AVLAYAH

UNIISPL

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

Identification

ManufacturerDenali Therapeutics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8497600101
1 VIAL in 1 CARTON (84976-001-01) / 5 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

QLD7UJN8CF

TIVIDENOFUSP ALFA

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QLD7UJN8CF",
    "rxcui": null,
    "inchikey": null,
    "display_name": "TIVIDENOFUSP ALFA",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "014d92c1-b643-4680-8ca6-f0b3307da915": {
      "match": "brand_token",
      "title": "AVLAYAH (TIVIDENOFUSP ALFA-EKNM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DENALI THERAPEUTICS INC.]",
      "spl_version": "2",
      "published_date": "2026-04-06"
    }
  },
  "productid": "84976-001_352edb2c-39aa-4955-b456-f5c731b746d0",
  "productndc": "84976-001",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIVIDENOFUSP ALFA",
  "proprietary_name": "AVLAYAH",
  "active_ingred_unit": "mg/5mL",
  "application_number": "BLA761485",
  "marketing_category": "BLA",
  "nonproprietary_name": "tividenofusp alfa-eknm",
  "start_marketing_date": "20260406",
  "active_numerator_strength": "150"
}

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