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FDA Approval

Esmolol Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
December 5, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Esmolol(10 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Esmolol Hydrochloride

Product Details

NDC Product Code
50090-4699
Application Number
ANDA076474
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
April 4, 2017
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0Class: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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