Medicine
Imbruvica 420 mg tablet
Imbruvica 420 mg tablet is a prescription medicine containing Ibrutinib for oral use, marketed by Pharmacyclics, 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
Do not freeze. Store bottles at room temperature 20°C to 25°C (68°F to 77°F)…
Key facts
- Active ingredient (INN)
- Ibrutinib
- Brand
- Imbruvica
- Strength
- 420 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 blister pack
- Marketing authorisation holder
- Pharmacyclics
- Manufacturer
- Pharmacyclics
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store bottles at room temperature 20°C to 25°C (68°F to 77°F). Brief exposure to 15°C to 30°C (59°F to 86°F) permitted. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-420-28 Store tablets in original packaging at room temperature 20°C to 25°C (68°F to 77°F). Store the oral suspension bottle at 2°C to 25°C (36°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01EL01 Ibrutinib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 February 2018
- Identifiers
- RxCUI 1442986, 1442992, 1994360 +7DailyMed set ID 0dfd0279-ff17-4ea9-89be-9803c71bab44NDC 57962-420Application NDA210563
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 |
|---|---|---|---|
| 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack | 57962-420-28 | Pharmacyclics | 16 February 2018 |
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
Other strengths and forms of Ibrutinib
Clinical summary
Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL), among other approved uses. It is available as tablets, capsules and oral suspension. MedsAcross supplies Ibrutinib 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 IbrutinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Imbruvica prescribing information (Pharmacyclics) · U.S. National Library of Medicine, DailyMed
- Imbruvica: European public assessment report (EPAR) · European Medicines Agency
Need Imbruvica 420 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.