Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Baxter Healthcare Corporation
005083209
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Baxter Healthcare Corporation
194684502
Products1
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
10019-120Application Number
NDA019386Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
April 1, 2014EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.9 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT