Medicine
Clobazam 2.5 mg/mL oral suspension
Clobazam 2.5 mg/mL oral suspension is a generic prescription medicine for oral 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store oral suspension at 20°C to 25°C (68°F to 77°F). Store and dispense…
Key facts
- Active ingredient (INN)
- Clobazam
- Brand
- Sold under the generic name
- Strength
- 2.5 mg/mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 1 bottle, 120 mL, 50 bags and 7 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAmneal Pharmaceuticals NYBionpharmaBryant Ranch PrepackChartwell RXNorthStar RxLLCPrecision Dose
- Origin register
- US FDA, United States
- Storage
- Store oral suspension at 20°C to 25°C (68°F to 77°F). Store and dispense clobazam 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
- 20 October 2017
- Identifiers
- RxCUI 1366192DailyMed set ID 574a3f91-d73e-46bc-b4a1-2388439521fb, 6332e71c-3b37-422c-838c-8a2489ac6009, fd1e63bf-496c-427c-83b7-6acabc00a5e5 +7NDC 16714-087, 68094-074, 51672-4227 +7Application ANDA209796, ANDA210039, ANDA210978 +4
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 120 mL in 1 bottle | 67877-658-61 | Ascend LaboratoriesIndia | 7 May 2021 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 59651-401-12 | Aurobindo PharmaIndia | 24 March 2022 |
| 1 bottle, glass in 1 carton / 120 mL in 1 bottle, glass | 31722-641-12 | Camber PharmaceuticalsIndia | 24 February 2020 |
| 120 mL in 1 bottle | 51672-4227-8 | Sun Pharmaceutical IndustriesIndia | 30 June 2021 |
| 1 bottle, glass in 1 carton / 120 mL in 1 bottle, glass | 69238-1535-2 | Amneal Pharmaceuticals NY | 22 October 2018 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 69452-116-45 | Bionpharma | 20 October 2017 |
| 120 mL in 1 bottle | 62135-527-41 | Chartwell RX | 1 August 2022 |
| 1 bottle in 1 carton / 120 mL in 1 bottle | 72162-2608-2 | Bryant Ranch Prepack | 21 April 2026 |
| 1 bottle, glass in 1 carton / 120 mL in 1 bottle, glass | 16714-087-01 | NorthStar RxLLC | 1 May 2020 |
| 50 bag in 1 case / 1 syringe, plastic in 1 bag / 4 mL in 1 syringe, plastic | 68094-074-58 | Precision Dose | 10 March 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 October 2011 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 2.5 mg/mL oral suspension.
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 ClobazamFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Onfi prescribing information (Lundbeck Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Clobazam 2.5 mg/mL oral suspension 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.