Letybo Injection, Powder, Lyophilized, For Solution
NDC Package 81165-050-01

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

Package Information

Letybo (letibotulinumtoxina-wlbg) injection is lETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Hugel, Inc., this product is identified by NDC 81165-050 and is authorized under FDA application BLA761225.

Identification & Billing

NDC Package Code
81165-050-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Product Code
81165-050
11-Digit Billing Format
81165005001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Letybo
Non-Proprietary Name
Letibotulinumtoxina-wlbg
Substance Name
Letibotulinumtoxina
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
LETIBOTULINUMTOXINA 50 U/1
Pharmacologic Class
Usage Information
LETYBO is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Regulatory & Marketing

Labeler Name
Hugel, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761225
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-30-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 81165-050-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose of Letybo, a human prescription drug labeled by Hugel, Inc.. This injection, powder, lyophilized, for solution is formulated for intramuscular use and contains letibotulinumtoxina 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 Hugel, Inc. on July 30, 2024. The current certification is valid through December 31, 2026.

How is this Hugel, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81165005001. 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)
81165-050-01
11-Digit CMS (5-4-2)
81165-0050-01

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