Ferric Carboxymaltose Injection, Solution
NDC Package 72078-060-99

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

Package Information

Ferric Carboxymaltose injection is a medication used to treat "iron-poor" blood (iron deficiency anemia). This formulation utilizes a injection, solution delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 72078-060 and is authorized under FDA application ANDA217769.

Identification & Billing

NDC Package Code
72078-060-99
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code
72078-060
11-Digit Billing Format
72078006099

Clinical Specifications

Proprietary Name
Ferric Carboxymaltose
Non-Proprietary Name
Ferric Carboxymaltose
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
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217769
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2026
Listing Expiration
12-31-2027
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 72078-060-99 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 2 ml in 1 vial, single-dose of Ferric Carboxymaltose, a human prescription drug labeled by Mylan Institutional Llc. 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 Mylan Institutional Llc on July 01, 2026. The current certification is valid through December 31, 2027.

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 Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72078006099. 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 (5-3-2)
72078-060-99
11-Digit CMS (5-4-2)
72078-0060-99

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