Quick answers
- What is Temozolomide used for?
- The FDA-approved label (Temodar, Merck Sharp & Dohme LLC, February 20, 2026) says: “TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Anaplastic astrocytoma. Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. Treatment of adults with refractory anaplastic astrocytoma. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Temozolomide have a boxed warning?
- The label we quote has no boxed warning, but 1 of 16 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Temozolomide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Temozolomide been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started March 3, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Temozolomide?
- 12 companies list prescription products of Temozolomide in the FDA NDC Directory, including Merck Sharp & Dohme LLC, Devatis, Inc. and Nivagen Pharmaceuticals, Inc..
What Temozolomide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Anaplastic astrocytoma. Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. Treatment of adults with refractory anaplastic astrocytoma. …
— FDA label: Temodar, Merck Sharp & Dohme LLC, effective February 20, 2026. Read the full label on DailyMed →
The FDA has 16 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.
The label quoted above has no boxed warning.
1 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 71 in the FDA NDC Directory |
| Brand names | Temodar |
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 |
|---|---|---|
| temozolomide 100 mg capsule | Generic | $4.28 per capsule |
| temozolomide 20 mg capsule | Generic | $0.8798 per capsule |
NADAC list of November 4, 2026; these prices took effect between September 23, 2026 and 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.
- Merck Sharp & Dohme LLC7 products
- Devatis, Inc.6 products
- Nivagen Pharmaceuticals, Inc.6 products
- CivicaScript LLC6 products
- Rising Pharma Holdings, Inc.6 products
- Camber Pharmaceuticals, Inc.6 products
- Amneal Pharmaceuticals LLC6 products
- Ascend Laboratories, LLC6 products
- Bryant Ranch Prepack6 products
- Accord Healthcare Inc.6 products
- Sun Pharmaceutical Industries, Inc.6 products
- OPKO Pharmaceuticals, LLC4 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 |
|---|---|---|---|
| NDA021029 TEMODAR | Merck Sharp Dohme | August 11, 1999 | 30, latest September 14, 2023 2023: Efficacy · 2023: Efficacy · 2023: Efficacy |
| NDA022277 TEMODAR | Merck Sharp Dohme | February 27, 2009 | 14, latest September 14, 2023 2023: Efficacy · 2023: Efficacy · 2023: Efficacy |
Generic approvals (8)
- ANDA201742Sun Pharm · February 12, 2014
- ANDA203691Amneal Pharms · May 8, 2015
- ANDA203898Eirgen · February 10, 2016
- ANDA206309Rising · April 27, 2016
- ANDA201528Accord Hlthcare · February 27, 2017
- ANDA207658Deva Holding As · April 26, 2017
- ANDA213328Nivagen · November 23, 2021
- ANDA210030Hetero Labs Ltd V · August 23, 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.
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March 3, 2026 · Class II · Ongoing · D-0384-2026
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51. — Rising Pharma Holding, Inc.
-
July 16, 2019 · Class II · Terminated · D-1509-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07), b) 14-count bottle (NDC 67877-538-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed — Deva Holding AS - Cerkezkoy Subesi
-
July 16, 2019 · Class II · Terminated · D-1512-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed — Deva Holding AS - Cerkezkoy Subesi
-
July 16, 2019 · Class II · Terminated · D-1510-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-07), b) 14-count bottle (NDC 67877-539-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed — Deva Holding AS - Cerkezkoy Subesi
-
July 16, 2019 · Class II · Terminated · D-1511-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed — Deva Holding AS - Cerkezkoy Subesi
-
July 16, 2019 · Class II · Terminated · D-1513-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07. — Deva Holding AS - Cerkezkoy Subesi
-
July 16, 2019 · Class II · Terminated · D-1508-2019
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed b — Deva Holding AS - Cerkezkoy Subesi
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December 12, 2012 · Class II · Terminated · D-139-2013
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033 — Schering-Plough Products, LLC
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) — Temodar, Merck Sharp & Dohme LLC, 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 →