Balfaxar Powder, For Solution
NDC Package 68982-261-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Balfaxar (prothrombin complex concentrate (human)) powders is bALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure. This formulation utilizes a powder, for solution delivery system. Marketed by Octapharma Usa Inc, this product is identified by NDC 68982-261 and is authorized under FDA application BLA125776.

Identification & Billing

NDC Package Code
68982-261-01
Package Description
1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS (68982-261-81)
Product Code
68982-261
11-Digit Billing Format
68982026101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 2643204 - prothrombin complex concentrate, human-lans 1 UNT Injection
  • RxCUI: 2643204 - coagulation factor IX, human-lans 1 UNT / coagulation factor X, human-lans 1 UNT / factor VII, human-lans 1 UNT / protein C, human-lans 1 UNT / protein S, human-lans 1 UNT / prothrombin, human-lans 1 UNT Injection
  • RxCUI: 2643209 - Balfaxar 1 UNT Injection
  • RxCUI: 2643209 - coagulation factor IX, human-lans 1 UNT / coagulation factor X, human-lans 1 UNT / factor VII, human-lans 1 UNT / protein C, human-lans 1 UNT / protein S, human-lans 1 UNT / prothrombin, human-lans 1 UNT Injection [Balfaxar]

Clinical Specifications

Proprietary Name
Balfaxar
Non-Proprietary Name
Prothrombin Complex Concentrate (human)
Substance Name
Coagulation Factor Ix Human; Coagulation Factor Vii Human; Coagulation Factor X Human; Protein C; Protein S Human; Prothrombin
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
Pharmacologic Class
Usage Information
BALFAXAR (prothrombin complex concentrate, human-lans) is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure.

Regulatory & Marketing

Labeler Name
Octapharma Usa Inc
Product Type
Plasma Derivative
FDA Application #
BLA125776
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
11-30-2023
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.

J7165
Source: OPPS
Inj, human-lans, per i.u
HCPCS Dosage PER FACTOR IX 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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68982-261). Click a package code to view its specific billing and regulatory data.

68982-261-02
1 VIAL, GLASS in 1 CARTON / 40 mL in 1 VIAL, GLASS (68982-261-82)

* 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 68982-261-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 20 ml in 1 vial, glass (68982-261-81) of Balfaxar, a plasma derivative labeled by Octapharma Usa Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This powder, for solution is formulated for intravenous use and contains coagulation factor ix human; coagulation factor vii human; coagulation factor x human; protein c; protein s human; prothrombin 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 Octapharma Usa Inc on November 30, 2023. The current certification is valid through December 31, 2026.

How is this Octapharma Usa Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68982026101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
68982-261-01
11-Digit CMS (5-4-2)
68982-0261-01

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