Kovaltry Kit
NDC Package 0026-3821-99
Package Information
Kovaltry (antihemophilic factor (recombinant)) kits is a medication used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). This formulation utilizes a kit delivery system. Marketed by Bayer Healthcare Llc, this product is identified by NDC 0026-3821 and is authorized under FDA application BLA125574.
Identification & Billing
- 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]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0026 - Bayer Healthcare Llc
- 0026-3821 - Kovaltry
- 0026-3821-99 - 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)
- 0026-3821 - Kovaltry
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (0026-3821). Click a package code to view its specific billing and regulatory data.
* 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 0026-3821-99 identifies a specific commercial 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. This kit is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bayer Healthcare Llc on March 17, 2016. The current certification is valid through December 31, 2027.
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 Bayer Healthcare Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00026382199. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
