Kalydeco
- Product NDC
- 51167-785
- 11-digit product format
- 511670785
- Labeler code
- 51167
- Product ID
- 51167-785_13eb3fc2-0dac-4ada-96a8-a2e0cea711b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ivacaftor
- Dosage form
- GRANULE
- Route
- ORAL
- Labeler
- Vertex Pharmaceuticals Incorporated
- Application
- NDA207925
- Marketing category
- NDA
- Marketing start
- 2023-05-03
- Substance
- IVACAFTOR
- Active strength
- 5.8 mg/1
- Pharmacologic classes
- Chloride Channel Activation Potentiators [MoA], Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1Y740ILL1Z | IVACAFTOR | 873054-44-5 | IVACAFTOR |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51167-785-01 | 51167078501 | 56 GRANULE in 1 CARTON (51167-785-01) | 56 granule | 2023-05-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Kalydeco | Vertex Pharmaceuticals Incorporated | 2026-03-23 | HUMAN PRESCRIPTION DRUG LABEL | 36 |
| Kalydeco | Vertex Pharmaceuticals Incorporated | 2025-06-03 | HUMAN PRESCRIPTION DRUG LABEL | 33 |