Medicine
Felbamate 600 mg/5 mL oral suspension
Felbamate 600 mg/5 mL oral suspension is a generic prescription medicine for oral use, made by 4 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 at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Felbamate
- Brand
- Sold under the generic name
- Strength
- 600 mg/5 mL
- Dosage form
- Oral suspension
- Route
- Oral
- Packs
- 237 mL, 473 mL and 5 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAmneal PharmaceuticalsNorthStar RxNovitium Pharma
- Origin register
- US FDA, United States
- Storage
- 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
- N03AX10 Felbamate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 December 2011
- Identifiers
- RxCUI 310285DailyMed set ID 556de35d-3b98-48d3-a670-50e9d93437a4, 2e325d79-d0a4-4af7-b09b-96ee5a5b2a37, 81c8a2e1-732c-4467-84e9-53fef1655ee2 +1NDC 16714-775, 65162-686, 70954-051 +1Application ANDA206314, ANDA202385, ANDA211333
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 |
|---|---|---|---|
| 237 mL in 1 bottle | 51672-4172-1 | Sun Pharmaceutical IndustriesIndia | 16 June 2017 |
| 473 mL in 1 bottle | 51672-4172-9 | Sun Pharmaceutical IndustriesIndia | 16 June 2017 |
| 237 mL in 1 bottle | 65162-686-88 | Amneal Pharmaceuticals | 16 December 2011 |
| 473 mL in 1 bottle | 65162-686-90 | Amneal Pharmaceuticals | 16 December 2011 |
| 237 mL in 1 bottle | 70954-051-10 | Novitium Pharma | 15 July 2022 |
| 473 mL in 1 bottle | 70954-051-20 | Novitium Pharma | 15 July 2022 |
| 237 mL in 1 bottle | 16714-775-01 | Northstar RX | 10 April 2018 |
| 473 mL in 1 bottle | 16714-775-02 | Northstar RX | 10 April 2018 |
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 29 July 1993 | 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
Other strengths and forms of Felbamate
Clinical summary
Felbamate is an anti-epileptic agent indicated as a first line antiepileptic treatment. It is available as tablets and oral suspension. MedsAcross supplies Felbamate 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 FelbamateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Felbatol prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Felbamate 600 mg/5 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.