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
840771732
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
63323-652Application Number
ANDA076573Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
February 22, 2016SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT