DUTASTERIDE - dutasteride capsule, liquid filled
Zydus Lifesciences Limited

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DUTASTERIDE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1347-3 in bottle of 30 capsules

Dutasteride Capsules, 0.5 mg

Rx only

30 Capsules

container label

DUTASTERIDE
dutasteride capsule, liquid filled

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1347
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)	DUTASTERIDE	0.5 mg

Ingredient Name	Strength
Inactive Ingredients
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALCOHOL (UNII: 3K9958V90M)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)
AMMONIA (UNII: 5138Q19F1X)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (OPAQUE-WHITE)	Score	no score
Shape	CAPSULE (Oblong Shaped)	Size	20mm
Flavor		Imprint Code	641
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1347-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2018
2	NDC:70771-1347-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204373	05/16/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1347) , MANUFACTURE(70771-1347)

Revised: 11/2022

Document Id: a00cd4b7-4f64-4228-a425-995dcf1bc38d

Set id: b8a00cff-6912-4544-8290-8c912ab2573a

Version: 5

Effective Time: 20221105

Zydus Lifesciences Limited