LETYBO

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHugel, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8116510001
1 VIAL, SINGLE-DOSE in 1 CARTON (81165-100-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

W5O50S8A59

LETIBOTULINUMTOXINA

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "W5O50S8A59",
    "rxcui": null,
    "inchikey": null,
    "display_name": "LETIBOTULINUMTOXINA",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "910e5d0e-4d0b-4de8-8e2d-97879a044181": {
      "match": "brand_token",
      "title": "LETYBO (LETIBOTULINUMTOXINA-WLBG) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUGEL, INC.]",
      "spl_version": "4",
      "published_date": "2024-11-27"
    }
  },
  "productid": "81165-100_2784ba3d-d3f8-1059-e063-6394a90a2ff1",
  "productndc": "81165-100",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LETIBOTULINUMTOXINA",
  "proprietary_name": "LETYBO",
  "active_ingred_unit": "U/1",
  "application_number": "BLA761225",
  "marketing_category": "BLA",
  "nonproprietary_name": "letibotulinumtoxinA-wlbg",
  "start_marketing_date": "20240730",
  "active_numerator_strength": "100"
}

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