Prescription medicine
Dalfampridine Brand names: Ampyra
Dalfampridine (Ampyra) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.399 per dalfampridine ER 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the dalfampridine FDA label on DailyMed (effective January 16, 2026, Merz Pharmaceuticals, LLC); the NDA 22250 record on Drugs@FDA; every dalfampridine label on DailyMed.
Highlights of the record
FDA label of January 16, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS).
Forms and strengths
- 10 mg
Film-coated extended-release tablet; extended-release tablet.
On the market
- Earliest approval on file
- January 22, 2010 Ampyra, Merz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first January 23, 2017; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.399 per tablet Dalfampridine ER 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 71,317 through July 30, 2026
What is dalfampridine used for?
From the label: indications and usageAMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14) ]. AMPYRA ® (dalfampridine) is a potassium channel blocker indicated to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed ( 1 , 14 ).
Conditions named in the indications of dalfampridine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Potassium Channel Blocker.
Source: FDA drug label (AMPYRA), Merz Pharmaceuticals, LLC, effective January 16, 2026 (SPL set 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783), via openFDA; the full label on DailyMed
What does the patient leaflet for dalfampridine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about AMPYRA?AMPYRA can cause seizures. You could have a seizure even if you never had a seizure before. Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50. Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking AMPYRA. Do not take AMPYRA if you have ever had a seizure. Before taking AMPYRA tell your doctor if you have kidney problems. Take AMPYRA exactly as prescribed by your doctor. See "How should I take AMPYRA?" Stop taking AMPYRA and call your doctor right away if you have a seizure while taking AMPYRA.
From the patient leaflet: What should I avoid while taking AMPYRA?AMPYRA may cause dizziness or vertigo. If you have these symptoms, do not drive, operate machinery, or do other dangerous activities.
From the patient leaflet: How should I store AMPYRA?Store AMPYRA at 59ºF to 86ºF (15ºC to 30ºC). Safely throw away AMPYRA that is out of date or no longer needed. Keep AMPYRA and all medicines out of the reach of children. General Information about the safe and effective use of AMPYRA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMPYRA for a condition for which it was not prescribed. Do not give AMPYRA to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about AMPYRA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about AMPYRA that is written for health professionals. For more information, go to www.AMPYRA.com or call 1-800-367-5109.
Source: FDA drug label (AMPYRA), Merz Pharmaceuticals, LLC, effective January 16, 2026 (SPL set 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783), via openFDA; the full label on DailyMed
Is there a generic for dalfampridine (Ampyra)?
The FDA approved the first generic dalfampridine on January 23, 2017. 8 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists dalfampridine from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2010 earliest approval on file
- 2017 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dalfampridine (Ampyra)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.399 per Dalfampridine ER 10 mg tablet, down 15% from $0.467 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dalfampridine ER 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dalfampridine ER 10 mg tablet | Generic | $0.399 per tablet | $11.98 | -15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the dalfampridine label say about other medicines?
The dalfampridine label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name dalfampridine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Baclofen | drug interactions | No interaction was identified between dalfampridine and baclofen [see Clinical Pharmacology (12.3) ]. |
| Cimetidine | drug interactions | Concurrent treatment with OCT2 inhibitors, such as cimetidine, may cause increased exposure to dalfampridine [ see Clinical Pharmacology (12.3) ]. |
Other labels that name dalfampridine
Source: FDA drug label (AMPYRA), Merz Pharmaceuticals, LLC, effective January 16, 2026 (SPL set 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783), via openFDA; the full label on DailyMed
What do FAERS reports show for dalfampridine?
The FDA Adverse Event Reporting System holds 71,317 reports that list dalfampridine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,759 are coded as a death and 10,146 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (12,012, against a median of 2,758 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dalfampridine?
8 other medicines are given the same way (oral) and in the same FDA class as dalfampridine or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dimethyl fumarate | Multiple sclerosis | 19 labelers | $0.467 per capsule 240 mg capsule | No current entry |
| Teriflunomide | Multiple sclerosis | 15 labelers | $0.233 per tablet 14 mg tablet | No current entry |
| Fingolimod | Multiple sclerosis | 21 labelers | $1.58 per capsule 0.5 mg capsule | No current entry |
| Cladribine | Multiple sclerosis | 3 labelers | n/a | No current entry |
| Siponimod | Multiple sclerosis | none listed | n/a | No current entry |
| Ponesimod | Multiple sclerosis | none listed | n/a | No current entry |
| Diroximel fumarate | Multiple sclerosis | none listed | n/a | No current entry |
| Monomethyl fumarate | Multiple sclerosis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as dalfampridine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dalfampridine
- 8 medicines for the same use
- Other potassium channel blockers
- the pharmacologic class, with prices and generics
- Dalfampridine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other