Finasteride

Product NDC: 50268-314
Requested package NDC: 50268-314-15
11-digit product format: 502680314
Labeler code: 50268
Product ID: 50268-314_47e3617a-bbfd-d911-e063-6294a90ace48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA090061
Marketing category: ANDA
Marketing start: 2019-01-23
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: 2027-12-31
Current FDA listing: Yes

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
A090061-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2010-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090061-001	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	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`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	A090061-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090061-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090061-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090061-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090061-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090061-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090061-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090061-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090061-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090061-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090061-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090061-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090061-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090061-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090061-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090061-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090061-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090061-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090061-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090061-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090061-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090061-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090061-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090061-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090061-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090061-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090061-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090061-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090061-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090061-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090061-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090061-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090061-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090061-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090061-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090061-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090061-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090061-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090061-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090061-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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
800fa54c-c008-ba1e-e053-2a91aa0a2b07	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-314-11	Finasteride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		5
50268-314-15	Finasteride	50 in 1 BOX	TABLET, FILM COATED	50		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-314-11	EA - Each	50268-314	39edc48a-9a54-4ba6-bc55-e681a9cdea1d	1	2019-04-11
50268-314-15	EA - Each	50268-314	f35f41cb-108d-4d1c-8c61-42821e745206	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-314	FINASTERIDE TABLET, FILM COATED [AVPAK]	4	Current NDC, Legacy NDC, 2 package rows	20220517_800fa54c-c008-ba1e-e053-2a91aa0a2b07.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	3fec2bcb-91b8-4041-9ee8-e5a4ebe5fd04	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Cardinal Health 107, LLC	22161236-6804-4a7f-86cb-cfa20bd1951e	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Preferred Pharmaceuticals, Inc.	9ae38bf5-17d7-4af1-922f-b3edb1e65392	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	REMEDYREPACK INC.	c2875bc7-e811-4860-9131-da06cecc2137	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Legacy Pharmaceutical Packaging, LLC	a3b49681-09b3-4c26-bb57-3dfd598d48b6	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	A-S Medication Solutions	2d726486-f9ef-49d1-b1ae-6b1c8650fa73	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	AvPAK	800fa54c-c008-ba1e-e053-2a91aa0a2b07	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061 ndc (package): 50268-314-15 ndc (product): 50268-314 ndc11 (package): 50268031415
Finasteride	FINASTERIDE	Major Pharmaceuticals	3272651f-b500-4d5d-9e29-22fcd8e24fcb	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Camber Pharmaceuticals, Inc.	cc9709ce-2d29-48bd-b46b-3f72114f2527	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Dr Reddys Laboratories Inc	c8ed59a3-c5b2-3156-b781-5e514b79011b	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	A-S Medication Solutions	d66fe4bd-534b-4674-a346-0cf3cdabbfaa	2024-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Aphena Pharma Solutions - Tennessee, LLC	57e73fff-2115-41ad-864b-4652f9fd4545	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061
Finasteride	FINASTERIDE	Exelan Pharmaceuticals Inc.	1c1bf77c-f99a-44e4-b71e-ce766afa99b6	2020-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090061 application number: ANDA090061

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	800fa54c-c008-ba1e-e053-2a91aa0a2b07	5
310346	finasteride 5 MG Oral Tablet	SCD	800fa54c-c008-ba1e-e053-2a91aa0a2b07	5
310346	FIN5C 5 MG Oral Tablet	SY	800fa54c-c008-ba1e-e053-2a91aa0a2b07	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-314-15	50268031415	50 BLISTER PACK in 1 BOX (50268-314-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-314-11)	50 blister pack	2019-01-23	0000-00-00	No	No	Current