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 March 18, 2016

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    OXYTOCIN 
    oxytocin injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-233
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN20 [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:52533-233-30500 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/18/2016
    Labeler - Cantrell Drug Company (035545763)