Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)
NDC Package 67467-182-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human) is wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. Marketed by Octapharma Pharmazeutika Produktionsgesellschaft M.b.h., this product is identified by NDC 67467-182 and is authorized under FDA application BLA125251.

Identification & Billing

NDC Package Code
67467-182-01
Package Description
5 mL in 1 VIAL
Product Code
11-Digit Billing Format
67467018201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1661332 - antihemophilic factor / von Willebrand factor complex, human 1 UNT Injection
  • RxCUI: 1661332 - factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection
  • RxCUI: 1661332 - factor VIII / von Willebrand Factor complex, human 1 UNT Injection
  • RxCUI: 1661335 - wilate (expressed as von Willebrand factor) 1 UNT Injection
  • RxCUI: 1661335 - factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Wilate]

Clinical Specifications

Proprietary Name
Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)
Dosage Form
-
Usage Information
Wilate is a von Willebrand Factor/Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. Clinical trials to evaluate the safety and efficacy of prophylactic dosing with Wilate to prevent spontaneous bleeding have not been conducted in VWD subjects. Wilate is not indicated for the prevention of excessive bleeding during and after surgery in VWD patients. Wilate is not indicated for Hemophilia A.

Regulatory & Marketing

Labeler Name
Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
FDA Application #
BLA125251
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-04-2009
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy 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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67467-182). Click a package code to view its specific billing and regulatory data.

10 mL in 1 VIAL

* 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 67467-182-01 identifies a specific commercial package of 5 ml in 1 vial of Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human), labeled by Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Octapharma Pharmazeutika Produktionsgesellschaft M.b.h. on December 04, 2009. The current certification is valid through December 31, 2017.

How is this Octapharma Pharmazeutika Produktionsgesellschaft M.b.h. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67467018201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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 (5-3-2)
67467-182-01
11-Digit CMS (5-4-2)
67467-0182-01

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