Active ingredient
Alpelisib
5 finished FDA listings contain Alpelisib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ALPELISIB
- Dosage forms
- Granule, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 125 mg/1 · 150 mg/1 · 200 mg/1 · 50 mg/1
- Brand names in FDA listings
- Piqray, Vijoice
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2169285
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 212526 | NOVARTIS | 2019-05-24 | 2 |
| NDA 215039 | NOVARTIS | 2022-04-05 | 2 |
| NDA 218466 | NOVARTIS | 2024-04-24 | 1 |
Official labeling on DailyMed
- PIQRAY (ALPELISIB) TABLET PIQRAY (ALPELISIB) KIT [NOVARTIS PHARMACEUTICALS CORPORATION] · version 13 · 2025-12-16
- VIJOICE (ALPELISIB) TABLET VIJOICE (ALPELISIB) KIT VIJOICE (ALPELISIB) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION] · version 10 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.