Home NDC 81165-050 LETYBO
Product NDC 81165-050
11-digit product format 811650050
Labeler code 81165
Product ID 81165-050_2784ba3d-d3f8-1059-e063-6394a90a2ff1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name letibotulinumtoxinA-wlbg
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Hugel, Inc.
Application BLA761225
Marketing category BLA
Marketing start 2024-07-30
Substance LETIBOTULINUMTOXINA
Active strength 50 U/1
Pharmacologic classes Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base LETYBO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LETIBOTULINUMTOXINA 50 U/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W5O50S8A59 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2689290 Internal RxNorm lookup 2689297 Internal RxNorm lookup 2689299 Internal RxNorm lookup 2689301 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81165-050-01 LETYBO 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 4 81165-050-01 LETYBO 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81165-050 LETYBO (LETIBOTULINUMTOXINA-WLBG) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUGEL, INC.] 4 Current NDC, 2 package rows 20241127_910e5d0e-4d0b-4de8-8e2d-97879a044181.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LETYBO LETIBOTULINUMTOXINA-WLBG Hugel, Inc. 910e5d0e-4d0b-4de8-8e2d-97879a044181 2024-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761225 ndc (product): 81165-050
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761225 Letybo letibotulinumtoxinA-wlbg 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81165-050-01 81165005001 1 VIAL, SINGLE-DOSE in 1 CARTON (81165-050-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2024-07-30 No No Current