Prescription Drug Information: Dutasteride

DUTASTERIDE- dutasteride capsule, liquid filled
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1347-3 in bottle of 30 capsules

Dutasteride Capsules, 0.5 mg

Rx only

30 Capsules

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DUTASTERIDE
dutasteride capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1347
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DUTASTERIDE (DUTASTERIDE) DUTASTERIDE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
GELATIN
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
TITANIUM DIOXIDE
ALCOHOL
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ACETATE PHTHALATE
PROPYLENE GLYCOL
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES
AMMONIA
WATER
Product Characteristics
Color WHITE (OPAQUE-WHITE) Score no score
Shape CAPSULE (Oblong Shaped) Size 20mm
Flavor Imprint Code 641
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1347-3 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:70771-1347-9 90 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204373 05/16/2018
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1347), MANUFACTURE (70771-1347)

Revised: 08/2020 Cadila Healthcare Limited

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