Medicine
Auvelity 105 mg/45 mg extended-release tablet
Auvelity 105 mg/45 mg extended-release tablet is a prescription medicine containing Bupropion and Dextromethorphan for oral use, 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)
- Bupropion and Dextromethorphan
- Brand
- Auvelity
- Strength
- 105 mg/45 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 30 tablets, 60 tablets
- 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
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 August 2022
- Identifiers
- RxCUI 2611260, 2611266, 2741701 +5DailyMed set ID dcefda7c-9a68-278e-e053-2995a90aec79NDC 81968-045Application 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 |
|---|---|---|---|
| 30 tablet, multilayer, extended release in 1 bottle | 81968-045-30 | Axsome Therapeutics | 18 August 2022 |
| 60 tablet, multilayer, extended release in 1 bottle | 81968-045-60 | Axsome Therapeutics | 28 June 2024 |
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 18 August 2022 | 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 Bupropion and Dextromethorphan
Clinical summary
Bupropion and Dextromethorphan is a fixed-dose combination of an aminoketone, a sigma-1 agonist and an uncompetitive N-methyl-D-aspartate receptor antagonist. It is available as extended-release tablets for oral use. MedsAcross supplies Bupropion and 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 Bupropion and 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 105 mg/45 mg extended-release tablet 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.