United States· US:81165-050_2784ba3d-d3f8-1059-e063-6394a90a2ff1

LETYBO

A medicinal product containing letibotulinumtoxina, registered in United States by Hugel, Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedLETYBOATC—REGISTER NO.US:81165-050_2784ba3d…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
LETIBOTULINUMTOXINA
Manufacturer
Hugel, Inc.
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    8116505001
    1 VIAL, SINGLE-DOSE in 1 CARTON (81165-050-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
  • ndc11
    81165-050-01

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Letibotulinumtoxina in 1 other country

What each register calls a product with the same active substance — salts and hydrates count as the same.

All letibotulinumtoxina products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/b4ed0187-7989-47f5-9b45-24d63f1530b9
GET /v1/drugs/b4ed0187-7989-47f5-9b45-24d63f1530b9?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "INTRAMUSCULAR",
  "source": "ndc",
  "strength": "50",
  "substance": "LETIBOTULINUMTOXINA",
  "productndc": "81165-050",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "U/1",
  "application_number": "BLA761225",
  "marketing_category": "BLA"
}

See everything about letibotulinumtoxina.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.