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United States · US · US:78206-147_9b665849-a59e-4da6-ae51-36b3c885b85b

Ontruzant

UNIISPLATC L01FD01

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeL01FD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7820614701
    1 VIAL, SINGLE-DOSE in 1 CARTON (78206-147-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (78206-147-99)

Annotations

UNII (FDA Substance ID)
P188ANX8CK
TRASTUZUMAB
RxCUI 224905
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P188ANX8CK",
    "rxcui": "224905",
    "inchikey": null,
    "display_name": "TRASTUZUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ce2a2492-85e3-4b0a-872a-047f44e4203d": {
      "match": "brand_token",
      "title": "ONTRUZANT (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ONTRUZANT KIT [ORGANON LLC]",
      "spl_version": "6",
      "published_date": "2026-04-24"
    }
  },
  "productid": "78206-147_9b665849-a59e-4da6-ae51-36b3c885b85b",
  "productndc": "78206-147",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRASTUZUMAB",
  "proprietary_name": "Ontruzant",
  "active_ingred_unit": "mg/1",
  "application_number": "BLA761100",
  "marketing_category": "BLA",
  "nonproprietary_name": "trastuzumab",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "150"
}

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