Esmolol Hydrochloride
These highlights do not include all the information needed to use ESMOLOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ESMOLOL HYDROCHLORIDE INJECTION. ESMOLOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1986
Approved
Approval ID
ac22475d-2d78-469f-9435-b403ac4ee380
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
Products 1
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 Code55150-194
Application NumberANDA205520
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateAugust 17, 2023
Generic NameEsmolol Hydrochloride
INGREDIENTS (6)
ESMOLOL HYDROCHLORIDEActive
Quantity: 100 mg in 10 mL
Code: V05260LC8D
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT