NDC 71104-805 Eloctate

Antihemophilic Factor (recombinant),Fc Fusion Protein Kit Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
71104-805
Proprietary Name:
Eloctate
Non-Proprietary Name: [1]
Antihemophilic Factor (recombinant), Fc Fusion Protein
NDC Directory Status:
Plasma Derivative
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Bioverativ Therapeutics Inc.
    Labeler Code:
    71104
    FDA Application Number: [6]
    BLA125487
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    09-06-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 71104-805-01

    Package Description: 1 KIT in 1 KIT * 3 mL in 1 VIAL (71104-487-08) * 3 mL in 1 SYRINGE (71104-035-01)

    Product Details

    What is NDC 71104-805?

    The NDC code 71104-805 is assigned by the FDA to the product Eloctate which is a plasma derivative product labeled by Bioverativ Therapeutics Inc.. The generic name of Eloctate is antihemophilic factor (recombinant), fc fusion protein. The product's dosage form is kit and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 71104-805-01 1 kit in 1 kit * 3 ml in 1 vial (71104-487-08) * 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 Eloctate?

    This medication is used to control and prevent bleeding that happens to people (usually males) with an inherited medical condition, hemophilia A (low levels of factor VIII). It is also given before surgery to prevent too much bleeding in people with this condition. Factor VIII is a protein (clotting factor) that is in normal blood, and helps form blood clots and stop bleeding after an injury. People with low factor VIII levels may bleed longer than normal after an injury/surgery and may have bleeding inside the body (especially in the joints and muscles). This medication contains man-made factor VIII (antihemophilic factor) to temporarily replace factor VIII in the body, connected to an antibody (immunoglobulin) that helps the man-made factor VIII work longer. When used to control and prevent bleeding, this medication may help relieve pain and long-term damage caused by hemophilia A. This medication should not be used to treat von Willebrand disease.

    Which are Eloctate UNII Codes?

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

    • (1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT) (UNII: 7PCM518YLR)
    • (1-743)-(1638-2332)-BLOOD-COAGULATION FACTOR VIII (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT), (1444-6'),(1447-9')-BIS(DISULFIDE) WITH IMMUNOGLOBULIN G1 (SYNTHETIC HUMAN FC DOMAIN FRAGMENT) (UNII: 7PCM518YLR) (Active Moiety)

    Which are Eloctate 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 Eloctate?

    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: 1719608 - factor VIII (b-domain deleted recombinant) FC fusion protein 1 UNT Injection
    • RxCUI: 1719608 - efmoroctocog alfa 1 UNT Injection
    • RxCUI: 1719608 - antihemophilic factor (b-domain deleted recombinant) FC fusion protein 1 UNT Injection
    • RxCUI: 1719611 - ELOCTATE 1 UNT Injection
    • RxCUI: 1719611 - efmoroctocog alfa 1 UNT Injection [Eloctate]

    * 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".