Medicine
Temozolomide 250 mg capsule
Temozolomide 250 mg capsule is a generic prescription medicine for oral use, made by 11 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store TEMOZOLOMIDE Capsules, USP at 25°C (77°F), excursions permitted to 15°C…
Key facts
- Active ingredient (INN)
- Temozolomide
- Brand
- Sold under the generic name
- Strength
- 250 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 1 bottle, 5 capsules, 14 capsules and 14 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaCamber PharmaceuticalsIndiaAccord HealthcareIndiaAscend LaboratoriesIndiaRising Pharma HoldingsAmneal PharmaceuticalsBryant Ranch PrepackCivicaScriptDevatisNivagen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store TEMOZOLOMIDE Capsules, USP at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AX03 Temozolomide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 13 February 2014
- Identifiers
- RxCUI 313209, 313210, 313211 +3DailyMed set ID 56245d21-4a42-471e-bbdc-80b129336e2f, 2d599ccf-8e63-4ff1-aa52-4809744ea97a, 33d67bce-38ae-45fc-a858-d51167b0ecfd +8NDC 82249-414, 16729-051, 67877-542 +8Application ANDA207658, ANDA201528, ANDA201742 +5
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, glass in 1 carton / 5 capsule in 1 bottle, glass | 16729-051-53 | Accord HealthcareIndia | 7 March 2017 |
| 5 capsule in 1 bottle | 67877-542-07 | Ascend LaboratoriesIndia | 28 April 2017 |
| 14 capsule in 1 bottle | 31722-416-14 | Camber PharmaceuticalsIndia | 23 August 2024 |
| 5 capsule in 1 bottle | 31722-416-31 | Camber PharmaceuticalsIndia | 23 August 2024 |
| 1 bottle in 1 carton / 14 capsule in 1 bottle | 47335-893-21 | Sun Pharmaceutical IndustriesIndia | 13 February 2014 |
| 5 blister pack in 1 carton / 1 capsule in 1 blister pack | 47335-893-74 | Sun Pharmaceutical IndustriesIndia | 13 February 2014 |
| 20 blister pack in 1 carton / 1 capsule in 1 blister pack | 47335-893-75 | Sun Pharmaceutical IndustriesIndia | 13 February 2014 |
| 1 bottle in 1 carton / 5 capsule in 1 bottle | 47335-893-80 | Sun Pharmaceutical IndustriesIndia | 13 February 2014 |
| 1 bottle in 1 carton / 20 capsule in 1 bottle | 47335-893-87 | Sun Pharmaceutical IndustriesIndia | 13 February 2014 |
| 1 bottle in 1 carton / 5 capsule in 1 bottle | 65162-806-51 | Amneal Pharmaceuticals | 3 April 2015 |
| 5 capsule in 1 bottle | 82249-414-05 | CivicaScript | 10 August 2026 |
| 5 capsule in 1 bottle | 73043-016-05 | Devatis | 1 April 2025 |
| 1 bottle in 1 carton / 5 capsule in 1 bottle | 75834-146-05 | Nivagen Pharmaceuticals | 7 December 2021 |
| 5 packet in 1 carton / 1 capsule in 1 packet | 70301-2011-1 | OPKO Pharmaceuticals | 16 September 2026 |
| 20 capsule in 1 bottle | 16571-821-02 | Rising Pharma Holdings | 4 October 2022 |
| 5 capsule in 1 bottle | 16571-821-51 | Rising Pharma Holdings | 4 October 2022 |
| 5 capsule in 1 bottle | 72162-2664-2 | Bryant Ranch Prepack | 9 June 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Temozolomide 250 mg capsule.
Other strengths and forms of Temozolomide
Clinical summary
Temozolomide is an alkylating drug indicated for the treatment of adults with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment, among other approved uses. MedsAcross supplies Temozolomide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about TemozolomideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TEMODAR prescribing information (Merck Sharp & Dohme) · U.S. National Library of Medicine, DailyMed
- Temodal: European public assessment report (EPAR) · European Medicines Agency
- Temomedac: European public assessment report (EPAR) · European Medicines Agency
Need Temozolomide 250 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.