1. Home
  2. Labeler Index
  3. Vertex Pharmaceuticals Incorporated
  4. 51167-113
  5. NDC Package Code: 51167-113-01 Symdeko

NDC Package 51167-113-01 Symdeko

Tezacaftor And Ivacaftor Kit - 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:
51167-113-01
Package Description:
1 KIT in 1 CARTON * 7 TABLET, FILM COATED in 1 BLISTER PACK * 7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
51167-113
Proprietary Name:
Symdeko
Non-Proprietary Name:
Tezacaftor And Ivacaftor
Usage Information:
This product contains 2 different tablets. One tablet contains 2 medications ("multi-drug"): tezacaftor and ivacaftor. The other tablet contains only ivacaftor. This product 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.
11-Digit NDC Billing Format:
51167011301
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1243046 - ivacaftor 150 MG Oral Tablet
  • RxCUI: 1999387 - ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet
  • RxCUI: 1999388 - {28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack
  • RxCUI: 1999388 - ivacaftor 150 MG / tezacaftor 100 MG (28) Oral Tablet / ivacaftor 150 MG (28) Oral Tablet Pack
  • RxCUI: 1999389 - {28 (ivacaftor 150 MG / tezacaftor 100 MG Oral Tablet) / 28 (ivacaftor 150 MG Oral Tablet) } Pack [Symdeko (100 MG / 150 MG; 150 MG)]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Vertex Pharmaceuticals Incorporated
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    NDA210491
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-21-2019
    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 51167-113-01?

    The NDC Packaged Code 51167-113-01 is assigned to a package of 1 kit in 1 carton * 7 tablet, film coated in 1 blister pack * 7 tablet, film coated in 1 blister pack of Symdeko, a human prescription drug labeled by Vertex Pharmaceuticals Incorporated. The product's dosage form is kit and is administered via form.

    Is NDC 51167-113 included in the NDC Directory?

    Yes, Symdeko with product code 51167-113 is active and included in the NDC Directory. The product was first marketed by Vertex Pharmaceuticals Incorporated on June 21, 2019 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 51167-113-01?

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

    What is the 11-digit format for NDC 51167-113-01?

    The 11-digit format is 51167011301. 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
    5-3-251167-113-015-4-251167-0113-01