United States· US:0713-0224_0abbbbe6-b694-1260-e063-6294a90a6f81
Fluocinolone Acetonide
A medicinal product containing fluocinolone acetonide, registered in United States by Cosette Pharmaceuticals, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- FLUOCINOLONE ACETONIDE
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- 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 · 4
- ndc1107130224151 TUBE in 1 CARTON (0713-0224-15) / 15 g in 1 TUBE
- ndc1107130224601 TUBE in 1 CARTON (0713-0224-60) / 60 g in 1 TUBE
- ndc110713-0224-15
- ndc110713-0224-60
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.
- PolandFlucinarMedezin Sp. z o.o.
- CzechiaFLUCINARBausch Health Ireland Limited, Dublin
- United KingdomILUVIEN 190microgram intravitreal implant in applicatorAlimera Sciences Ltd
- NorwayIluvienAlimera Sciences Limited (1)
- FinlandIluvienAbacus Medicine A/S
- Japanフルオシノロンアセトニド田辺ファーマ
- GermanyFlucinarAbanta Pharma Gmbh
- SwedenIluvien 190 mikrogram Intravitrealt implantat i applikatorAlimera Sciences Europe Limited
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/b566776c-9782-46e1-a8d2-8b58da12a824 GET /v1/drugs/b566776c-9782-46e1-a8d2-8b58da12a824?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": ".25",
"substance": "FLUOCINOLONE ACETONIDE",
"productndc": "0713-0224",
"dosage_form": "OINTMENT",
"dea_schedule": null,
"strength_unit": "mg/g",
"application_number": "ANDA089524",
"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.