Label: OXYTOCIN injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 3, 2014

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  • PRINCIPAL DISPLAY PANEL

    Label

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    OXYTOCIN 
    oxytocin injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-054
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN30 [USP'U]  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2) 25 g  in 500 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 3 g  in 500 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) 1.55 g  in 500 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) 0.15 g  in 500 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 0.1 g  in 500 mL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containACETIC ACID (UNII: Q40Q9N063P)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-054-30500 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/20/2011
    Labeler - Cantrell Drug Company (035545763)