United States· US:76420-856_38689a7c-8af1-e4b0-e063-6394a90a94d8

tadalafil

A medicinal product containing tadalafil, registered in United States by Asclemed USA, Inc..

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedtadalafilATC—REGISTER NO.US:76420-856_38689a7c…PACKS LISTED10CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TADALAFIL
Manufacturer
Asclemed USA, 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 · 10

  • ndc11
    7642085601
    100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-01)
  • ndc11
    7642085605
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-05)
  • ndc11
    7642085630
    30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-30)
  • ndc11
    7642085660
    60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-60)
  • ndc11
    7642085690
    90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-856-90)
  • ndc11
    76420-856-01
  • ndc11
    76420-856-05
  • ndc11
    76420-856-30
  • ndc11
    76420-856-60
  • ndc11
    76420-856-90

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.

All tadalafil products

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/ba5e51c3-0414-49fe-8b8a-13dbbb4d4ae6
GET /v1/drugs/ba5e51c3-0414-49fe-8b8a-13dbbb4d4ae6?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": "10",
  "substance": "TADALAFIL",
  "productndc": "76420-856",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA209250",
  "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.