Label: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE capsule

  • NDC Code(s): 70771-1356-3, 70771-1356-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 26, 2020

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  • SPL UNCLASSIFIED SECTION

  • 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
  • INGREDIENTS AND APPEARANCE
    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 - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (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 - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1356) , MANUFACTURE(70771-1356)