Gvoke Pfs Injection, Solution
NDC Package 72065-131-12

11-digit billing NDC: 72065013112 · Billing unit: ML · 0.4 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Gvoke Pfs (glucagon injection, solution) injection is gVOKE and GVOKE VialDx are contraindicated in patients with:Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1)]Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2)]Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. This formulation utilizes a injection, solution delivery system. Marketed by Xeris Pharmaceuticals, Inc., this product is identified by NDC 72065-131 and is authorized under FDA application NDA212097.

Identification & Billing

NDC Package Code
72065-131-12
Package Description
2 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC
Product Code
72065-131
11-Digit Billing Format
72065013112
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
0.4 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gvoke Pfs 1 Mg Pre-filled Syringe
Non-Proprietary Name
Glucagon Injection, Solution
Substance Name
Glucagon
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
GLUCAGON 1 mg/.2mL
Pharmacologic Class
Usage Information
GVOKE and GVOKE VialDx are contraindicated in patients with:Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1)]Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2)]Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)].GVOKE VialDx for use as a diagnostic aid is also contraindicated in patients with glucagonoma because of risk of hypoglycemia [see Warnings and Precautions (5.8)]

Regulatory & Marketing

Labeler Name
Xeris Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA212097
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-10-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72065-131). Click a package code to view its specific billing and regulatory data.

72065-131-11
1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC
72065-131-99
1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC

* 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 72065-131-12 identifies a specific commercial package of 2 pouch in 1 carton / 1 syringe, plastic in 1 pouch / .2 ml in 1 syringe, plastic of Gvoke Pfs 1 Mg Pre-filled Syringe, a human prescription drug labeled by Xeris Pharmaceuticals, Inc.. This injection, solution is formulated for subcutaneous use and contains glucagon 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 Xeris Pharmaceuticals, Inc. on September 10, 2019. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72065013112. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 0.4 total billable units per package. 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)
72065-131-12
11-Digit CMS (5-4-2)
72065-0131-12

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