Dofetilide by Accord Healthcare, Inc. / Intas Pharmaceuticals Limited DOFETILIDE capsule

Dofetilide by

Drug Labeling and Warnings

Dofetilide by is a Prescription medication manufactured, distributed, or labeled by Accord Healthcare, Inc., Intas Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • SPL UNCLASSIFIED SECTION

    Manufactured For:
    Accord Healthcare, Inc.,
    8041 Arco Corporate Drive,
    Suite 200,
    Raleigh, NC 27617,
    USA


    Manufactured By:
    Intas Pharmaceuticals Limited,
    Plot No 5 to 14, Pharmez,
    Sarkhej-Bavla, National Highway No 8-A,
    Near Village Matoda, Tal Sanand,
    Ahmedabad - 382 213, Gujarat, India


    51 3377 2 735303


    Issued May 2024

  • PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label

    125 mcg (0.125 mg)

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

    250 mcg (0.25 mg)

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

    500 mcg (0.5 mg)

    PRINCIPAL DISPLAY PANEL - 0.5 mg Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOFETILIDE 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16729-490
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND) DOFETILIDE0.125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    Colororange (Light Orange) , whiteScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code HC1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16729-490-1260 in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    2NDC: 16729-490-59180 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21333808/20/2020
    DOFETILIDE 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16729-491
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND) DOFETILIDE0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    Colorpink (Peach) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code HC2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16729-491-1260 in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    2NDC: 16729-491-59180 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21333808/20/2020
    DOFETILIDE 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16729-492
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOFETILIDE (UNII: R4Z9X1N2ND) (DOFETILIDE - UNII:R4Z9X1N2ND) DOFETILIDE0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    Colorpink (Peach) , whiteScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code HC3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16729-492-1260 in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
    2NDC: 16729-492-59180 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21333808/20/2020
    Labeler - Accord Healthcare, Inc. (604222237)
    Establishment
    NameAddressID/FEIBusiness Operations
    Intas Pharmaceuticals Limited915837971manufacture(16729-490, 16729-491, 16729-492) , analysis(16729-490, 16729-491, 16729-492)

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