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NDC 68982-261 Balfaxar

Prothrombin Complex Concentrate (human) Powder, For Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 68982-261?
  4. Balfaxar Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes

Product Information

NDC Product Code:
68982-261
Proprietary Name:
Balfaxar
Non-Proprietary Name: [1]
Prothrombin Complex Concentrate (human)
Substance Name: [2]
Coagulation Factor Ix Human; Coagulation Factor Vii Human; Coagulation Factor X Human; Protein C; Protein S Human; Prothrombin
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Octapharma Usa Inc
    Labeler Code:
    68982
    Product Label ID:
    68fa4f90-8b01-6498-4140-e0be5247c3fe
    FDA Application Number: [6]
    BLA125776
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    11-30-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 68982-261?

    The NDC code 68982-261 is assigned by the FDA to the product Balfaxar which is a plasma derivative product labeled by Octapharma Usa Inc. The generic name of Balfaxar is prothrombin complex concentrate (human). The product's dosage form is powder, for solution and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 68982-261-01 1 vial, glass in 1 carton / 20 ml in 1 vial, glass (68982-261-81), 68982-261-02 1 vial, glass in 1 carton / 40 ml in 1 vial, glass (68982-261-82). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Balfaxar?

    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.

    What are Balfaxar Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Balfaxar UNII Codes?

    The UNII codes for the active ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Balfaxar?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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]

    Which are the Pharmacologic Classes for Balfaxar?

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".