Yimmugo Solution
NDC Package 70573-605-01

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

Yimmugo (immune globulin intravenous, human - dira) solution is yIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older. This formulation utilizes a solution delivery system. Marketed by Kedrion Biopharma Inc, this product is identified by NDC 70573-605 and is authorized under FDA application BLA125810.

Identification & Billing

NDC Package Code
70573-605-01
Package Description
1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS (70573-605-02)
Product Code
70573-605
11-Digit Billing Format
70573060501

Clinical Specifications

Proprietary Name
Yimmugo
Non-Proprietary Name
Immune Globulin Intravenous, Human - Dira
Substance Name
Human Immunoglobulin G
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN IMMUNOGLOBULIN G 10 g/100mL
Pharmacologic Class
Usage Information
YIMMUGO (immune globulin intravenous, human – dira), is a 10% immune globulin liquid, indicated for the treatment of primary humoral immunodeficiency (PI) including but not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia (XLA), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID) in patients 2 years of age and older.

Regulatory & Marketing

Labeler Name
Kedrion Biopharma Inc
Product Type
Plasma Derivative
FDA Application #
BLA125810
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2025
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 (70573-605). Click a package code to view its specific billing and regulatory data.

70573-605-11
1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (70573-605-12)
70573-605-21
1 VIAL, GLASS in 1 CARTON / 200 mL in 1 VIAL, GLASS (70573-605-22)

* 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 70573-605-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 50 ml in 1 vial, glass (70573-605-02) of Yimmugo, a plasma derivative labeled by Kedrion Biopharma Inc. This solution is formulated for intravenous use and contains human immunoglobulin g 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 Kedrion Biopharma Inc on July 01, 2025. The current certification is valid through December 31, 2027.

How is this Kedrion Biopharma Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70573060501. 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)
70573-605-01
11-Digit CMS (5-4-2)
70573-0605-01

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