NDC Code(s) : 71335-1304-1, 71335-1304-2, 71335-1304-3, 71335-1304-4, 71335-1304-5
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FinasterideFinasteride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-1304(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:71335-1304-130 in 1 BOTTLE Type 0: Not a Combination Product16/08/2019
2NDC:71335-1304-290 in 1 BOTTLE Type 0: Not a Combination Product16/08/2019
3NDC:71335-1304-360 in 1 BOTTLE Type 0: Not a Combination Product20/11/2019
4NDC:71335-1304-428 in 1 BOTTLE Type 0: Not a Combination Product29/04/2022
5NDC:71335-1304-5180 in 1 BOTTLE Type 0: Not a Combination Product06/05/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207750 01/06/2017

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-1304), RELABEL(71335-1304)

PRINCIPAL DISPLAY PANEL

Finasteride 1mg Tablet

Label