ZOLMITRIPTAN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]

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ZOLMITRIPTAN TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]
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NDC 65841-765-86, 65841-766-82
Set ID 3f12276b-835b-4bc3-84b4-4996948a01c0
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cadila Healthcare Limited
Generic Name
Product Class
Product Number
Application Number ANDA203019
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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-765-86 in unit-dose blister cartons of 6 (1 x 6) unit dose tablets

    Zolmitriptan Tablets, 2.5 mg

    Rx only

    100 tablets

    ZYDUS

     

    Zolmitriptan tablets, 2.5 mg
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-766-82 in unit-dose blister cartons of 3 (1 x 3) unit dose tablets

    Zolmitriptan Tablets, 5 mg

    Rx only

    100 tablets

    ZYDUS

    Zolmitriptan Tablets, 5 mg
  • INGREDIENTS AND APPEARANCE
    ZOLMITRIPTAN 
    zolmitriptan tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-765
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorYELLOW (LIGHT YELLOW to YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-765-861 in 1 CARTON11/12/2018
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20301911/12/2018
    ZOLMITRIPTAN 
    zolmitriptan tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-766
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (LIGHT ORANGE TO ORANGE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 714
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-766-821 in 1 CARTON11/12/2018
    13 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20301911/12/2018
    Labeler - Cadila Healthcare Limited (918596198)
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