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  5. NDC Package Code: 67643-0035-1 Mepolizumab Drug Substance

NDC Package 67643-0035-1 Mepolizumab Drug Substance

Liquid - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
67643-0035-1
Package Description:
12000 mL in 1 BAG
Product Code:
67643-0035
Non-Proprietary Name:
Mepolizumab Drug Substance
Substance Name:
Mepolizumab
Usage Information:
This medication is used along with other medications to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you do your normal activities and decreases time lost from work or school. Mepolizumab works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. Mepolizumab is also used to treat a certain immune system diseases (eosinophilic granulomatosis with polyangiitis-EGPA, hypereosinophilic syndrome-HES). It helps to control and prevent symptoms (such as wheezing, shortness of breath, runny nose, facial pain, tiredness) caused by these diseases. It works by decreasing the amount of certain white blood cells (eosinophils) which may cause these diseases. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks or breathing problems. If an asthma attack occurs, use your quick-relief inhaler as prescribed.
11-Digit NDC Billing Format:
67643003501
Product Type:
Drug For Further Processing
Labeler Name:
Lonza Biologics, Inc.
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):
MEPOLIZUMAB 132 mg/mL
Sample Package:
N/A
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:
06-27-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Unfinished Product:
Yes
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 67643-0035-1?

The NDC Packaged Code 67643-0035-1 is assigned to an UNFINISHED drug package of 12000 ml in 1 bag of Mepolizumab Drug Substance, drug for further processing labeled by Lonza Biologics, Inc.. The product's dosage form is liquid and is administered via form.

Is NDC 67643-0035 included in the NDC Directory?

Yes, Mepolizumab Drug Substance is an UNFINISHED PRODUCT with code 67643-0035 that is active and included in the NDC Directory. The product was first marketed by Lonza Biologics, Inc. on June 27, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 67643-0035-1?

The 11-digit format is 67643003501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-167643-0035-15-4-267643-0035-01