Quick answers
- What is Imatinib mesylate used for?
- The FDA-approved label (Gleevec, Novartis Pharmaceuticals Corporation, July 13, 2026) says: “Gleevec is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Imatinib mesylate have a boxed warning?
- No. None of the 18 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Imatinib mesylate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Imatinib mesylate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 8, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Imatinib mesylate?
- 22 companies list prescription products of Imatinib mesylate in the FDA NDC Directory, including BluePoint Laboratories, Novartis Pharmaceuticals Corporation and Upsher-Smith Laboratories, LLC.
What Imatinib mesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Gleevec is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. …
— FDA label: Gleevec, Novartis Pharmaceuticals Corporation, effective July 13, 2026. Read the full label on DailyMed →
The FDA has 18 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 18 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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 |
|---|---|---|
| imatinib mesylate 100 mg tablet | Generic | $0.6442 per tablet |
| imatinib mesylate 100 mg tablet, film coated | Generic | $0.6442 per tablet |
| imatinib mesylate 400 mg tablet | Generic | $2.68 per tablet |
| imatinib mesylate 400 mg tablet, film coated | Generic | $2.68 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.
- BluePoint Laboratories4 products
- Novartis Pharmaceuticals Corporation3 products
- Upsher-Smith Laboratories, LLC2 products
- Major Pharmaceuticals2 products
- Golden State Medical Supply, Inc.2 products
- Archis Pharma LLC2 products
- Civica Script LLC2 products
- Mylan Institutional Inc.2 products
- Safecor Health LLC2 products
- Chartwell RX, LLC2 products
- Qilu Pharmaceutical Co., Ltd.2 products
- Camber Pharmaceuticals, Inc.2 products
- Ascend Laboratories, LLC2 products
- Mylan Pharmaceuticals Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Quallent Pharmaceuticals Health LLC2 products
- Teva Pharmaceuticals USA, Inc.2 products
- Apotex Corp.2 products
- Aurobindo Pharma Limited2 products
- Armas Pharmaceuticals Inc.2 products
- Shorla Oncology Inc.1 product
- American Health Packaging1 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 |
|---|---|---|---|
| NDA021588 GLEEVEC | Novartis | April 18, 2003 | 46, latest July 13, 2026 2026: Labeling · 2026: Labeling · 2024: Manufacturing (CMC) |
| NDA219097 IMKELDI | Shorla Oncology | November 22, 2024 | 1, latest October 16, 2026 2026: Labeling |
Generic approvals (9)
- ANDA078340Sun Pharm · December 3, 2015
- ANDA204285Teva Pharms USA · August 4, 2016
- ANDA079179Apotex · August 5, 2016
- ANDA204644Mylan · June 21, 2017
- ANDA208302Shilpa · January 17, 2019
- ANDA208429Chartwell Rx · January 17, 2019
- ANDA212773Eugia Pharma · July 23, 2020
- ANDA212135Qilu Pharm Hainan · June 21, 2022
- ANDA212975Hetero Labs Ltd V · April 14, 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.
-
December 8, 2020 · Class II · Terminated · D-0124-2021
CGMP Deviations
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90. — Shilpa Medicare Limited
-
December 8, 2020 · Class II · Terminated · D-0125-2021
CGMP Deviations
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30. — Shilpa Medicare Limited
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) | 403878, 403879, 404588, 404589 |
|---|---|
| SPL set ID of the quoted label | 211ef2da-2868-4a77-8055-1cb2cd78e24b |
| FDA labels (SPL) | 18 |
| FDA applications | NDA021588, NDA219097, 9 ANDA |
| Active ingredients (FDA) | IMATINIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Gleevec, Novartis Pharmaceuticals Corporation, effective July 13, 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 →