Label: OXYTOCIN injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated December 11, 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:52533-105
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN2 [USP'U]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 5 g  in 100 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:52533-105-441000 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/12/2012
    Labeler - Cantrell Drug Company (035545763)
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