Xyntha Kit
NDC 58394-016

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58394-016?
  4. Xyntha Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

Xyntha (antihemophilic factor (recombinant)) is a BLA-approved product labeled by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc. This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is supplied as a kit. This product entry covers the primary NDC 58394-016 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58394-016
Proprietary Name:
Xyntha
Non-Proprietary Name: [1]
Antihemophilic Factor (recombinant)
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc
Labeler Code:
58394
Product Label ID:
25ea1c3c-14a2-ef11-302e-012bd683924f
HCPCS Code:
J7185 - Xyntha inj
FDA Application Number: [6]
BLA125264
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
08-13-2010
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 58394-016?

The NDC code 58394-016 is assigned by the FDA to the product Xyntha. It is commonly known by its generic name, antihemophilic factor (recombinant). This pharmaceutical product is labeled by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 58394-016-03. 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?

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 the associated UNII Codes?

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

  • ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED (UNII: 113E3Z3CJJ)
  • ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED (UNII: 113E3Z3CJJ) (Active Moiety)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302) (Active Moiety)

Which are the Inactive Ingredients associated 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 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: 1720165 - antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe
  • RxCUI: 1720165 - factor VIII, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe
  • RxCUI: 1720166 - Xyntha 1 UNT Prefilled Syringe
  • RxCUI: 1720166 - antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe [Xyntha]
  • RxCUI: 797544 - isopropyl alcohol 70 % Medicated Pad

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Product & Regulatory Definitions
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.
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.
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".