TIKOSYN- dofetilide capsule

Tikosyn by

Drug Labeling and Warnings

Tikosyn by is a Prescription medication manufactured, distributed, or labeled by Pfizer Laboratories Div Pfizer Inc, Pfizer Pharmaceuticals LLC, Pfizer Ireland Pharmaceuticals, Pfizer Italia S.r.l., Pfizer Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION


    Rx only

    Logo

    LAB-0405-3.0

    Revised January 2014

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

  • PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label

    ALWAYS DISPENSE WITH MEDICATION GUIDE

    Pfizer
    NDC: 0069-5800-60

    Tikosyn®

    (dofetilide) Capsules

    125 mcg (0.125 mg)

    60 Capsules
    Rx only

    PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack

    FOR INSTITUTION USE

    Tikosyn®

    (dofetilide) Capsule

    125mcg (0.125mg)

    PFIZER LABS
    DIV. OF PFIZER INC, NY, NY 10017

    LOT: XXXXXXX
    EXP: YYYY MMM

    PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack
  • PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack Carton

    ALWAYS DISPENSE WITH MEDICATION GUIDE

    Pfizer
    NDC: 0069-5800-43

    Tikosyn®

    (dofetilide) capsules

    125 mcg (0.125 mg)

    For in-institution use only

    40 Capsules

    Rx only
    UNIT DOSE

    PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Bottle Label

    ALWAYS DISPENSE WITH MEDICATION GUIDE

    Pfizer
    NDC: 0069-5810-60

    Tikosyn®

    (dofetilide) Capsules

    250 mcg (0.25 mg)

    60 Capsules
    Rx only

    PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack

    FOR INSTITUTION USE

    Tikosyn®

    (dofetilide) Capsule

    250mcg (0.25mg)

    PFIZER LABS
    DIV. OF PFIZER INC, NY, NY 10017

    LOT: XXXXXXX
    EXP: YYYY MMM

    PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack
  • PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack Carton

    ALWAYS DISPENSE WITH MEDICATION GUIDE

    Pfizer
    NDC: 0069-5810-43

    Tikosyn®

    (dofetilide) capsules

    250 mcg (0.25 mg)

    For in-institution use only

    40 Capsules

    Rx only
    UNIT DOSE

    PRINCIPAL DISPLAY PANEL - 0.25 mg Capsule Blister Pack Carton
  • PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Bottle Label

    ALWAYS DISPENSE WITH MEDICATION GUIDE

    Pfizer
    NDC: 0069-5820-60

    Tikosyn®

    (dofetilide) Capsules

    500 mcg (0.5 mg)

    60 Capsules
    Rx only

    PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack

    FOR INSTITUTION USE

    Tikosyn®

    (dofetilide) Capsule

    500mcg (0.5mg)

    PFIZER LABS
    DIV. OF PFIZER INC, NY, NY 10017

    LOT: XXXXXXX
    EXP: YYYY MMM

    PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack
  • PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack Carton

    ALWAYS DISPENSE WITH MEDICATION GUIDE

    Pfizer
    NDC: 0069-5820-43

    Tikosyn®

    (dofetilide) capsules

    500 mcg (0.5 mg)

    For in-institution use only

    40 Capsules

    Rx only
    UNIT DOSE

    PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    TIKOSYN 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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: 0069-5800-6114 in 1 BOTTLE; Type 0: Not a Combination Product10/01/1999
    2NDC: 0069-5800-6060 in 1 BOTTLE; Type 0: Not a Combination Product10/01/1999
    3NDC: 0069-5800-4340 in 1 CARTON10/01/1999
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02093110/01/1999
    TIKOSYN 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0069-5810
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND) DOFETILIDE0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorPINK (Peach) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code TKN;250;PFIZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0069-5810-6114 in 1 BOTTLE; Type 0: Not a Combination Product10/01/1999
    2NDC: 0069-5810-6060 in 1 BOTTLE; Type 0: Not a Combination Product10/01/1999
    3NDC: 0069-5810-4340 in 1 CARTON10/01/1999
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02093110/01/1999
    TIKOSYN 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0069-5820
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND) DOFETILIDE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorPINK (Peach) , WHITEScoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code TKN;500;PFIZER
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0069-5820-6114 in 1 BOTTLE; Type 0: Not a Combination Product10/01/1999
    2NDC: 0069-5820-6060 in 1 BOTTLE; Type 0: Not a Combination Product10/01/1999
    3NDC: 0069-5820-4340 in 1 CARTON10/01/1999
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02093110/01/1999
    Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Pharmaceuticals LLC829084545ANALYSIS(0069-5800, 0069-5810, 0069-5820) , MANUFACTURE(0069-5800, 0069-5810, 0069-5820) , PACK(0069-5800, 0069-5810, 0069-5820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Ireland Pharmaceuticals985104227ANALYSIS(0069-5800, 0069-5810, 0069-5820) , API MANUFACTURE(0069-5800, 0069-5810, 0069-5820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Pharmaceuticals LLC829084552PACK(0069-5800, 0069-5810, 0069-5820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Italia S.r.l.458521908ANALYSIS(0069-5800, 0069-5810, 0069-5820) , MANUFACTURE(0069-5800, 0069-5810, 0069-5820) , PACK(0069-5800, 0069-5810, 0069-5820)

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