Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Exela Pharma Sciences, LLC
Exela Phrama Sciences, LLC
831274399
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Vazculep
Product Details
NDC Product Code
51754-4020Application Number
NDA204300Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
March 26, 2021SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Vazculep
Product Details
NDC Product Code
51754-4010Application Number
NDA204300Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
March 26, 2021PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Vazculep
Product Details
NDC Product Code
51754-4000Application Number
NDA204300Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
March 26, 2021SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 3.5 mg in 1 mL
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 10 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 4 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 1 mg in 1 mL
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACTQuantity: 2 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT