Hyqvia Kit
NDC Package 0944-2513-02

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

Package Information

Hyqvia (immune globulin infusion (human), 10% with recombinant human hyaluronidase) kits is this kit contains two medications: immune globulin and hyaluronidase. This formulation utilizes a kit delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 0944-2513 and is authorized under FDA application BLA125402.

Identification & Billing

NDC Package Code
0944-2513-02
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL, GLASS (0944-2723-03) * 200 mL in 1 VIAL, GLASS (0944-2718-20)
Product Code
0944-2513
11-Digit Billing Format
00944251302
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1549687 - {1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack
  • RxCUI: 1549687 - immunoglobulin G, human 30 GM / hyaluronidase, human recombinant 2400 UNT Kit
  • RxCUI: 1549688 - {1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 30 G / 300 ML Kit]
  • RxCUI: 1549688 - HYQVIA 30 GM / 300 ML Kit
  • RxCUI: 1549688 - Hyqvia 2400 UNT per 15 ML / 30 G per 300 ML (10 % ) Kit

Clinical Specifications

Proprietary Name
Hyqvia
Non-Proprietary Name
Immune Globulin Infusion (human), 10% With Recombinant Human Hyaluronidase
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This kit contains two medications: immune globulin and hyaluronidase. Immune globulin is used to boost the body's natural defense system against infection in persons with a weakened immune system (primary immune deficiency). Immune globulin contains natural substances called antibodies (a type called IgG) that come from healthy human blood (plasma). These antibodies help protect your body against infections and help you to fight an infection if you get sick. Hyaluronidase is used to help the body absorb the immune globulin.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125402
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-12-2014
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.

J1575
Source: PDAC
INJECTION, IMMUNE GLOBULIN/HYALURONIDASE, (HYQVIA), 100 MG IMMUNEGLOBULIN
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0944-2513-02 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial, glass (0944-2723-03) * 200 ml in 1 vial, glass (0944-2718-20) of Hyqvia, a plasma derivative labeled by Takeda Pharmaceuticals America, 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 Takeda Pharmaceuticals America, Inc. on September 12, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This kit contains two medications: immune globulin and hyaluronidase. Immune globulin is used to boost the body's natural defense system against infection in persons with a weakened immune system (primary immune deficiency). Immune globulin contains natural substances called antibodies (a type called IgG) that come from healthy human blood (plasma). These antibodies help protect your body against infections and help you to fight an infection if you get sick. Hyaluronidase is used to help the body absorb the immune globulin.

How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00944251302. 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)
0944-2513-02
11-Digit CMS (5-4-2)
00944-2513-02

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