Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC
023648251
Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SENSORCAINE MPF
Product Details
NDC Product Code
63323-460Application Number
NDA018304Marketing Category
NDA (C73594)Route of Administration
EPIDURAL, RETROBULBAREffective Date
July 12, 2019CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.2 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 7.5 mg in 1 mL
EpinephrineActive
Code: 30Q7KI53AKClass: ACTIMQuantity: 0.005 mg in 1 mL
SENSORCAINE MPF
Product Details
NDC Product Code
63323-466Application Number
NDA018304Marketing Category
NDA (C73594)Route of Administration
EPIDURAL, INTRACAUDAL, PERINEURALEffective Date
July 12, 2019SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 5 mg in 1 mL
SENSORCAINE MPF
Product Details
NDC Product Code
63323-462Application Number
NDA018304Marketing Category
NDA (C73594)Route of Administration
EPIDURAL, INTRACAUDAL, PERINEURALEffective Date
July 12, 2019SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.5 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.2 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 5 mg in 1 mL
EpinephrineActive
Code: 30Q7KI53AKClass: ACTIMQuantity: 0.005 mg in 1 mL
SENSORCAINE
Product Details
NDC Product Code
63323-465Application Number
NDA018304Marketing Category
NDA (C73594)Route of Administration
INFILTRATION, PERINEURALEffective Date
July 12, 2019METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 2.5 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SENSORCAINE
Product Details
NDC Product Code
63323-467Application Number
NDA018304Marketing Category
NDA (C73594)Route of Administration
PERINEURALEffective Date
July 12, 2019METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 5 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SENSORCAINE MPF
Product Details
NDC Product Code
63323-464Application Number
NDA018304Marketing Category
NDA (C73594)Route of Administration
INFILTRATION, EPIDURAL, INTRACAUDAL, PERINEURALEffective Date
July 12, 2019SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 2.5 mg in 1 mL