Medicine
Lamotrigine 50 mg extended-release tablet
Lamotrigine 50 mg extended-release tablet is a generic prescription medicine for oral use, made by 10 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° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Lamotrigine
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 500 tablets, 30 tablets, 90 tablets and 27 more
- Manufacturers
- Zydus LifesciencesIndiaTorrent PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaCamber PharmaceuticalsIndiaProficient RxRemedyrepackYiling PharmaceuticalAmneal PharmaceuticalsAvKARENorthStar Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted between 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
- N03AX09 Lamotrigine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 June 2013
- Identifiers
- RxCUI 850087, 850091, 900156 +3DailyMed set ID a63e19c0-a093-e896-e053-2a95a90a7ccd, ffa46cb2-16e7-45f3-9940-5cb88d0cda9d, de7f61ca-e3c0-4a09-b664-0df2de6a0c30 +12NDC 42291-444, 82804-105, 70518-1153 +12Application ANDA207497, ANDA203370, ANDA213949 +2
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 |
|---|---|---|---|
| 500 tablet, extended release in 1 bottle | 68382-980-05 | Zydus LifesciencesIndia | 14 May 2020 |
| 30 tablet, extended release in 1 bottle | 68382-980-06 | Zydus LifesciencesIndia | 14 May 2020 |
| 90 tablet, extended release in 1 bottle | 68382-980-16 | Zydus LifesciencesIndia | 14 May 2020 |
| 30 tablet, extended release in 1 bottle | 70771-1515-3 | Zydus LifesciencesIndia | 14 May 2020 |
| 10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack | 70771-1515-4 | Zydus LifesciencesIndia | 14 May 2020 |
| 500 tablet, extended release in 1 bottle | 70771-1515-5 | Zydus LifesciencesIndia | 14 May 2020 |
| 90 tablet, extended release in 1 bottle | 70771-1515-9 | Zydus LifesciencesIndia | 14 May 2020 |
| 30 tablet, film coated, extended release in 1 bottle | 31722-241-30 | Camber PharmaceuticalsIndia | 9 December 2021 |
| 500 tablet, extended release in 1 bottle | 55111-718-05 | Dr. Reddy's LaboratoriesIndia | 20 June 2013 |
| 30 tablet, extended release in 1 bottle | 55111-718-30 | Dr. Reddy's LaboratoriesIndia | 20 June 2013 |
| 100 tablet, extended release in 1 bottle | 13668-340-01 | Torrent PharmaceuticalsIndia | 23 December 2013 |
| 500 tablet, extended release in 1 bottle | 13668-340-05 | Torrent PharmaceuticalsIndia | 23 December 2013 |
| 30 tablet, extended release in 1 bottle | 13668-340-30 | Torrent PharmaceuticalsIndia | 23 December 2013 |
| 30 tablet, film coated, extended release in 1 bottle | 65162-956-03 | Amneal Pharmaceuticals | 30 November 2018 |
| 90 tablet, film coated, extended release in 1 bottle | 65162-956-09 | Amneal Pharmaceuticals | 30 November 2018 |
| 30 tablet, film coated, extended release in 1 bottle | 69117-0045-1 | Yiling Pharmaceutical | 9 December 2021 |
| 100 tablet, film coated, extended release in 1 bottle | 69117-0045-2 | Yiling Pharmaceutical | 9 December 2021 |
| 500 tablet, film coated, extended release in 1 bottle | 69117-0045-3 | Yiling Pharmaceutical | 9 December 2021 |
| 50 pouch in 1 box / 1 tablet, extended release in 1 pouch | 70518-1153-1 | Remedyrepack | 24 April 2026 |
| 30 tablet, extended release in 1 blister pack | 70518-4121-0 | Remedyrepack | 10 July 2024 |
| 30 tablet, film coated, extended release in 1 blister pack | 70518-4442-0 | Remedyrepack | 14 August 2025 |
| 30 tablet, extended release in 1 blister pack | 70518-4702-0 | Remedyrepack | 19 July 2026 |
| 30 tablet, film coated, extended release in 1 bottle | 82804-022-30 | Proficient Rx | 11 October 2023 |
| 60 tablet, film coated, extended release in 1 bottle | 82804-022-60 | Proficient Rx | 11 October 2023 |
| 90 tablet, film coated, extended release in 1 bottle | 82804-022-90 | Proficient Rx | 11 October 2023 |
| 30 tablet, extended release in 1 bottle | 82804-105-30 | Proficient Rx | 13 May 2024 |
| 60 tablet, extended release in 1 bottle | 82804-105-60 | Proficient Rx | 13 May 2024 |
| 90 tablet, extended release in 1 bottle | 82804-105-90 | Proficient Rx | 13 May 2024 |
| 30 tablet, film coated, extended release in 1 bottle | 42291-444-30 | AvKARE | 22 May 2020 |
| 30 tablet, extended release in 1 bottle | 16714-624-01 | NorthStar Rx | 20 June 2017 |
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
Alternatives
Other makers and brands of Lamotrigine 50 mg extended-release tablet.
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 extended-release tablet for your hospital or patient?
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