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  5. NDC Package Code: 61434-019-02 Lanadelumab-flyo

NDC Package 61434-019-02 Lanadelumab-flyo

Injection, Solution - 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:
61434-019-02
Package Description:
560 VIAL in 1 CASE / 2.25 mL in 1 VIAL
Product Code:
61434-019
Non-Proprietary Name:
Lanadelumab-flyo
Substance Name:
Lanadelumab
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.
11-Digit NDC Billing Format:
61434001902
Product Type:
Human Prescription Drug
Labeler Name:
Catalent Indiana, Llc
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
    • 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:
    08-24-2018
    Listing Expiration Date:
    12-31-2025
    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 61434-019-02?

    The NDC Packaged Code 61434-019-02 is assigned to an UNFINISHED drug package of 560 vial in 1 case / 2.25 ml in 1 vial of Lanadelumab-flyo, a human prescription drug labeled by Catalent Indiana, Llc. The product's dosage form is injection, solution and is administered via form.

    Is NDC 61434-019 included in the NDC Directory?

    Yes, Lanadelumab-flyo is an UNFINISHED PRODUCT with code 61434-019 that is active and included in the NDC Directory. The product was first marketed by Catalent Indiana, Llc on August 24, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 61434-019-02?

    The 11-digit format is 61434001902. 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
    5-3-261434-019-025-4-261434-0019-02