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  5. NDC Package Code: 81165-050-01 Letybo

NDC Package 81165-050-01 Letybo

Letibotulinumtoxina-wlbg Injection, Powder, Lyophilized, For Solution Intramuscular - 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:
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
Proprietary Name:
Letybo
Non-Proprietary Name:
Letibotulinumtoxina-wlbg
Substance Name:
Letibotulinumtoxina
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.
11-Digit NDC Billing Format:
81165005001
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Hugel, Inc.
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(s):
Intramuscular - Administration within a muscle.
Active Ingredient(s):
LETIBOTULINUMTOXINA 50 U/1
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
BLA761225
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
07-30-2024
Listing Expiration Date:
12-31-2025
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 81165-050-01?

The NDC Packaged Code 81165-050-01 is assigned to a 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.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intramuscular form.

Is NDC 81165-050 included in the NDC Directory?

Yes, Letybo with product code 81165-050 is active and included in the NDC Directory. The product was first marketed by Hugel, Inc. on July 30, 2024 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 81165-050-01?

The 11-digit format is 81165005001. 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
5-3-281165-050-015-4-281165-0050-01