Quick answers
- What is Dimethyl fumarate used for?
- The FDA-approved label (Dimethyl Fumarate, Golden State Medical Supply, Inc., June 3, 2026) says: “Dimethyl fumarate delayed-release capsules are 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dimethyl fumarate have a boxed warning?
- No. None of the 19 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dimethyl fumarate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dimethyl fumarate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started June 23, 2020 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Dimethyl fumarate?
- 20 companies list prescription products of Dimethyl fumarate in the FDA NDC Directory, including Golden State Medical Supply, Inc., Biogen Inc. and Amneal Pharmaceuticals NY LLC.
What Dimethyl fumarate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Dimethyl fumarate delayed-release capsules are 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. …
— FDA label: Dimethyl Fumarate, Golden State Medical Supply, Inc., effective June 3, 2026. Read the full label on DailyMed →
The FDA has 19 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 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule, delayed release · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 40 in the FDA NDC Directory |
| Brand names | Tecfidera |
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 |
|---|---|---|
| dimethyl fumarate 120 mg capsule, delayed release | Generic | $0.3817 per capsule |
| dimethyl fumarate 240 mg capsule, delayed release | Generic | $0.4534 per capsule |
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.
- Golden State Medical Supply, Inc.4 products
- Biogen Inc.2 products
- Amneal Pharmaceuticals NY LLC2 products
- Zydus Lifesciences Limited2 products
- Upsher-Smith Laboratories, LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Macleods Pharmaceuticals Limited2 products
- Solco Healthcare US, LLC2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Cipla USA Inc.2 products
- CivicaScript LLC2 products
- MSN Laboratories Private Limited2 products
- Accord Healthcare Inc.2 products
- Aurobindo Pharma Limited2 products
- Ascend Laboratories, LLC2 products
- Dr. Reddy's Laboratories Inc.2 products
- SOLA Pharmaceuticals, LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Quallent Pharmaceuticals Health LLC1 product
- A-S Medication Solutions1 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 |
|---|---|---|---|
| NDA204063 TECFIDERA | Biogen | March 27, 2013 | 24, latest March 12, 2024 2024: Labeling · 2023: Labeling · 2023: Efficacy |
Generic approvals (13)
- ANDA210305Cipla · September 24, 2020
- ANDA210402Amneal · September 24, 2020
- ANDA210440Alkem Labs Ltd · September 24, 2020
- ANDA210460Msn · September 24, 2020
- ANDA210499Accord Hlthcare · September 24, 2020
- ANDA210500Hetero Labs Ltd III · September 24, 2020
- ANDA210538Zydus Pharms · September 24, 2020
- ANDA210309Glenmark Pharms Ltd · October 6, 2020
- ANDA210382Twi Pharms · October 14, 2020
- ANDA210436Sola Pharms · March 26, 2021
- ANDA210414Prinston Inc · October 18, 2022
- ANDA210385Aurobindo Pharma · December 22, 2022
- ANDA210377Macleods Pharms · June 26, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: 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.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1373483, 1373491, 1373497 |
|---|---|
| SPL set ID of the quoted label | 5361d5c6-c3eb-88e6-e063-6294a90ac08c |
| FDA labels (SPL) | 19 |
| FDA applications | NDA204063, 13 ANDA |
| Active ingredients (FDA) | DIMETHYL FUMARATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Dimethyl Fumarate, Golden State Medical Supply, Inc., effective June 3, 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 →