United States· US:65162-351_de64b88f-aefc-40f1-8db7-d65dba8194aa
Sildenafil
A medicinal product containing sildenafil citrate, registered in United States by Amneal Pharmaceuticals 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
- SILDENAFIL CITRATE
- Manufacturer
- Amneal Pharmaceuticals 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
- ndc1165162-351-09
- ndc1165162-351-11
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sildenafil citrate in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomGranpidam 20mg tabletsAccord-UK Ltd
- CanadaJAMP-SILDENAFIL RJAMP PHARMA CORPORATION
- CzechiaAMFIDOREgis Pharmaceuticals PLC, Budapešť
- SpainABECED 25 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGAdamed Pharma S.A.
- PolandActigraBiofarm Sp. z o.o.
- FinlandBalcogaSandoz A/S
- NetherlandsAzulsix 100 mg, kauwtablettenFarmalider S.A.
- BelgiumBalcoga 20 mgSandoz
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Direktan, Erixil
- Belgium · Balcoga, Sildenafil Ab
- Bulgaria · Azurvig, Balcoga Sandoz Pharmaceuticals D.D.
- Cyprus · Lekap, Olvion
- Czechia · Amfidor, Azurvig
- Germany · Becedek, Duraviril
- Denmark · Revastad, Sildenafil "orion"
- Estonia · Mexonup, Olvion
- Spain · Abeced, Azulsix
- Finland · Balcoga Sandoz A/S, Orisild
- France · Azulvig, Cetinor
- United Kingdom (Northern Ireland) · Almus Erectile Dysfunction Relief, Aronix
- Greece · Azurvig, Bluozi
- Croatia · Azurvig, Dinamico
- Hungary · Azurvig, Defelek
- Ireland · Hezkue, Sidena
- Iceland · Granpidam, Mysildecard
- Italy · Azurvig, Balcoga
- Liechtenstein · Granpidam, Mysildecard
- Lithuania · Abedel, Avixar
- Luxembourg · Sildenafil Ab, Sildenafil Eg
- Latvia · Sildenafil Accord, Sildenafil Adamed
- Malta · Sasah, Sibefil
- Netherlands · Azulsix, Balcoga
- Norway · Granpidam, Mysildecard
- Poland · Actigra, Actigra Forte
- Portugal · Amfidor, Erepry
- Romania · Azurvig, Entranin
- Sweden · Lekap, Olvion
- Slovenia · Balcoga, Belfil
- Slovakia · Amfidor, Azurvig
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/ecdeaeb7-8fa3-4b07-bd25-73a7d2081d54 GET /v1/drugs/ecdeaeb7-8fa3-4b07-bd25-73a7d2081d54?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": "20",
"substance": "SILDENAFIL CITRATE",
"productndc": "65162-351",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA202025",
"marketing_category": "ANDA"
}See everything about sildenafil citrate.
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.