Ferumoxytol Injection
NDC 0781-3154
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Ferumoxytol is a ANDA-approved product labeled by Sandoz Inc. This medication is used to treat "iron-poor" blood (iron deficiency anemia). It is supplied as a injection for intravenous administration. This product entry covers the primary NDC 0781-3154 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0781-3154
Proprietary Name:
Ferumoxytol
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
Code Navigator:
Clinical Specifications
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 & Regulatory Data
Labeler Name: [5]
Labeler Code:
0781
Product Label ID:
HCPCS Code:
Q0138
- Ferumoxytol, non-esrd
FDA Application Number: [6]
ANDA206604
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
07-15-2021
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 0781-3154?
The NDC code 0781-3154 is assigned by the FDA to the product Ferumoxytol. This pharmaceutical product is labeled by Sandoz Inc and is currently categorized as listed product. The medication is a injection administered via intravenous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0781-3154-01, 0781-3154-95. 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 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 Active Ingredients of this product?
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 the associated 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 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:
- MANNITOL (UNII: 3OWL53L36A)
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: 860605 - iron (as ferumoxytol) 510 MG in 17 ML Injection
- RxCUI: 860605 - 17 ML ferumoxytol 30 MG/ML Injection
- RxCUI: 860605 - iron (as ferumoxytol) 510 MG per 17 ML Injection
Which are the Pharmacologic Classes of this product?
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 full disclaimer at the bottom of this page.
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.
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* Please review the full disclaimer at the bottom of this page.
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 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.
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 are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".
