United States· US:35573-461_da1eee2b-ebe6-4af3-ad52-2b349a360a9a
tadalafil
A medicinal product containing tadalafil, registered in United States by Burel 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
- TADALAFIL
- Manufacturer
- Burel 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
- ndc11355734613030 TABLET, FILM COATED in 1 BOTTLE (35573-461-30)
- ndc1135573-461-30
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tadalafil in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaCIALISEli Lilly Nederland B.V., Utrecht
- SpainACORE 5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGGp Pharm S.A.
- PolandAdaliftAdamed Pharma S.A.
- SwedenAkyris 5 mg Filmdragerad tablettZentiva k.s.
- NetherlandsGerocilan 5 mg filmomhulde tablettenG.L. Pharma GmbH
- FranceCIALIS 5 mg, comprimé pelliculéELI LILLY NEDERLAND BV (PAY-BAS)
- SwitzerlandCialis 5 mg, comprimés pelliculésEli Lilly (Suisse) SA
- FinlandCialisHexpress Healthcare Limited
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Lanrektan, Pultadev
- Belgium · Quator, Tadalafil Ab
- Bulgaria · Героцилан, Гуднес
- Cyprus · Codalis, Genement
- Czechia · Rekifre, Tadalafil Medreg
- Germany · Comaxo, Pultadev
- Denmark · Pultadev, Quator
- Estonia · Quator, Tadalafil Accord
- Spain · Acore, Alneo
- Finland · Pultadev, Tadalafil Accord
- France · Kronalis, Tadalafil Accord
- United Kingdom (Northern Ireland) · Cialis Together, Stamiz
- Greece · Adrotan, Diozi
- Croatia · Kasario, Tadalafil Aop
- Hungary · Actowill, Bonton
- Ireland · Cialis For Men, Tadalafil Accord Healthcare Ireland
- Iceland · Adcirca, Cialis
- Italy · Dalerpen, Dinamis
- Liechtenstein · Adcirca, Cialis
- Lithuania · Quator, Tadalafil Accord
- Luxembourg · Tadalafil Eg, Tadalafil Eurogenerics
- Latvia · Quator, Tadalafil Accord
- Malta · Avarante, Goyuma
- Netherlands · Gerocilan, Lafaval
- Norway · Adcirca, Avarante
- Poland · Adalift, Akyris
- Portugal · Direxyn, Filaz
- Romania · Arvalti, Gerocilan
- Sweden · Pultadev, Tadalafil 1a Farma
- Slovenia · Kasario, Quator
- Slovakia · Gerocilan, Tadalafil Medreg
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/d2b0db51-fd58-4883-a818-2ea1382812ff GET /v1/drugs/d2b0db51-fd58-4883-a818-2ea1382812ff?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": "5",
"substance": "TADALAFIL",
"productndc": "35573-461",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA215556",
"marketing_category": "ANDA"
}See everything about tadalafil.
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.