FDA.reportPublic FDA data

Finasteride

Product NDC
42291-280
11-digit product format
422910280
Labeler code
42291
Product ID
42291-280_6361db95-e3d1-4b99-e053-2991aa0a94fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Finasteride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA076511
Marketing category
ANDA
Marketing start
2013-02-26
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-280-30EA - Each42291-280cb043b08-1cea-4246-8eb0-61f0c08bd5dc12013-05-02
42291-280-50EA - Each42291-28011f2a863-0e0b-4c6e-b645-577bdc26279a12013-05-02
42291-280-90EA - Each42291-28090af7bc3-3f40-45fe-979b-90cd8640bcb712013-05-02