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United States· US:0168-0059_7c4e6b9b-d444-4afe-a658-cdb4a6205ad2

Fluocinolone Acetonide

A medicinal product containing fluocinolone acetonide, registered in United States by Fougera Pharmaceuticals, LLC.

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…normalisedFluocinolone AcetonideATC—REGISTER NO.US:0168-0059_7c4e6b9b…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FLUOCINOLONE ACETONIDE
Manufacturer
Fougera Pharmaceuticals, LLC
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
    0168-0059-60
  • ndc11
    0168005960
    60 mL in 1 BOTTLE (0168-0059-60)

Regulatory notes

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

Same medicine, other countries

Fluocinolone acetonide in 13 other countries

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

All fluocinolone acetonide products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Iluvien
  • Belgium · Iluvien
  • Bulgaria · Абрикорт, Флуцинар
  • Czechia · Flucinar, Iluvien
  • Germany · Flucinar, Iluvien
  • Denmark · Iluvien, Otazem
  • Spain · Ekzem, Fluocid Forte
  • Finland · Iluvien, Otazem
  • France · Iluvien
  • United Kingdom (Northern Ireland) · Iluvien, Synalar
  • Greece · Synalar Simple
  • Hungary · Flucinar
  • Ireland · Iluvien
  • Italy · Ekzem, Fluovitef
  • Lithuania · Flucinar
  • Luxembourg · Iluvien
  • Latvia · Flucinar
  • Netherlands · Iluvien
  • Norway · Iluvien, Otazem
  • Poland · Flucinar, Iluvien
  • Portugal · Ekzem, Iluvien
  • Romania · Fluocinolon Acetonid Laropharm
  • Sweden · Iluvien, Otazem
  • Slovakia · Flucinar

Source: European Medicines Agency, Article 57 product data.

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/e6e80ea6-fcec-408a-9073-dc55e7d6ca95
GET /v1/drugs/e6e80ea6-fcec-408a-9073-dc55e7d6ca95?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": ".1",
  "substance": "FLUOCINOLONE ACETONIDE",
  "productndc": "0168-0059",
  "dosage_form": "SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "ANDA088167",
  "marketing_category": "ANDA"
}

See everything about fluocinolone acetonide.

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.