NDC 0026-3828 Kovaltry
Antihemophilic Factor (recombinant) Kit

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0026-3828?
    4. Kovaltry Uses
    5. Active Ingredients UNII Codes
    6. Inactive Ingredients UNII Codes
    7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code0026-3828
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.		Kovaltry
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)
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.		Plasma Derivative
NDC Directory StatusACTIVE PRODUCT INCLUDED in the 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.		Bayer Healthcare Llc
Labeler Code0026
SPL SET ID:89ba5048-469c-4f08-a173-81b0c6f3004d
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.		BLA125574
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.		03-17-2016
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.		12-31-2023
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". 		N
NDC Code Structure

Product Packages

NDC Code 0026-3828-50

Package Description: 1 KIT in 1 BOX * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-01)

NDC Code 0026-3828-99

Package Description: 1 KIT in 1 BOX * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-01)

Product Details

What is NDC 0026-3828?

The NDC code 0026-3828 is assigned by the FDA to the product Kovaltry which is a plasma derivative product labeled by Bayer Healthcare Llc. The generic name of Kovaltry is antihemophilic factor (recombinant). The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 0026-3828-50 1 kit in 1 box * 5 ml in 1 vial, single-use (0026-4828-99) * 5 ml in 1 syringe (0026-0426-05) * 5 ml in 1 vial, single-use (0026-4828-01), 0026-3828-99 1 kit in 1 box * 5 ml in 1 vial, single-use (0026-4828-99) * 5 ml in 1 syringe (0026-0426-05) * 5 ml in 1 vial, single-use (0026-4828-01). 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 Kovaltry?

This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the bleeding can stop. This medication should not be used to treat von Willebrand disease.

Which are Kovaltry UNII Codes?

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

  • ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54)
  • ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (Active Moiety)

Which are Kovaltry 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 Kovaltry?

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:

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