Esmolol Hydrochloride
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1986
Approved
Approval ID
55def2c7-b354-47e6-bd25-6ecd92860795
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-4699
Application NumberANDA076474
Product Classification
M
Marketing Category
C73584
G
Generic Name
esmolol hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 4, 2017
FDA Product Classification
INGREDIENTS (6)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT