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Medicine

Ibutilide 1 mg/10 mL injection

Ibutilide · Intravenous
Available on requestPrescription onlyUS FDAGeneric name

Ibutilide 1 mg/10 mL injection is a generic prescription medicine for intravenous use, 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

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…

Key facts

Active ingredient (INN)
Ibutilide
Brand
Sold under the generic name
Strength
1 mg/10 mL
Dosage form
Injection
Route
Intravenous
Packs
1 vial of 10 mL
Manufacturer
Avet PharmaceuticalsIndia
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F). Store vial in carton until used.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C01BD05 Ibutilide
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 April 2024
Identifiers
RxCUI 979120DailyMed set ID 0cf8724a-f0d1-4ce2-b7c1-cf5fac345fd0NDC 23155-326Application ANDA204146

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

PackCodeLabelerMarketed since
1 vial, glass in 1 carton / 10 mL in 1 vial, glass23155-326-31Avet PharmaceuticalsIndia1 April 2024

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 28 December 1995Drugs@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 Ibutilide 1 mg/10 mL injection.

Compare 1

Clinical summary

Ibutilide is an antiarrhythmic indicated for the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. It is available as injection for intravenous use. MedsAcross supplies Ibutilide 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 Ibutilide

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

Data sources

Need Ibutilide 1 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.