Medicine
Auvelity kit
Auvelity kit is a prescription medicine containing Dextromethorphan, marketed by Axsome Therapeutics, 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 AUVELITY in original bottle at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Dextromethorphan
- Brand
- Auvelity
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Axsome Therapeutics
- Manufacturer
- Axsome Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store AUVELITY in original bottle at 20°C to 25°C (68°F to 77°F), excursions permitted to 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
- R05DA09 Dextromethorphan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 2026
- Identifiers
- RxCUI 2611260, 2611266, 2741701 +5DailyMed set ID dcefda7c-9a68-278e-e053-2995a90aec79NDC 81968-453, 81968-345Application NDA215430
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 |
|---|---|---|---|
| 1 kit in 1 kit * 30 tablet, multilayer, extended release in 1 bottle * 1 bottle in 1 carton / 14 tablet, multilayer, extended release in 1 bottle * 1 bottle in 1 carton / 21 tablet, multilayer, extended release in 1 bottle | 81968-345-01 | Axsome Therapeutics | 1 June 2026 |
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 |
| 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
Clinical summary
Dextromethorphan is a prescription medicine indicated for the treatment of major depressive disorder (MDD) in adults the treatment of agitation associated with dementia due to Alzheimer’s disease, among other approved uses. It is available as kits. MedsAcross supplies Dextromethorphan 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 DextromethorphanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AUVELITY prescribing information (Axsome Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Auvelity kit 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.