Finasteride

Product NDC: 68788-8275
11-digit product format: 687888275
Labeler code: 68788
Product ID: 68788-8275_a4242cc3-63e0-4514-8594-e69887285baa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA207750
Marketing category: ANDA
Marketing start: 2022-10-14
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 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…`

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
b84a67d6-695e-4a7c-9b60-95e9ad18a501	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
68788-8275-3	Finasteride	30 in 1 BOTTLE	TABLET, COATED	30	4
68788-8275-6	Finasteride	60 in 1 BOTTLE	TABLET, COATED	60	4
68788-8275-9	Finasteride	90 in 1 BOTTLE	TABLET, 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
68788-8275-3	EA - Each	68788-8275	d928b4a4-9b81-4684-b8a9-893ca921d19c	1	2022-11-07
68788-8275-6	EA - Each	68788-8275	6814b956-f782-48c2-8319-b3772d53f812	1	2022-11-07
68788-8275-9	EA - Each	68788-8275	0a5f8ce2-e1ed-4bee-870c-f25b8cc6a328	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8275	FINASTERIDE TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 3 package rows	20240426_b84a67d6-695e-4a7c-9b60-95e9ad18a501.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 · 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 ndc (product): 68788-8275
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200172	finasteride 1 MG Oral Tablet	PSN	b84a67d6-695e-4a7c-9b60-95e9ad18a501	4
200172	finasteride 1 MG Oral Tablet	SCD	b84a67d6-695e-4a7c-9b60-95e9ad18a501	4
200172	FIN5C 1 MG Oral Tablet	SY	b84a67d6-695e-4a7c-9b60-95e9ad18a501	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8275-3	68788827503	30 TABLET, COATED in 1 BOTTLE (68788-8275-3)	2022-10-14	0000-00-00	No	No	Current
68788-8275-6	68788827506	60 TABLET, COATED in 1 BOTTLE (68788-8275-6)	2022-10-14	0000-00-00	No	No	Current
68788-8275-9	68788827509	90 TABLET, COATED in 1 BOTTLE (68788-8275-9)	2022-10-14	0000-00-00	No	No	Current