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  5. NDC Package Code: 47783-644-01 Takhzyro

NDC Package 47783-644-01 Takhzyro

Lanadelumab-flyo Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
47783-644-01
Package Description:
1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS
Product Code:
47783-644
Proprietary Name:
Takhzyro
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:
47783064401
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2055645 - lanadelumab-flyo 300 MG in 2 ML Injection
  • RxCUI: 2055645 - 2 ML lanadelumab-flyo 150 MG/ML Injection
  • RxCUI: 2055645 - lanadelumab-flyo 300 MG per 2 ML Injection
  • RxCUI: 2055650 - TAKHZYRO 300 MG in 2 ML Injection
  • RxCUI: 2055650 - 2 ML lanadelumab-flyo 150 MG/ML Injection [Takhzyro]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Takeda Pharmaceuticals America, Inc.
    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.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • LANADELUMAB 300 mg/2mL
    • Pharmacologic Class(es):
  • Kallikrein Inhibitors - [MoA] (Mechanism of Action)
  • Plasma Kallikrein Inhibitor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA761090
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-24-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 47783-644-01?

    The NDC Packaged Code 47783-644-01 is assigned to a package of 1 vial, glass in 1 carton / 5 ml in 1 vial, glass of Takhzyro, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 47783-644 included in the NDC Directory?

    Yes, Takhzyro with product code 47783-644 is active and included in the NDC Directory. The product was first marketed by Takeda Pharmaceuticals America, Inc. on August 24, 2018 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 NDC billing unit for package 47783-644-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 47783-644-01?

    The 11-digit format is 47783064401. 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
    5-3-247783-644-015-4-247783-0644-01