Yimmugo Solution
NDC Package 83372-605-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

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 Biotest Ag, this product is identified by NDC 83372-605 and is authorized under FDA application BLA125810.

Identification & Billing

NDC Package Code
83372-605-01
Package Description
1 VIAL, GLASS in 1 CARTON / 50 mL in 1 VIAL, GLASS (83372-605-02)
Product Code
11-Digit Billing Format
83372060501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2706386 - immune globulin intravenous (human) - dira 10 % in 50 ML Injection
  • RxCUI: 2706386 - 50 ML immune globulin intravenous (human) - dira 100 MG/ML Injection
  • RxCUI: 2706393 - Yimmugo 10 % in 50 ML Injection
  • RxCUI: 2706393 - 50 ML immune globulin intravenous (human) - dira 100 MG/ML Injection [Yimmugo]
  • RxCUI: 2706393 - 50 ML Yimmugo 100 MG/ML Injection

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)
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
Biotest Ag
Product Type
Plasma Derivative
FDA Application #
BLA125810
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-01-2025
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1553
Source: PDAC
INJECTION, IMMUNE GLOBULIN (YIMMUGO), 100 MG
HCPCS Dosage 100 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (83372-605). Click a package code to view its specific billing and regulatory data.

1 VIAL, GLASS in 1 CARTON / 100 mL in 1 VIAL, GLASS (83372-605-12)
1 VIAL, GLASS in 1 CARTON / 200 mL in 1 VIAL, GLASS (83372-605-22)

* 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 83372-605-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 50 ml in 1 vial, glass (83372-605-02) of Yimmugo, a plasma derivative labeled by Biotest Ag. 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 Biotest Ag on March 01, 2025. The current certification is valid through December 31, 2027.

How is this Biotest Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83372060501. 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 (5-3-2)
83372-605-01
11-Digit CMS (5-4-2)
83372-0605-01

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