Label: TOPIRAMATE capsule, extended release

  • NDC Code(s): 70771-1315-1, 70771-1315-2, 70771-1315-3, 70771-1315-4, view more
    70771-1315-5, 70771-1315-9, 70771-1316-1, 70771-1316-2, 70771-1316-3, 70771-1316-4, 70771-1316-5, 70771-1316-9, 70771-1317-1, 70771-1317-2, 70771-1317-3, 70771-1317-4, 70771-1317-5, 70771-1317-9
  • 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 70771-1315-3

    Topiramate extended-release capsules, 25 mg

    30 capsules

    Rx only

    25 mg

    NDC 70771-1316-3

    Topiramate extended-release capsules, 50 mg

    30 capsules

    Rx only

    50 mg

    NDC 70771-1317-3

    Topiramate extended-release capsules, 100 mg

    30 capsules

    Rx only

    100 mg
  • INGREDIENTS AND APPEARANCE
    TOPIRAMATE 
    topiramate capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Scoreno score
    ShapeCAPSULESize18mm
    FlavorImprint Code 863
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1315-330 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    2NDC:70771-1315-990 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    3NDC:70771-1315-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    4NDC:70771-1315-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    5NDC:70771-1315-410 in 1 CARTON04/05/2018
    5NDC:70771-1315-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20738204/05/2018
    TOPIRAMATE 
    topiramate capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1316
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Scoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code 864
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1316-330 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    2NDC:70771-1316-990 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    3NDC:70771-1316-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    4NDC:70771-1316-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    5NDC:70771-1316-410 in 1 CARTON04/05/2018
    5NDC:70771-1316-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20738204/05/2018
    TOPIRAMATE 
    topiramate capsule, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1317
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391) TOPIRAMATE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (WHITE OPAQUE) , WHITE (WHITE OPAQUE) Scoreno score
    ShapeCAPSULESize23mm
    FlavorImprint Code 769
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1317-330 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    2NDC:70771-1317-990 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    3NDC:70771-1317-1100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    4NDC:70771-1317-5500 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    5NDC:70771-1317-410 in 1 CARTON04/05/2018
    5NDC:70771-1317-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20738204/05/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1315, 70771-1316, 70771-1317) , MANUFACTURE(70771-1315, 70771-1316, 70771-1317)