Quick answers
- What is Dalfampridine used for?
- The FDA-approved label (Ampyra, Merz Pharmaceuticals, LLC, January 16, 2026) says: “AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed […]. 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 ).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dalfampridine have a boxed warning?
- No. None of the 10 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dalfampridine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dalfampridine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dalfampridine?
- 10 companies list prescription products of Dalfampridine in the FDA NDC Directory, including Merz Pharmaceuticals, LLC, CivicaScript LLC and Aurobindo Pharma Limited.
What Dalfampridine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed […]. 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 ).
— FDA label: Ampyra, Merz Pharmaceuticals, LLC, effective January 16, 2026. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated, extended release · Tablet, extended release |
|---|---|
| Route | Oral |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Ampyra |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| dalfampridine 10 mg tablet, extended release | Generic | $0.3666 per tablet |
| dalfampridine 10 mg tablet, film coated, extended release | Generic | $0.3666 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merz Pharmaceuticals, LLC2 products
- CivicaScript LLC1 product
- Aurobindo Pharma Limited1 product
- Accord Healthcare Inc.1 product
- Micro Labs Limited1 product
- Golden State Medical Supply, Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Bryant Ranch Prepack1 product
- Actavis Pharma, Inc.1 product
- Ascend Laboratories, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022250 AMPYRA | Merz | January 22, 2010 | 13, latest November 18, 2021 2021: Labeling · 2021: Labeling · 2019: Labeling |
Generic approvals (6)
- ANDA206811Aurobindo Pharma · January 23, 2017
- ANDA206836Actavis Labs Fl Inc · January 23, 2017
- ANDA206863Accord Hlthcare · July 11, 2018
- ANDA206765Alkem Labs Ltd · July 30, 2018
- ANDA210158Micro Labs · March 11, 2019
- ANDA208292Sun Pharm · May 21, 2019
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 897021, 897025 |
|---|---|
| SPL set ID of the quoted label | 550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783 |
| FDA labels (SPL) | 10 |
| FDA applications | NDA022250, 6 ANDA |
| Active ingredients (FDA) | DALFAMPRIDINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ampyra, Merz Pharmaceuticals, LLC, effective January 16, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →