Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)
NDC 67467-182
View dosage, usage, ingredients, routes, and UNII mappings.
Product 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 a BLA-approved product labeled by Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 67467-182 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
67467-182
Proprietary Name:
Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
67467
Product Label ID:
FDA Application Number: [6]
BLA125251
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Marketing Timeline
Start Marketing Date: [9]
12-04-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 67467-182?
The NDC code 67467-182 is assigned by the FDA to the product Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human). This pharmaceutical product is labeled by Octapharma Pharmazeutika Produktionsgesellschaft M.b.h. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 67467-182-01, 67467-182-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ANTIHEMOPHILIC FACTOR HUMAN (UNII: 839MOZ74GK)
- ANTIHEMOPHILIC FACTOR HUMAN (UNII: 839MOZ74GK) (Active Moiety)
- VON WILLEBRAND FACTOR HUMAN (UNII: ZE22NE22F1)
- VON WILLEBRAND FACTOR HUMAN (UNII: ZE22NE22F1) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- 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]
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
