Prescription medicine
Temozolomide Brand names: Temodar
Temozolomide (Temodar) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $0.880 per temozolomide 20 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the temozolomide FDA label on DailyMed (effective February 20, 2026, Merck Sharp & Dohme LLC); the NDA 21029 record on Drugs@FDA; every temozolomide label on DailyMed.
Highlights of the record
FDA label of February 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.
Forms and strengths
- 5 mg
- 20 mg
- 100 mg
- 140 mg
- 180 mg
- 250 mg
- 2.5 mg/ml
Capsule; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 11, 1999 Temodar, Merck Sharp Dohme; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first March 1, 2010; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 11 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.880 per capsule Temozolomide 20 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 18 since 2012 0 Class I among all firms' recalls; latest March 3, 2026
- FAERS reports
- 20,949 through July 30, 2026
What is temozolomide used for?
From the label: indications and usageTEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma. ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. […]
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (TEMODAR), Merck Sharp & Dohme LLC, effective February 20, 2026 (SPL set 046a9011-3911-4d3f-a15f-fbb56d5aad56), via openFDA; the full label on DailyMed
Is there a generic for temozolomide (Temodar)?
The FDA approved the first generic temozolomide on March 1, 2010. 16 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists temozolomide from 11 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2010 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for temozolomide (Temodar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.880 per Temozolomide 20 mg capsule, down 79% from $4.11 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Temozolomide 20 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Temozolomide 100 mg capsule | Generic | $4.38 per capsule | $131.26 | -52% |
| Temozolomide 20 mg capsule | Generic | $0.880 per capsule | $26.39 | -79% |
| Temozolomide 250 mg capsule | Generic | $20.53 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $616.00 | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has temozolomide been recalled?
The FDA's Enforcement Report lists 18 recalls naming temozolomide since 2012: 0 Class I (the most serious), 14 Class II, 4 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 3, 2026 | Class II | Rising Pharma Holding, Inc. | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing |
| July 16, 2019 | Class II | Deva Holding AS - Cerkezkoy Subesi | CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products. |
| February 19, 2019 | Class III | Amerigen Pharmaceuticals Inc. | Failed dissolution specifications |
| December 20, 2018 | Class III | Amerigen Pharmaceuticals Inc. | Failed Dissolution Specifications |
| October 5, 2018 | Class III | Amerigen Pharmaceuticals Inc. | Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing. |
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
| December 20, 2016 | Class II | Mylan LLC. | Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle. |
| December 12, 2012 | Class II | Schering-Plough Products, LLC | Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the temozolomide label say about other medicines?
The temozolomide label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dacarbazine | contraindications | CONTRAINDICATIONS TEMODAR is contraindicated in patients with a history of serious hypersensitivity reactions to: temozolomide or any other ingredients in TEMODAR; and dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. |
Source: FDA drug label (TEMODAR), Merck Sharp & Dohme LLC, effective February 20, 2026 (SPL set 046a9011-3911-4d3f-a15f-fbb56d5aad56), via openFDA; the full label on DailyMed
What do FAERS reports show for temozolomide?
The FDA Adverse Event Reporting System holds 20,949 reports that list temozolomide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,436 are coded as a death and 6,699 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Temozolomide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other