United States· US:10122-310_0b380ed5-013d-47af-8113-4d708bb92180

FILSUVEZ

A medicinal product containing birch triterpenes, registered in United States by Chiesi 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…normalisedFILSUVEZATC—REGISTER NO.US:10122-310_0b380ed5…PACKS LISTED2CHECKEDJuly 26, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BIRCH TRITERPENES
Manufacturer
Chiesi 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
July 26, 2026

Packs & prices · 2

  • ndc11
    1012231002
    1 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01)
  • ndc11
    10122-310-02

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/e6340eef-3668-4e08-976d-fbfcfe75a146
GET /v1/drugs/e6340eef-3668-4e08-976d-fbfcfe75a146?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": "TOPICAL",
  "source": "ndc",
  "strength": "100",
  "substance": "BIRCH TRITERPENES",
  "productndc": "10122-310",
  "dosage_form": "GEL",
  "dea_schedule": null,
  "strength_unit": "mg/g",
  "application_number": "NDA215064",
  "marketing_category": "NDA"
}

See everything about birch triterpenes.

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.