Takhzyro Injection, Solution
NDC Package 47783-644-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Takhzyro (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 Takeda Pharmaceuticals America, Inc., this product is identified by NDC 47783-644 and is authorized under FDA application BLA761090.

Identification & Billing

NDC Package Code
47783-644-01
Package Description
1 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS
Product Code
47783-644
11-Digit Billing Format
47783064401
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Takhzyro
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.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
LANADELUMAB 300 mg/2mL
Pharmacologic Class
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
Takeda Pharmaceuticals America, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761090
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-24-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0593
Source: PDAC
INJECTION, LANADELUMAB-FLYO, 1 MG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF-ADMINISTERED)
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 47783-644-01 identifies a specific commercial 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.. This injection, solution is formulated for subcutaneous 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 Takeda Pharmaceuticals America, Inc. 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 Takeda Pharmaceuticals America, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47783064401. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
47783-644-01
11-Digit CMS (5-4-2)
47783-0644-01

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