Kalydeco Granule
NDC Package 51167-600-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Kalydeco (ivacaftor) granules is a medication used to treat cystic fibrosis in certain people (those with an abnormal "CFTR" gene). This formulation utilizes a granule delivery system. Marketed by Vertex Pharmaceuticals Incorporated, this product is identified by NDC 51167-600 and is authorized under FDA application NDA207925.

Identification & Billing

NDC Package Code
51167-600-01
Package Description
56 GRANULE in 1 CARTON
Product Code
51167-600
11-Digit Billing Format
51167060001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
56 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kalydeco
Non-Proprietary Name
Ivacaftor
Substance Name
Ivacaftor
Dosage Form
Granule - A small particle or grain.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
IVACAFTOR 25 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat cystic fibrosis in certain people (those with an abnormal "CFTR" gene). It may help to improve breathing, reduce the risk of lung infections, and improve weight gain.

Regulatory & Marketing

Labeler Name
Vertex Pharmaceuticals Incorporated
Product Type
Human Prescription Drug
FDA Application #
NDA207925
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-29-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51167-600-01 identifies a specific commercial package of 56 granule in 1 carton of Kalydeco, a human prescription drug labeled by Vertex Pharmaceuticals Incorporated. This product is billed for "EA" each discreet unit and contains an estimated amount of 56 billable units per package. This granule is formulated for oral use and contains ivacaftor as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Vertex Pharmaceuticals Incorporated on April 29, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat cystic fibrosis in certain people (those with an abnormal "CFTR" gene). It may help to improve breathing, reduce the risk of lung infections, and improve weight gain.

How is this Vertex Pharmaceuticals Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51167060001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 56 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
51167-600-01
11-Digit CMS (5-4-2)
51167-0600-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.