Label: FENTANYL CITRATE - fentanyl citrate injection, solution

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated August 13, 2014

If you are a consumer or patient please visit this version.

  • INGREDIENTS AND APPEARANCE
    FENTANYL CITRATE 
    fentanyl citrate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-024
    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 10 ug  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:52533-024-04 50 mL in 1 SYRINGE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/23/2012
    Labeler - Cantrell Drug Company (035545763)
    Close