Zegalogue Injection, Solution
NDC Package 0169-1913-01

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

Zegalogue (dasiglucagon) injection is zEGALOGUE® is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. This formulation utilizes a injection, solution delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-1913 and is authorized under FDA application NDA214231.

Identification & Billing

NDC Package Code
0169-1913-01
Package Description
1 CONTAINER in 1 PACKAGE / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS
Product Code
0169-1913
11-Digit Billing Format
00169191301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Zegalogue
Non-Proprietary Name
Dasiglucagon
Substance Name
Dasiglucagon
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)
DASIGLUCAGON .6 mg/.6mL
Pharmacologic Class
Usage Information
ZEGALOGUE® is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

Regulatory & Marketing

Labeler Name
Novo Nordisk
Product Type
Human Prescription Drug
FDA Application #
NDA214231
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-26-2023
End Marketing Date
08-31-2027
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 (0169-1913). Click a package code to view its specific billing and regulatory data.

0169-1913-02
2 PACKAGE in 1 CARTON / 1 CONTAINER in 1 PACKAGE (0169-1913-12) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS

* 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 0169-1913-01 identifies a specific commercial package of 1 container in 1 package / 1 syringe, glass in 1 container / .6 ml in 1 syringe, glass of Zegalogue, a human prescription drug labeled by Novo Nordisk. This injection, solution is formulated for subcutaneous use and contains dasiglucagon 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 Novo Nordisk on June 26, 2023.

How is this Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169191301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0169-1913-01
11-Digit CMS (5-4-2)
00169-1913-01

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