DUTASTERIDE- dutasteride capsule, liquid filled 
Cadila Healthcare 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1347
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I) DUTASTERIDE0.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (OPAQUE-WHITE) Scoreno score
ShapeCAPSULE (Oblong Shaped) Size20mm
FlavorImprint Code 641
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1347-330 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2018
2NDC:70771-1347-990 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20437305/16/2018
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(70771-1347) , MANUFACTURE(70771-1347)

Revised: 8/2020
Document Id: 3205a012-ce2b-4ab7-9b22-61e0179b211f
Set id: b8a00cff-6912-4544-8290-8c912ab2573a
Version: 4
Effective Time: 20200821
 
Cadila Healthcare Limited