Ecallantide Injection, Solution
NDC Package 63508-001-01

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.

Ecallantide injection is a medication used to treat an acute attack of a certain immune disease passed down through families (hereditary angioedema-HAE). This formulation utilizes a injection, solution delivery system. Marketed by Fujifilm Diosynth Biotechnologies Uk Ltd., this product is identified by NDC 63508-001.

Identification & Billing

NDC Package Code
63508-001-01
Package Description
2000 mL in 1 BOTTLE
Product Code
63508-001
11-Digit Billing Format
63508000101

Clinical Specifications

Proprietary Name
Ecallantide
Non-Proprietary Name
Ecallantide
Substance Name
Ecallantide
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
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.

Regulatory & Marketing

Labeler Name
Fujifilm Diosynth Biotechnologies Uk Ltd.
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
02-02-2010
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 (63508-001). Click a package code to view its specific billing and regulatory data.

63508-001-02
1000 mL in 1 BOTTLE
63508-001-03
500 mL in 1 BOTTLE
63508-001-04
125 mL in 1 BOTTLE

* 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 63508-001-01 identifies a specific commercial package of 2000 ml in 1 bottle of Ecallantide (UNFINISHED drug), drug for further processing labeled by Fujifilm Diosynth Biotechnologies Uk Ltd.. This injection, solution is formulated for use and contains ecallantide 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 Fujifilm Diosynth Biotechnologies Uk Ltd. on February 02, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Fujifilm Diosynth Biotechnologies Uk Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63508000101. 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)
63508-001-01
11-Digit CMS (5-4-2)
63508-0001-01

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