Vonvendi Kit
NDC Package 0944-7553-02
Package Information
Vonvendi (von willebrand factor (recombinant)) kits is a medication used to treat and control bleeding episodes in people with von Willebrand disease. This formulation utilizes a kit delivery system. Marketed by Takeda Pharmaceuticals America, Inc., this product is identified by NDC 0944-7553 and is authorized under FDA application BLA125577.
Identification & Billing
- RxCUI: 1812593 - vonicog alfa 1 UNT Injection
- RxCUI: 1812598 - Vonvendi 1 UNT Injection
- RxCUI: 1812598 - vonicog alfa 1 UNT Injection [Vonvendi]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0944 - Takeda Pharmaceuticals America, Inc.
- 0944-7553 - Vonvendi
- 0944-7553-02 - 1 KIT in 1 CARTON * 10 mL in 1 VIAL, SINGLE-DOSE (0944-7552-01) * 10 mL in 1 VIAL, GLASS (64764-516-10)
- 0944-7553 - Vonvendi
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 0944-7553-02 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial, single-dose (0944-7552-01) * 10 ml in 1 vial, glass (64764-516-10) of Vonvendi, a plasma derivative labeled by Takeda Pharmaceuticals America, Inc.. 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 Takeda Pharmaceuticals America, Inc. on December 08, 2015. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This product is used to treat and control bleeding episodes in people with von Willebrand disease. It may also be used to prevent the loss of too much blood during surgery. Von Willebrand factor is a protein normally found in the blood that helps the blood to thicken (clot) and stop bleeding. People with this disease do not have enough of this factor. This product contains a man-made form of von Willebrand factor.
How is this Takeda Pharmaceuticals America, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00944755302. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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.
