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 0.1% 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:52533-124
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 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-124-61250 mL in 1 BAG; Type 0: Not a Combination Product09/09/201312/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/09/201312/06/2017
Labeler - Cantrell Drug Company (035545763)

Revised: 12/2017
Document Id: 5faecfad-6602-ee00-e053-2991aa0ad0b3
Set id: d33ab284-dcda-43d9-8fad-b1fd988a7bc9
Version: 3
Effective Time: 20171206
 
Cantrell Drug Company