Gattex Injection, Powder, Lyophilized, For Solution
NDC Package 68875-0101-2

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

Package Information

Gattex (teduglutide) injection is teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 68875-0101 and is authorized under FDA application NDA203441.

Identification & Billing

NDC Package Code
68875-0101-2
Package Description
30 VIAL in 1 CARTON / .5 mL in 1 VIAL (68875-0101-1)
Product Code
68875-0101
11-Digit Billing Format
68875010102
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gattex
Non-Proprietary Name
Teduglutide
Substance Name
Teduglutide
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
TEDUGLUTIDE 5 mg/.5mL
Pharmacologic Class
Usage Information
Teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. It may help to decrease the amount of intravenous nutrition needed by the patient. Teduglutide is similar to a natural hormone in your body (GLP-2). It works by helping to improve intestinal absorption of fluids and nutrients.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203441
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-21-2012
Listing Expiration
12-31-2026
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 68875-0101-2 identifies a specific commercial package of 30 vial in 1 carton / .5 ml in 1 vial (68875-0101-1) of Gattex, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. This injection, powder, lyophilized, for solution is formulated for subcutaneous use and contains teduglutide 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 Takeda Pharmaceuticals America, Inc. on December 21, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. It may help to decrease the amount of intravenous nutrition needed by the patient. Teduglutide is similar to a natural hormone in your body (GLP-2). It works by helping to improve intestinal absorption of fluids and nutrients.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68875010102. 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 (5-4-1)
68875-0101-2
11-Digit CMS (5-4-2)
68875-0101-02

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