Medicine
Dalfampridine 10 mg extended-release tablet
Dalfampridine 10 mg extended-release tablet is a generic prescription medicine for oral use, made by 9 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 25°C (77°F), excursions permitted between 15ºC to 30ºC (59ºF to 86ºF).
Key facts
- Active ingredient (INN)
- Dalfampridine
- Brand
- Sold under the generic name
- Strength
- 10 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 500 tablets, 90 tablets and 12 more
- Manufacturers
- Ascend LaboratoriesIndiaAurobindo PharmaIndiaMicro LabsIndiaAccord HealthcareIndiaSun Pharmaceutical IndustriesIndiaActavis PharmaBryant Ranch PrepackCivicaScriptGolden State Medical Supply
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted between 15ºC to 30ºC (59ºF to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N07XX07 Dalfampridine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 June 2018
- Identifiers
- RxCUI 897021DailyMed set ID e10b2d92-2824-4395-8883-6fd52c784aa4, c40dcc84-b839-44aa-94f2-886fb1c3d75c, 43996322-7d83-4420-9e61-4ed37f710fee +6NDC 67877-444, 82249-702, 65862-863 +6Application ANDA206765, ANDA206811, ANDA210158 +3
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 tablet, film coated, extended release in 1 bottle | 16729-292-12 | Accord HealthcareIndia | 18 September 2018 |
| 500 tablet, film coated, extended release in 1 bottle | 67877-444-05 | Ascend LaboratoriesIndia | 31 July 2018 |
| 60 tablet, film coated, extended release in 1 bottle | 67877-444-60 | Ascend LaboratoriesIndia | 31 July 2018 |
| 90 tablet, film coated, extended release in 1 bottle | 67877-444-90 | Ascend LaboratoriesIndia | 31 July 2018 |
| 100 tablet, film coated, extended release in 1 bottle | 65862-863-01 | Aurobindo PharmaIndia | 25 June 2018 |
| 500 tablet, film coated, extended release in 1 bottle | 65862-863-05 | Aurobindo PharmaIndia | 25 June 2018 |
| 60 tablet, film coated, extended release in 1 bottle | 65862-863-60 | Aurobindo PharmaIndia | 25 June 2018 |
| 500 tablet, extended release in 1 bottle | 42571-275-05 | Micro LabsIndia | 21 March 2019 |
| 1000 tablet, extended release in 1 bottle | 42571-275-10 | Micro LabsIndia | 21 March 2019 |
| 60 tablet, extended release in 1 bottle | 42571-275-60 | Micro LabsIndia | 21 March 2019 |
| 60 tablet, extended release in 1 bottle | 62756-429-86 | Sun Pharmaceutical IndustriesIndia | 22 May 2019 |
| 60 tablet, film coated, extended release in 1 bottle | 0591-2533-60 | Actavis Pharma | 31 May 2022 |
| 60 tablet, film coated, extended release in 1 bottle | 82249-702-60 | CivicaScript | 21 July 2025 |
| 60 tablet, extended release in 1 bottle | 72162-2459-6 | Bryant Ranch Prepack | 12 February 2025 |
| 60 tablet, film coated, extended release in 1 bottle | 51407-876-60 | Golden State Medical Supply | 5 February 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 22 January 2010 | 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 Dalfampridine 10 mg extended-release tablet.
Clinical summary
Dalfampridine is a potassium channel blocker indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). It is available as extended-release tablets for oral use. MedsAcross supplies Dalfampridine 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 DalfampridineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AMPYRA prescribing information (Merz Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Dalfampridine 10 mg extended-release tablet for your hospital or patient?
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