Label: SUMATRIPTAN- sumatriptan succinate tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 7, 2019

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    Sumatriptan Succinate Tablets

  • HOW SUPPLIED

    Product: 63629-8134

    NDC: 63629-8134-1 9 TABLET in a BOTTLE

    Product: 63629-8188

    NDC: 63629-8188-1 9 TABLET in a BOTTLE

  • SUMATRIPTAN 50MG TABLET

    Label Image
  • SUMATRIPTAN SUCCINATE 100MG TAB

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUMATRIPTAN 
    sumatriptan succinate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-8134(NDC:65862-147)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN50 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorWHITE (White to off-white) Scoreno score
    ShapeCAPSULE (biconvex) Size11mm
    FlavorImprint Code C;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-8134-19 in 1 BOTTLE; Type 0: Not a Combination Product07/29/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07832708/17/2009
    SUMATRIPTAN 
    sumatriptan succinate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-8188(NDC:65862-148)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO) SUMATRIPTAN100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    ColorWHITE (White to off-white) Scoreno score
    ShapeCAPSULE (biconvex) Size12mm
    FlavorImprint Code C;34
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63629-8188-19 in 1 BOTTLE; Type 0: Not a Combination Product08/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07832708/17/2009
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(63629-8188, 63629-8134) , RELABEL(63629-8134, 63629-8188)