FENTANYL CITRATE, BUPIVACAINE HCL injection, solution

Fentanyl Citrate, Bupivacaine HCl by

Drug Labeling and Warnings

Fentanyl Citrate, Bupivacaine HCl by is a Prescription medication manufactured, distributed, or labeled by Cantrell Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

SPL UNCLASSIFIED SECTION

INGREDIENTS AND APPEARANCE

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: 52533-080-75	100 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/25/2013

Labeler - Cantrell Drug Company (035545763)