Ferric Carboxymaltose Powder
NDC Package 72166-026-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ferric Carboxymaltose powders is a medication used to treat "iron-poor" blood (iron deficiency anemia). This formulation utilizes a powder delivery system. Marketed by Kalintis Healthcare Private Limited, this product is identified by NDC 72166-026.

Identification & Billing

NDC Package Code
72166-026-01
Package Description
50 kg in 1 DRUM
Product Code
72166-026
11-Digit Billing Format
72166002601

Clinical Specifications

Proprietary Name
Ferric Carboxymaltose
Non-Proprietary Name
Ferric Carboxymaltose
Substance Name
Ferric Carboxymaltose
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
FERRIC CARBOXYMALTOSE 1 kg/kg
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
Kalintis Healthcare Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-07-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 72166-026-01 identifies a specific commercial package of 50 kg in 1 drum of Ferric Carboxymaltose (UNFINISHED drug), a bulk ingredient labeled by Kalintis Healthcare Private Limited. This powder is formulated for 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 Kalintis Healthcare Private Limited on February 07, 2025. 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 Kalintis Healthcare Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72166002601. 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)
72166-026-01
11-Digit CMS (5-4-2)
72166-0026-01

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