Label: OXYTOCIN injection, solution

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 24, 2014

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL

    Label

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    OXYTOCIN 
    oxytocin injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-055
    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
    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
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containACETIC ACID (UNII: Q40Q9N063P)  
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-055-30500 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)