United States· US:65219-080_f05922b7-99d4-48c7-972a-7966bbbbc3b4
Gadoterate Meglumine
A medicinal product containing gadoterate meglumine, registered in United States by Fresenius Kabi USA, LLC.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- GADOTERATE MEGLUMINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc11652190800510 CARTON in 1 BOX (65219-080-05) / 1 VIAL in 1 CARTON (65219-080-01) / 5 mL in 1 VIAL
- ndc1165219-080-05
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Gadoterate meglumine in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaCLARISCANGE Healthcare AS, Oslo
- BelgiumClariscan 0.5 mmol/mlGE Healthcare
- FranceCLARISCAN 0,5 mmol/mL, solution injectableGE HEALTHCARE
- CanadaDOTAREMGUERBET
- GermanyArtiremGuerbet
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Belgium · Dotarem
- Germany · Artirem
- Spain · Dotarem
- Portugal · Dotarem
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/ee9f6e0f-3f7b-4906-b77c-d898f31e646e GET /v1/drugs/ee9f6e0f-3f7b-4906-b77c-d898f31e646e?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.
{
"route": "INTRAVENOUS",
"source": "ndc",
"strength": "376.9",
"substance": "GADOTERATE MEGLUMINE",
"productndc": "65219-080",
"dosage_form": "INJECTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA215304",
"marketing_category": "ANDA"
}See everything about gadoterate meglumine.
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.