Active ingredient
Ivacaftor
6 finished FDA listings contain Ivacaftor as their only active ingredient; 5 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- IVACAFTOR
- Dosage forms
- Granule, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 13.4 mg/1 · 150 mg/1 · 25 mg/1 · 5.8 mg/1 · 50 mg/1 · 75 mg/1
- Brand names in FDA listings
- Kalydeco
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1243041
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 203188 | VERTEX PHARMS | 2012-01-31 | 1 |
| NDA 207925 | VERTEX PHARMS INC | 2015-03-17 | 5 |
Official labeling on DailyMed
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.