United States· US:46708-750_71121026-1496-4154-b61b-9afe9b62bf2a
Difluprednate
A difluprednate product containing difluprednate, registered in United States by Alembic Pharmaceuticals Limited.
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
- DIFLUPREDNATE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Country
- United States (US)
- ATC code
- S01BA16
- ATC class
- Difluprednate
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1146708750051 BOTTLE in 1 CARTON (46708-750-05) / 5 mL in 1 BOTTLE
- ndc1146708-750-05
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Difluprednate in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaDUREZOLNOVARTIS PHARMACEUTICALS CANADA INC
- FranceEPITOPIC 0,05 POUR CENT, crèmeETHYX PHARMACEUTICALS
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- France · Epitopic
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/bd328b95-8a6f-4e30-9e7b-b8d16bb54edd GET /v1/drugs/bd328b95-8a6f-4e30-9e7b-b8d16bb54edd?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": ".5",
"substance": "DIFLUPREDNATE",
"productndc": "46708-750",
"dosage_form": "EMULSION",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA213774",
"marketing_category": "ANDA"
}See everything about difluprednate.
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.