Label: TOPIRAMATE tablet, film coated

  • NDC Code(s): 65841-647-01, 65841-647-05, 65841-647-14, 65841-647-16, view more
    65841-648-01, 65841-648-05, 65841-648-14, 65841-648-16, 65841-649-01, 65841-649-05, 65841-649-14, 65841-649-16, 65841-650-01, 65841-650-05, 65841-650-14, 65841-650-16
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

If you are a consumer or patient please visit this version.

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-647-14 in bottle of 60 tablets

    Topiramate Tablets USP, 25 mg

    60 tablets

    Rx only

    Topiramate Tablets

    NDC 65841-648-14 in bottle of 60 tablets

    Topiramate Tablets USP, 50 mg

    60 tablets

    Rx only

    Topiramate Tablets

    NDC 65841-649-14 in bottle of 60 tablets

    Topiramate Tablets USP, 100 mg

    60 tablets

    Rx only

    Topiramate Tablets

    NDC 65841-650-14 in bottle of 60 tablets

    Topiramate Tablets USP, 200 mg

    60 tablets

    Rx only

    Topiramate Tablets
  • INGREDIENTS AND APPEARANCE
    TOPIRAMATE 
    topiramate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-647
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code ZD;16
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-647-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    2NDC:65841-647-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    3NDC:65841-647-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    4NDC:65841-647-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07823503/27/2009
    TOPIRAMATE 
    topiramate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-648
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code ZD;15
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-648-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    2NDC:65841-648-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    3NDC:65841-648-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    4NDC:65841-648-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07823503/27/2009
    TOPIRAMATE 
    topiramate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-649
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZD;14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-649-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    2NDC:65841-649-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    3NDC:65841-649-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    4NDC:65841-649-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07823503/27/2009
    TOPIRAMATE 
    topiramate tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-650
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code ZD;13
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-650-1460 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    2NDC:65841-650-1690 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    3NDC:65841-650-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    4NDC:65841-650-05500 in 1 BOTTLE; Type 0: Not a Combination Product03/27/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07823503/27/2009
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-647, 65841-648, 65841-649, 65841-650) , MANUFACTURE(65841-647, 65841-648, 65841-649, 65841-650)