1. Home
  2. Labeler Index
  3. American Regent, Inc.
  4. 0517-2901
  5. NDC Package Code: 0517-2901-10 Gvoke Vialdx

NDC Package 0517-2901-10 Gvoke Vialdx

Glucagon Injection Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0517-2901-10
Package Description:
10 VIAL in 1 CARTON / .2 mL in 1 VIAL
Product Code:
0517-2901
Proprietary Name:
Gvoke Vialdx
Non-Proprietary Name:
Glucagon Injection
Substance Name:
Glucagon
Usage Information:
This medication is the same as your body's own glucagon, a natural substance that raises blood sugar by causing the body to release sugar stored in the liver. It is used to treat very low blood sugar (hypoglycemia) that may cause you to need help from others. Make sure a family member or caregiver knows where you keep this medication and how to use it before you need their help.
11-Digit NDC Billing Format:
00517290110
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
American Regent, Inc.
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
GLUCAGON 1 mg/.2mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA212097
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-19-2025
Listing Expiration Date:
12-31-2026
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
0517-2901-011 VIAL in 1 CARTON / .2 mL in 1 VIAL

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 0517-2901-10?

The NDC Packaged Code 0517-2901-10 is assigned to a package of 10 vial in 1 carton / .2 ml in 1 vial of Gvoke Vialdx, a human prescription drug labeled by American Regent, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

Is NDC 0517-2901 included in the NDC Directory?

Yes, Gvoke Vialdx with product code 0517-2901 is active and included in the NDC Directory. The product was first marketed by American Regent, Inc. on August 19, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0517-2901-10?

The 11-digit format is 00517290110. 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 4-4-2 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
4-4-20517-2901-105-4-200517-2901-10