Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
HF Acquisition Co LLC, DBA HealthFirst
045657305
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
045657305
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
51662-1427Application Number
NDA019386Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
February 22, 2020EsmololActive
Code: V05260LC8DClass: ACTIBQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.9 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 2.8 mg in 1 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 0.546 mg in 1 mL