Ferric Carboxymaltose Injection, Solution
NDC Package 72078-048-20

11-digit billing NDC: 72078004820 · Billing unit: ML · 20 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ferric Carboxymaltose injection is indicated for the treatment of:•iron deficiency anemia (IDA) in:oadult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. This formulation utilizes a injection, solution delivery system. Marketed by Mylan Institutional Llc, this product is identified by NDC 72078-048 and is authorized under FDA application ANDA217076.

Identification & Billing

NDC Package Code
72078-048-20
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code
72078-048
11-Digit Billing Format
72078004820
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
20 ML
RxNorm Crosswalk
  • RxCUI: 2552400 - ferric carboxymaltose (iron) 1000 MG in 20 mL Injection
  • RxCUI: 2552400 - 20 ML ferric carboxymaltose 50 MG/ML Injection
  • RxCUI: 2552400 - ferric carboxymaltose (as elemental iron) 1000 MG per 20 ML Injection

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
Ferric carboxymaltose injection is indicated for the treatment of:•iron deficiency anemia (IDA) in:oadult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. oadult patients who have non-dialysis dependent chronic kidney disease. •iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

Regulatory & Marketing

Labeler Name
Mylan Institutional Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217076
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-2026
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 72078-048-20 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Ferric Carboxymaltose, a human prescription drug labeled by Mylan Institutional Llc. This product is billed per "ML" milliliter and contains an estimated amount of 20 billable units per package. 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 August 31, 2026. The current certification is valid through December 31, 2027.

How is this Mylan Institutional Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72078004820. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 20 total billable units per package. 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)
72078-048-20
11-Digit CMS (5-4-2)
72078-0048-20

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