Genglycos Kit
NDC Package 69794-345-03

11-digit billing NDC: 69794034503
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Genglycos (pariglasgene brecaparvovec-opnr) kits is gENGLYCOS is indicated to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa).This indication is approved under accelerated approval based on reduction in daily cornstarch intake [see Clinical Studies (14)]. This formulation utilizes a kit delivery system. Marketed by Ultragenyx Pharmaceutical Inc., this product is identified by NDC 69794-345 and is authorized under FDA application BLA125858.

Identification & Billing

NDC Package Code
69794-345-03
Package Description
1 KIT in 1 CARTON * 2 mL in 1 VIAL (69794-332-01)
Product Code
69794-345
11-Digit Billing Format
69794034503

Clinical Specifications

Proprietary Name
Genglycos
Non-Proprietary Name
Pariglasgene Brecaparvovec-opnr
Dosage Form
Kit - A packaged collection of related material.
Usage Information
GENGLYCOS is indicated to reduce daily cornstarch intake as an adjunct to nutritional management in adult and pediatric patients 8 years of age and older with glycogen storage disease type Ia (GSDIa).This indication is approved under accelerated approval based on reduction in daily cornstarch intake [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Ultragenyx Pharmaceutical Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125858
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-17-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69794-345-03 identifies a specific commercial package of 1 kit in 1 carton * 2 ml in 1 vial (69794-332-01) of Genglycos, a human prescription drug labeled by Ultragenyx Pharmaceutical Inc.. This kit is formulated for use and contains 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 Ultragenyx Pharmaceutical Inc. on September 17, 2026. The current certification is valid through December 31, 2027.

How is this Ultragenyx Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69794034503. 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)
69794-345-03
11-Digit CMS (5-4-2)
69794-0345-03

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