Mylotarg

UNIISPLATC L01FX02

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 codeL01FX02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0008451001
1 VIAL, SINGLE-DOSE in 1 CARTON (0008-4510-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

8GZG754X6M

GEMTUZUMAB OZOGAMICIN

RxCUI 1294580

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "8GZG754X6M",
    "rxcui": "1294580",
    "inchikey": null,
    "display_name": "GEMTUZUMAB OZOGAMICIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "32fd2bb2-1cfa-4250-feb8-d7956c794e05": {
      "match": "brand_token",
      "title": "MYLOTARG (GEMTUZUMAB OZOGAMICIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "19",
      "published_date": "2025-12-22"
    }
  },
  "productid": "0008-4510_ef242018-af2a-4c03-99b7-908e2610f86f",
  "productndc": "0008-4510",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GEMTUZUMAB OZOGAMICIN",
  "proprietary_name": "Mylotarg",
  "active_ingred_unit": "mg/5mL",
  "application_number": "BLA761060",
  "marketing_category": "BLA",
  "nonproprietary_name": "gemtuzumab ozogamicin",
  "start_marketing_date": "20170907",
  "active_numerator_strength": "5"
}

Related drugs

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