NDC Code(s) : 67877-455-30, 67877-455-90, 67877-455-05, 67877-455-34, 67877-455-94
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Finasteride Finasteride TABLET, COATED
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-455
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)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
LAUROYL PEG-32 GLYCERIDES(UNII: H5ZC52369M)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color RED (REDDISH BROWN) Score no score
Shape ROUND (biconvex) Size 7 mm
Flavor Imprint Code F1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-455-3030 in 1 BOTTLE Type 0: Not a Combination Product01/06/2017
2NDC:67877-455-9090 in 1 BOTTLE Type 0: Not a Combination Product01/06/2017
3NDC:67877-455-05500 in 1 BOTTLE Type 0: Not a Combination Product01/06/2017
4NDC:67877-455-943 in 1 CARTON 01/06/2017
4NDC:67877-455-3410 in 1 BLISTER PACK Type 0: Not a Combination Product01/06/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207750 01/06/2017

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 677605851 ANALYSIS(67877-455), MANUFACTURE(67877-455), PACK(67877-455)

PRINCIPAL DISPLAY PANEL



Finasteride Tablets, USP 1 mg
Warning: Finasteride Tablets, USP 1 mg should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP 1 mg. They should also not handle crushed or broken tablets of Finasteride Tablets, USP 1 mg. (See Package Insert.)
Rx only
30 Tablets


finasteride-1mg-30s

Finasteride Tablets, USP 1 mg
Warning: Finasteride Tablets, USP 1 mg should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP 1 mg. They should also not handle crushed or broken tablets of Finasteride Tablets, USP 1 mg. (See Package Insert.)
Rx only
90 Tablets
finasteride-1mg-30s
Finasteride Tablets, USP 1 mg
Warning: Finasteride Tablets, USP 1 mg should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP 1 mg. They should also not handle crushed or broken tablets of Finasteride Tablets, USP 1 mg. (See Package Insert.)
Rx only
500 Tablets


finasteride-1mg-30s