letybo

Generic: letibotulinumtoxina-wlbg

Labeler: hugel, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name letybo
Generic Name letibotulinumtoxina-wlbg
Labeler hugel, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

letibotulinumtoxina 50 U/1

Manufacturer
Hugel, Inc.

Identifiers & Regulatory

Product NDC 81165-050
Product ID 81165-050_2784ba3d-d3f8-1059-e063-6394a90a2ff1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761225
Listing Expiration 2026-12-31
Marketing Start 2024-07-30

Pharmacologic Class

Established (EPC)
acetylcholine release inhibitor [epc] neuromuscular blocker [epc]
Mechanism of Action
acetylcholine release inhibitors [moa]
Physiologic Effect
neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81165050
Hyphenated Format 81165-050

Supplemental Identifiers

RxCUI
2689290 2689297 2689299 2689301
UNII
W5O50S8A59
NUI
N0000175771 N0000175770 N0000193962 N0000175731

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name letybo (source: ndc)
Generic Name letibotulinumtoxina-wlbg (source: ndc)
Application Number BLA761225 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 U/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (81165-050-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

81165-050-01 1 VIAL, SINGLE-DOSE in 1 CARTON (81165-050-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

letibotulinumtoxina (50 U/1)

Linked Drug Pages (1)

LETYBO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "2784ba3d-d3f8-1059-e063-6394a90a2ff1", "openfda": {"nui": ["N0000175771", "N0000175770", "N0000193962", "N0000175731"], "unii": ["W5O50S8A59"], "rxcui": ["2689290", "2689297", "2689299", "2689301"], "spl_set_id": ["910e5d0e-4d0b-4de8-8e2d-97879a044181"], "pharm_class_pe": ["Neuromuscular Blockade [PE]"], "pharm_class_epc": ["Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]"], "pharm_class_moa": ["Acetylcholine Release Inhibitors [MoA]"], "manufacturer_name": ["Hugel, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (81165-050-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "81165-050-01", "marketing_start_date": "20240730"}], "brand_name": "LETYBO", "product_id": "81165-050_2784ba3d-d3f8-1059-e063-6394a90a2ff1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Acetylcholine Release Inhibitor [EPC]", "Acetylcholine Release Inhibitors [MoA]", "Neuromuscular Blockade [PE]", "Neuromuscular Blocker [EPC]"], "product_ndc": "81165-050", "generic_name": "letibotulinumtoxinA-wlbg", "labeler_name": "Hugel, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LETYBO", "active_ingredients": [{"name": "LETIBOTULINUMTOXINA", "strength": "50 U/1"}], "application_number": "BLA761225", "marketing_category": "BLA", "marketing_start_date": "20240730", "listing_expiration_date": "20261231"}