Eculizumab Injection, Solution, Concentrate
NDC Package 68225-042-00

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.

Eculizumab injection is a medication used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Patheon Italia S.p.a, this product is identified by NDC 68225-042.

Identification & Billing

NDC Package Code
68225-042-00
Package Description
5184 VIAL in 1 CONTAINER / 30 mL in 1 VIAL
Product Code
68225-042
11-Digit Billing Format
68225004200

Clinical Specifications

Proprietary Name
Eculizumab
Non-Proprietary Name
Eculizumab
Substance Name
Eculizumab
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Active Ingredient(s)
ECULIZUMAB 300 mg/30mL
Usage Information
This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder can cause a decrease in red blood cells (anemia). This medication helps to block the decrease in red blood cells and can improve the symptoms of anemia (e.g., tiredness, shortness of breath) and decrease the need for blood transfusions. This medication may also be used to treat a certain immune system disorder (atypical Hemolytic Uremic Syndrome). It helps to prevent blood clots caused by this disorder. Eculizumab is also used to treat a certain muscle condition (generalized Myasthenia Gravis). It may help to improve symptoms of this condition (such as difficulty swallowing, trouble breathing). Eculizumab is also used to treat a certain nervous system disorder that affects the spinal cord and eye nerve (neuromyelitis optica spectrum disorder). It may help to reduce the number of hospital stays due to the disease.

Regulatory & Marketing

Labeler Name
Patheon Italia S.p.a
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
04-02-2007
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 68225-042-00 identifies a specific commercial package of 5184 vial in 1 container / 30 ml in 1 vial of Eculizumab (UNFINISHED drug), drug for further processing labeled by Patheon Italia S.p.a. This injection, solution, concentrate is formulated for use and contains eculizumab 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 Patheon Italia S.p.a on April 02, 2007. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder can cause a decrease in red blood cells (anemia). This medication helps to block the decrease in red blood cells and can improve the symptoms of anemia (e.g., tiredness, shortness of breath) and decrease the need for blood transfusions. This medication may also be used to treat a certain immune system disorder (atypical Hemolytic Uremic Syndrome). It helps to prevent blood clots caused by this disorder. Eculizumab is also used to treat a certain muscle condition (generalized Myasthenia Gravis). It may help to improve symptoms of this condition (such as difficulty swallowing, trouble breathing). Eculizumab is also used to treat a certain nervous system disorder that affects the spinal cord and eye nerve (neuromyelitis optica spectrum disorder). It may help to reduce the number of hospital stays due to the disease.

How is this Patheon Italia S.p.a product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68225004200. 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)
68225-042-00
11-Digit CMS (5-4-2)
68225-0042-00

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