Tegsedi
NDC Package 72126-007-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tegsedi is a medication used to treat nerve problems due to a certain inherited condition (transthyretin-mediated amyloidosis). Marketed by Akcea Therapeutics, Inc., this product is identified by NDC 72126-007 and is authorized under FDA application NDA211172.

Identification & Billing

NDC Package Code
72126-007-01
Package Description
4 TRAY in 1 CARTON / 1 SYRINGE in 1 TRAY (72126-007-02) / 1.5 mL in 1 SYRINGE
Product Code
72126-007
11-Digit Billing Format
72126000701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tegsedi
Dosage Form
-
Usage Information
This medication is used to treat nerve problems due to a certain inherited condition (transthyretin-mediated amyloidosis). This condition causes a protein that your body normally makes (transthyretin-TTR), to change shape and build up in different parts of your body, which can affect the nerves, heart, eyes, and gut. This medication works by decreasing the buildup of TTR in your body.

Regulatory & Marketing

Labeler Name
Akcea Therapeutics, Inc.
FDA Application #
NDA211172
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-05-2018
Listing Expiration
12-31-2025
Exclude Flag
I
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 72126-007-01 identifies a specific commercial package of 4 tray in 1 carton / 1 syringe in 1 tray (72126-007-02) / 1.5 ml in 1 syringe of Tegsedi, labeled by Akcea Therapeutics, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Akcea Therapeutics, Inc. on October 05, 2018. The current certification is valid through December 31, 2025.

What are the primary indications for this medication?

This medication is used to treat nerve problems due to a certain inherited condition (transthyretin-mediated amyloidosis). This condition causes a protein that your body normally makes (transthyretin-TTR), to change shape and build up in different parts of your body, which can affect the nerves, heart, eyes, and gut. This medication works by decreasing the buildup of TTR in your body.

How is this Akcea Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72126000701. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
72126-007-01
11-Digit CMS (5-4-2)
72126-0007-01

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