Glucagon Injection, Powder, Lyophilized, For Solution
NDC Package 63323-596-16

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

Package Information

Glucagon injection is a medication 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. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-596 and is authorized under FDA application NDA201849.

Identification & Billing

NDC Package Code
63323-596-16
Package Description
10 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-08)
Product Code
63323-596
11-Digit Billing Format
63323059616
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
RxCUI: 310497 - glucagon (rDNA) 1 MG Injection

Clinical Specifications

Proprietary Name
Glucagon
Non-Proprietary Name
Glucagon
Substance Name
Glucagon Hydrochloride
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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA201849
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-08-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63323-596). Click a package code to view its specific billing and regulatory data.

63323-596-13
10 VIAL, SINGLE-DOSE in 1 TRAY / 1 mL in 1 VIAL, SINGLE-DOSE (63323-596-11)

* 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 63323-596-16 identifies a specific commercial package of 10 vial, single-dose in 1 tray / 1 ml in 1 vial, single-dose (63323-596-08) of Glucagon, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intramuscular; intravenous use and contains glucagon hydrochloride 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 Fresenius Kabi Usa, Llc on May 08, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323059616. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
63323-596-16
11-Digit CMS (5-4-2)
63323-0596-16

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