Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Eugia Pharma Specialities Limited
Eugia US LLC
650498244
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
esmolol hydrochloride
Product Details
NDC Product Code
55150-420Application Number
ANDA216244Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 4, 2023SODIUM 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
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
esmolol hydrochloride
Product Details
NDC Product Code
55150-421Application Number
ANDA216244Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
August 4, 2023EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 20 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 4.1 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT