KYMRIAH

UNIISPLATC L01XL04

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

Identification

ManufacturerNovartis Pharmaceuticals Corporation

CountryUS (United States)

ATC codeL01XL04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0078095819
1 INJECTION, SUSPENSION in 1 BAG (0078-0958-19)

Annotations

UNII (FDA Substance ID)

Q6C9WHR03O

TISAGENLECLEUCEL

RxCUI 1986438

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Q6C9WHR03O",
    "rxcui": "1986438",
    "inchikey": null,
    "display_name": "TISAGENLECLEUCEL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "aad3ba54-dfd3-4cb3-9e2b-c5ef89559189": {
      "match": "brand_token",
      "title": "KYMRIAH (TISAGENLECLEUCEL) INJECTION, SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]",
      "spl_version": "18",
      "published_date": "2025-12-22"
    }
  },
  "productid": "0078-0958_381f1ba3-f115-424f-9890-75eb06ab6666",
  "productndc": "0078-0958",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "CELLULAR THERAPY",
  "substance_name": "TISAGENLECLEUCEL",
  "proprietary_name": "KYMRIAH",
  "active_ingred_unit": "1/1",
  "application_number": "BLA125646",
  "marketing_category": "BLA",
  "nonproprietary_name": "tisagenlecleucel",
  "start_marketing_date": "20180501",
  "active_numerator_strength": "60000000"
}

Related drugs

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