Medicine
Dimethyl 240 mg delayed-release capsule
Dimethyl 240 mg delayed-release capsule is a generic prescription medicine for oral use, made by 17 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 to 25 • C (68 • F to 77 • F), excursions permitted between 15…
Key facts
- Active ingredient (INN)
- Dimethyl
- Brand
- Sold under the generic name
- Strength
- 240 mg
- Dosage form
- Delayed-release capsule
- Route
- Oral
- Packs
- 60 capsules, 180 capsules, 1000 capsules and 25 more
- Manufacturers
- Ascend LaboratoriesIndiaCamber PharmaceuticalsIndiaAccord HealthcareIndiaMacleods PharmaceuticalsIndiaMSN LaboratoriesIndiaAurobindo PharmaIndiaCiplaIndiaDr. Reddy's LaboratoriesIndiaGolden State Medical SupplySolco Healthcare17 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20 • C to 25 • C (68 • F to 77 • F), excursions permitted between 15 • C and 30 • C (59 • F and 86 • F). Store in original container.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AX07 Dimethyl
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 September 2020
- Identifiers
- RxCUI 1373483, 1373491, 1373497DailyMed set ID a3677dce-a44b-481f-8a76-9ff3a4d42105, 7203a262-de0f-42dd-b4fb-8856758b82e9, 5361d5c6-c3eb-88e6-e063-6294a90ac08c +15NDC 16729-417, 43547-025, 70771-1531 +16Application ANDA210499, ANDA210414, ANDA210538 +9
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 |
|---|---|---|---|
| 60 capsule, delayed release in 1 bottle | 16729-417-12 | Accord HealthcareIndia | 13 January 2021 |
| 180 capsule, delayed release in 1 bottle | 16729-417-59 | Accord HealthcareIndia | 20 January 2021 |
| 1000 capsule, delayed release in 1 bottle, plastic | 67877-556-10 | Ascend LaboratoriesIndia | 26 September 2020 |
| 10 capsule, delayed release in 1 blister pack | 67877-556-33 | Ascend LaboratoriesIndia | 26 September 2020 |
| 46 capsule, delayed release in 1 bottle, plastic | 67877-556-46 | Ascend LaboratoriesIndia | 26 September 2020 |
| 60 capsule, delayed release in 1 bottle, plastic | 67877-556-60 | Ascend LaboratoriesIndia | 26 September 2020 |
| 90 capsule, delayed release in 1 bottle, plastic | 67877-556-90 | Ascend LaboratoriesIndia | 26 September 2020 |
| 60 capsule, delayed release in 1 bottle | 59651-084-60 | Aurobindo PharmaIndia | 22 December 2022 |
| 1 bottle in 1 carton / 46 capsule, delayed release in 1 bottle | 31722-658-31 | Camber PharmaceuticalsIndia | 24 September 2020 |
| 1 bottle in 1 carton / 60 capsule, delayed release in 1 bottle | 31722-658-32 | Camber PharmaceuticalsIndia | 24 September 2020 |
| 10 blister pack in 1 carton / 10 capsule, delayed release in 1 blister pack | 31722-658-33 | Camber PharmaceuticalsIndia | 24 September 2020 |
| 1 bottle, plastic in 1 carton / 60 capsule, delayed release in 1 bottle, plastic | 69097-323-03 | CiplaIndia | 24 September 2020 |
| 1 bottle in 1 carton / 60 capsule, delayed release in 1 bottle | 43598-430-60 | Dr. Reddy's LaboratoriesIndia | 25 September 2020 |
| 60 capsule, delayed release in 1 bottle | 33342-350-09 | Macleods PharmaceuticalsIndia | 26 June 2024 |
| 46 capsule, delayed release in 1 bottle | 33342-350-95 | Macleods PharmaceuticalsIndia | 27 June 2025 |
| 1 bottle in 1 carton / 500 capsule, delayed release in 1 bottle | 69539-043-05 | MSN LaboratoriesIndia | 28 September 2020 |
| 1 bottle in 1 carton / 60 capsule, delayed release in 1 bottle | 69539-043-60 | MSN LaboratoriesIndia | 28 September 2020 |
| 1 bottle in 1 carton / 60 capsule, delayed release in 1 bottle | 69238-1319-6 | Amneal Pharmaceuticals NY | 28 September 2020 |
| 60 capsule, delayed release in 1 bottle, plastic | 82249-747-60 | CivicaScript | 11 June 2025 |
| 1 bottle in 1 carton / 60 capsule, delayed release in 1 bottle | 70512-853-60 | SOLA Pharmaceuticals | 12 March 2023 |
| 60 capsule, delayed release in 1 bottle, plastic | 43547-025-06 | Solco Healthcare | 18 October 2022 |
| 46 capsule, delayed release in 1 bottle, plastic | 43547-025-46 | Solco Healthcare | 18 October 2022 |
| 500 capsule, delayed release in 1 bottle, plastic | 24979-128-02 | Upsher-Smith Laboratories | 1 December 2020 |
| 60 capsule, delayed release in 1 bottle, plastic | 24979-128-04 | Upsher-Smith Laboratories | 1 December 2020 |
| 60 capsule, delayed release in 1 bottle, plastic | 51407-441-60 | Golden State Medical Supply | 5 January 2021 |
| 60 capsule, delayed release in 1 bottle | 84677-030-60 | Golden State Medical Supply | 12 May 2026 |
| 1 capsule, delayed release in 1 kit | 50090-5288-0 | A-S Medication Solutions | 23 October 2020 |
| 1 bottle in 1 carton / 60 capsule, delayed release in 1 bottle | 82009-138-60 | Quallent Pharmaceuticals Health | 15 June 2024 |
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 Dimethyl
Clinical summary
Dimethyl is a prescription medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Dimethyl 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 DimethylFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TECFIDERA prescribing information (Biogen) · U.S. National Library of Medicine, DailyMed
- Skilarence: European public assessment report (EPAR) · European Medicines Agency
- Tecfidera: European public assessment report (EPAR) · European Medicines Agency
Need Dimethyl 240 mg delayed-release capsule for your hospital or patient?
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