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Medicine

Esmolol 100 mg/10 mL injection

Esmolol · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Esmolol 100 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 10 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Protect from freezing. Store at 20° to 25°C (68° to 77°F).

Key facts

Active ingredient (INN)
Esmolol
Brand
Sold under the generic name
Strength
100 mg/10 mL
Dosage form
Injection
Route
Intravenous
Packs
25 vials of 10 mL, 10 vials of 10 mL, 10 mL and 13 more
Manufacturers
EugiaIndiaGland PharmaIndiaHealthFirstFresenius KabiHenry ScheinMedical Purchasing SolutionsBaxter HealthcareMylan InstitutionalProPharma DistributionRemedyrepack
Origin register
US FDA, United States
Storage
Protect from freezing. Store at 20° to 25°C (68° to 77°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C07AB09 Esmolol
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
31 December 1986
Identifiers
RxCUI 1736546, 979432, 1736541DailyMed set ID 789730fa-eaca-4986-e053-2a91aa0a5339, ac22475d-2d78-469f-9435-b403ac4ee380, 9c1e3a64-0ef0-4071-ad6f-63ff8789b198 +11NDC 51662-1322, 55150-194, 0404-9785 +12Application ANDA076474, ANDA205520, NDA019386 +2

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
25 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose55150-194-10EugiaIndia23 July 2015
25 vial in 1 carton / 10 mL in 1 vial68083-211-25Gland PharmaIndia19 August 2019
25 vial, single-dose in 1 tray / 10 mL in 1 vial, single-dose63323-652-10Fresenius Kabi30 November 2004
25 vial, single-dose in 1 tray / 10 mL in 1 vial, single-dose63323-661-14Fresenius Kabi13 January 2025
25 vial in 1 carton / 10 mL in 1 vial10019-120-01Baxter Healthcare31 December 1986
10 vial in 1 carton / 10 mL in 1 vial67457-182-10Mylan Institutional29 May 2007
10 mL in 1 vial51662-1322-1HealthFirst19 October 2018
10 mL in 1 vial, single-dose51662-1371-1HealthFirst8 December 2019
10 mL in 1 vial, single-dose51662-1444-1HealthFirst22 December 2019
25 pouch in 1 case / 1 vial, single-dose in 1 pouch / 10 mL in 1 vial, single-dose51662-1444-3HealthFirst12 September 2022
1 vial in 1 bag / 10 mL in 1 vial0404-9785-10Henry Schein10 June 2025
1 vial, single-dose in 1 bag / 10 mL in 1 vial, single-dose0404-9858-10Henry Schein10 January 2022
1 vial, single-dose in 1 bag / 10 mL in 1 vial, single-dose71872-7049-1Medical Purchasing Solutions19 February 2018
1 vial in 1 bag / 10 mL in 1 vial71872-7136-1Medical Purchasing Solutions19 April 2018
10 mL in 1 vial, single-dose84549-194-10ProPharma Distribution27 August 2025
25 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose70518-4410-0Remedyrepack29 July 2025

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 31 December 1986Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Esmolol 100 mg/10 mL injection.

Compare 1

Other strengths and forms of Esmolol

Clinical summary

Esmolol is a beta-adrenergic blocker indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia, among other approved uses. MedsAcross supplies Esmolol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Esmolol

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Esmolol 100 mg/10 mL injection for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.