United States· US:82576-080_e56ac6db-56ac-4d3d-8f56-5497bab115df

REZDIFFRA

A resmetirom product containing resmetirom, registered in United States by Madrigal Pharmaceuticals, Inc.. The same ATC class is registered in 9 of our 19 countries.

ATC A05BA11US 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…normalisedREZDIFFRAATCA05BA11REGISTER NO.US:82576-080_e56ac6db…PACKS LISTED4CHECKEDAugust 2, 2026

Where it is registered

Resmetirom is registered in 9 of 19 countries.

Countries holding a registration under ATC A05BA11 (resmetirom), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 6 of them publish a price we can compare per daily dose

Resmetirom · ATC A05BA11

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
RESMETIROM
Manufacturer
Madrigal Pharmaceuticals, Inc.
Country
United States (US)
ATC code
A05BA11
ATC class
Resmetirom
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 2, 2026

Packs & prices · 4

  • ndc11
    8257608030
    30 TABLET, COATED in 1 BOTTLE (82576-080-30)
  • ndc11
    8257608090
    90 TABLET, COATED in 1 BOTTLE (82576-080-90)
  • ndc11
    82576-080-30
  • ndc11
    82576-080-90

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/afd8e741-d63c-44c9-9e5f-d271fcf9a320
GET /v1/drugs/afd8e741-d63c-44c9-9e5f-d271fcf9a320?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": "80",
  "substance": "RESMETIROM",
  "productndc": "82576-080",
  "dosage_form": "TABLET, COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA217785",
  "marketing_category": "NDA"
}

See everything about resmetirom.

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.