Ferric Carboxy Maltose Powder
NDC Package 68022-7070-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Carboxy Maltose powders is a medication used to treat "iron-poor" blood (iron deficiency anemia). This formulation utilizes a powder delivery system. Marketed by Cohance Lifesciences Limited, this product is identified by NDC 68022-7070.

Identification & Billing

NDC Package Code
68022-7070-2
Package Description
25 kg in 1 DRUM
Product Code
68022-7070
11-Digit Billing Format
68022707002

Clinical Specifications

Proprietary Name
Ferric Carboxy Maltose
Non-Proprietary Name
Ferric Carboxy Maltose
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
Cohance Lifesciences Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
12-25-2023
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68022-7070). Click a package code to view its specific billing and regulatory data.

68022-7070-3
10 kg in 1 DRUM
68022-7070-8
1 kg in 1 DRUM
68022-7070-9
.001 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

* 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 68022-7070-2 identifies a specific commercial package of 25 kg in 1 drum of Ferric Carboxy Maltose (UNFINISHED drug), a bulk ingredient labeled by Cohance Lifesciences 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 Cohance Lifesciences Limited on December 25, 2023. 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 Cohance Lifesciences Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68022707002. 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 (5-4-1)
68022-7070-2
11-Digit CMS (5-4-2)
68022-7070-02

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