Injectafer Injection, Solution
NDC Package 0517-0650-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Injectafer (ferric carboxymaltose injection) injection is a medication used to treat "iron-poor" blood (iron deficiency anemia). This formulation utilizes a injection, solution delivery system. Marketed by American Regent, Inc., this product is identified by NDC 0517-0650 and is authorized under FDA application NDA203565.

Identification & Billing

NDC Package Code
0517-0650-01
Package Description
1 VIAL, SINGLE-DOSE in 1 BOX / 15 mL in 1 VIAL, SINGLE-DOSE
Product Code
0517-0650
11-Digit Billing Format
00517065001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1435169 - ferric carboxymaltose (as iron) 750 MG in 15 mL Injection
  • RxCUI: 1435169 - 15 ML ferric carboxymaltose 50 MG/ML Injection
  • RxCUI: 1435169 - ferric carboxymaltose (as elemental iron) 750 MG per 15 ML Injection
  • RxCUI: 1435174 - Injectafer (iron) 750 MG in 15 mL Injection
  • RxCUI: 1435174 - 15 ML ferric carboxymaltose 50 MG/ML Injection [Injectafer]

Clinical Specifications

Proprietary Name
Injectafer
Non-Proprietary Name
Ferric Carboxymaltose Injection
Substance Name
Ferric Carboxymaltose
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FERRIC CARBOXYMALTOSE 50 mg/mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
American Regent, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203565
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-12-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0517-0650-01 identifies a specific commercial 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.. This injection, solution is formulated for intravenous use and contains ferric carboxymaltose as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by American Regent, Inc. on August 12, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517065001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0517-0650-01
11-Digit CMS (5-4-2)
00517-0650-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.