Label: TOPIRAMATE capsule, coated pellets

  • NDC Code(s): 65841-651-01, 65841-651-05, 65841-651-10, 65841-651-14, view more
    65841-651-16, 65841-652-01, 65841-652-05, 65841-652-10, 65841-652-14, 65841-652-16, 65841-652-17
  • 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.

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-651-14 in bottle of 60 capsules

    Topiramate Capsules USP, 15 mg

    60 capsules

    Rx only

    Topiramate Capsules (Sprinkle), 15 mg

    NDC 65841-652-14 in bottle of 60 capsules

    Topiramate Capsules USP, 25 mg

    60 capsules

    Rx only

    Topiramate Capsules (Sprinkle), 25 mg
  • INGREDIENTS AND APPEARANCE
    TOPIRAMATE 
    topiramate capsule, coated pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-651
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size18mm
    FlavorImprint Code ZA63;15mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-651-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    2NDC:65841-651-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    3NDC:65841-651-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    4NDC:65841-651-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    5NDC:65841-651-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07887710/14/2009
    TOPIRAMATE 
    topiramate capsule, coated pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-652
    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)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code ZA64;25mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-652-1728 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    2NDC:65841-652-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    3NDC:65841-652-1690 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    4NDC:65841-652-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    5NDC:65841-652-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    6NDC:65841-652-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/14/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07887710/14/2009
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-651, 65841-652) , MANUFACTURE(65841-651, 65841-652)