Label: FENTANYL CITRATE - fentanyl citrate injection, solution

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

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Drug Label Information

Updated May 2, 2014

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  • INGREDIENTS AND APPEARANCE
    FENTANYL CITRATE 
    fentanyl citrate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-074
    Route of Administration INTRAVENOUS DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ) Fentanyl 50 ug  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    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:52533-074-15 5 mL in 1 SYRINGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/20/2011
    Labeler - Cantrell Drug Company (035545763)
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