United States· US:81942-125_1f574fcb-3810-2e5c-e063-6394a90aafd3

XDEMVY

A lotilaner product containing lotilaner, registered in United States by Tarsus Pharmaceuticals, Inc..

ATC S01AX25US 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…normalisedXDEMVYATCS01AX25REGISTER NO.US:81942-125_1f574fcb…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
LOTILANER
Manufacturer
Tarsus Pharmaceuticals, Inc.
Country
United States (US)
ATC code
S01AX25
ATC class
Lotilaner
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    8194212501
    1 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPER
  • ndc11
    8194212599
    1 BOTTLE, DROPPER in 1 CARTON (81942-125-99) / 1.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    81942-125-01
  • ndc11
    81942-125-99

Regulatory notes

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

Same medicine, other countries

Lotilaner in 2 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All lotilaner products

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/ff69333a-dc45-4ff0-aa6f-6d2dc668cbef
GET /v1/drugs/ff69333a-dc45-4ff0-aa6f-6d2dc668cbef?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": "OPHTHALMIC",
  "source": "ndc",
  "strength": "2.5",
  "substance": "LOTILANER",
  "productndc": "81942-125",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "NDA217603",
  "marketing_category": "NDA"
}

See everything about lotilaner.

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.