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  5. NDC Package Code: 68875-0101-2 Gattex

NDC Package 68875-0101-2 Gattex

Teduglutide Injection, Powder, Lyophilized, For Solution Subcutaneous - 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:
68875-0101-2
Package Description:
30 VIAL in 1 CARTON / .5 mL in 1 VIAL (68875-0101-1)
Product Code:
68875-0101
Proprietary Name:
Gattex
Non-Proprietary Name:
Teduglutide
Substance Name:
Teduglutide
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.
11-Digit NDC Billing Format:
68875010102
NDC to RxNorm Crosswalk:
  • RxCUI: 1364472 - teduglutide 5 MG Injection
  • RxCUI: 1364477 - Gattex 5 MG Injection
  • RxCUI: 1364477 - teduglutide 5 MG Injection [Gattex]
  • RxCUI: 1489307 - ethanol 70 % Medicated Pad
  • RxCUI: 1489307 - ethanol 0.7 ML/ML Medicated Pad
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Takeda Pharmaceuticals America, Inc.
    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(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • TEDUGLUTIDE 5 mg/.5mL
    • Pharmacologic Class(es):
  • Analogs/Derivatives - [Chemical/Ingredient]
  • GLP-2 Analog - [EPC] (Established Pharmacologic Class)
  • Glucagon-Like Peptide 2 - [Chemical/Ingredient]
  • Glucagon-like Peptide-2 (GLP-2) Agonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA203441
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-21-2012
    Listing Expiration Date:
    12-31-2025
    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 68875-0101-2?

    The NDC Packaged Code 68875-0101-2 is assigned to a 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.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via subcutaneous form.

    Is NDC 68875-0101 included in the NDC Directory?

    Yes, Gattex with product code 68875-0101 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals America, Inc. on December 21, 2012 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68875-0101-2?

    The 11-digit format is 68875010102. 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 5-4-1 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
    5-4-168875-0101-25-4-268875-0101-02