TIKOSYN- dofetilide capsule

Tikosyn by

Drug Labeling and Warnings

Tikosyn by is a Prescription medication manufactured, distributed, or labeled by Avera McKennan Hospital. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION


    Rx only

    Logo

    LAB-0405-3.0

    January 2014

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

  • PRINCIPAL DISPLAY PANEL

    Dofetilide 0.125 mg capsule

  • INGREDIENTS AND APPEARANCE
    TIKOSYN 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 69189-5800(NDC:0069-5800)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND) DOFETILIDE0.125 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorORANGE (Light Orange) , WHITEScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code TKN;125;PFIZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 69189-5800-11 in 1 DOSE PACK; Type 0: Not a Combination Product06/28/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02093106/28/2016
    Labeler - Avera McKennan Hospital (068647668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avera McKennan Hospital068647668relabel(69189-5800) , repack(69189-5800)

  • Trademark Results [Tikosyn]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TIKOSYN
    TIKOSYN
    75320488 2375648 Live/Registered
    Pfizer Inc.
    1997-07-07

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