Orkambi Tablet, Film Coated
NDC Package 51167-809-01

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

Package Information

Orkambi (lumacaftor and ivacaftor) tablets is a medication a combination of 2 medications: lumacaftor and ivacaftor. This formulation utilizes a tablet, film coated delivery system. Marketed by Vertex Pharmaceuticals Incorporated, this product is identified by NDC 51167-809 and is authorized under FDA application NDA206038.

Identification & Billing

NDC Package Code
51167-809-01
Package Description
4 CARTON in 1 BOX / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
51167-809
11-Digit Billing Format
51167080901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orkambi
Non-Proprietary Name
Lumacaftor And Ivacaftor
Substance Name
Ivacaftor; Lumacaftor
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is a combination of 2 medications: lumacaftor and ivacaftor. It is used to treat cystic fibrosis in certain people (those with 2 copies of 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 #
NDA206038
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-02-2015
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 51167-809-01 identifies a specific commercial package of 4 carton in 1 box / 7 blister pack in 1 carton / 4 tablet, film coated in 1 blister pack of Orkambi, a human prescription drug labeled by Vertex Pharmaceuticals Incorporated. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This tablet, film coated is formulated for oral use and contains ivacaftor; lumacaftor 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 July 02, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is a combination of 2 medications: lumacaftor and ivacaftor. It is used to treat cystic fibrosis in certain people (those with 2 copies of 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: 51167080901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
51167-809-01
11-Digit CMS (5-4-2)
51167-0809-01

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