United States· US:11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9
FML FORTE
A medicinal product containing fluorometholone, registered in United States by Allergan, 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
- FLUOROMETHOLONE
- Manufacturer
- Allergan, 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
- ndc1111980228051 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER
- ndc1111980228101 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER
- ndc1111980-228-05
- ndc1111980-228-10
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fluorometholone in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomFML Liquifilm 0.1% ophthalmic suspensionMawdsley-Brooks & Company Ltd
- PolandFlarexInPharm Sp. z o.o.
- BelgiumFlarex 1 mg/mlNovartis Pharma
- NorwayEfflumidexAbbvie AS
- CzechiaEFFLUMIDEX LIQUIFILMAbbVie s.r.o., Praha
- FinlandFML LIQUIFILMOrifarm Oy
- SpainFML 1 mg/ml colirio en suspensiónAbbvie Spain, S.L.U.
- CanadaFMLABBVIE CORPORATION
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Belgium · Fml
- Bulgaria · Фларекс
- Czechia · Efflumidex Liquifilm, Flarex
- Germany · Efflumidex, Fluoropos
- Spain · Fml, Isopto Flucon
- Finland · Fml Liquifilm
- France · Flucon
- United Kingdom (Northern Ireland) · Fml Liquifilm Ophthalmic
- Greece · Flucon, Fml
- Hungary · Efflumidex Liquifilm, Flucon
- Ireland · Fml
- Italy · Flarex, Fluaton
- Lithuania · Flarex
- Luxembourg · Fml
- Netherlands · Fml Liquifilm
- Poland · Flarex, Flucon
- Portugal · Fml - Liquifilm
- Romania · Flumetol S
- Slovenia · Flarex
- Slovakia · Efflumidex Liquifilm
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/c885de76-a332-47dd-aea5-1f90277b20e8 GET /v1/drugs/c885de76-a332-47dd-aea5-1f90277b20e8?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": "FLUOROMETHOLONE",
"productndc": "11980-228",
"dosage_form": "SUSPENSION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "NDA019216",
"marketing_category": "NDA"
}See everything about fluorometholone.
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.