Label: FENTANYL CITRATE, BUPIVACAINE HCL - fentanyl citrate and bupivacaine hydrochloride injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 01/15

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  • INGREDIENTS AND APPEARANCE
    FENTANYL CITRATE, BUPIVACAINE HCL 
    fentanyl citrate, bupivacaine hcl injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-080
    Route of Administration EPIDURAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ) Fentanyl 2 ug  in 1 mL
    BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 1.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Chloride (UNII: 451W47IQ8X) 9 mg  in 1 mL
    Water (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    May contain HYDROCHLORIC ACID (UNII: QTT17582CB)  
    May contain SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52533-080-64 125 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/17/2013
    Labeler - Cantrell Drug Company (035545763)
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