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Medicine

Onfi 20 mg tablet

Clobazam · Oral · Lundbeck Pharmaceuticals
Available on requestPrescription onlyUS FDAControlled, schedule CIV

Onfi 20 mg tablet is a prescription medicine containing Clobazam for oral use, marketed by Lundbeck Pharmaceuticals, 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 tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP…

Key facts

Active ingredient (INN)
Clobazam
Brand
Onfi
Strength
20 mg
Dosage form
Tablet
Route
Oral
Packs
1 bottle
Marketing authorisation holder
Lundbeck Pharmaceuticals
Manufacturer
Lundbeck Pharmaceuticals
Origin register
US FDA, United States
Storage
Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature. Store and dispense ONFI oral suspension in its original bottle in an upright position.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CIV
ATC code
N05BA09 Clobazam
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
10 December 2013
Identifiers
RxCUI 199450, 246172, 1191056 +3DailyMed set ID de03bd69-2dca-459c-93b4-541fd3e9571cNDC 67386-315Application NDA202067

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 bottle in 1 carton / 100 tablet in 1 bottle67386-315-01Lundbeck Pharmaceuticals10 December 2013

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 21 October 2011Drugs@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 Clobazam 20 mg tablet.

Compare 1

Other strengths and forms of Clobazam

Clinical summary

Clobazam is a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. It is available as tablets, oral suspension and oral films. MedsAcross supplies Clobazam 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 Clobazam

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

Data sources

Need Onfi 20 mg tablet for your hospital or patient?

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