United States· US:0407-2943_10209370-babb-44f2-a9db-3e82f54a54d7
CLARISCAN
A medicinal product containing gadoterate meglumine, registered in United States by GE Healthcare.
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
- GE Healthcare
- 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 · 14
- ndc11040729430110 VIAL, GLASS in 1 BOX (0407-2943-01) / 10 mL in 1 VIAL, GLASS
- ndc11040729430210 VIAL, GLASS in 1 BOX (0407-2943-02) / 15 mL in 1 VIAL, GLASS
- ndc11040729430510 VIAL, GLASS in 1 BOX (0407-2943-05) / 20 mL in 1 VIAL, GLASS
- ndc11040729430610 VIAL, GLASS in 1 BOX (0407-2943-06) / 5 mL in 1 VIAL, GLASS
- ndc11040729431210 SYRINGE, PLASTIC in 1 BOX (0407-2943-12) / 10 mL in 1 SYRINGE, PLASTIC
- ndc11040729431710 SYRINGE, PLASTIC in 1 BOX (0407-2943-17) / 15 mL in 1 SYRINGE, PLASTIC
- ndc11040729432210 SYRINGE, PLASTIC in 1 BOX (0407-2943-22) / 20 mL in 1 SYRINGE, PLASTIC
- ndc110407-2943-22
- ndc110407-2943-01
- ndc110407-2943-02
- ndc110407-2943-05
- ndc110407-2943-06
- ndc110407-2943-12
- ndc110407-2943-17
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/1eca0941-1386-4e12-8b7c-05399f5af50a GET /v1/drugs/1eca0941-1386-4e12-8b7c-05399f5af50a?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": "0407-2943",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA210016",
"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.