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Esmolol Hydrochloride in Water

Esmolol Hydrochloride · Injection

Prescription NDA RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

Esmolol Hydrochloride in Water

Generic name

Esmolol Hydrochloride

Dosage form

Injection

Route

Intravenous

Marketing category

NDA · NDA

Labeler

WG Critical Care, LLC

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Esmolol Hydrochloride	10 mg/mL	979432	View
Esmolol Hydrochloride	20 mg/mL	979432	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Injection

Route of administration

Intravenous

Presentations

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Adrenergic beta-Antagonists [MoA]	MoA	All 72 members
beta-Adrenergic Blocker [EPC]	EPC	All 72 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

205703

Application type

NDA · New Drug Application

Approval date

April 7, 2016

Sponsor

HQ SPCLT PHARMA

Products on application

Submissions recorded

Products approved under application 205703.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
205703-001	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	SOLUTION		ESMOLOL HYDROCHLORIDE	Prescription	—	RLD RS
205703-002	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	SOLUTION		ESMOLOL HYDROCHLORIDE	Prescription	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book

Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent	Expires	Product	Substance	Submitted
8829054	March 15, 2033	001	No	May 18, 2016
8835505	March 15, 2033	001	No	May 18, 2016
8835505	March 15, 2033	002	No	May 18, 2016
8829054	March 15, 2033	002	No	May 18, 2016

Approval history

Source: Drugs@FDA

Most recent submissions on application 205703.
Type	No.	Action	Status	Date	Review
Supplement	3	Labeling	Approved	May 2, 2024	Standard
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	April 7, 2016	Standard

Review documents

0 · Supplement · May 6, 2024
0 · Supplement · May 3, 2024
0 · Original application · October 20, 2016
0 · Original application · October 20, 2016
0 · Original application · April 11, 2016
0 · Original application · April 8, 2016
0 · Original application · April 16, 2014

Adverse event reports

Source: openFDA FAERS

265

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ESMOLOL HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
44567-811-10	44567-811	WG Critical Care, LLC	10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG	December 4, 2017
44567-812-10	44567-812	WG Critical Care, LLC	10 BAG in 1 CARTON (44567-812-10) / 100 mL in 1 BAG	December 4, 2017
44567-811	44567-811	WG Critical Care, LLC	—	December 4, 2017
44567-812	44567-812	WG Critical Care, LLC	—	December 4, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.