United States· US:60219-1366_867b7a8d-85c2-4b5c-8391-49d0a69cb97b
loteprednol etabonate
A medicinal product containing loteprednol etabonate, registered in United States by Amneal Pharmaceuticals NY LLC.
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
- LOTEPREDNOL ETABONATE
- Manufacturer
- Amneal Pharmaceuticals NY 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
- ndc1160219136631 BOTTLE in 1 CARTON (60219-1366-3) / 5 mL in 1 BOTTLE
- ndc1160219-1366-3
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Loteprednol etabonate in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandLotemax 0,5%Delfarma Sp. z o.o.
- CanadaALREXBAUSCH & LOMB INC
- CzechiaLOTEPREDNOL OLIKLAOlikla s.r.o., Kostelec nad Černými Lesy
- GermanyLotemaxDr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh
- BelgiumLotemax 5 mg/mlBausch & Lomb Pharma
- IrelandLotemax 0.5% w/v eye drops, suspensionDr. Gerhard Mann, chem.-pharm. Fabrik GmbH
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Austria · Lotemax
- Cyprus · Lotemax
- Czechia · Loteprednol Olikla
- Germany · Lotemax
- Estonia · Lotemax
- United Kingdom (Northern Ireland) · Lotemax
- Greece · Lotemax
- Ireland · Lotemax
- Italy · Lotemax, Nolok
- Lithuania · Lotemax
- Poland · Lotemax
- Portugal · Xafex
- Slovenia · Lotemax
- Slovakia · Lotemax, Loteprednol Olikla
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/dd261a1c-6546-48bb-9a0f-e906b01a8f9a GET /v1/drugs/dd261a1c-6546-48bb-9a0f-e906b01a8f9a?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",
"substance": "LOTEPREDNOL ETABONATE",
"productndc": "60219-1366",
"dosage_form": "SUSPENSION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL",
"application_number": "ANDA216345",
"marketing_category": "ANDA"
}See everything about loteprednol etabonate.
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.