TECVAYLI

UNIISPLATC L01FX24

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

Identification

ManufacturerJanssen Biotech, Inc.

CountryUS (United States)

ATC codeL01FX24

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5789444901
1 VIAL, SINGLE-DOSE in 1 CARTON (57894-449-01) / 3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

54534MX6Z9

TECLISTAMAB

RxCUI 2619426

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "54534MX6Z9",
    "rxcui": "2619426",
    "inchikey": null,
    "display_name": "TECLISTAMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "54e0f974-ccee-44ea-9254-40e9883cee1e": {
      "match": "brand_token",
      "title": "TECVAYLI (TECLISTAMAB-CQYV) INJECTION [JANSSEN BIOTECH, INC.]",
      "spl_version": "16",
      "published_date": "2026-04-22"
    }
  },
  "productid": "57894-449_5900ea09-1687-4d73-912f-5b0527cba6be",
  "productndc": "57894-449",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TECLISTAMAB",
  "proprietary_name": "TECVAYLI",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761291",
  "marketing_category": "BLA",
  "nonproprietary_name": "teclistamab-cqyv",
  "start_marketing_date": "20221025",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code L01FX24.

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