NDC 71104-981 Altuviiio
Antihemophilic Factor (recombinant), Fc-vwf-xten Fusion Protein-ehtl Kit

Product Information

NDC Product Code71104-981
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name 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.
Antihemophilic Factor (recombinant), Fc-vwf-xten Fusion Protein-ehtl
Product Type 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.
Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT and included in NDC Directory
Dosage FormKit - A packaged collection of related material.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Bioverativ Therapeutics Inc.
Labeler Code71104
SPL SET ID:01411972-df40-4ccf-88f0-d3220e5abda9
FDA Application Number 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.
Marketing Category 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.
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 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.
Exclude Flag 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".
NDC Code Structure

Product Packages

NDC Code 71104-981-01

Package Description: 1 KIT in 1 KIT * 3 mL in 1 VIAL (71104-988-08) * 3 mL in 1 SYRINGE (71104-035-01)

Product Details

What is NDC 71104-981?

The NDC code 71104-981 is assigned by the FDA to the product Altuviiio which is a human prescription drug product labeled by Bioverativ Therapeutics Inc.. The generic name of Altuviiio is antihemophilic factor (recombinant), fc-vwf-xten fusion protein-ehtl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 71104-981-01 1 kit in 1 kit * 3 ml in 1 vial (71104-988-08) * 3 ml in 1 syringe (71104-035-01). 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 Altuviiio?

ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a von Willebrand Factor (VWF) independent recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:Routine prophylaxis to reduce the frequency of bleeding episodesOn-demand treatment and control of bleeding episodesPerioperative management of bleeding

Which are Altuviiio UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Altuviiio?

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: 2631088 - antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection
  • RxCUI: 2631093 - ALTUVIIIO 1 UNT Injection
  • RxCUI: 2631093 - antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 1 UNT Injection [Altuviiio]
  • RxCUI: 2631093 - Altuviiio 1 UNT Injection

Which are Altuviiio 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:

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Product Label

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