Quick answers
- What is Teriflunomide used for?
- The FDA-approved label (Aubagio, Genzyme Corporation, February 20, 2026) says: “AUBAGIO ® is 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 Teriflunomide have a boxed warning?
- Yes. The FDA label for Aubagio has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Teriflunomide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Teriflunomide been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 13, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Teriflunomide?
- 17 companies list prescription products of Teriflunomide in the FDA NDC Directory, including MSN Laboratories Private Limited, Civica Script LLC and Camber Pharmaceuticals, Inc..
What Teriflunomide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AUBAGIO ® is 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: Aubagio, Genzyme Corporation, effective February 20, 2026. Read the full label on DailyMed →
The FDA has 15 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.
This label has a boxed warning. Read it on the full label →
14 of 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 36 in the FDA NDC Directory |
| Brand names | Aubagio |
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 |
|---|---|---|
| teriflunomide 14 mg tablet | Generic | $0.2234 per tablet |
| teriflunomide 14 mg tablet, film coated | Generic | $0.2234 per tablet |
| teriflunomide 7 mg tablet | Generic | $0.3044 per tablet |
| teriflunomide 7 mg tablet, film coated | Generic | $0.3044 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.
- MSN Laboratories Private Limited4 products
- Civica Script LLC2 products
- Camber Pharmaceuticals, Inc.2 products
- Mylan Pharmaceuticals Inc.2 products
- Biocon Pharma Inc.2 products
- Teva Pharmaceuticals, Inc.2 products
- Aurobindo Pharma Limited2 products
- AvKARE2 products
- Alembic Pharmaceuticals Limited2 products
- Genzyme Corporation2 products
- Alembic Pharmaceuticals Inc.2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Zydus Lifesciences Limited2 products
- Accord Healthcare Inc.2 products
- Concord Biotech Limited2 products
- Natco Pharma USA LLC2 products
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 |
|---|---|---|---|
| NDA202992 AUBAGIO | Sanofi Aventis Us | September 12, 2012 | 13, latest February 11, 2026 2026: Labeling · 2024: Labeling · 2021: Labeling |
Generic approvals (12)
- ANDA209700Teva Pharms USA · September 4, 2018
- ANDA209638Aurobindo Pharma · October 26, 2018
- ANDA209663Glenmark Speclt · November 15, 2018
- ANDA209668Zydus Pharms · November 30, 2018
- ANDA209690Accord Hlthcare · January 7, 2019
- ANDA209572Alembic · April 19, 2019
- ANDA209623Msn · April 24, 2019
- ANDA209702Somerset Theraps LLC · February 28, 2020
- ANDA209598Hetero Labs Ltd V · March 13, 2023
- ANDA209639Biocon Pharma · March 13, 2023
- ANDA209555Natco · May 15, 2023
- ANDA218663Neocubes Pharma · April 7, 2025
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.
-
March 13, 2025 · Class II · Ongoing · D-0334-2025
CGMP Deviations
Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. ND — Glenmark Pharmaceuticals Inc., USA
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) | 1310525, 1310531, 1310533, 1310535 |
|---|---|
| SPL set ID of the quoted label | 4650d12c-b9c8-4525-b07f-a2d773eca155 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA202992, 12 ANDA |
| Active ingredients (FDA) | TERIFLUNOMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Aubagio, Genzyme Corporation, effective February 20, 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 →