Coagadex Kit
NDC Package 64208-7752-1

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

Coagadex (coagulation factor x human) kits is a medication used to prevent or control bleeding in people with little or no factor X, a condition also known as Stuart-Prower deficiency. This formulation utilizes a kit delivery system. Marketed by Bio Products Laboratory Ltd, this product is identified by NDC 64208-7752 and is authorized under FDA application BLA125506.

Identification & Billing

NDC Package Code
64208-7752-1
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL, GLASS (64208-7754-1) * 2.5 mL in 1 VIAL, GLASS (64208-7755-1)
Product Code
64208-7752
11-Digit Billing Format
64208775201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Coagadex
Non-Proprietary Name
Coagulation Factor X Human
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to prevent or control bleeding in people with little or no factor X, a condition also known as Stuart-Prower deficiency. This condition may occur due to being passed down through families (inherited). It may also be caused by a lack of vitamin K or by certain medical conditions (such as amyloidosis, liver disease). Factor X is a clotting factor in the blood that helps bleeding stop normally. People with little or no factor X are at risk for easy bruising, nose or mouth bleeds, heavy menstrual periods (women), bleeding longer after an injury/surgery, or sudden bleeding (such as in the joints, muscles, head, stomach/gut) without a clear cause.

Regulatory & Marketing

Labeler Name
Bio Products Laboratory Ltd
Product Type
Human Prescription Drug
FDA Application #
BLA125506
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-21-2015
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.

J7175
Source: ASP
Inj, factor x, (human), 1iu
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 64208-7752-1 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial, glass (64208-7754-1) * 2.5 ml in 1 vial, glass (64208-7755-1) of Coagadex, a human prescription drug labeled by Bio Products Laboratory Ltd. 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 Bio Products Laboratory Ltd on October 21, 2015. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to prevent or control bleeding in people with little or no factor X, a condition also known as Stuart-Prower deficiency. This condition may occur due to being passed down through families (inherited). It may also be caused by a lack of vitamin K or by certain medical conditions (such as amyloidosis, liver disease). Factor X is a clotting factor in the blood that helps bleeding stop normally. People with little or no factor X are at risk for easy bruising, nose or mouth bleeds, heavy menstrual periods (women), bleeding longer after an injury/surgery, or sudden bleeding (such as in the joints, muscles, head, stomach/gut) without a clear cause.

How is this Bio Products Laboratory Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64208775201. 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 (5-4-1)
64208-7752-1
11-Digit CMS (5-4-2)
64208-7752-01

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