Medicine
Aplenzin 348 mg extended-release tablet
Aplenzin 348 mg extended-release tablet is a prescription medicine containing Bupropion for oral use, marketed by Bausch Health, 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Bupropion
- Brand
- Aplenzin
- Strength
- 348 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 7 tablets, 30 tablets
- Marketing authorisation holder
- Bausch Health
- Manufacturer
- Bausch Health
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N06AX12 Bupropion
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 April 2008
- Identifiers
- RxCUI 993550, 993552, 993567 +3DailyMed set ID 6494d2d9-0ce4-4126-b1c7-49684395942bNDC 0187-5811Application NDA022108
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 |
|---|---|---|---|
| 7 tablet, extended release in 1 bottle | 0187-5811-07 | Bausch Health | 23 April 2008 |
| 30 tablet, extended release in 1 bottle | 0187-5811-30 | Bausch Health | 23 April 2008 |
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 30 December 1985 | 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 Bupropion 348 mg extended-release tablet.
Other strengths and forms of Bupropion
Clinical summary
Bupropion is an aminoketone indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). It is available as extended-release tablets and tablets for oral use. MedsAcross supplies Bupropion 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 BupropionFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- WELLBUTRIN SR prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
Need Aplenzin 348 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.