Finasteride

Product NDC: 35573-400
11-digit product format: 355730400
Labeler code: 35573
Product ID: 35573-400_6752dcb1-091e-40a9-a6e2-069d543398a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Burel Pharmaceuticals, LLC
Application: ANDA203687
Marketing category: ANDA
Marketing start: 2018-07-13
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: 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
A203687-001	FINASTERIDE	FINASTERIDE	1MG	TABLET / ORAL	AB		2013-11-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203687-001	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	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203687-001	FINASTERIDE	1MG	TABLET / ORAL	AB	2013-11-05	`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	A203687-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203687-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203687-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203687-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203687-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203687-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203687-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203687-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203687-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203687-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203687-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203687-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203687-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203687-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203687-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203687-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203687-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203687-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203687-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203687-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203687-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203687-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203687-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203687-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203687-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203687-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203687-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203687-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203687-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203687-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203687-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203687-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203687-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203687-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203687-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203687-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203687-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203687-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203687-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203687-001	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	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
c8516eaa-98d0-4eb1-bc65-aa765baea5db	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
35573-400-99	Finasteride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35573-400-99	EA - Each	35573-400	61f9aef6-102f-4665-876b-28b37b11d0a2	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35573-400	FINASTERIDE TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20240507_c8516eaa-98d0-4eb1-bc65-aa765baea5db.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.	03429cec-c6b5-47fe-bb11-6b42f977df7e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	NuCare Pharmaceuticals, Inc.	51286a03-c29c-2c0b-e063-6394a90af33c	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Preferred Pharmaceuticals Inc.	74b90430-8ce1-470c-939c-685ca9dfd74f	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	NuCare Pharmaceuticals,Inc.	8488cd17-365c-701c-e053-2991aa0af5f9	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Burel Pharmaceuticals, LLC	c8516eaa-98d0-4eb1-bc65-aa765baea5db	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687 ndc (product): 35573-400
Finasteride	FINASTERIDE	Rising Pharma Holdings, Inc.	01b88593-99d3-4dd6-a7b6-5438c15bd7b7	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Aurobindo Pharma Limited	7d140366-2388-488e-bd86-67e6edf44345	2024-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687
Finasteride	FINASTERIDE	Asclemed USA, Inc.	b2cac9e5-ea52-44b7-ae88-78e11a732904	2022-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203687 application number: ANDA203687

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	c8516eaa-98d0-4eb1-bc65-aa765baea5db	6
200172	finasteride 1 MG Oral Tablet	SCD	c8516eaa-98d0-4eb1-bc65-aa765baea5db	6
200172	FIN5C 1 MG Oral Tablet	SY	c8516eaa-98d0-4eb1-bc65-aa765baea5db	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
35573-400-99	35573040099	1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99)	2018-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Finasteride	Burel Pharmaceuticals, LLC \| Aurobindo Pharma Limited	2024-04-25	Human Prescription Drug Label	6