NDC Code(s) : 63629-8207-1, 63629-8207-2, 63629-8207-3
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DutasterideDutasteride CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8207(NDC:31722-131)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE(UNII: O0J6XJN02I)
(DUTASTERIDE - UNII:O0J6XJN02I) 		DUTASTERIDE0.5 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
GLYCERYL MONO AND DICAPRYLOCAPRATE(UNII: U72Q2I8C85)
GLYCERIN(UNII: PDC6A3C0OX)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code AT131
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-8207-130 in 1 BOTTLE Type 0: Not a Combination Product08/01/2019
2NDC:63629-8207-290 in 1 BOTTLE Type 0: Not a Combination Product22/07/2020
3NDC:63629-8207-3180 in 1 BOTTLE Type 0: Not a Combination Product04/11/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206574 10/24/2016

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-8207), RELABEL(63629-8207)

PRINCIPAL DISPLAY PANEL

Dutasteride 0.5mg Capsule

Label