Advate Kit
NDC Package 0944-3045-10

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

Advate (antihemophilic factor (recombinant)) kits is a medication used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). This formulation utilizes a kit delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 0944-3045 and is authorized under FDA application BLA125063.

Identification & Billing

NDC Package Code
0944-3045-10
Package Description
1 BLISTER PACK in 1 CONTAINER / 1 CONTAINER in 1 BLISTER PACK (0944-3045-12) / 1 KIT in 1 CONTAINER (0944-3045-11) * 5 mL in 1 VIAL, GLASS (0944-2945-01) * 5 mL in 1 VIAL, GLASS (64764-515-50)
Product Code
0944-3045
11-Digit Billing Format
00944304510
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Advate
Non-Proprietary Name
Antihemophilic Factor (recombinant)
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.

Regulatory & Marketing

Labeler Name
Takeda Pharmaceuticals America, Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125063
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-12-2006
Listing Expiration
12-31-2026
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.

J7192
Source: ASP
Factor viii recombinant nos
HCPCS Dosage 1 IU
Units / Pkg 1

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 0944-3045-10 identifies a specific commercial package of 1 blister pack in 1 container / 1 container in 1 blister pack (0944-3045-12) / 1 kit in 1 container (0944-3045-11) * 5 ml in 1 vial, glass (0944-2945-01) * 5 ml in 1 vial, glass (64764-515-50) of Advate, 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 April 12, 2006. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.

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: 00944304510. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
0944-3045-10
11-Digit CMS (5-4-2)
00944-3045-10

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