Label: LOPINAVIR AND RITONAVIR granule

  • NDC Code(s): 65015-299-49, 65015-299-50
  • Packager: Mylan Laboratories Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated February 6, 2019

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Lopinavir and Ritonavir Oral Granules Carton Label
  • INGREDIENTS AND APPEARANCE
    LOPINAVIR AND RITONAVIR 
    lopinavir and ritonavir granule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65015-299
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPINAVIR (UNII: 2494G1JF75) (LOPINAVIR - UNII:2494G1JF75) LOPINAVIR40 mg  in 50 mg
    RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825) RITONAVIR10 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    VANILLA (UNII: Q74T35078H)  
    Product Characteristics
    ColorWHITE (white to creamish) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65015-299-50120 in 1 CARTON02/06/2019
    1NDC:65015-299-4950 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only02/06/2019
    Labeler - Mylan Laboratories Limited (650547156)