Adbry Injection, Solution
NDC Package 50222-350-01

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

Package Information

Adbry (tralokinumab-ldrm) injection is aDBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. This formulation utilizes a injection, solution delivery system. Marketed by Leo Pharma Inc., this product is identified by NDC 50222-350 and is authorized under FDA application BLA761180.

Identification & Billing

NDC Package Code
50222-350-01
Package Description
1 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS (50222-350-00)
Product Code
50222-350
11-Digit Billing Format
50222035001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Adbry
Non-Proprietary Name
Tralokinumab-ldrm
Substance Name
Tralokinumab
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)
TRALOKINUMAB 300 mg/2mL
Pharmacologic Class
Usage Information
ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.

Regulatory & Marketing

Labeler Name
Leo Pharma Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761180
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50222-350). Click a package code to view its specific billing and regulatory data.

50222-350-02
2 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS (50222-350-00)
50222-350-91
1 SYRINGE, GLASS in 1 CARTON / 2 mL in 1 SYRINGE, GLASS (50222-350-90)

* 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 50222-350-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / 2 ml in 1 syringe, glass (50222-350-00) of Adbry, a human prescription drug labeled by Leo Pharma Inc.. This injection, solution is formulated for subcutaneous use and contains tralokinumab 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 Leo Pharma Inc. on July 01, 2024. The current certification is valid through December 31, 2026.

How is this Leo Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50222035001. 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)
50222-350-01
11-Digit CMS (5-4-2)
50222-0350-01

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