Finasteride

Product NDC: 70518-3616
Requested package NDC: 70518-3616-1
11-digit product format: 705183616
Labeler code: 70518
Product ID: 70518-3616_4f6b9cfd-9605-6f66-e063-6294a90a13a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078341
Marketing category: ANDA
Marketing start: 2023-01-18
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

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 · 9 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
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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
A078341-001	FINASTERIDE	FINASTERIDE	5MG	TABLET / ORAL	AB		2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078341-001	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	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078341-001	FINASTERIDE	5MG	TABLET / ORAL	AB	2007-10-30	`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	A078341-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078341-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078341-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078341-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078341-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078341-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078341-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078341-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078341-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078341-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078341-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078341-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078341-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078341-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078341-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078341-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078341-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078341-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078341-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078341-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078341-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078341-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078341-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078341-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078341-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078341-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078341-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078341-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078341-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078341-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078341-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078341-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078341-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078341-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078341-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078341-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078341-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078341-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078341-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078341-001	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
e482a50d-db15-4407-85c9-160c88e8a657	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
70518-3616-0	Finasteride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	12
70518-3616-1	Finasteride	30 in 1 BOX	TABLET, FILM COATED	30	12
70518-3616-2	Finasteride	1 in 1 POUCH	TABLET, FILM COATED	1	12
70518-3616-3	Finasteride	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	12
70518-3616-4	Finasteride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	12
70518-3616-5	Finasteride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3616	FINASTERIDE TABLET, FILM COATED [REMEDYREPACK INC.]	7	Current NDC, 6 package rows	20241012_e482a50d-db15-4407-85c9-160c88e8a657.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finasteride	FINASTERIDE	REMEDYREPACK INC.	da4e8a51-cf1c-4018-976f-edecc4934a39	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	REMEDYREPACK INC.	e482a50d-db15-4407-85c9-160c88e8a657	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341 ndc (package): 70518-3616-1 ndc (product): 70518-3616 ndc11 (package): 70518361601
Finasteride	FINASTERIDE	Bryant Ranch Prepack	c9a3cb34-9a8e-4538-ab90-32e08d8acc3a	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	Aurobindo Pharma Limited	32266029-c710-44dd-943f-7e31d0afa622	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	Coupler LLC	5087f6f2-92c0-3feb-e063-6394a90ab17d	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	cdde1382-a995-4f53-9497-7724d5e25b66	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	2c688ec5-1b0f-2269-e063-6394a90a7220	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	6360d8cc-72df-c571-e053-2991aa0a72c5	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	fc9c4996-302c-2ad8-e053-6294a90a5f38	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	American Health Packaging	8f468081-254a-4f11-9f0b-c0311e353a50	2024-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	Bryant Ranch Prepack	61e6cbb8-ddd2-4e07-b182-6348f216858b	2024-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	5efc695c-d9fd-4892-a63f-a35cceb8d3c7	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	Rising Pharma Holdings, Inc.	9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341
Finasteride	FINASTERIDE	Asclemed USA, Inc.	bafe8674-b7ee-47b2-94c1-842164ca6fa1	2021-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078341 application number: ANDA078341

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	e482a50d-db15-4407-85c9-160c88e8a657	12
310346	finasteride 5 MG Oral Tablet	SCD	e482a50d-db15-4407-85c9-160c88e8a657	12
310346	FIN5C 5 MG Oral Tablet	SY	e482a50d-db15-4407-85c9-160c88e8a657	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3616-1	70518361601	30 POUCH in 1 BOX (70518-3616-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3616-2)	30 pouch	2023-02-10	No	No	Current