Quick answers
- What is Tecfidera?
- Tecfidera is a brand name of Dimethyl fumarate, a prescription medicine. The FDA NDC Directory lists 2 Tecfidera products in 2 strengths and forms.
- Who makes Tecfidera?
- Biogen holds the FDA application for Tecfidera (NDA204063, approved March 27, 2013).
- Is there a generic or store brand of Tecfidera?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Tecfidera product, 2 of them generic. Ask your pharmacist whether one is right for you.
- Has Tecfidera been recalled?
- FDA enforcement reports list 1 recall of Tecfidera products; the newest started June 23, 2020. A recall usually concerns specific lots, not every product.
What Tecfidera is
Each Tecfidera product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Dimethyl fumarate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dimethyl fumarate 120 mg capsule (oral) | Tecfidera | 1 product, 1 company | — |
| dimethyl fumarate 240 mg capsule (oral) | Tecfidera | 1 product, 1 company | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dimethyl fumarate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Tecfidera
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tecfidera products.
- Biogen Inc.2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 23, 2020 · Class III · Terminated · D-1381-2020
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02 — Biogen MA Inc.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.