United States· US:82968-005_464c2d55-32ca-db41-e063-6294a90a9103

Tadalafil

A medicinal product containing tadalafil, registered in United States by FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED.

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:82968-005_464c2d55…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TADALAFIL
Manufacturer
FOURRTS (INDIA) LABORATORIES PRIVATE 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 · 2

  • ndc11
    8296800501
    30 TABLET, FILM COATED in 1 BOTTLE (82968-005-01)
  • ndc11
    82968-005-01

Regulatory notes

No shortage, Orange Book or US label notes for this record.

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/f834eef6-6761-46aa-a370-8c11796ec6fe
GET /v1/drugs/f834eef6-6761-46aa-a370-8c11796ec6fe?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": "TADALAFIL",
  "productndc": "82968-005",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA217606",
  "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.