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  5. NDC Package Code: 68982-261-01 Balfaxar

NDC Package 68982-261-01 Balfaxar

Prothrombin Complex Concentrate (human) Powder, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
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
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.
11-Digit NDC Billing Format:
68982026101
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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]
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Octapharma Usa Inc
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • COAGULATION FACTOR IX HUMAN 25.5 [iU]/mL
  • COAGULATION FACTOR VII HUMAN 16.5 [iU]/mL
  • COAGULATION FACTOR X HUMAN 24 [iU]/mL
  • PROTEIN C 22 [iU]/mL
  • PROTEIN S HUMAN 22 [iU]/mL
  • PROTHROMBIN 26 [iU]/mL
    • Pharmacologic Class(es):
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Blood Coagulation Factors - [CS]
  • Decreased Coagulation Factor Activity - [PE] (Physiologic Effect)
  • Enzyme Precursors - [CS]
  • Human Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Activity - [PE] (Physiologic Effect)
  • Protein C - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA125776
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-30-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    68982-261-021 VIAL, GLASS in 1 CARTON / 40 mL in 1 VIAL, GLASS (68982-261-82)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68982-261-01?

    The NDC Packaged Code 68982-261-01 is assigned to a 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. The product's dosage form is powder, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 68982-261 included in the NDC Directory?

    Yes, Balfaxar with product code 68982-261 is active and included in the NDC Directory. The product was first marketed by Octapharma Usa Inc on November 30, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68982-261-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 68982-261-01?

    The 11-digit format is 68982026101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-268982-261-015-4-268982-0261-01