Kalydeco
- Product NDC
- 51167-400
- 11-digit product format
- 511670400
- Labeler code
- 51167
- Product ID
- 51167-400_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
- 2015-03-23
- Substance
- IVACAFTOR
- Active strength
- 75 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kalydeco
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IVACAFTOR | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1Y740ILL1Z |
| Rxcui | 1243046, 1243052, 1606862, 1606866, 1606868, 1606870, 2166399, 2166401, 2636787, 2636789, 2636791, 2636793 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51167-400-01 | Kalydeco | 56 in 1 CARTON | GRANULE | 56 | | 36 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51167-400 | KALYDECO (IVACAFTOR) TABLET, FILM COATED KALYDECO (IVACAFTOR) GRANULE [VERTEX PHARMACEUTICALS INCORPORATED] | 32 | Current NDC, Legacy NDC, 1 package rows | 20240628_0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51167-400-01 | 51167040001 | 56 GRANULE in 1 CARTON (51167-400-01) | 56 granule | 2015-03-23 | 0000-00-00 | No | No | Current |