47314fb6	2020-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090121 application number: ANDA090121

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	54c73290-bdc1-3453-e054-00144ff88e88	4
310346	finasteride 5 MG Oral Tablet	SCD	54c73290-bdc1-3453-e054-00144ff88e88	4
310346	FIN5C 5 MG Oral Tablet	SY	54c73290-bdc1-3453-e054-00144ff88e88	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-3354-9	68071335409	90 TABLET, FILM COATED in 1 BOTTLE (68071-3354-9)	2017-07-20	0000-00-00	No	No	Current