Symdeko Kit
NDC Package 51167-113-01

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

Package Information

Symdeko (tezacaftor and ivacaftor) kits is this product contains 2 different tablets. This formulation utilizes a kit delivery system. Marketed by Vertex Pharmaceuticals Incorporated, this product is identified by NDC 51167-113 and is authorized under FDA application NDA210491.

Identification & Billing

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
11-Digit Billing Format
51167011301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
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)]

Clinical Specifications

Proprietary Name
Symdeko
Non-Proprietary Name
Tezacaftor And Ivacaftor
Dosage Form
Kit - A packaged collection of related material.
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.

Regulatory & Marketing

Labeler Name
Vertex Pharmaceuticals Incorporated
Product Type
Human Prescription Drug
FDA Application #
NDA210491
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-21-2019
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 51167-113-01 identifies a specific commercial 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. This kit is formulated for use and contains 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 June 21, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51167011301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
51167-113-01
11-Digit CMS (5-4-2)
51167-0113-01

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