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Pill Identifier Information of topiramate 25 MG Oral Capsule

Drug Information

topiramate 25 MG Oral Capsule

Imprint: ZA64;25mg
Shape: C48336
Color: C48325
Ingredients: topiramate
Size: 19.00
Score: 1
Rxtty: SCD
Author: Cadila Healthcare Limited
Inactive Ingredients: HYPROMELLOSES / CELLULOSE ACETATE / GELATIN / POVIDONE / SODIUM LAURYL SULFATE / SUCROSE / TALC / TITANIUM DIOXIDE>

Complete Information

  • 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

    NDC 65841-100-14 in bottle of 60 capsules

    Topiramate Capsules USP, 50 mg

    60 capsules

    Rx only

    50 mg label
  • 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)  
    WATER (UNII: 059QF0KO0R)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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
    TOPIRAMATE 
    topiramate capsule, coated pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-846
    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)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SHELLAC (UNII: 46N107B71O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size22mm
    FlavorImprint Code 50mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-846-1460 in 1 BOTTLE; Type 0: Not a Combination Product10/24/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07887710/24/2024
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-651, 65841-652, 65841-846) , MANUFACTURE(65841-651, 65841-652, 65841-846)
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