Prescription drug · NDA
Kalydeco (ivacaftor) NDC 51167-400
Ivacaftor 75 mg/1 · Granule · Oral · Vertex Pharmaceuticals Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51167-400-01 | 51167040001 | 56 GRANULE in 1 CARTON (51167-400-01)Marketed from Mar 23, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Kalydeco
- Generic name (nonproprietary)
- ivacaftor
- Active ingredients
- Ivacaftor — 75 mg/1
- Dosage form
- Granule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207925
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activation Potentiators (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 51167-400_13eb3fc2-0dac-4ada-96a8-a2e0cea711b7SPL ID 13eb3fc2-0dac-4ada-96a8-a2e0cea711b7SPL set ID 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25RxCUI 1243046, 1243052, 1606862, 1606866, 1606868, 1606870, 2166399, 2166401, 2636787, 2636789, 2636791, 2636793UNII 1Y740ILL1Z
- Pharmacologic class
- Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N451167040001followed by a unit qualifier and the quantityPackage 51167-0400-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data [see Clinical Pharmacology (12.1) and Clinical Studies (14) ] . If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients aged 1 …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 207925
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Kalydecoivacaftor | Ivacaftor 50 mg/1 | GranuleOral | Vertex Pharmaceuticals Incorporated | 51167-300 |
| Kalydecoivacaftor | Ivacaftor 25 mg/1 | GranuleOral | Vertex Pharmaceuticals Incorporated | 51167-600 |
| Kalydecoivacaftor | Ivacaftor 5.8 mg/1 | GranuleOral | Vertex Pharmaceuticals Incorporated | 51167-785 |
| Kalydecoivacaftor | Ivacaftor 13.4 mg/1 | GranuleOral | Vertex Pharmaceuticals Incorporated | 51167-770 |