Finasteride

Product NDC: 31722-525
11-digit product format: 317220525
Labeler code: 31722
Product ID: 31722-525_2c74278f-8221-8804-e063-6394a90a7eaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA090061
Marketing category: ANDA
Marketing start: 2015-06-13
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 06:07:40	2026-07	A090061-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2010-06-07	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090061-001	AB	1	`caaa826d4ba7…`
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…`

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
cc9709ce-2d29-48bd-b46b-3f72114f2527	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	SPL version
31722-525-01	Finasteride	100 in 1 BOTTLE	TABLET, FILM COATED	100	10
31722-525-05	Finasteride	500 in 1 BOTTLE	TABLET, FILM COATED	500	10
31722-525-10	Finasteride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	10
31722-525-30	Finasteride	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
31722-525-30	Finasteride	12 in 1 CASE	TABLET, FILM COATED	12	10
31722-525-90	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90	10
31722-525-90	Finasteride	12 in 1 CASE	TABLET, FILM COATED	12	10
31722-525-01	Finasteride	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
31722-525-05	Finasteride	500 in 1 BOTTLE	TABLET, FILM COATED	500	4
31722-525-10	Finasteride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	4
31722-525-30	Finasteride	12 in 1 CASE	TABLET, FILM COATED	12	4
31722-525-30	Finasteride	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
31722-525-90	Finasteride	12 in 1 CASE	TABLET, FILM COATED	12	4
31722-525-90	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-525-01	EA - Each	31722-525	2dff9b3e-ca6d-452d-8f3f-a89fd6f1519d	1	2012-07-24
31722-525-10	EA - Each	31722-525	43ebfb38-bbff-4dbc-a940-c85be46e8cb4	1	2013-09-04
31722-525-30	EA - Each	31722-525	c2793c4d-dc59-4fbc-a265-ec6351261ded	1	2012-07-24
31722-525-90	EA - Each	31722-525	dbdcf86e-ce15-44f3-bca7-8878f44bd227	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FINASTERIDE	ACTIVE INGREDIENT	57GNO57U7G	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
FINASTERIDE	ACTIVE MOIETY	57GNO57U7G	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	8
FINASTERIDE	ACTIVE INGREDIENT	57GNO57U7G	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
FINASTERIDE	ACTIVE MOIETY	57GNO57U7G	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-525	FINASTERIDE (FINASTERIDE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]	10	Current NDC, Legacy NDC, 7 package rows	20250125_cc9709ce-2d29-48bd-b46b-3f72114f2527.zip
31722-525	FINASTERIDE TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 7 package rows	20110111_c59f8018-fff8-4884-a3c8-bc306e2c8f64.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
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 ndc (product): 31722-525
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	2d726486-f9ef-49d1-b1ae-6b1c8650fa73	16
310346	finasteride 5 MG Oral Tablet	SCD	2d726486-f9ef-49d1-b1ae-6b1c8650fa73	16
310346	FIN5C 5 MG Oral Tablet	SY	2d726486-f9ef-49d1-b1ae-6b1c8650fa73	16
310346	finasteride 5 MG Oral Tablet	PSN	cc9709ce-2d29-48bd-b46b-3f72114f2527	10
310346	finasteride 5 MG Oral Tablet	PSN	a3b49681-09b3-4c26-bb57-3dfd598d48b6	10
310346	finasteride 5 MG Oral Tablet	SCD	cc9709ce-2d29-48bd-b46b-3f72114f2527	10
