Koate Kit
NDC Package 76125-672-50

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

Package Information

Koate (antihemophilic factor (human)) 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 Kedrion Biopharma, Inc., this product is identified by NDC 76125-672 and is authorized under FDA application BLA101130.

Identification & Billing

NDC Package Code
76125-672-50
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL, GLASS (13533-000-05) * 10 mL in 1 VIAL, GLASS (76125-673-51)
Product Code
76125-672
11-Digit Billing Format
76125067250
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Koate
Non-Proprietary Name
Antihemophilic Factor (human)
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 human 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.

Regulatory & Marketing

Labeler Name
Kedrion Biopharma, Inc.
Product Type
Plasma Derivative
FDA Application #
BLA101130
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-20-1999
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76125-672-50 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial, glass (13533-000-05) * 10 ml in 1 vial, glass (76125-673-51) of Koate, a plasma derivative labeled by Kedrion Biopharma, 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 Kedrion Biopharma, Inc. on May 20, 1999. 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 human 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76125067250. 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 (5-3-2)
76125-672-50
11-Digit CMS (5-4-2)
76125-0672-50

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