United States· US:59651-467_a3d2b07e-f9d2-4f17-9a80-025d77ff8f7e
SUNITINIB MALATE
A medicinal product containing sunitinib malate, registered in United States by Aurobindo Pharma Limited.
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
- Aurobindo Pharma Limited
- 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
- ndc11596514672828 CAPSULE in 1 BOTTLE (59651-467-28)
- ndc1159651467294 BLISTER PACK in 1 CARTON (59651-467-29) / 7 CAPSULE in 1 BLISTER PACK
- ndc1159651-467-28
- ndc1159651-467-29
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.
- CzechiaSUNITINIB SANEXCELJ.J. BISHOP HEALTH a.s., Praha
- FinlandSunitinib AvansorAvansor Pharma Oy
- BelgiumSunitinib Krka 50 mgKRKA d.d. Novo mesto
- SwedenSunitinib Avansor 50 mg Kapsel, hårdAvansor Pharma Oy
- IrelandSutent 50 mg hard capsulesPfizer Europe MA EEIG
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/afbcc803-68e0-4c03-ae82-9d937db4a1de GET /v1/drugs/afbcc803-68e0-4c03-ae82-9d937db4a1de?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": "50",
"substance": "SUNITINIB MALATE",
"productndc": "59651-467",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA218615",
"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.