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:
Approved
Approval ID
59ba978b-a393-421c-9a67-77e690249d88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2023
Manufacturers
FDA
WG Critical Care, LLC
DUNS: 829274633
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Esmolol Hydrochloride in Sodium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44567-451
Application NumberANDA214172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esmolol Hydrochloride in Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (2)
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM
ESMOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
Esmolol Hydrochloride in Sodium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44567-450
Application NumberANDA214172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esmolol Hydrochloride in Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 23, 2023
FDA Product Classification
INGREDIENTS (2)
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
NATURAL LATEX RUBBERInactive
Quantity: 0 1 in 1 mL
Code: 2LQ0UUW8IN
Classification: CNTM