Medicine
Imatinib 400 mg tablet
Imatinib 400 mg tablet is a generic prescription medicine for oral use, made by 19 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 at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and…
Key facts
- Active ingredient (INN)
- Imatinib
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 3 blister pack, 500 tablets and 26 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaApotexQilu PharmaceuticalBluePoint LaboratoriesArchis PharmaArmas PharmaceuticalsChartwell RX
- 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
- 1 February 2016
- Identifiers
- RxCUI 403878, 403879DailyMed set ID 9de8d8b9-cf88-4960-82b7-89e5ceb7720e, a819a954-41c9-4d49-a74e-c8c4b338b22a, 9fc5ec7b-98c4-4b1a-890c-be1343177dbd +17NDC 72819-186, 82009-087, 82249-021 +17Application ANDA212135, ANDA212773, ANDA212975 +6
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 |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 67877-634-30 | Ascend LaboratoriesIndia | 1 February 2019 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 59651-241-03 | Aurobindo PharmaIndia | 23 July 2020 |
| 30 tablet, film coated in 1 bottle | 59651-241-30 | Aurobindo PharmaIndia | 23 July 2020 |
| 30 tablet, film coated in 1 bottle | 31722-297-30 | Camber PharmaceuticalsIndia | 14 April 2025 |
| 500 tablet, film coated in 1 bottle | 47335-475-13 | Sun Pharmaceutical IndustriesIndia | 1 February 2016 |
| 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 47335-475-64 | Sun Pharmaceutical IndustriesIndia | 1 February 2016 |
| 100 tablet, film coated in 1 bottle | 47335-475-88 | Sun Pharmaceutical IndustriesIndia | 1 February 2016 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 60505-2901-0 | Apotex | 5 August 2016 |
| 100 tablet, film coated in 1 bottle | 60505-2901-1 | Apotex | 5 August 2016 |
| 30 tablet, film coated in 1 bottle | 60505-2901-3 | Apotex | 5 August 2016 |
| 500 tablet, film coated in 1 bottle | 60505-2901-5 | Apotex | 5 August 2016 |
| 90 tablet, film coated in 1 bottle | 60505-2901-9 | Apotex | 5 August 2016 |
| 30 tablet in 1 bottle | 72819-186-03 | Archis Pharma | 1 September 2022 |
| 30 tablet, film coated in 1 bottle | 72485-203-30 | Armas Pharmaceuticals | 15 March 2019 |
| 30 tablet, film coated in 1 bottle | 62135-659-30 | Chartwell RX | 28 February 2024 |
| 30 tablet, film coated in 1 bottle | 82249-021-30 | Civica Script | 3 July 2026 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 42292-044-03 | Mylan Institutional | 7 September 2017 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-2246-93 | Mylan Pharmaceuticals | 28 September 2017 |
| 30 tablet in 1 bottle | 67184-0533-1 | Qilu Pharmaceutical | 21 June 2022 |
| 300 tablet in 1 bottle | 67184-0533-2 | Qilu Pharmaceutical | 21 June 2022 |
| 30 blister pack in 1 carton / 10 tablet in 1 blister pack | 67184-0533-3 | Qilu Pharmaceutical | 21 June 2022 |
| 30 tablet, film coated in 1 bottle | 0093-7630-56 | Teva Pharmaceuticals | 4 August 2016 |
| 30 tablet in 1 bottle | 0832-0533-03 | Upsher-Smith Laboratories | 17 May 2024 |
| 30 tablet, film coated in 1 bottle | 68001-491-04 | BluePoint Laboratories | 26 March 2021 |
| 30 tablet, film coated in 1 bottle | 68001-623-04 | BluePoint Laboratories | 21 February 2025 |
| 30 tablet, film coated in 1 bottle, plastic | 51407-270-30 | Golden State Medical Supply | 21 August 2019 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0904-6621-04 | Major Pharmaceuticals | 5 August 2016 |
| 30 tablet, film coated in 1 bottle | 82009-087-30 | Quallent Pharmaceuticals Health | 1 September 2023 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 48433-050-03 | Safecor Health | 10 April 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 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 Imatinib 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.