Esmolol Hydrochloride
Esmolol Hydrochloride Injection
Approved
Approval ID
a70baf53-e38a-4b23-8905-ee284170236d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2007
Manufacturers
FDA
West Ward Pharmaceutical Corporation
DUNS: 946499746
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 Code0641-2965
Application NumberNDA019386
Product Classification
M
Marketing Category
C73594
G
Generic Name
ESMOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 6, 2007
FDA Product Classification
INGREDIENTS (7)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 5.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT