Ferumoxytol Drug Substance Liquid
NDC Package 0441-1521-01

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.

Ferumoxytol Drug Substance liquids is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a liquid delivery system. Marketed by Sigma-aldrich Corporation, this product is identified by NDC 0441-1521.

Identification & Billing

NDC Package Code
0441-1521-01
Package Description
200 kg in 1 BAG
Product Code
0441-1521
11-Digit Billing Format
00441152101

Clinical Specifications

Proprietary Name
Ferumoxytol Drug Substance
Non-Proprietary Name
Ferumoxytol Drug Substance
Substance Name
Ferumoxytol Non-stoichiometric Magnetite
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE 200 kg/200kg

Regulatory & Marketing

Labeler Name
Sigma-aldrich Corporation
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-19-2010
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 0441-1521-01 identifies a specific commercial package of 200 kg in 1 bag of Ferumoxytol Drug Substance (UNFINISHED drug), a bulk ingredient labeled by Sigma-aldrich Corporation. This liquid is formulated for use and contains ferumoxytol non-stoichiometric magnetite 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 Sigma-aldrich Corporation on October 19, 2010. The current certification is valid through December 31, 2026.

How is this Sigma-aldrich Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00441152101. 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)
0441-1521-01
11-Digit CMS (5-4-2)
00441-1521-01

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