Label: FENTANYL CITRATE, BUPIVACAINE HCL injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated August 12, 2014

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  • PRINCIPAL DISPLAY PANEL

    Label

  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    FENTANYL CITRATE, BUPIVACAINE HCL 
    fentanyl citrate, bupivacaine hcl injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-081
    Route of AdministrationEPIDURALDEA ScheduleCII    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ) Fentanyl3 ug  in 1 mL
    BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X) 9 mg  in 1 mL
    Water (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52533-081-62200 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/18/2013
    Labeler - Cantrell Drug Company (035545763)
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