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United States · US · US:63459-303_49f6182a-5e0f-45ea-8a0f-b774ef28a98f

HERZUMA

UNIISPLATC L01FD01

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

Identification

ManufacturerCephalon, Inc.
CountryUS (United States)
ATC codeL01FD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6345930343
    1 VIAL, SINGLE-DOSE in 1 CARTON (63459-303-43) / 20 mL in 1 VIAL, SINGLE-DOSE

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": {
    "ae71c003-883a-4cd8-ad50-e8cc9a54e971": {
      "match": "brand_token",
      "title": "HERZUMA (TRASTUZUMAB) KIT HERZUMA (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INC.]",
      "spl_version": "14",
      "published_date": "2025-12-23"
    }
  },
  "productid": "63459-303_49f6182a-5e0f-45ea-8a0f-b774ef28a98f",
  "productndc": "63459-303",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRASTUZUMAB",
  "proprietary_name": "HERZUMA",
  "active_ingred_unit": "mg/7.15mL",
  "application_number": "BLA761091",
  "marketing_category": "BLA",
  "nonproprietary_name": "TRASTUZUMAB",
  "start_marketing_date": "20200316",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code L01FD01.

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