NDC Code(s) : 71713-099-90
Packager : Thirty Madison Inc

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Finasteride Finasteride TABLET
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71713-099
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FINASTERIDE(UNII: 57GNO57U7G)
(FINASTERIDE - UNII:57GNO57U7G) 		FINASTERIDE1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LAUROYL PEG-32 GLYCERIDES(UNII: H5ZC52369M)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BROWN (BROWN) Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code F1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71713-099-9090 in 1 CONTAINER Type 0: Not a Combination Product22/03/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207750 03/22/2021

LABELER - Thirty Madison Inc(080774087)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 677605851 MANUFACTURE(71713-099)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL- CONTAINER PACK OF 90 TABLETS

NDC 71713-099-90

Finasteride Tablets, USP


1 mg

WARNING : Finasteride Tablets, USP should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP. They should also not handle crushed or broken tablets of Finasteride Tablets, USP. (See Package Insert). 

Rx Only


90 Tablets

Keeps

finasteride-label.jpg