Finasteride

Product NDC: 68071-1648
11-digit product format: 680711648
Labeler code: 68071
Product ID: 68071-1648_518c0b9e-331b-0a48-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA078341
Marketing category: ANDA
Marketing start: 2007-10-30
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: 2019-12-31
Current FDA listing: Historical FDA.report record

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1648-9	2025-01-30	C162847	48780-1	9d75b9d0-5fef-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets, for oral use Initial U.S. Approval: 1992
68071-1648-9	2020-04-15	C162847	48780-1	9d75b9d0-5fef-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets, for oral use Initial U.S. Approval: 1992
68071-1648-9	2020-01-31	C162847	48780-1	9d75b9d0-5fef-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FINASTERIDE TABLETS safely and effectively. See full prescribing information for FINASTERIDE TABLETS. FINASTERIDE tablets, for oral use Initial U.S. Approval: 1992

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1648-9	Finasteride	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1648	FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]	4	Legacy NDC, 1 package rows	20230715_518c0b9e-331a-0a48-e054-00144ff8d46c.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	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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68071-1648-9	68071164809	90 in 1 BOTTLE	Historical