OXYTOCIN INJECTION, SOLUTION [CANTRELL DRUG COMPANY]

OXYTOCIN INJECTION, SOLUTION [CANTRELL DRUG COMPANY]
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NDC 52533-054-30
Set ID d0c29c3a-4dc1-4c00-add9-3075318e74ca
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Cantrell Drug Company
Generic Name
Product Class
Product Number
Application Number
  • PRINCIPAL DISPLAY PANEL

    Label

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    OXYTOCIN 
    oxytocin injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-054
    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
    DEXTROSE (UNII: IY9XDZ35W2) 25 g  in 500 mL
    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
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containACETIC ACID (UNII: Q40Q9N063P)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-054-30500 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)