Label: DOLUTEGRAVIR tablet, for suspension

  • NDC Code(s): 65015-353-14, 65015-353-17, 65015-353-18
  • Packager: Mylan Laboratories Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated March 5, 2021

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  • PRINCIPAL DISPLAY PANEL – 10 mg

    Dolutegravir Tablets for Oral Suspension 10 mg Bottle Label
  • INGREDIENTS AND APPEARANCE
    DOLUTEGRAVIR 
    dolutegravir tablet, for suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65015-353
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOLUTEGRAVIR SODIUM (UNII: 1Q1V9V5WYQ) (DOLUTEGRAVIR - UNII:DKO1W9H7M1) DOLUTEGRAVIR10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE DIHYDRATE (UNII: 4846Q921YM)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeOVALSize12mm
    FlavorSTRAWBERRY (strawberry cream) Imprint Code D;T;M
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65015-353-1430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    2NDC:65015-353-1760 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    3NDC:65015-353-1890 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only11/19/2020
    Labeler - Mylan Laboratories Limited (650547156)
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