Quick answers
- What is Temodar?
- Temodar is a brand name of Temozolomide, a prescription medicine. The FDA NDC Directory lists 7 Temodar products in 7 strengths and forms.
- Who makes Temodar?
- Merck Sharp Dohme holds the FDA application for Temodar (NDA021029, approved August 11, 1999).
- Is there a generic or store brand of Temodar?
- Yes. The FDA NDC Directory lists 64 other products with the same active ingredients, strength and form as a Temodar product, 64 of them generic. Ask your pharmacist whether one is right for you.
- Has Temodar been recalled?
- FDA enforcement reports list 1 recall of Temodar products; the newest started December 12, 2012. A recall usually concerns specific lots, not every product.
What Temodar is
Each Temodar product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Temozolomide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| temozolomide 100 mg capsule (oral) | Temodar | 11 products, 11 companies | DailyMed |
| temozolomide 140 mg capsule (oral) | Temodar | 11 products, 11 companies | DailyMed |
| temozolomide 180 mg capsule (oral) | Temodar | 11 products, 11 companies | DailyMed |
| temozolomide 2.5 mg/mL injection, powder, lyophilized, for solution (intravenous) | Temodar | None listed | DailyMed |
| temozolomide 20 mg capsule (oral) | Temodar | 10 products, 10 companies | DailyMed |
| temozolomide 250 mg capsule (oral) | Temodar | 11 products, 11 companies | DailyMed |
| temozolomide 5 mg capsule (oral) | Temodar | 10 products, 10 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Temozolomide →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Companies that list Temodar
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Temodar products.
- Merck Sharp & Dohme LLC7 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.