FENTANYL CITRATE, BUPIVACAINE HCL - fentanyl citrate and bupivacaine hydrochloride 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 DRUG LABELItem Code (Source)NDC:52533-080
Route of AdministrationEPIDURALDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Fentanyl Citrate (Fentanyl) Fentanyl2 ug  in 1 mL
BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride9 mg  in 1 mL
Water 
Other Ingredients
Ingredient KindIngredient NameQuantity
May containHYDROCHLORIC ACID 
May containSODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-080-61250 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/16/2012
Labeler - Cantrell Drug Company (035545763)

Revised: 8/2014
Document Id: c2d97900-1e9f-46cf-b5c7-773da45f87e2
Set id: cfecc5f4-5ce0-46d5-b1d4-92654246fcb2
Version: 8
Effective Time: 20140813
 
Cantrell Drug Company