FENTANYL CITRATE, BUPIVACAINE HCL - fentanyl citrate, bupivacaine hcl 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 3 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 200 mL Bag

Label

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)

Revised: 8/2014
Document Id: 56079bf1-a667-48e7-9392-85166d7aff21
Set id: 0aad9e57-d33f-444f-90b6-67138387e631
Version: 5
Effective Time: 20140812
 
Cantrell Drug Company