Eloctate Kit
NDC Package 71104-809-01

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

Eloctate (antihemophilic factor (recombinant), fc fusion protein) kits is a medication used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). This formulation utilizes a kit delivery system. Marketed by Bioverativ Therapeutics Inc., this product is identified by NDC 71104-809 and is authorized under FDA application BLA125487.

Identification & Billing

NDC Package Code
71104-809-01
Package Description
1 KIT in 1 KIT * 3 mL in 1 VIAL (71104-491-08) * 3 mL in 1 SYRINGE (71104-035-01)
Product Code
71104-809
11-Digit Billing Format
71104080901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Eloctate
Non-Proprietary Name
Antihemophilic Factor (recombinant), Fc Fusion Protein
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intravenous - Administration within or into a vein or veins.
Usage Information
This medication is used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury. People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A. This medication should not be used to treat von Willebrand disease.

Regulatory & Marketing

Labeler Name
Bioverativ Therapeutics Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125487
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-06-2017
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.

J7205
Source: ASP
Factor viii fc fusion recomb
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 71104-809-01 identifies a specific commercial package of 1 kit in 1 kit * 3 ml in 1 vial (71104-491-08) * 3 ml in 1 syringe (71104-035-01) of Eloctate, a plasma derivative labeled by Bioverativ Therapeutics Inc.. This kit is formulated for intravenous 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 Bioverativ Therapeutics Inc. on September 06, 2017. 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 that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury. People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A. This medication should not be used to treat von Willebrand disease.

How is this Bioverativ Therapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71104080901. 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)
71104-809-01
11-Digit CMS (5-4-2)
71104-0809-01

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