Medicine
Gleevec 400 mg tablet
Gleevec 400 mg tablet is a prescription medicine containing Imatinib for oral use, marketed by Novartis Pharmaceuticals, 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 at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Imatinib
- Brand
- Gleevec
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 3 blister pack, 30 tablets
- Marketing authorisation holder
- Novartis Pharmaceuticals
- Manufacturer
- Novartis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EA01 Imatinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 December 2014
- Identifiers
- RxCUI 403878, 403879, 404588 +1DailyMed set ID 211ef2da-2868-4a77-8055-1cb2cd78e24bNDC 0078-1490, 0078-0649Application NDA021588
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 0078-0649-13 | Novartis Pharmaceuticals | 1 March 2024 |
| 30 tablet in 1 box, unit-dose | 0078-0649-30 | Novartis Pharmaceuticals | 23 December 2014 |
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 0078-1490-13 | Novartis Pharmaceuticals | 20 December 2025 |
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 Imatinib 400 mg tablet.
Other strengths and forms of Imatinib
Clinical summary
Imatinib 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, among other approved uses. MedsAcross supplies Imatinib 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 ImatinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gleevec prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Glivec: European public assessment report (EPAR) · European Medicines Agency
- Imatinib Accord: European public assessment report (EPAR) · European Medicines Agency
Need Gleevec 400 mg tablet 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.