NDC Package 0944-4626-01 Adynovate

Antihemophilic Factor (recombinant) Pegylated Kit - View Billable Units, 11-Digit Format, RxNorm

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:
0944-4626-01
Package Description:
1 KIT in 1 CARTON / 1 CONTAINER in 1 KIT (0944-4626-02) / 1 KIT in 1 CONTAINER (0944-4626-03) * 5 mL in 1 VIAL, GLASS (0944-4139-01) * 2 mL in 1 VIAL, GLASS (64764-514-02)
Product Code:
Proprietary Name:
Adynovate
Non-Proprietary Name:
Antihemophilic Factor (recombinant) Pegylated
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:
00944462601
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 1741407 - antihemophilic factor (recombinant) pegylated 1 UNT Injection
  • RxCUI: 1741407 - rurioctocog alfa pegol 1 UNT Injection
  • RxCUI: 1741409 - Adynovate 1 UNT Injection
  • RxCUI: 1741409 - antihemophilic factor (recombinant) pegylated 1 UNT Injection [Adynovate]
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Takeda Pharmaceuticals Amercia, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125566
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-25-2016
    Listing Expiration Date:
    12-31-2025
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0944-4626-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00944462601J7207Factor viii pegylated recomb1 IU1111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0944-4626-01?

    The NDC Packaged Code 0944-4626-01 is assigned to a package of 1 kit in 1 carton / 1 container in 1 kit (0944-4626-02) / 1 kit in 1 container (0944-4626-03) * 5 ml in 1 vial, glass (0944-4139-01) * 2 ml in 1 vial, glass (64764-514-02) of Adynovate, a plasma derivative labeled by Takeda Pharmaceuticals Amercia, Inc.. The product's dosage form is kit and is administered via form.

    Is NDC 0944-4626 included in the NDC Directory?

    Yes, Adynovate with product code 0944-4626 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals Amercia, Inc. on October 25, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0944-4626-01?

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

    What is the 11-digit format for NDC 0944-4626-01?

    The 11-digit format is 00944462601. 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
    4-4-20944-4626-015-4-200944-4626-01