Medicine
Bupropion Hydrochloride (XL) 300 mg extended-release tablet
Bupropion Hydrochloride (XL) 300 mg extended-release tablet is a prescription medicine containing Bupropion for oral use, marketed by ScieGen 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 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Key facts
- Active ingredient (INN)
- Bupropion
- Brand
- Bupropion Hydrochloride (XL)
- Strength
- 300 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 90 tablets and 31 more
- Marketing authorisation holder
- ScieGen Pharmaceuticals
- Manufacturers
- ScieGen PharmaceuticalsDr. Reddy's LaboratoriesIndiaBryant Ranch PrepackPreferred PharmaceuticalsRemedyrepackA-S Medication SolutionsAdvanced Rx of TennesseeRadha Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (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
- N06AX12 Bupropion
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 April 2017
- Identifiers
- RxCUI 993541, 993557DailyMed set ID 16a788ff-8bd5-4f70-a3fd-a89db019e435, 05f82eca-cc87-4580-acd7-e6491c651881, a5417808-f767-48fc-9f5d-c1aeee4e57c3 +9NDC 77771-145, 50228-145, 63629-8475 +9Application ANDA207479
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 |
|---|---|---|---|
| 500 tablet, film coated, extended release in 1 bottle, plastic | 50228-145-05 | ScieGen Pharmaceuticals,Inc | 12 April 2017 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 50228-145-30 | ScieGen Pharmaceuticals,Inc | 12 April 2017 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 50228-145-90 | ScieGen Pharmaceuticals,Inc | 12 April 2017 |
| 500 tablet, film coated, extended release in 1 bottle, plastic | 43598-656-05 | Dr. Reddy's LaboratoriesIndia | 12 April 2017 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 43598-656-30 | Dr. Reddy's LaboratoriesIndia | 12 April 2017 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 43598-656-90 | Dr. Reddy's LaboratoriesIndia | 12 April 2017 |
| 500 tablet, film coated, extended release in 1 bottle, plastic | 77771-145-05 | Radha Pharmaceuticals | 26 October 2022 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 77771-145-30 | Radha Pharmaceuticals | 26 October 2022 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 77771-145-90 | Radha Pharmaceuticals | 26 October 2022 |
| 500 tablet, film coated, extended release in 1 bottle, plastic | 63629-8475-1 | Bryant Ranch Prepack | 12 April 2017 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 63629-8476-1 | Bryant Ranch Prepack | 12 April 2017 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 71335-2312-1 | Bryant Ranch Prepack | 21 December 2023 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 71335-2312-2 | Bryant Ranch Prepack | 21 December 2023 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 71335-2312-3 | Bryant Ranch Prepack | 21 December 2023 |
| 120 tablet, film coated, extended release in 1 bottle, plastic | 71335-2312-4 | Bryant Ranch Prepack | 21 December 2023 |
| 8 tablet, film coated, extended release in 1 bottle, plastic | 71335-2312-5 | Bryant Ranch Prepack | 21 December 2023 |
| 180 tablet, film coated, extended release in 1 bottle, plastic | 71335-2312-6 | Bryant Ranch Prepack | 21 December 2023 |
| 30 tablet, film coated, extended release in 1 bottle | 72162-1527-3 | Bryant Ranch Prepack | 12 April 2017 |
| 500 tablet, film coated, extended release in 1 bottle | 72162-1527-5 | Bryant Ranch Prepack | 12 April 2017 |
| 30 tablet, film coated, extended release in 1 bottle | 50090-7334-0 | A-S Medication Solutions | 15 October 2024 |
| 90 tablet, film coated, extended release in 1 bottle | 50090-7334-1 | A-S Medication Solutions | 15 October 2024 |
| 90 tablet, film coated, extended release in 1 bottle | 50090-7335-0 | A-S Medication Solutions | 15 October 2024 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 80425-0539-1 | Advanced Rx of Tennessee | 29 August 2025 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 80425-0539-2 | Advanced Rx of Tennessee | 29 August 2025 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 80425-0539-3 | Advanced Rx of Tennessee | 29 August 2025 |
| 100 tablet, film coated, extended release in 1 bottle, plastic | 68788-4172-1 | Preferred Pharmaceuticals | 24 July 2026 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 68788-4172-3 | Preferred Pharmaceuticals | 24 July 2026 |
| 60 tablet, film coated, extended release in 1 bottle, plastic | 68788-4172-6 | Preferred Pharmaceuticals | 24 July 2026 |
| 120 tablet, film coated, extended release in 1 bottle, plastic | 68788-4172-8 | Preferred Pharmaceuticals | 24 July 2026 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 68788-4172-9 | Preferred Pharmaceuticals | 24 July 2026 |
| 30 tablet, film coated, extended release in 1 bottle, plastic | 70518-3790-1 | Remedyrepack | 7 June 2024 |
| 30 tablet, film coated, extended release in 1 blister pack | 70518-3790-2 | Remedyrepack | 20 March 2026 |
| 90 tablet, film coated, extended release in 1 bottle, plastic | 70518-3790-3 | Remedyrepack | 15 April 2026 |
| 30 tablet, film coated, extended release in 1 blister pack | 70518-3790-4 | Remedyrepack | 20 July 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 |
| 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 300 mg extended-release tablet.
- Bupropion 300 mg extended-release tabletAvailable on request—US FDA40 packs
- Bupropion Hydrochloride XL 300 mg extended-release tabletAvailable on requestLupinIndiaUS FDA9 packs
- Bupropion Hydrochloride XL 300 mg extended-release tabletAvailable on requestEpic PharmaUS FDA11 packs
- Bupropion hydrochloride (XL) 300 mg extended-release tabletAvailable on requestLannettUS FDA12 packs
- Bupropion Hydrochloride (XL) 300 mg extended-release tabletAvailable on requestCiplaIndiaUS FDA8 packs
- Bupropion Hydrochloride XL 300 mg extended-release tabletAvailable on requestEpic PharmaUS FDA5 packs
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 Bupropion Hydrochloride (XL) 300 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.