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Active ingredient

Esmolol

36 finished FDA listings contain Esmolol as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ESMOLOL HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution
Routes
Intravenous
Manufacturers / labelers
15
Strengths listed
10 mg/ml · 100 mg/10ml · 20 mg/ml
Brand names in FDA listings
Brevibloc, Esmolol Hydrochloride, Esmolol Hydrochloride In Water

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 49737

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 019386BAXTER HLTHCARE1986-12-3111
ANDA 076474MYLAN INSTITUTIONAL2005-05-023
ANDA 076573FRESENIUS KABI USA2005-05-023
ANDA 205520EUGIA PHARMA2015-07-236
NDA 205703HQ SPCLT PHARMA2016-04-072
ANDA 207107SAGENT PHARMS INC2018-06-082
ANDA 206608MYLAN LABS LTD2018-06-082
ANDA 208538GLAND2019-08-141
ANDA 216244EUGIA PHARMA2022-03-212
ANDA 214172HQ SPCLT PHARMA2022-12-022
ANDA 216603AMNEAL2022-12-132

Official labeling on DailyMed

Showing the 12 most recent of 22 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.