Label: ZOLMITRIPTAN tablet, orally disintegrating

  • NDC Code(s): 65841-767-01, 65841-767-06, 65841-767-10, 65841-767-16, view more
    65841-767-30, 65841-767-69, 65841-767-77, 65841-767-86, 65841-768-01, 65841-768-06, 65841-768-10, 65841-768-16, 65841-768-30, 65841-768-77, 65841-768-82, 65841-768-87
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    NDC 65841-767-10 in bottle of 1000 Tablets

    Zolmitriptan Orally Disintegrating Tablets, 2.5 mg

    Rx only

    1000 Tablets

    Zolmitriptan OD Tablets, 2.5 mg
  • PRINCIPAL DISPLAY PANEL

    NDC 65841-768-10 in bottle of 1000 Tablets

    Zolmitriptan Orally Disintegrating Tablets, 5 mg

    Rx only

    1000 Tablets

    Zolmitritan OD Tablets, 5 mg
  • INGREDIENTS AND APPEARANCE
    ZOLMITRIPTAN 
    zolmitriptan tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-767
    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 CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ORANGE (UNII: 5EVU04N5QU)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorWHITE (WHITE/MOTTLED WHITE TO CREAM WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorORANGE (ORANGE) Imprint Code 715
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-767-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    2NDC:65841-767-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    3NDC:65841-767-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    4NDC:65841-767-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    5NDC:65841-767-861 in 1 CARTON05/16/2013
    5NDC:65841-767-696 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:65841-767-7710 in 1 CARTON05/16/2013
    6NDC:65841-767-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289005/16/2013
    ZOLMITRIPTAN 
    zolmitriptan tablet, orally disintegrating
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-768
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZOLMITRIPTAN (UNII: 2FS66TH3YW) (ZOLMITRIPTAN - UNII:2FS66TH3YW) ZOLMITRIPTAN5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASPARTAME (UNII: Z0H242BBR1)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ORANGE (UNII: 5EVU04N5QU)  
    POLACRILIN POTASSIUM (UNII: 0BZ5A00FQU)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorWHITE (WHITE/MOTTLED WHITE TO CREAM WHITE) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorORANGE (ORANGE) Imprint Code 717
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-768-0630 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    2NDC:65841-768-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    3NDC:65841-768-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    4NDC:65841-768-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/16/2013
    5NDC:65841-768-821 in 1 CARTON05/16/2013
    5NDC:65841-768-873 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:65841-768-7710 in 1 CARTON05/16/2013
    6NDC:65841-768-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20289005/16/2013
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-767, 65841-768) , MANUFACTURE(65841-767, 65841-768)
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