Finasteride

Product NDC: 68071-2695
11-digit product format: 680712695
Labeler code: 68071
Product ID: 68071-2695_dee6b60d-3b6d-35a4-e053-2995a90acf56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Finasteride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090061
Marketing category: ANDA
Marketing start: 2015-06-13
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

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
68071-2695-3	2025-01-30	C162847	48780-1	2cef2736-b547-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use finasteride tablets USP safely and effectively. See full prescribing information for finasteride tablets USP. FINASTERIDE Tablets USP, 5 mg for oral use Initial U.S. Approval: 1992

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2695-3	Finasteride	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2695	FINASTERIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220514_dee6b60d-3b6c-35a4-e053-2995a90acf56.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	dee6b60d-3b6c-35a4-e053-2995a90acf56	1
310346	finasteride 5 MG Oral Tablet	SCD	dee6b60d-3b6c-35a4-e053-2995a90acf56	1
310346	FIN5C 5 MG Oral Tablet	SY	dee6b60d-3b6c-35a4-e053-2995a90acf56	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2695-3	68071269503	30 TABLET, FILM COATED in 1 BOTTLE (68071-2695-3)	2022-05-13	0000-00-00	No	No	Current