DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE - dutasteride and tamsulosin hydrochloride capsule 
Zydus Lifesciences Limited

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DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1356-3

Dutasteride and tamsulosin hydrochloride Capsules, 0.4/0.5 mg

Rx only

30 Capsules

Dutasteride and tamsulosin hydrochloride capsules
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE 
dutasteride and tamsulosin hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1356
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DUTASTERIDE (UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I) DUTASTERIDE0.5 mg
TAMSULOSIN HYDROCHLORIDE (UNII: 11SV1951MR) (TAMSULOSIN - UNII:G3P28OML5I) TAMSULOSIN HYDROCHLORIDE0.4 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SHELLAC (UNII: 46N107B71O)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorYELLOW (OPAQUE YELLOW CAP) , WHITE (OPAQUE WHITE BODY) Scoreno score
ShapeCAPSULE (CAPSULE) Size23mm
FlavorImprint Code 640
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1356-330 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2018
2NDC:70771-1356-990 in 1 BOTTLE; Type 0: Not a Combination Product06/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20776906/04/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1356) , MANUFACTURE(70771-1356)

Revised: 8/2022
Document Id: 458221ba-8343-44fb-a46c-d75b1f67f403
Set id: 4b89b07e-9d19-47a2-bd53-bc5eef9deed1
Version: 4
Effective Time: 20220812
 
Zydus Lifesciences Limited