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United States · US · US:84612-889_752e3a9f-41e2-469d-b90c-1e5bd2379df3

WEZLANA

UNIISPLATC L04AC05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNuvaila Limited
CountryUS (United States)
ATC codeL04AC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8461288901
    1 SYRINGE in 1 CARTON (84612-889-01) / 1 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
FU77B4U5Z0
USTEKINUMAB
RxCUI 847083
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FU77B4U5Z0",
    "rxcui": "847083",
    "inchikey": null,
    "display_name": "USTEKINUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "a6c23978-09f0-4796-88f7-d0ce7e3ed04e": {
      "match": "brand_token",
      "title": "WEZLANA (USTEKINUMAB-AUUB) INJECTION, SOLUTION [NUVAILA LIMITED]",
      "spl_version": "8",
      "published_date": "2026-05-28"
    }
  },
  "productid": "84612-889_752e3a9f-41e2-469d-b90c-1e5bd2379df3",
  "productndc": "84612-889",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "USTEKINUMAB",
  "proprietary_name": "WEZLANA",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761285",
  "marketing_category": "BLA",
  "nonproprietary_name": "ustekinumab-auub",
  "start_marketing_date": "20250101",
  "active_numerator_strength": "90"
}

Related drugs

Other records sharing ATC code L04AC05.

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