Medicine
Qelbree 200 mg extended-release capsule
Qelbree 200 mg extended-release capsule is a prescription medicine containing Viloxazine for oral use, marketed by Supernus 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
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Viloxazine
- Brand
- Qelbree
- Strength
- 200 mg
- Dosage form
- Extended-release capsule
- Route
- Oral
- Packs
- 100 capsules, 30 capsules, 60 capsules and 1 more
- Marketing authorisation holder
- Supernus Pharmaceuticals
- Manufacturer
- Supernus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AX09 Viloxazine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 April 2021
- Identifiers
- RxCUI 2536548, 2536554, 2536750 +3DailyMed set ID aedf408d-0f84-418d-9416-7c39ddb0d29aNDC 17772-133Application NDA211964
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 capsule, extended release in 1 bottle | 17772-133-01 | Supernus Pharmaceuticals | 2 April 2021 |
| 30 capsule, extended release in 1 bottle | 17772-133-30 | Supernus Pharmaceuticals | 2 April 2021 |
| 60 capsule, extended release in 1 bottle | 17772-133-60 | Supernus Pharmaceuticals | 2 April 2021 |
| 90 capsule, extended release in 1 bottle | 17772-133-90 | Supernus Pharmaceuticals | 2 April 2021 |
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 2 April 2021 | 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 Viloxazine
Clinical summary
Viloxazine is a norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. It is available as extended-release capsules for oral use. MedsAcross supplies Viloxazine 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 ViloxazineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- QELBREE prescribing information (Supernus Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Qelbree 200 mg extended-release capsule 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.