Fentanyl Citrate, Bupivacaine HCl
Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 125 mL Bag
Approved
Approval ID
2eb63a37-acd7-4b8a-a002-48e5060a703d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2015
Manufacturers
FDA
Cantrell Drug Company
DUNS: 035545763
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fentanyl Citrate, Bupivacaine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52533-080
Product Classification
G
Generic Name
Fentanyl Citrate, Bupivacaine HCl
Product Specifications
Route of AdministrationEPIDURAL
Effective DateJanuary 12, 2015
FDA Product Classification
INGREDIENTS (6)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
Fentanyl CitrateActive
Quantity: 2 ug in 1 mL
Code: MUN5LYG46H
Classification: ACTIM
WaterInactive
Code: 059QF0KO0R
Classification: IACT
BUPIVACAINE HYDROCHLORIDEActive
Quantity: 1.25 mg in 1 mL
Code: 7TQO7W3VT8
Classification: ACTIR
Sodium ChlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT