Columvi

UNIISPLATC L01FX28

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

Identification

ManufacturerGenentech, Inc.

CountryUS (United States)

ATC codeL01FX28

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5024212701
1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

06P3KLK2J8

GLOFITAMAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "06P3KLK2J8",
    "rxcui": null,
    "inchikey": null,
    "display_name": "GLOFITAMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3516e753-f064-4d30-9bd5-e3f2e143f75d": {
      "match": "brand_token",
      "title": "COLUMVI (GLOFITAMAB) CONCENTRATE COLUMVI (GLOFITAMAB) SOLUTION, CONCENTRATE [GENENTECH, INC.]",
      "spl_version": "7",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50242-127_5e794f49-9344-4145-82e3-c2f7f96988c5",
  "productndc": "50242-127",
  "dosage_form": "CONCENTRATE",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GLOFITAMAB",
  "proprietary_name": "Columvi",
  "active_ingred_unit": "mg/10mL",
  "application_number": "BLA761309",
  "marketing_category": "BLA",
  "nonproprietary_name": "Glofitamab",
  "start_marketing_date": "20230615",
  "active_numerator_strength": "10"
}

Related drugs

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