Finasteride

Product NDC: 50090-1718
Requested package NDC: 50090-1718-2
11-digit product format: 500901718
Labeler code: 50090
Product ID: 50090-1718_e20deff0-183a-4afc-afb5-62c8e7fe6738
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090121
Marketing category: ANDA
Marketing start: 2010-05-28
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-1718	50090-1718-2	D	Discontinued by firm		2026-08-07

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 · 11 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
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
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…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1718-0	EA - Each	50090-1718	59d1e9fd-fdce-4035-bb88-4a70b518132e	1	2018-11-06
50090-1718-1	EA - Each	50090-1718	ba731d11-727d-47b1-a7a9-99272058fcd7	1	2018-08-13
50090-1718-2	EA - Each	50090-1718	6d66aa5b-21f1-4764-9feb-5492ce137b7c	1	2018-08-13

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1718-2	50090171802	100 TABLET, FILM COATED in 1 BOTTLE (50090-1718-2)	2015-02-26	0000-00-00	No	No	Current