Namuscla Lupin Europe GmbH · Authorised · authorised 18 Dec 2018 · ATC C01BB02
Therapeutic indication (EMA)
Namuscla is indicated for the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders.
Active substance
Mexiletine
- US FDA 13
- EMA 1
- Health Canada 4
- US price lines 3
- NHS prices 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | TEVA | Prescription | 16 May 1995 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | ANI PHARMS | Prescription | 16 May 1996 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | CROSSMEDIKA SA | Prescription | 22 Jul 2020 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | INGENUS PHARMS LLC | Prescription | 25 Jan 2021 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | SENORES PHARMS | Prescription | 1 Oct 2021 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | RISING | Prescription | 26 Aug 2022 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | ANNORA PHARMA | Prescription | 9 Nov 2022 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | QUAGEN | Prescription | 27 Feb 2023 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | MACLEODS PHARMS | Prescription | 23 Mar 2026 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | ZYDUS PHARMS | Prescription | 23 Sep 2026 |
| MEXITIL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | BOEHRINGER INGELHEIM | Discontinued | 30 Dec 1985 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | WATSON LABS | Discontinued | 26 Feb 1997 |
| MEXILETINE HYDROCHLORIDE | 150MG; 200MG; 250MG | capsule · oral | WATSON LABS | Discontinued | 13 Apr 1998 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MINT-MEXILETINE | 02536846 | 100 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| MINT-MEXILETINE | 02536854 | 200 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| TEVA-MEXILETINE | 02230359 | 100 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
| TEVA-MEXILETINE | 02230360 | 200 MG | CAPSULE · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | MEXILETINE 150 MG CAPSULE | $0.22248 | per EA | 23 Sep 2026 |
| US NADAC | MEXILETINE 200 MG CAPSULE | $0.25737 | per EA | 23 Sep 2026 |
| US NADAC | MEXILETINE 250 MG CAPSULE | $0.38721 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Mexiletine hydrochloride 100mg (Mexiletine 83mg) capsules | £375.00 | 84 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Mexiletine hydrochloride 200mg (Mexiletine 167mg) capsules | £2300.00 | 100 capsule | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.