NDC 0517-0650-01 Injectafer

Ferric Carboxymaltose Injection

NDC Package Code 0517-0650-01

The NDC Code 0517-0650-01 is assigned to a package of 1 vial, single-dose in 1 box > 15 ml in 1 vial, single-dose of Injectafer, a human prescription drug labeled by American Regent, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

Field Name Field Value
NDC Code 0517-0650-01
Package Description 1 VIAL, SINGLE-DOSE in 1 BOX > 15 mL in 1 VIAL, SINGLE-DOSE
Proprietary Name Injectafer 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.
Non-Proprietary Name Ferric Carboxymaltose Injection 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.
Drug Uses This medication is used to treat "iron-poor" blood (iron deficiency anemia). Low iron levels can occur due to many conditions, including when your body cannot get enough iron from food (because of poor nutrition or poor absorption) or when there is long-term blood loss. Ferric carboxymaltose 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 mineral that your body needs to make enough healthy red blood cells to carry oxygen throughout your body.
11-Digit NDC Billing Format 00517065001 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk1435169, 1435174, 2552400 and 2552401 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug 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.
Labeler Name American Regent, Inc.
Dosage Form Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s)
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
  • FERRIC CARBOXYMALTOSE 50 mg/mL
Pharmacological Class(es)
  • Iron - [CS]
  • Parenteral Iron Replacement - [EPC] (Established Pharmacologic Class)
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA203565 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.
Start Marketing Date 08-12-2013 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 0517 - American Regent, Inc.
    • 0517-0650 - Injectafer
      • 0517-0650-01 - 1 VIAL, SINGLE-DOSE in 1 BOX

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 0517-0650-01 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
00517065001J1439Inj ferric carboxymaltos 1mg1mg151750750

* Please review the disclaimer below.