Quick answers
- What is Deferasirox used for?
- The FDA-approved label (Exjade, Novartis Pharmaceuticals Corporation, January 28, 2026) says: “Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Deferasirox have a boxed warning?
- Yes. The FDA label for Exjade has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Deferasirox?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Deferasirox been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 20, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Deferasirox?
- 21 companies list prescription products of Deferasirox in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation, Ascend Laboratories, LLC and Novadoz Pharmaceuticals LLC.
What Deferasirox is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin …
— FDA label: Exjade, Novartis Pharmaceuticals Corporation, effective January 28, 2026. Read the full label on DailyMed →
The FDA has 30 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.
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 →
29 of 30 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, for suspension · Tablet, film coated · Granule · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 94 in the FDA NDC Directory |
| Brand names | Jadenu, Deferasorox, Exjade, Deferasirox Oral Granules |
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 |
|---|---|---|
| deferasirox 360 mg tablet | Generic | $1.12 per tablet |
| deferasirox 360 mg tablet, film coated | Generic | $1.12 per tablet |
| deferasirox 500 mg tablet, for suspension | Generic | $5.85 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.
- Novartis Pharmaceuticals Corporation9 products
- Ascend Laboratories, LLC9 products
- Novadoz Pharmaceuticals LLC6 products
- Camber Pharmaceuticals, Inc.6 products
- Dr. Reddy's Laboratories Inc.6 products
- Aurobindo Pharma Limited6 products
- Alembic Pharmaceuticals Inc.6 products
- MSN Laboratories Private Limited6 products
- Alembic Pharmaceuticals Limited6 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Xiromed, LLC3 products
- Zydus Pharmaceuticals USA Inc.3 products
- NorthStar Rx LLC3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Cipla USA Inc.3 products
- Epic Pharma, LLC3 products
- Zydus Lifesciences Limited3 products
- Amneal Pharmaceuticals NY LLC3 products
- Teva Pharmaceuticals, Inc.3 products
- Bionpharma Inc.3 products
- AvKARE1 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 |
|---|---|---|---|
| NDA021882 EXJADE | Novartis | November 2, 2005 | 24, latest January 17, 2023 2023: Manufacturing (CMC) · 2020: Efficacy · 2019: Efficacy |
| NDA206910 JADENU | Novartis Pharms Corp | March 30, 2015 | 14, latest February 11, 2022 2022: Manufacturing (CMC) · 2020: Efficacy · 2019: Efficacy |
| NDA207968 JADENU SPRINKLE | Novartis | May 18, 2017 | 8, latest July 23, 2020 2020: Efficacy · 2019: Efficacy · 2019: Efficacy |
Generic approvals (21)
- ANDA209782Sun Pharm · November 20, 2019
- ANDA209878Msn · November 20, 2019
- ANDA210060Alembic · November 20, 2019
- ANDA210519Alkem Labs Ltd · November 20, 2019
- ANDA210920Bionpharma · November 20, 2019
- ANDA210945Msn · November 20, 2019
- ANDA211383Zydus Pharms · November 20, 2019
- ANDA211824Alembic · November 20, 2019
- ANDA210727Stevens J · December 27, 2019
- ANDA212995Piramal · December 30, 2019
- ANDA209433Glenmark Speclt · January 3, 2020
- ANDA210555Alkem Labs Ltd · March 30, 2020
- ANDA213374Alkem Labs Ltd · July 14, 2020
- ANDA214559Pharmazone · March 9, 2021
- ANDA214650Msn · March 17, 2021
- ANDA214341Annora Pharma · May 14, 2021
- ANDA215026Cipla · February 23, 2022
- ANDA216229Annora Pharma · September 22, 2022
- ANDA207124Teva Pharms USA · September 23, 2022
- ANDA214474Aurobindo Pharma Ltd · October 16, 2023
- ANDA215137Aurobindo Pharma · September 8, 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.
-
October 20, 2023 · Class II · Ongoing · D-0095-2024
Failed Dissolution Specifications
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30 — 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Exjade, Novartis Pharmaceuticals Corporation, effective January 28, 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 →