Label: ELETRIPTAN HYDROBROMIDE tablet, film coated

  • NDC Code(s): 70771-1107-0, 70771-1107-2, 70771-1107-3, 70771-1107-4, view more
    70771-1107-6, 70771-1108-2, 70771-1108-3, 70771-1108-4, 70771-1108-5, 70771-1108-6
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 25, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Eletriptan hydrobromide Tablets, 20 mg

    NDC 70771-1107-3

    Rx only

    30 Tablets

    ELETRIPTAN HYDROBROMIDE TABLET

    Eletriptan hydrobromide Tablets, 40 mg

    NDC 70771-1108-3

    Rx only

    30 Tablets

    Eletriptan hydrobromide tablet
  • INGREDIENTS AND APPEARANCE
    ELETRIPTAN HYDROBROMIDE 
    eletriptan hydrobromide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1107
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI) ELETRIPTAN20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 112 (UNII: X7XJ6RM9Q2)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorORANGE (ORANGE TO MOTTLED ORANGE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code 922
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1107-330 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
    2NDC:70771-1107-01000 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
    3NDC:70771-1107-410 in 1 CARTON07/12/2017
    3NDC:70771-1107-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70771-1107-61 in 1 CARTON07/12/2017
    46 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20640907/12/2017
    ELETRIPTAN HYDROBROMIDE 
    eletriptan hydrobromide tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ELETRIPTAN HYDROBROMIDE (UNII: M41W832TA3) (ELETRIPTAN - UNII:22QOO9B8KI) ELETRIPTAN40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 112 (UNII: X7XJ6RM9Q2)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBROWN (BROWN) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 923
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1108-330 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
    2NDC:70771-1108-5500 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2017
    3NDC:70771-1108-410 in 1 CARTON07/12/2017
    3NDC:70771-1108-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:70771-1108-61 in 1 CARTON07/12/2017
    46 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20640907/12/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1107, 70771-1108) , MANUFACTURE(70771-1107, 70771-1108)
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