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 125 mL Bag

MM1

FENTANYL CITRATE, BUPIVACAINE HCL 
fentanyl citrate, bupivacaine hcl injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-080
Route of Administration EPIDURAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fentanyl Citrate (UNII: MUN5LYG46H) (Fentanyl - UNII:UF599785JZ) Fentanyl 2 ug  in 1 mL
BUPIVACAINE HYDROCHLORIDE (UNII: 7TQO7W3VT8) (BUPIVACAINE - UNII:Y8335394RO) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 1.25 mg  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:52533-080-64 125 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/17/2013
Labeler - Cantrell Drug Company (035545763)

Revised: 1/2015
Document Id: 10c0befd-7161-4f4c-9a5c-ebf2422d33aa
Set id: 2eb63a37-acd7-4b8a-a002-48e5060a703d
Version: 2
Effective Time: 20150112
 
Cantrell Drug Company