Lanadelumab-flyo Injection, Solution
NDC Package 61434-019-02

11-digit billing NDC: 61434001902
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.
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 human prescription drug. This formulation utilizes a injection, solution delivery system. Marketed by Catalent Indiana, Llc, this product is identified by NDC 61434-019.

Identification & Billing

NDC Package Code
61434-019-02
Package Description
560 VIAL in 1 CASE / 2.25 mL in 1 VIAL
Product Code
61434-019
11-Digit Billing Format
61434001902

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/2.25mL

Regulatory & Marketing

Labeler Name
Catalent Indiana, Llc
Product Type
Human Prescription Drug
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
08-24-2018
End Marketing Date
12-01-2026
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 61434-019-02 identifies a specific commercial package of 560 vial in 1 case / 2.25 ml in 1 vial of Lanadelumab-flyo (UNFINISHED drug), a human prescription drug labeled by Catalent Indiana, Llc. 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 Catalent Indiana, Llc on August 24, 2018.

How is this Catalent Indiana, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61434001902. 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)
61434-019-02
11-Digit CMS (5-4-2)
61434-0019-02

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