310346	finasteride 5 MG Oral Tablet	SCD	a3b49681-09b3-4c26-bb57-3dfd598d48b6	10
310346	FIN5C 5 MG Oral Tablet	SY	cc9709ce-2d29-48bd-b46b-3f72114f2527	10
310346	FIN5C 5 MG Oral Tablet	SY	a3b49681-09b3-4c26-bb57-3dfd598d48b6	10
310346	finasteride 5 MG Oral Tablet	PSN	c2875bc7-e811-4860-9131-da06cecc2137	8
310346	finasteride 5 MG Oral Tablet	SCD	c2875bc7-e811-4860-9131-da06cecc2137	8
310346	FIN5C 5 MG Oral Tablet	SY	c2875bc7-e811-4860-9131-da06cecc2137	8
310346	finasteride 5 MG Oral Tablet	PSN	3272651f-b500-4d5d-9e29-22fcd8e24fcb	7
310346	finasteride 5 MG Oral Tablet	SCD	3272651f-b500-4d5d-9e29-22fcd8e24fcb	7
310346	FIN5C 5 MG Oral Tablet	SY	3272651f-b500-4d5d-9e29-22fcd8e24fcb	7
310346	finasteride 5 MG Oral Tablet	PSN	9ae38bf5-17d7-4af1-922f-b3edb1e65392	5
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	finasteride 5 MG Oral Tablet	SCD	9ae38bf5-17d7-4af1-922f-b3edb1e65392	5
310346	FIN5C 5 MG Oral Tablet	SY	800fa54c-c008-ba1e-e053-2a91aa0a2b07	5
310346	FIN5C 5 MG Oral Tablet	SY	9ae38bf5-17d7-4af1-922f-b3edb1e65392	5
310346	finasteride 5 MG Oral Tablet	PSN	c59f8018-fff8-4884-a3c8-bc306e2c8f64	4
310346	finasteride 5 MG Oral Tablet	SCD	c59f8018-fff8-4884-a3c8-bc306e2c8f64	4
310346	FIN5C 5 MG Oral Tablet	SY	c59f8018-fff8-4884-a3c8-bc306e2c8f64	4
310346	finasteride 5 MG Oral Tablet	PSN	d66fe4bd-534b-4674-a346-0cf3cdabbfaa	1
310346	finasteride 5 MG Oral Tablet	PSN	dee6b60d-3b6c-35a4-e053-2995a90acf56	1
310346	finasteride 5 MG Oral Tablet	SCD	d66fe4bd-534b-4674-a346-0cf3cdabbfaa	1
310346	finasteride 5 MG Oral Tablet	SCD	dee6b60d-3b6c-35a4-e053-2995a90acf56	1
310346	FIN5C 5 MG Oral Tablet	SY	d66fe4bd-534b-4674-a346-0cf3cdabbfaa	1
310346	FIN5C 5 MG Oral Tablet	SY	dee6b60d-3b6c-35a4-e053-2995a90acf56	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-525-01	31722052501	100 TABLET, FILM COATED in 1 BOTTLE (31722-525-01)		2015-06-13	0000-00-00	No	No	Current
31722-525-05	31722052505	500 TABLET, FILM COATED in 1 BOTTLE (31722-525-05)		2015-06-13	0000-00-00	No	No	Current
31722-525-10	31722052510	1000 TABLET, FILM COATED in 1 BOTTLE (31722-525-10)		2015-06-13	0000-00-00	No	No	Current
31722-525-30	31722052530	12 BOTTLE in 1 CASE (31722-525-30) / 30 TABLET, FILM COATED in 1 BOTTLE	12 bottle	2015-06-13	0000-00-00	No	No	Current
31722-525-90	31722052590	12 BOTTLE in 1 CASE (31722-525-90) / 90 TABLET, FILM COATED in 1 BOTTLE	12 bottle	2015-06-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Finasteride	Major Pharmaceuticals	2026-08-05	HUMAN PRESCRIPTION DRUG LABEL	8
Finasteride	Preferred Pharmaceuticals, Inc.	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
Finasteride	REMEDYREPACK INC.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	8
Finasteride	Legacy Pharmaceutical Packaging, LLC	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL	10
Finasteride	A-S Medication Solutions	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	16
Finasteride	AvPAK	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	5
Finasteride	Camber Pharmaceuticals, Inc.	2025-01-24	HUMAN PRESCRIPTION DRUG LABEL	10
Finasteride	A-S Medication Solutions	2024-08-26	Human Prescription Drug Label	1
Finasteride	NuCare Pharmaceuticals,Inc.	2022-05-12	HUMAN PRESCRIPTION DRUG LABEL	1
Finasteride Tablets USP, 5 mg RX Only	Camber Pharmaceuticals Inc. \| Hetero Drug LTD	2010-07-15	HUMAN PRESCRIPTION DRUG LABEL	4