Lanadelumab-flyo Injection, Solution
NDC Package 64538-644-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Lanadelumab-flyo injection is a medication used to help prevent severe swelling attacks due to a certain inherited immune disease (hereditary angioedema-HAE). This formulation utilizes a injection, solution delivery system. Marketed by Rentschler Biopharma Se, this product is identified by NDC 64538-644.

Identification & Billing

NDC Package Code
64538-644-00
Package Description
5 mL in 1 VIAL, GLASS
Product Code
64538-644
11-Digit Billing Format
64538064400

Clinical Specifications

Proprietary Name
Lanadelumab-flyo
Non-Proprietary Name
Lanadelumab-flyo
Substance Name
Lanadelumab
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)
LANADELUMAB 300 mg/2mL
Usage Information
This medication is used to help prevent severe swelling attacks due to a certain inherited immune disease (hereditary angioedema-HAE). Lanadelumab-flyo works by binding to a natural substance made by the body (kallikrein) and blocking its effect. This blocking effect lowers the amount of another natural substance (bradykinin) that causes symptoms during an attack of HAE. Lanadelumab-flyo may help decrease symptoms such as abdominal pain/cramps, diarrhea, vomiting, or rapid swelling and pain of the hands, feet, limbs, face, tongue, or throat.

Regulatory & Marketing

Labeler Name
Rentschler Biopharma Se
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
08-24-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64538-644-00 identifies a specific commercial package of 5 ml in 1 vial, glass of Lanadelumab-flyo (UNFINISHED drug), a bulk ingredient labeled by Rentschler Biopharma Se. This injection, solution is formulated for use and contains lanadelumab 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 Rentschler Biopharma Se on August 24, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to help prevent severe swelling attacks due to a certain inherited immune disease (hereditary angioedema-HAE). Lanadelumab-flyo works by binding to a natural substance made by the body (kallikrein) and blocking its effect. This blocking effect lowers the amount of another natural substance (bradykinin) that causes symptoms during an attack of HAE. Lanadelumab-flyo may help decrease symptoms such as abdominal pain/cramps, diarrhea, vomiting, or rapid swelling and pain of the hands, feet, limbs, face, tongue, or throat.

How is this Rentschler Biopharma Se product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64538064400. 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)
64538-644-00
11-Digit CMS (5-4-2)
64538-0644-00

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