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United States · US · US:57894-111_b911e9ec-28f1-4ddc-b0b9-49086f83300b

CARVYKTI

UNIISPLATC L01XL05

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

Identification

ManufacturerJanssen Biotech, Inc.
CountryUS (United States)
ATC codeL01XL05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5789411101
    1 INJECTION, SUSPENSION in 1 BAG (57894-111-01)
  • ndc11
    5789411102
    1 INJECTION, SUSPENSION in 1 BAG (57894-111-02)

Annotations

UNII (FDA Substance ID)
0L1F17908Q
CILTACABTAGENE AUTOLEUCEL
RxCUI 2594775
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0L1F17908Q",
    "rxcui": "2594775",
    "inchikey": null,
    "display_name": "CILTACABTAGENE AUTOLEUCEL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "7d040b91-3fb8-41db-ba7f-60a36f06e2c2": {
      "match": "brand_token",
      "title": "CARVYKTI (CILTACABTAGENE AUTOLEUCEL) INJECTION, SUSPENSION [JANSSEN BIOTECH, INC.]",
      "spl_version": "17",
      "published_date": "2026-03-18"
    }
  },
  "productid": "57894-111_b911e9ec-28f1-4ddc-b0b9-49086f83300b",
  "productndc": "57894-111",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "CELLULAR THERAPY",
  "substance_name": "CILTACABTAGENE AUTOLEUCEL",
  "proprietary_name": "CARVYKTI",
  "active_ingred_unit": "1/1",
  "application_number": "BLA125746",
  "marketing_category": "BLA",
  "nonproprietary_name": "ciltacabtagene autoleucel",
  "start_marketing_date": "20220228",
  "active_numerator_strength": "100000000"
}

Related drugs

Other records sharing ATC code L01XL05.

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