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  5. NDC Package Code: 0026-3821-99 Kovaltry

NDC Package 0026-3821-99 Kovaltry

Antihemophilic Factor (recombinant) Kit - 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:
0026-3821-99
Package Description:
1 KIT in 1 BOX * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01)
Product Code:
0026-3821
Proprietary Name:
Kovaltry
Non-Proprietary Name:
Antihemophilic Factor (recombinant)
Usage Information:
This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.
11-Digit NDC Billing Format:
00026382199
NDC to RxNorm Crosswalk:
  • RxCUI: 1719222 - antihemophilic factor, human recombinant 1 UNT Injection
  • RxCUI: 1719222 - factor VIII, human recombinant 1 UNT Injection
  • RxCUI: 1743374 - Kovaltry 1 UNT Injection
  • RxCUI: 1743374 - antihemophilic factor, human recombinant 1 UNT Injection [Kovaltry]
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Bayer Healthcare Llc
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125574
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-17-2016
    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
    0026-3821-251 KIT in 1 BOX * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-99) * 2.5 mL in 1 SYRINGE (0026-0426-02) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4821-01)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0026-3821-99?

    The NDC Packaged Code 0026-3821-99 is assigned to a package of 1 kit in 1 box * 2.5 ml in 1 vial, single-use (0026-4821-99) * 2.5 ml in 1 syringe (0026-0426-02) * 2.5 ml in 1 vial, single-use (0026-4821-01) of Kovaltry, a plasma derivative labeled by Bayer Healthcare Llc. The product's dosage form is kit and is administered via form.

    Is NDC 0026-3821 included in the NDC Directory?

    Yes, Kovaltry with product code 0026-3821 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Llc on March 17, 2016 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 11-digit format for NDC 0026-3821-99?

    The 11-digit format is 00026382199. 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 4-4-2 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
    4-4-20026-3821-995-4-200026-3821-99