Alprolix Kit
NDC Package 71104-944-01

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

Alprolix (coagulation factor ix (recombinant), fc fusion protein) kits is a medication used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). This formulation utilizes a kit delivery system. Marketed by Bioverativ Therapeutics Inc., this product is identified by NDC 71104-944 and is authorized under FDA application BLA125444.

Identification & Billing

NDC Package Code
71104-944-01
Package Description
1 KIT in 1 KIT * 5 mL in 1 VIAL (71104-956-09) * 5 mL in 1 VIAL (71104-045-01)
Product Code
71104-944
11-Digit Billing Format
71104094401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • RxCUI: 1666320 - coagulation factor ix (recombinant), fc fusion protein 1 UNT Injection
  • RxCUI: 1666320 - coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection
  • RxCUI: 1666323 - ALPROLIX 1 UNT Injection
  • RxCUI: 1666323 - coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection [Alprolix]
  • RxCUI: 1666323 - Alprolix 1 UNT Injection

Clinical Specifications

Proprietary Name
Alprolix
Non-Proprietary Name
Coagulation Factor Ix (recombinant), Fc Fusion Protein
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 IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause. This medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).

Regulatory & Marketing

Labeler Name
Bioverativ Therapeutics Inc.
Product Type
Plasma Derivative
FDA Application #
BLA125444
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-05-2014
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.

J7201
Source: ASP
Factor ix alprolix 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 71104-944-01 identifies a specific commercial package of 1 kit in 1 kit * 5 ml in 1 vial (71104-956-09) * 5 ml in 1 vial (71104-045-01) of Alprolix, a plasma derivative labeled by Bioverativ Therapeutics 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 Bioverativ Therapeutics Inc. on May 05, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause. This medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71104094401. 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)
71104-944-01
11-Digit CMS (5-4-2)
71104-0944-01

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