TECELRA

UNIISPL

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

Identification

ManufacturerUSWM, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8320500012
1 INJECTION, SUSPENSION in 1 BAG (83205-0001-2)

Annotations

UNII (FDA Substance ID)

CUY18BJ7BP

AFAMITRESGENE AUTOLEUCEL

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "CUY18BJ7BP",
    "rxcui": null,
    "inchikey": null,
    "display_name": "AFAMITRESGENE AUTOLEUCEL",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ab24631f-3364-46e1-8074-7244863bcbab": {
      "match": "brand_token",
      "title": "TECELRA (AFAMITRESGENE AUTOLEUCEL) INJECTION, SUSPENSION [USWM, LLC]",
      "spl_version": "13",
      "published_date": "2026-01-23"
    }
  },
  "productid": "83205-0001_28fa3284-38e4-4fdf-8991-2b52fe3f19fc",
  "productndc": "83205-0001",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "CELLULAR THERAPY",
  "substance_name": "AFAMITRESGENE AUTOLEUCEL",
  "proprietary_name": "TECELRA",
  "active_ingred_unit": "1/1",
  "application_number": "BLA125789",
  "marketing_category": "BLA",
  "nonproprietary_name": "afamitresgene autoleucel",
  "start_marketing_date": "20240802",
  "active_numerator_strength": "10000000000"
}

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