Finasteride

Product NDC: 57237-062
11-digit product format: 572370062
Labeler code: 57237
Product ID: 57237-062_c44c39d5-9ec1-4714-838b-b03b69494caf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA078341
Marketing category: ANDA
Marketing start: 2007-10-30
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
FINASTERIDE	5 mg/1

Field, Values table
Field	Values
Unii	57GNO57U7G
Rxcui	310346

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57237-062-05	Finasteride	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
57237-062-30	Finasteride	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
57237-062-90	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90	11

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-062-05	EA - Each	57237-062	576f4396-35a7-45b2-9660-f8c0747ac56d	1	2016-05-16
57237-062-30	EA - Each	57237-062	a4b8d8d7-1b4c-43dc-bf0d-8c61036b5771	1	2016-05-16
57237-062-90	EA - Each	57237-062	11940c28-f784-4b79-90f7-97f1fddf83dc	1	2016-05-16

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FINASTERIDE	ACTIVE INGREDIENT	57GNO57U7G	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
FINASTERIDE	ACTIVE MOIETY	57GNO57U7G	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FINASTERIDE TABLET, FILM COATED [CITRON PHARMA LLC]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-062	FINASTERIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]	11	Current NDC, Legacy NDC, 3 package rows	20240303_9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57GNO57U7G	FINASTERIDE	98319-26-7	FINASTERIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310346	finasteride 5 MG Oral Tablet	PSN	9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d	11
310346	finasteride 5 MG Oral Tablet	SCD	9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d	11
310346	FIN5C 5 MG Oral Tablet	SY	9cb6a9f1-f7a6-46be-9b2b-8f228c821b4d	11
310346	finasteride 5 MG Oral Tablet	PSN	da4e8a51-cf1c-4018-976f-edecc4934a39	10
310346	finasteride 5 MG Oral Tablet	SCD	da4e8a51-cf1c-4018-976f-edecc4934a39	10
310346	FIN5C 5 MG Oral Tablet	SY	da4e8a51-cf1c-4018-976f-edecc4934a39	10
310346	finasteride 5 MG Oral Tablet	PSN	518c0b9e-331a-0a48-e054-00144ff8d46c	4
310346	finasteride 5 MG Oral Tablet	SCD	518c0b9e-331a-0a48-e054-00144ff8d46c	4
310346	FIN5C 5 MG Oral Tablet	SY	518c0b9e-331a-0a48-e054-00144ff8d46c	4
310346	finasteride 5 MG Oral Tablet	PSN	61e6cbb8-ddd2-4e07-b182-6348f216858b	3
310346	finasteride 5 MG Oral Tablet	SCD	61e6cbb8-ddd2-4e07-b182-6348f216858b	3
310346	FIN5C 5 MG Oral Tablet	SY	61e6cbb8-ddd2-4e07-b182-6348f216858b	3
310346	finasteride 5 MG Oral Tablet	PSN	bafe8674-b7ee-47b2-94c1-842164ca6fa1	1
310346	finasteride 5 MG Oral Tablet	SCD	bafe8674-b7ee-47b2-94c1-842164ca6fa1	1
310346	FIN5C 5 MG Oral Tablet	SY	bafe8674-b7ee-47b2-94c1-842164ca6fa1	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-062-05	57237006205	500 TABLET, FILM COATED in 1 BOTTLE (57237-062-05)	2007-10-30	0000-00-00	No	No	Current
57237-062-30	57237006230	30 TABLET, FILM COATED in 1 BOTTLE (57237-062-30)	2007-10-30	0000-00-00	No	No	Current
57237-062-90	57237006290	90 TABLET, FILM COATED in 1 BOTTLE (57237-062-90)	2007-10-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Finasteride	REMEDYREPACK INC.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	10
Finasteride	Bryant Ranch Prepack	2024-05-20	HUMAN PRESCRIPTION DRUG LABEL	3
Finasteride	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-02-28	Human Prescription Drug Label	11
Finasteride	NuCare Pharmaceuticals, Inc.	2023-07-14	HUMAN PRESCRIPTION DRUG LABEL	4
Finasteride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2021-07-28	HUMAN PRESCRIPTION DRUG LABEL	1