Label: NINEPERCENT- 0.9% saline injection, solution

  • NDC Code(s): 69389-010-24
  • Packager: US Specialty Formulations LLC
  • Category: HUMAN COMPOUNDED DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated December 1, 2014

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  • PRINCIPAL DISPLAY PANEL

    0.9% Saline Example Label

  • INGREDIENTS AND APPEARANCE
    NINEPERCENT 
    0.9% saline injection, solution
    Product Information
    Product TypeHUMAN COMPOUNDED DRUGItem Code (Source)NDC:69389-010
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CATION (UNII: LYR4M0NH37) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CATION90 g  in 1000 g
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGR0.9% SODIUM CHLORIDE IRRIGATION (UNII: 0338-0047) 90 g  in 1000 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69389-010-24100 g in 1 VIAL; Number of Units = 50
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2014
    Labeler - US Specialty Formulations LLC (079181064)