Active ingredient
Ribociclib
3 finished FDA listings contain Ribociclib as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- RIBOCICLIB, RIBOCICLIB SUCCINATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 200 mg/1
- Brand names in FDA listings
- Kisqali
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1873916
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 209092 | NOVARTIS | 2017-03-13 | 3 |
Official labeling on DailyMed
- KISQALI (RIBOCICLIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] · version 28 · 2026-07-13
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.