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
Products4
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
63323-468Application Number
ANDA070966Marketing Category
ANDA (C73584)Route of Administration
INFILTRATION, EPIDURAL, INTRACAUDAL, PERINEURALEffective Date
April 30, 2023CITRIC 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
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 2.5 mg in 1 mL
EpinephrineActive
Code: 30Q7KI53AKClass: ACTIMQuantity: 0.005 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SENSORCAINE
Product Details
NDC Product Code
63323-461Application Number
ANDA070967Marketing Category
ANDA (C73584)Route of Administration
INFILTRATION, PERINEURALEffective Date
April 30, 2023CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.2 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 0.5 mg in 1 mL
METHYLPARABENInactive
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: 2.5 mg in 1 mL
EpinephrineActive
Code: 30Q7KI53AKClass: ACTIMQuantity: 0.005 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SENSORCAINE
Product Details
NDC Product Code
63323-463Application Number
ANDA070968Marketing Category
ANDA (C73584)Route of Administration
PERINEURALEffective Date
April 30, 2023CITRIC 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
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1 mg in 1 mL
EpinephrineActive
Code: 30Q7KI53AKClass: ACTIMQuantity: 0.005 mg in 1 mL
BupivacaineActive
Code: 7TQO7W3VT8Class: ACTIRQuantity: 5 mg in 1 mL
SENSORCAINE MPF
Product Details
NDC Product Code
63323-472Application Number
ANDA070554Marketing Category
ANDA (C73584)Route of Administration
EPIDURAL, RETROBULBAREffective Date
April 30, 2023SODIUM 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