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NDC 63833-616 Humate-p

Antihemophilic Factor/von Willebrand Factor Complex (human) Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63833-616?
  4. Humate-p Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
63833-616
Proprietary Name:
Humate-p
Non-Proprietary Name: [1]
Antihemophilic Factor/von Willebrand Factor Complex (human)
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Csl Behring Gmbh
Labeler Code:
63833
Product Label ID:
c5f4b63b-8d8b-45b3-b530-2f1c32a1b852
FDA Application Number: [6]
BLA103960
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
05-01-1986
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 63833-616?

The NDC code 63833-616 is assigned by the FDA to the product Humate-p which is a plasma derivative product labeled by Csl Behring Gmbh. The generic name of Humate-p is antihemophilic factor/von willebrand factor complex (human). The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 63833-616-02 1 kit in 1 carton * 10 ml in 1 vial (63833-626-01) * 10 ml in 1 vial, single-dose (63833-765-54). 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 Humate-p?

This product contains human factor VIII (also called antihemophilic factor) and von Willebrand factor complex. Factors are proteins normally found in the blood that help the blood to thicken (clot) and stop any bleeding. People with low levels of factor VIII and von Willebrand factor are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product is used to temporarily replace the missing factors and reduce bleeding. Different brands of this product have different amounts of these factors, and therefore different uses. These products are not interchangeable. Do not change brands of this medication without the approval of your doctor. Some products are used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). Some products are used to treat bleeding episodes in people with low levels of von Willebrand factor (von Willebrand disease) who do not respond to or cannot tolerate desmopressin. Some products are used to prevent excessive bleeding during and after surgery in patients with von Willebrand disease.

Which are Humate-p UNII Codes?

The UNII codes for the active ingredients in this product are:

  • HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX (UNII: 5T6B772R4Q)
  • HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEX (UNII: 5T6B772R4Q) (Active Moiety)

Which are Humate-p Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Humate-p?

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: 1661352 - Humate-P (expressed as von Willebrand factor) 1 UNT Injection
  • RxCUI: 1661352 - factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Humate-P]

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".