Esmolol Hydrochloride
These highlights do not include all the information needed to use ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION. ESMOLOL HYDROCHLORIDE in sodium chloride injection, for intravenous use Initial U.S. Approval: 1986
Approved
Approval ID
4cfdfa50-579b-43e7-bc0a-e831d3099bfd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 19, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1717
Application NumberANDA216603
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esmolol Hydrochloride in Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 18, 2023
FDA Product Classification
INGREDIENTS (7)
ESMOLOL HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 2.8 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.1 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Esmolol Hydrochloride in Sodium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1716
Application NumberANDA216603
Product Classification
M
Marketing Category
C73584
G
Generic Name
Esmolol Hydrochloride in Sodium Chloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 18, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ESMOLOL HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: V05260LC8D
Classification: ACTIB
ACETIC ACIDInactive
Quantity: 0.546 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT