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  5. NDC Package Code: 63508-001-02 Ecallantide

NDC Package 63508-001-02 Ecallantide

Injection, Solution - View Billable Units, 11-Digit Format, RxNorm

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.

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:
63508-001-02
Package Description:
1000 mL in 1 BOTTLE
Product Code:
63508-001
Non-Proprietary Name:
Ecallantide
Substance Name:
Ecallantide
Usage Information:
This medication is used to treat an acute attack of a certain immune disease passed down through families (hereditary angioedema-HAE). Ecallantide blocks a natural substance produced by the body (kallikrein) which acts to increase amounts of another natural substance (bradykinin) thought to cause the symptoms seen during an acute attack of HAE. This medication does not cure HAE. Ecallantide may lessen the symptoms during an acute attack of HAE such as rapid swelling and pain of the hands, feet, limbs, face, tongue, or throat. When attacks involve the intestines, symptoms may include abdominal pain/cramps, diarrhea or vomiting. Attacks of swelling may occur without reason. However, anxiety, stress, sickness, and surgery may trigger attacks in some people.
11-Digit NDC Billing Format:
63508000102
Product Type:
Drug For Further Processing
Labeler Name:
Fujifilm Diosynth Biotechnologies Uk Ltd.
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s):
  • ECALLANTIDE 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:
    02-02-2010
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63508-001-012000 mL in 1 BOTTLE
    63508-001-03500 mL in 1 BOTTLE
    63508-001-04125 mL in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63508-001-02?

    The NDC Packaged Code 63508-001-02 is assigned to an UNFINISHED drug package of 1000 ml in 1 bottle of Ecallantide, drug for further processing labeled by Fujifilm Diosynth Biotechnologies Uk Ltd.. The product's dosage form is injection, solution and is administered via form.

    Is NDC 63508-001 included in the NDC Directory?

    Yes, Ecallantide is an UNFINISHED PRODUCT with code 63508-001 that is active and included in the NDC Directory. The product was first marketed by Fujifilm Diosynth Biotechnologies Uk Ltd. on February 02, 2010 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 63508-001-02?

    The 11-digit format is 63508000102. 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 5-3-2 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
    5-3-263508-001-025-4-263508-0001-02