Label: LINEZOLID tablet, film coated

  • NDC Code(s): 70771-1111-0, 70771-1111-1, 70771-1111-2, 70771-1111-3, view more
    70771-1111-5, 70771-1111-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 13, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1111-1

    Linezolid Tablets, 600 mg

    Rx only

    100 tablets

    Linezolid Tablets, 600mg
  • INGREDIENTS AND APPEARANCE
    LINEZOLID 
    linezolid tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1111
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LINEZOLID (UNII: ISQ9I6J12J) (LINEZOLID - UNII:ISQ9I6J12J) LINEZOLID600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code 413
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1111-220 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    2NDC:70771-1111-330 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    3NDC:70771-1111-990 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    4NDC:70771-1111-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    5NDC:70771-1111-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    6NDC:70771-1111-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20609708/09/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1111) , MANUFACTURE(70771-1111)
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