ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE INJECTION 100 mg/10 mL (10mg/mL) 10 mL VIAL
Approved
Approval ID
993df35b-0006-4892-e053-2a95a90a0dba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2022
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1371
Application NumberANDA076573
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESMOLOL HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 10, 2022
FDA Product Classification
INGREDIENTS (5)
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT