Label: ZONISAMIDE capsule

  • NDC Code(s): 70771-1142-1, 70771-1142-5, 70771-1143-1, 70771-1143-5, view more
    70771-1144-0, 70771-1144-1, 70771-1144-5
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 4, 2023

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  • MEDICATION GUIDE

    Manufactured by:

    Cadila Healthcare Ltd.

    India

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1142-1 in bottle of 100 Capsules

    Zonisamide Capsules, 25 mg

    Rx only

    100 Capsules

    Zonisamide Capsules, 25 mg

    NDC 70771-1143-1 in bottle of 100 Capsules

    Zonisamide Capsules, 50 mg

    Rx only

    100 Capsules

    Zonisamide Capsules, 50 mg

    NDC 70771-1144-1 in bottle of 100 Capsules

    Zonisamide Capsules, 100 mg

    Rx only

    100 Capsules

    Zonisamide Capsules, 100 mg
  • INGREDIENTS AND APPEARANCE
    ZONISAMIDE 
    zonisamide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1142
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (PINK) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code ZA;31;25;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1142-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    2NDC:70771-1142-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762511/22/2017
    ZONISAMIDE 
    zonisamide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1143
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (PINK) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code ZA;32;50;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1143-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    2NDC:70771-1143-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762511/22/2017
    ZONISAMIDE 
    zonisamide capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1144
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V) ZONISAMIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (PINK) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code ZA;33;100;mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1144-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    2NDC:70771-1144-5500 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    3NDC:70771-1144-01000 in 1 BOTTLE; Type 0: Not a Combination Product11/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762511/22/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(70771-1142, 70771-1143, 70771-1144) , MANUFACTURE(70771-1142, 70771-1143, 70771-1144)
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