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 March 18, 2016

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  • INGREDIENTS AND APPEARANCE
    OXYTOCIN 
    oxytocin injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-234
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN 30 [USP'U]  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 50 g  in 1000 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 4.5 g  in 1000 mL
    WATER (UNII: 059QF0KO0R)  
    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:52533-234-24 1000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/18/2016
    Labeler - Cantrell Drug Company (035545763)
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