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  5. NDC Package Code: 51167-135-01 Alyftrek

NDC Package 51167-135-01 Alyftrek

Vanzacaftor,Tezacaftor,And Deutivacaftor Tablet, Film Coated 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:
51167-135-01
Package Description:
4 BLISTER PACK in 1 CARTON / 21 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
51167-135
Proprietary Name:
Alyftrek
Non-Proprietary Name:
Vanzacaftor, Tezacaftor, And Deutivacaftor
Substance Name:
Deutivacaftor; Tezacaftor; Vanzacaftor
Usage Information:
ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (see Table 5) [see Clinical Pharmacology (12.1)].If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation.
11-Digit NDC Billing Format:
51167013501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
4 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2701438 - deutivacaftor 125 MG / tezacaftor 50 MG / vanzacaftor 10 MG Oral Tablet
  • RxCUI: 2701438 - deutivacaftor 125 MG / tezacaftor 50 MG / vanzacaftor 10 MG (equivalent to vanzacaftor calcium dihydrate 10.6 MG) Oral Tablet
  • RxCUI: 2701444 - alyftrek 125 MG / 50 MG / 10 MG Oral Tablet
  • RxCUI: 2701444 - deutivacaftor 125 MG / tezacaftor 50 MG / vanzacaftor 10 MG Oral Tablet [Alyftrek]
  • RxCUI: 2701444 - Alyftrek 125 MG / 50 MG / 10 MG (equivalent to vanzacaftor calcium dihydrate 10.6 MG) Oral Tablet
Product Type:
Human Prescription Drug
Labeler Name:
Vertex Pharmaceuticals Incorporated
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
NDA218730
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
12-20-2024
Listing Expiration Date:
12-31-2026
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 51167-135-01?

The NDC Packaged Code 51167-135-01 is assigned to a package of 4 blister pack in 1 carton / 21 tablet, film coated in 1 blister pack of Alyftrek, a human prescription drug labeled by Vertex Pharmaceuticals Incorporated. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package.

Is NDC 51167-135 included in the NDC Directory?

Yes, Alyftrek with product code 51167-135 is active and included in the NDC Directory. The product was first marketed by Vertex Pharmaceuticals Incorporated on December 20, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 51167-135-01?

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 4.

What is the 11-digit format for NDC 51167-135-01?

The 11-digit format is 51167013501. 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
5-3-251167-135-015-4-251167-0135-01