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Medicine

Bupropion Hydrochloride XL 300 mg extended-release tablet

Bupropion · Oral · Lupin
Available on requestPrescription onlyUS FDAIndian manufacturer

Bupropion Hydrochloride XL 300 mg extended-release tablet is a prescription medicine containing Bupropion for oral use, marketed by Lupin, 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

Available on request

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
Bupropion Hydrochloride XL
Strength
300 mg
Dosage form
Extended-release tablet
Route
Oral
Packs
500 tablets, 30 tablets, 90 tablets and 6 more
Marketing authorisation holder
Lupin
Manufacturers
LupinIndiaA-S Medication SolutionsAmerican Health PackagingMajor PharmaceuticalsNuCare Pharmaceuticals,IncQuallent Pharmaceuticals HealthRemedyrepack
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
14 June 2017
Identifiers
RxCUI 993557, 993541DailyMed set ID eee88553-acff-4bdd-acd1-f39bcb6fcdca, 8dab6d17-bf41-4a28-90db-b66959c0e143, 45789ff4-af5d-96b0-e063-6394a90a0644 +4NDC 50090-7602, 60687-793, 68071-3928 +4Application ANDA090693

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

PackCodeLabelerMarketed since
500 tablet, extended release in 1 bottle68180-320-02LupinIndia14 June 2017
30 tablet, extended release in 1 bottle68180-320-06LupinIndia14 June 2017
90 tablet, extended release in 1 bottle68180-320-09LupinIndia14 June 2017
90 tablet, extended release in 1 bottle50090-7602-0A-S Medication Solutions14 July 2025
30 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack60687-793-21American Health Packaging15 January 2024
30 blister pack in 1 carton / 1 tablet, extended release in 1 blister pack0904-7469-04Major Pharmaceuticals7 October 2024
90 tablet, extended release in 1 bottle68071-3928-9NuCare Pharmaceuticals,Inc8 December 2025
500 tablet, extended release in 1 bottle82009-052-05Quallent Pharmaceuticals Health7 July 2023
30 tablet, extended release in 1 blister pack70518-4446-0Remedyrepack18 August 2025

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 December 1985Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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.

Compare all 9

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 Bupropion

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

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.