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  4. NDC Product Code: 59338-775 Feraheme

NDC 59338-775 Feraheme

Ferumoxytol Injection Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 59338-775?
  4. Feraheme Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
59338-775
Proprietary Name:
Feraheme
Non-Proprietary Name: [1]
Ferumoxytol
Substance Name: [2]
Ferumoxytol Non-stoichiometric Magnetite
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    Amag Pharmaceuticals, Inc.
    Labeler Code:
    59338
    Product Label ID:
    32b0e320-a739-11dc-a704-0002a5d5c51b
    FDA Application Number: [6]
    NDA022180
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-13-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 59338-775-01

    Package Description: 1 VIAL, SINGLE-USE in 1 CARTON / 17 mL in 1 VIAL, SINGLE-USE

    NDC Code 59338-775-10

    Package Description: 10 VIAL, SINGLE-USE in 1 CARTON / 17 mL in 1 VIAL, SINGLE-USE

    Product Details

    What is NDC 59338-775?

    The NDC code 59338-775 is assigned by the FDA to the product Feraheme which is a human prescription drug product labeled by Amag Pharmaceuticals, Inc.. The generic name of Feraheme is ferumoxytol. The product's dosage form is injection and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 59338-775-01 1 vial, single-use in 1 carton / 17 ml in 1 vial, single-use, 59338-775-10 10 vial, single-use in 1 carton / 17 ml in 1 vial, single-use. 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 Feraheme?

    This medication is used to treat "iron-poor" blood (iron deficiency anemia). Ferumoxytol is a form of injectable iron that is used if you cannot take iron by mouth because of side effects or an unsuccessful response to treatment. It is also used by people who have anemia due to long-term kidney disease. Iron is an important part of your red blood cells and is needed to carry oxygen throughout the body. Many people with kidney disease cannot get enough iron from food and require injections. People with kidney disease may also need extra iron because of blood loss during kidney dialysis treatment.

    What are Feraheme Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Feraheme UNII Codes?

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

    • FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE (UNII: CLH5FT6412)
    • FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE (UNII: CLH5FT6412) (Active Moiety)

    Which are Feraheme 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 Feraheme?

    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:

    Which are the Pharmacologic Classes for Feraheme?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Ferumoxytol Injection


    Ferumoxytol injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working). Ferumoxytol injection is used to treat iron-deficiency anemia in people who did not respond or are unable to tolerate taking iron preparations by mouth. Ferumoxytol injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.
    [Learn More]


    * 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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".