FENTANYL CITRATE - fentanyl citrate injection, solution 
Cantrell Drug Company

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.

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Fentanyl Citrate 50 mcg/mL in Sterile Water 5 mL Syringe

Label

FENTANYL CITRATE 
fentanyl citrate injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-074
Route of AdministrationINTRAVENOUSDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ) Fentanyl50 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
Other Ingredients
Ingredient KindIngredient NameQuantity
May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-074-155 mL in 1 SYRINGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/20/2011
Labeler - Cantrell Drug Company (035545763)

Revised: 5/2014
Document Id: 7ade28d7-cb42-4daf-bea8-9bcce175c477
Set id: 58c3bcc5-4e6b-4cb9-9912-940a664e9d71
Version: 5
Effective Time: 20140502
 
Cantrell Drug Company