Medicine
Nilotinib 50 mg capsule
Nilotinib 50 mg capsule is a generic prescription medicine for oral use, made by 4 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 from 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Nilotinib
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 120 capsules, 7 blister pack and 2 more
- Manufacturers
- CiplaIndiaDr. Reddy's LaboratoriesIndiaNovadoz PharmaceuticalsIndiaApotex
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted from 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
- L01EA03 Nilotinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 May 2025
- Identifiers
- RxCUI 746606, 997653, 2002717 +3DailyMed set ID 8283672c-619f-fe60-3d25-040f95ac1440, 805cc504-60bb-7743-5ada-679eb3badc7f, 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 +1NDC 60505-3803, 43598-055, 72205-237 +1Application ANDA203640, ANDA218350, ANDA218544 +1
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 |
|---|---|---|---|
| 120 capsule in 1 bottle, plastic | 69097-030-08 | CiplaIndia | 18 June 2025 |
| 7 blister pack in 1 carton / 4 capsule in 1 blister pack | 69097-030-63 | CiplaIndia | 18 June 2025 |
| 120 capsule in 1 bottle | 43598-055-04 | Dr. Reddy's LaboratoriesIndia | 19 November 2025 |
| 120 capsule in 1 bottle | 72205-237-92 | Novadoz PharmaceuticalsIndia | 20 November 2025 |
| 120 capsule in 1 bottle | 60505-3803-7 | Apotex | 23 May 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 Nilotinib 50 mg capsule.
Other strengths and forms of Nilotinib
Clinical summary
Nilotinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. MedsAcross supplies Nilotinib 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 NilotinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tasigna prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Tasigna: European public assessment report (EPAR) · European Medicines Agency
- Nilotinib Accord: European public assessment report (EPAR) · European Medicines Agency
Need Nilotinib 50 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.