Medicine
Lamotrigine 50 mg tablet
Lamotrigine 50 mg tablet is a generic prescription medicine for oral use, made by 4 labelers, 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 20°C and 25°C, (68°F and 77°F),.
Key facts
- Active ingredient (INN)
- Lamotrigine
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 8 more
- Manufacturers
- Zydus LifesciencesIndiaSun Pharmaceutical IndustriesIndiaGolden State Medical SupplyNordic Pharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C and 25°C, (68°F and 77°F),.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AX09 Lamotrigine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 January 2009
- Identifiers
- RxCUI 103968, 198430, 252478 +7DailyMed set ID 67cf961e-02b9-4a99-944f-43a55df6a544, 57f04b9b-06cd-8044-e063-6394a90ae733, 0f2f7421-56d4-45d0-9d2d-dc1edaede039 +2NDC 69918-360, 84677-032, 65841-683 +2Application ANDA214124, ANDA219677, ANDA077633
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 65841-683-01 | Zydus LifesciencesIndia | 27 January 2009 |
| 500 tablet in 1 bottle | 65841-683-05 | Zydus LifesciencesIndia | 27 January 2009 |
| 1000 tablet in 1 bottle | 65841-683-10 | Zydus LifesciencesIndia | 27 January 2009 |
| 90 tablet in 1 bottle | 65841-683-16 | Zydus LifesciencesIndia | 27 January 2009 |
| 100 tablet in 1 bottle | 68382-007-01 | Zydus LifesciencesIndia | 27 January 2009 |
| 500 tablet in 1 bottle | 68382-007-05 | Zydus LifesciencesIndia | 27 January 2009 |
| 1000 tablet in 1 bottle | 68382-007-10 | Zydus LifesciencesIndia | 27 January 2009 |
| 90 tablet in 1 bottle | 68382-007-16 | Zydus LifesciencesIndia | 27 January 2009 |
| 30 tablet in 1 bottle | 51672-4253-6 | Sun Pharmaceutical IndustriesIndia | 27 January 2026 |
| 30 tablet in 1 bottle | 69918-360-30 | Nordic Pharma | 14 February 2022 |
| 30 tablet in 1 bottle | 84677-032-30 | Golden State Medical Supply | 30 April 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 27 December 1994 | 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 Lamotrigine
Clinical summary
Lamotrigine is an anti-epileptic agent indicated for epilepsy—adjunctive therapy in patients aged 2 years and older, among other approved uses. It is available as tablets, extended-release tablets and orally disintegrating tablets. MedsAcross supplies Lamotrigine 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 LamotrigineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- LAMICTAL prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
Need Lamotrigine 50 mg 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.