Label: AMIKACIN SULFATE INJECTION, 500 MG/2ML injection

  • NDC Code(s): 71309-996-05
  • Packager: Safrel Pharmaceuticals, LLC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 3, 2021

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  • PRINCIPAL DISPLAY PANEL

    amikacin

  • INGREDIENTS AND APPEARANCE
    AMIKACIN SULFATE INJECTION, 500 MG/2ML 
    amikacin sulfate injection, 500 mg/2ml injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71309-996
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMIKACIN SULFATE (UNII: N6M33094FD) (AMIKACIN - UNII:84319SGC3C) AMIKACIN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SULFURIC ACID (UNII: O40UQP6WCF)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71309-996-05500 in 1 VIAL; Type 0: Not a Combination Product08/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only08/01/2020
    Labeler - Safrel Pharmaceuticals, LLC. (080566287)