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Prescription medicine

Ibrutinib

Brand names: Imbruvica

Drug class: Kinase Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2013First FDA approval on file

Quick answers

What is Ibrutinib used for?
The FDA-approved label (Imbruvica, Pharmacyclics LLC, October 21, 2025) says: “IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion. Adult patients with Waldenström’s macroglobulinemia (WM). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ibrutinib have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Ibrutinib?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ibrutinib been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Ibrutinib?
1 company lists prescription products of Ibrutinib in the FDA NDC Directory, including Pharmacyclics LLC.

What Ibrutinib is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

IMBRUVICA is a kinase inhibitor indicated for the treatment of: Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL). Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion. Adult patients with Waldenström’s macroglobulinemia (WM). …

— FDA label: Imbruvica, Pharmacyclics LLC, effective October 21, 2025. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Chronic Lymphocytic Leukemia

Related medical specialties

Oncology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Capsule · Suspension
RouteOral
Prescription products6 in the FDA NDC Directory
Brand namesImbruvica

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA205552
IMBRUVICA		 Pharmacyclics LLCNovember 13, 2013 35, latest October 21, 2025
2025: Labeling · 2024: Labeling · 2024: Labeling
NDA210563
IMBRUVICA		 Pharmacyclics LLCFebruary 16, 2018 16, latest October 21, 2025
2025: Labeling · 2024: Labeling · 2024: Labeling
NDA217003
IMBRUVICA		 Pharmacyclics LLCAugust 24, 2022 4, latest October 21, 2025
2025: Labeling · 2024: Labeling · 2024: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)1442986, 1442992, 1994360, 1994362, 2000017, 2000019, 2000021, 2000023, 2000025, 2000027 … (+2)
SPL set ID of the quoted label0dfd0279-ff17-4ea9-89be-9803c71bab44
FDA labels (SPL)1
FDA applicationsNDA205552, NDA210563, NDA217003
Active ingredients (FDA)IBRUTINIB

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Imbruvica, Pharmacyclics LLC, effective October 21, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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