Active ingredient
Acalabrutinib
3 finished FDA listings contain Acalabrutinib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ACALABRUTINIB, ACALABRUTINIB MALEATE, ACALABRUTINIB MALEATE MONOHYDRATE
- Dosage forms
- Capsule, Gelatin Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 100 mg/1
- Brand names in FDA listings
- Calquence
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1986808
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 210259 | ASTRAZENECA | 2017-10-31 | 1 |
| NDA 216387 | ASTRAZENECA | 2022-08-03 | 2 |
Official labeling on DailyMed
- CALQUENCE (ACALABRUTINIB) CAPSULE, GELATIN COATED [ASTRAZENECA PHARMACEUTICALS LP] · version 27 · 2026-03-05
- CALQUENCE (ACALABRUTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] · version 8 · 2026-03-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.