United States· US:63304-093_2971c7ca-50dc-e36c-e063-6294a90a4b7d
Sunitinib malate
A medicinal product containing sunitinib malate, registered in United States by Sun Pharmaceutical Industries Inc..
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
- SUNITINIB MALATE
- Manufacturer
- Sun Pharmaceutical Industries Inc.
- 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 · 4
- ndc1163304-093-27
- ndc1163304-093-86
- ndc11633040932728 CAPSULE in 1 BOTTLE (63304-093-27)
- ndc1163304093864 BLISTER PACK in 1 BOX (63304-093-86) / 7 CAPSULE in 1 BLISTER PACK (63304-093-11)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sunitinib malate in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSUTENTPfizer Europe MA EEIG, Bruxelles
- BelgiumSutent 37.5 mgPfizer Europe MA
- FinlandSutentPfizer Europe MA EEIG
- IrelandSutent 37.5 mg hard capsulesPfizer Europe MA EEIG
- SwedenSunitinib Newbury 37,5 mg Kapsel, hårdNewbury Pharmaceuticals AB
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Finland · Sunitinib Avansor
- Luxembourg · Sunitinib Synthon
- Malta · Subinit
- Netherlands · Sunitinib Malate Eugia, Sunitinib Synthon
- Poland · Sunitinib, Sunitinib Synthon
- Sweden · Sunitinib Avansor
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/94e9fd61-3f36-486a-b35f-b7b8c9ac525c GET /v1/drugs/94e9fd61-3f36-486a-b35f-b7b8c9ac525c?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": "ORAL",
"source": "ndc",
"strength": "37.5",
"substance": "SUNITINIB MALATE",
"productndc": "63304-093",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA213914",
"marketing_category": "ANDA"
}See everything about sunitinib malate.
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.