Active ingredient
Ibrutinib
6 finished FDA listings contain Ibrutinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IBRUTINIB
- Dosage forms
- Capsule, Suspension, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 140 mg/1 · 280 mg/1 · 420 mg/1 · 70 mg/1 · 70 mg/ml
- Brand names in FDA listings
- Imbruvica
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1442981
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 205552 | PHARMACYCLICS LLC | 2013-11-13 | 2 |
| NDA 210563 | PHARMACYCLICS LLC | 2018-02-16 | 3 |
| NDA 217003 | PHARMACYCLICS LLC | 2022-08-24 | 1 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.