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 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 250 mL Bag

MM1

FENTANYL CITRATE, BUPIVACAINE HCL 
fentanyl citrate, bupivacaine hcl injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52533-080
Route of AdministrationEPIDURALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ) Fentanyl2 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:52533-080-11250 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/25/2014
Labeler - Cantrell Drug Company (035545763)

Revised: 8/2014
Document Id: 3b56263f-62bd-4571-84d6-83b2930ff721
Set id: 17606e46-f2c4-4821-b67d-a76b41a227e1
Version: 3
Effective Time: 20140813
 
Cantrell Drug Company