United States· US:0597-0385_ca86ce8b-9c04-47d8-94e3-ae041f251fab

Trijardy XR

A metformin, linagliptin and empagliflozin product containing empagliflozin; linagliptin; metformin hydrochloride, registered in United States by Boehringer Ingelheim Pharmaceuticals, Inc..

ATC A10BD27US 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…normalisedTrijardy XRATCA10BD27REGISTER NO.US:0597-0385_ca86ce8b…PACKS LISTED4CHECKEDAugust 23, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Country
United States (US)
ATC code
A10BD27
ATC class
Metformin, linagliptin and empagliflozin
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
August 23, 2026

Packs & prices · 4

  • ndc11
    0597038577
    60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0385-77)
  • ndc11
    0597038586
    180 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0385-86)
  • ndc11
    0597-0385-77
  • ndc11
    0597-0385-86

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/bd01cb11-e675-4c1f-ac90-92f454c152fe
GET /v1/drugs/bd01cb11-e675-4c1f-ac90-92f454c152fe?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": "12.5; 2.5; 1000",
  "substance": "EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE",
  "productndc": "0597-0385",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA212614",
  "marketing_category": "NDA"
}

See everything about metformin, linagliptin and empagliflozin.

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.