Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
SYNGENE INTERNATIONAL LIMITED
Baxter Healthcare Corporation
915833842
Baxter Healthcare Corporation
Baxter Healthcare Corporation
001728059
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brevibloc
Product Details
NDC Product Code
10019-115Application Number
NDA019386Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
April 1, 2014EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.9 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Brevibloc
Product Details
NDC Product Code
10019-075Application Number
NDA019386Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
April 1, 2014SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 20 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 4.1 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Brevibloc
Product Details
NDC Product Code
10019-055Application Number
NDA019386Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
April 1, 2014SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.9 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT