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  4. NDC Product Code: 67467-182 Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)

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

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 67467-182?
  4. Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human) Uses
  5. Active Ingredients UNII Codes
  6. NDC to RxNorm Crosswalk

Product Information

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

Get all the details for National Drug Code (NDC) 67467-182 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

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
Labeler Name: [5]
Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
Labeler Code:
67467
Product Label ID:
d0379e0c-bb51-554e-a58b-b2afa60019d4
FDA Application Number: [6]
BLA125251
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
12-04-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
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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) which is product labeled by Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 67467-182-01 5 ml in 1 vial , 67467-182-02 10 ml in 1 vial . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)?

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 Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human) 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 Wilate - Von Willebrand Factor/coagulation Factor Viii Complex (human)?

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 Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".