1. Home
  2. Labeler Index
  3. Vertex Pharmaceuticals Incorporated
  4. 51167-900
  5. NDC Package Code: 51167-900-01 Orkambi

NDC Package 51167-900-01 Orkambi

Lumacaftor And Ivacaftor Granule Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
51167-900-01
Package Description:
56 PACKET in 1 CARTON / 1 GRANULE in 1 PACKET
Product Code:
51167-900
Proprietary Name:
Orkambi
Non-Proprietary Name:
Lumacaftor And Ivacaftor
Substance Name:
Ivacaftor; Lumacaftor
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.
11-Digit NDC Billing Format:
51167090001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
56 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1655928 - lumacaftor 200 MG / ivacaftor 125 MG Oral Tablet
  • RxCUI: 1655928 - ivacaftor 125 MG / lumacaftor 200 MG Oral Tablet
  • RxCUI: 1655934 - ORKAMBI 200 MG / 125 MG Oral Tablet
  • RxCUI: 1655934 - ivacaftor 125 MG / lumacaftor 200 MG Oral Tablet [ORKAMBI]
  • RxCUI: 1655934 - ORKAMBI (lumacaftor 200 MG / ivacaftor 125 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Vertex Pharmaceuticals Incorporated
    Dosage Form:
    Granule - A small particle or grain.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • IVACAFTOR 125 mg/1
  • LUMACAFTOR 100 mg/1
    • Pharmacologic Class(es):
  • Chloride Channel Activation Potentiators - [MoA] (Mechanism of Action)
  • Cystic Fibrosis Transmembrane Conductance Regulator Potentiator - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 2B6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C8 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C8 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C9 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inducers - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA211358
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-07-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 51167-900-01?

    The NDC Packaged Code 51167-900-01 is assigned to a package of 56 packet in 1 carton / 1 granule in 1 packet of Orkambi, a human prescription drug labeled by Vertex Pharmaceuticals Incorporated. The product's dosage form is granule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 56 billable units per package.

    Is NDC 51167-900 included in the NDC Directory?

    Yes, Orkambi with product code 51167-900 is active and included in the NDC Directory. The product was first marketed by Vertex Pharmaceuticals Incorporated on August 07, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 51167-900-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 56.

    What is the 11-digit format for NDC 51167-900-01?

    The 11-digit format is 51167090001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-251167-900-015-4-251167-0900-01