Ravulizumab 100 Mg/ml Liquid
NDC Package 42098-0004-3

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.

Ravulizumab 100 Mg/ml liquids is ravulizumab-cwvz is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This formulation utilizes a liquid delivery system. Marketed by Lonza Biologics Porrino, S.l., this product is identified by NDC 42098-0004.

Identification & Billing

NDC Package Code
42098-0004-3
Package Description
18000 mL in 1 BAG
Product Code
42098-0004
11-Digit Billing Format
42098000403

Clinical Specifications

Proprietary Name
Ravulizumab 100 Mg/ml
Non-Proprietary Name
Ravulizumab 100 Mg/ml
Substance Name
Ravulizumab-cwvz
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)
RAVULIZUMAB-CWVZ 100 mg/mL
Usage Information
Ravulizumab-cwvz is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce 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. Ravulizumab-cwvz belongs to a class of medications known as monoclonal antibodies.

Regulatory & Marketing

Labeler Name
Lonza Biologics Porrino, S.l.
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
04-24-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42098-0004). Click a package code to view its specific billing and regulatory data.

42098-0004-4
12000 mL in 1 BAG

* 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 42098-0004-3 identifies a specific commercial package of 18000 ml in 1 bag of Ravulizumab 100 Mg/ml (UNFINISHED drug), drug for further processing labeled by Lonza Biologics Porrino, S.l.. This liquid is formulated for use and contains ravulizumab-cwvz 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 Lonza Biologics Porrino, S.l. on April 24, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ravulizumab-cwvz is used to treat a certain blood disorder (paroxysmal nocturnal hemoglobinuria). This disorder causes your body's immune system to destroy red blood cells, which results in anemia. It works by helping block your body's destruction of red blood cells. This effect helps lessen symptoms of anemia (such as tiredness, shortness of breath), and may reduce 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. Ravulizumab-cwvz belongs to a class of medications known as monoclonal antibodies.

How is this Lonza Biologics Porrino, S.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42098000403. 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)
42098-0004-3
11-Digit CMS (5-4-2)
42098-0004-03

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