Medicine
Mexiletine 250 mg capsule
Mexiletine 250 mg capsule is a generic prescription medicine for oral use, made by 13 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).
Key facts
- Active ingredient (INN)
- Mexiletine
- Brand
- Sold under the generic name
- Strength
- 250 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 100 capsules, 10 blister pack, 90 capsules and 14 more
- Manufacturers
- Macleods PharmaceuticalsIndiaCamber PharmaceuticalsIndiaSenores PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackAmerisynANI PharmaceuticalsAvKAREChartwell RXGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C01BB02 Mexiletine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 5 June 1995
- Identifiers
- RxCUI 1362720, 1362706, 1362712DailyMed set ID e2c0430d-35ee-460c-b0d5-f117d43430c5, 0ff45dbf-b555-4f55-a286-98bfaea9ea29, c4a60f9e-fed1-4172-adc4-0be84ac65db9 +13NDC 72162-1774, 72162-1784, 82012-029 +13Application ANDA074450, ANDA214089, ANDA216463 +5
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 capsule in 1 bottle | 31722-038-01 | Camber PharmaceuticalsIndia | 9 November 2022 |
| 100 capsule in 1 container | 33342-557-11 | Macleods PharmaceuticalsIndia | 23 March 2026 |
| 10 blister pack in 1 carton / 10 capsule in 1 blister pack | 33342-557-12 | Macleods PharmaceuticalsIndia | 23 March 2026 |
| 100 capsule in 1 bottle | 82012-029-04 | Senores PharmaceuticalsIndia | 29 November 2021 |
| 100 capsule in 1 bottle | 62756-957-01 | Sun Pharmaceutical IndustriesIndia | 29 November 2021 |
| 100 capsule in 1 bottle | 87564-054-10 | Amerisyn | 6 August 2026 |
| 100 capsule in 1 bottle | 62559-822-01 | ANI Pharmaceuticals | 22 June 2020 |
| 90 capsule in 1 bottle | 62135-785-90 | Chartwell RX | 25 October 2023 |
| 100 capsule in 1 bottle | 50742-241-01 | Ingenus Pharmaceuticals | 26 January 2021 |
| 100 capsule in 1 bottle | 64980-668-01 | Rising Pharma Holdings | 5 February 2025 |
| 100 capsule in 1 bottle | 0093-8741-01 | Teva Pharmaceuticals | 5 June 1995 |
| 100 capsule in 1 bottle | 63629-1964-1 | Bryant Ranch Prepack | 14 January 2021 |
| 100 capsule in 1 bottle | 63629-9181-1 | Bryant Ranch Prepack | 22 February 2022 |
| 100 capsule in 1 bottle | 72162-1774-1 | Bryant Ranch Prepack | 25 March 2026 |
| 100 capsule in 1 bottle | 72162-1784-1 | Bryant Ranch Prepack | 4 April 2024 |
| 100 capsule in 1 bottle | 42291-626-01 | AvKARE | 9 July 2013 |
| 100 capsule in 1 bottle | 51407-381-01 | Golden State Medical Supply | 18 December 2020 |
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.
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 Mexiletine
Clinical summary
Mexiletine is an antiarrhythmic indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. It is available as capsules for oral use. MedsAcross supplies Mexiletine 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 MexiletineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- MEXILETINE HYDROCHLORIDE prescribing information (Amerisyn) · U.S. National Library of Medicine, DailyMed
- Namuscla: European public assessment report (EPAR) · European Medicines Agency
Need Mexiletine 250 mg capsule 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.