Quick answers
- What is Leflunomide used for?
- The FDA-approved label (Arava, sanofi-aventis U.S. LLC, June 4, 2025) says: “ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA). ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Leflunomide have a boxed warning?
- Yes. The FDA label for Arava has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Leflunomide?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated June 8, 2026). Ask your pharmacist about alternatives.
- Has Leflunomide been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 14, 2007 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Leflunomide?
- 17 companies list prescription products of Leflunomide in the FDA NDC Directory, including Bryant Ranch Prepack, Sanofi-Aventis U.S. LLC and Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..
What Leflunomide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA). ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.
— FDA label: Arava, sanofi-aventis U.S. LLC, effective June 4, 2025. Read the full label on DailyMed →
The FDA has 24 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 →
24 of 24 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 40 in the FDA NDC Directory |
| Brand names | Arava |
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 |
|---|---|---|
| leflunomide 10 mg tablet | Generic | $0.3337 per tablet |
| leflunomide 10 mg tablet, film coated | Generic | $0.3337 per tablet |
| leflunomide 20 mg tablet | Generic | $0.3100 per tablet |
| leflunomide 20 mg tablet, film coated | Generic | $0.3100 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.
- Bryant Ranch Prepack7 products
- Sanofi-Aventis U.S. LLC3 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Burel Pharmaceuticals, LLC2 products
- A-S Medication Solutions2 products
- Alembic Pharmaceuticals Inc.2 products
- KVK-Tech, Inc.2 products
- AvKARE2 products
- NuCare Pharmaceuticals, Inc.2 products
- AvPAK2 products
- Aurobindo Pharma Limited2 products
- Lupin Pharmaceuticals, Inc.2 products
- Apotex Corp.2 products
- Zydus Lifesciences Limited2 products
- Alembic Pharmaceuticals Limited2 products
- Chartwell RX, LLC2 products
- Zydus Pharmaceuticals USA Inc.2 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 |
|---|---|---|---|
| NDA020905 ARAVA | Sanofi Aventis Us | September 10, 1998 | 20, latest June 28, 2024 2024: Labeling · 2016: Labeling · 2015: Labeling |
Generic approvals (8)
- ANDA077086Heritage · September 13, 2005
- ANDA077090Apotex · September 13, 2005
- ANDA091369Alembic Pharms Ltd · November 21, 2011
- ANDA212308Zydus Lifesciences · April 24, 2019
- ANDA212453Abhai LLC · June 3, 2019
- ANDA211863Lupin · February 4, 2020
- ANDA213652Aurobindo Pharma · March 29, 2021
- ANDA213497Aet Pharma · May 10, 2021
Shortage status
To be discontinued · updated June 8, 2026 · first posted June 8, 2026
| Product | Arava, Tablet, 20 mg (NDC 0088-2161-30) |
|---|---|
| Company | Sanofi-Aventis U.S. LLC |
Ask your pharmacist whether your product is affected and what the options are.
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 14, 2007 · Class II · Terminated · D-1661-2012
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9 — Apotex Corp.
-
June 14, 2007 · Class II · Terminated · D-1662-2012
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3 — Apotex Corp.
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Arava, sanofi-aventis U.S. LLC, effective June 4, 2025; 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 →