MedPath

Esmolol Hydrochloride

These highlights do not include all the information needed to use Esmolol Hydrochloride 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

6bdd5315-75ce-1537-e053-2991aa0a6549

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 22, 2023

Manufacturers
FDA

Medical Purchasing Solutions, LLC

DUNS: 601458529

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 Code71872-7136
Application NumberNDA019386
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateMay 22, 2023
Generic NameEsmolol Hydrochloride

INGREDIENTS (7)

SODIUM CHLORIDEInactive
Quantity: 5.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2.8 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Esmolol Hydrochloride - FDA Drug Approval Details