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  5. NDC Package Code: 69438-0001-1 Eculizumab

NDC Package 69438-0001-1 Eculizumab

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:
69438-0001-1
Package Description:
100000 mL in 1 BAG
Product Code:
69438-0001
Non-Proprietary Name:
Eculizumab
Substance Name:
Eculizumab
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.
11-Digit NDC Billing Format:
69438000101
Product Type:
Drug For Further Processing
Labeler Name:
Lonza Biologics Tuas Pte Ltd.
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):
  • ECULIZUMAB 10 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:
    04-01-2007
    Listing Expiration Date:
    12-31-2024
    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 69438-0001-1?

    The NDC Packaged Code 69438-0001-1 is assigned to an UNFINISHED drug package of 100000 ml in 1 bag of Eculizumab, drug for further processing labeled by Lonza Biologics Tuas Pte Ltd.. The product's dosage form is liquid and is administered via form.

    Is NDC 69438-0001 included in the NDC Directory?

    Yes, Eculizumab is an UNFINISHED PRODUCT with code 69438-0001 that is active and included in the NDC Directory. The product was first marketed by Lonza Biologics Tuas Pte Ltd. on April 01, 2007 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69438-0001-1?

    The 11-digit format is 69438000101. 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
    5-4-169438-0001-15-4-269438-0001-01