Dofetilide by Northstar Rx LLC / Mayne Pharma Inc. DOFETILIDE capsule

Dofetilide by

Drug Labeling and Warnings

Dofetilide by is a Prescription medication manufactured, distributed, or labeled by Northstar Rx LLC, Mayne Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label

    Rx only

    NDC: 16714-840-01

    Dofetilide
    Capsules

    125 mcg (0.125 mg)

    PHARMACIST: Dispense the accompanying
    medication guide to each patient.

    60 Capsules

    NORTHSTARX™

    PRINCIPAL DISPLAY PANEL - 0.125 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.250 mg Capsule Bottle Label

    Rx only

    NDC: 16714-841-01

    Dofetilide
    Capsules

    250 mcg (0.250 mg)

    PHARMACIST: Dispense the accompanying
    medication guide to each patient.

    60 Capsules

    NORTHSTARX™

    PRINCIPAL DISPLAY PANEL - 0.250 mg Capsule Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.500 mg Capsule Bottle Label

    Rx only

    NDC: 16714-842-01

    Dofetilide
    Capsules

    500 mcg (0.500 mg)

    PHARMACIST: Dispense the accompanying
    medication guide to each patient.

    60 Capsules

    NORTHSTARX™

    PRINCIPAL DISPLAY PANEL - 0.500 mg Capsule Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOFETILIDE 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16714-840
    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)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Shellac (UNII: 46N107B71O)  
    ALCOHOL (UNII: 3K9958V90M)  
    Butyl Alcohol (UNII: 8PJ61P6TS3)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Ammonia (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorWHITE, BROWN (Dark Caramel) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code ML;125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16714-840-0160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20705806/18/2018
    DOFETILIDE 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16714-841
    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)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Shellac (UNII: 46N107B71O)  
    ALCOHOL (UNII: 3K9958V90M)  
    Butyl Alcohol (UNII: 8PJ61P6TS3)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Ammonia (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorORANGE (Light Orange) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code ML;250
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16714-841-0160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20705806/18/2018
    DOFETILIDE 
    dofetilide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 16714-842
    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)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Shellac (UNII: 46N107B71O)  
    ALCOHOL (UNII: 3K9958V90M)  
    Butyl Alcohol (UNII: 8PJ61P6TS3)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Ammonia (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorWHITE, ORANGE (Light Orange) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code ML;500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 16714-842-0160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20705806/18/2018
    Labeler - Northstar Rx LLC (830546433)
    Registrant - Mayne Pharma Inc. (867220261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mayne Pharma Inc.867220261ANALYSIS(16714-840, 16714-841, 16714-842) , MANUFACTURE(16714-840, 16714-841, 16714-842) , PACK(16714-840, 16714-841, 16714-842) , LABEL(16714-840, 16714-841, 16714-842)

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