Label: OXYTOCIN - 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 January 16, 2015

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  • INGREDIENTS AND APPEARANCE
    OXYTOCIN 
    oxytocin injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-051
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN 2 [USP'U]  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 600 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) 310 mg  in 100 mL
    POTASSIUM CHLORIDE (UNII: 660YQ98I10) 30 mg  in 100 mL
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M) 20 mg  in 100 mL
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    May contain ACETIC ACID (UNII: Q40Q9N063P)  
    May contain SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52533-051-24 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/20/2011
    Labeler - Cantrell Drug Company (035545763)
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