Adynovate
NDC Package 0944-4136-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Adynovate is a medication used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). Marketed by Baxalta Us Inc., this product is identified by NDC 0944-4136 and is authorized under FDA application BLA125566.

Identification & Billing

NDC Package Code
0944-4136-02
Package Description
1 KIT in 1 CARTON * 5 mL in 1 VIAL, GLASS (0944-4141-01) * 2 mL in 1 VIAL
Product Code
0944-4136
11-Digit Billing Format
00944413602

Clinical Specifications

Proprietary Name
Adynovate
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Baxalta Us Inc.
FDA Application #
BLA125566
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-28-2016
End Marketing Date
06-03-2018
Listing Expiration
06-03-2018
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0944-4136-02 identifies a specific commercial package of 1 kit in 1 carton * 5 ml in 1 vial, glass (0944-4141-01) * 2 ml in 1 vial of Adynovate, labeled by Baxalta Us Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Baxalta Us Inc. on July 28, 2016. The current certification is valid through June 03, 2018.

What are the primary indications for this medication?

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.

How is this Baxalta Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00944413602. 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 (4-4-2)
0944-4136-02
11-Digit CMS (5-4-2)
00944-4136-02

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