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United States· US:50242-127_5e794f49-9344-4145-82e3-c2f7f96988c5

Columvi

A glofitamab product containing glofitamab, registered in United States by Genentech, Inc.. The same ATC class is registered in 13 of our 19 countries.

ATC L01FX28US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedColumviATCL01FX28REGISTER NO.US:50242-127_5e794f49…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about glofitamabAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Glofitamab is registered in 13 of 19 countries.

Countries holding a registration under ATC L01FX28 (glofitamab), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose
Search glofitamab products by name

Glofitamab · ATC L01FX28

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Glofitamab
Manufacturer
Genentech, Inc.
Country
United States (US)
ATC code
L01FX28
ATC class
Glofitamab
Defined daily dose
1.43 mg, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

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

Regulatory notes

UNII (FDA substance ID)
06P3KLK2J8
GLOFITAMAB
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Glofitamab in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All glofitamab products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Columvi
  • Liechtenstein · Columvi
  • Norway · Columvi

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/56a0278f-225f-41b9-8b6f-ea7698fb860c
GET /v1/drugs/56a0278f-225f-41b9-8b6f-ea7698fb860c?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "06P3KLK2J8",
    "rxcui": null,
    "inchikey": null,
    "display_name": "GLOFITAMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": null
  },
  "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"
}
API referenceMCP serverPlans

See everything about glofitamab.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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