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FDA Approval

Fentanyl Citrate, Bupivacaine HCl

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Cantrell Drug Company
DUNS: 035545763
Effective Date
January 12, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fentanyl(1 ug in 1 mL)
Bupivacaine(1.25 mg in 1 mL)

Products1

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

NDC Product Code
52533-174
Route of Administration
EPIDURAL
Effective Date
January 13, 2015
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 1 ug in 1 mL
Code: 7TQO7W3VT8Class: ACTIRQuantity: 1.25 mg in 1 mL
Code: 55X04QC32IClass: CNTM
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Code: QTT17582CBClass: CNTM
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