Besponsa

UNIISPLATC L01FB01

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

Identification

ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

CountryUS (United States)

ATC codeL01FB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0008010001
1 VIAL, SINGLE-DOSE in 1 CARTON (0008-0100-01) / 4 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

P93RUU11P7

INOTUZUMAB OZOGAMICIN

RxCUI 1942950

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "P93RUU11P7",
    "rxcui": "1942950",
    "inchikey": null,
    "display_name": "INOTUZUMAB OZOGAMICIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "cc7014b1-c775-411d-b374-8113248b4077": {
      "match": "brand_token",
      "title": "BESPONSA (INOTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "8",
      "published_date": "2026-02-09"
    }
  },
  "productid": "0008-0100_427d10d2-c29d-4b71-a5fe-c97736d59aa6",
  "productndc": "0008-0100",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INOTUZUMAB OZOGAMICIN",
  "proprietary_name": "Besponsa",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761040",
  "marketing_category": "BLA",
  "nonproprietary_name": "inotuzumab ozogamicin",
  "start_marketing_date": "20170818",
  "active_numerator_strength": ".25"
}

Related drugs

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