United States· US:84826-002_33504c5f-664b-4f6b-e063-6294a90a2aea

Omlonti

A medicinal product containing omidenepag isopropyl, registered in United States by Ocuvex Therapeutics, Inc..

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…normalisedOmlontiATC—REGISTER NO.US:84826-002_33504c5f…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
OMIDENEPAG ISOPROPYL
Manufacturer
Ocuvex Therapeutics, 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

  • ndc11
    8482600201
    1 BOTTLE, PLASTIC in 1 CARTON (84826-002-01) / 2.5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    8482600203
    3 BOTTLE, PLASTIC in 1 CARTON (84826-002-03) / 2.5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    84826-002-01
  • ndc11
    84826-002-03

Regulatory notes

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

Same medicine, other countries

Omidenepag isopropyl in 1 other country

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

All omidenepag isopropyl products

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/78233f3e-9637-4ef8-8b35-da1c877016e7
GET /v1/drugs/78233f3e-9637-4ef8-8b35-da1c877016e7?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": ".02",
  "substance": "OMIDENEPAG ISOPROPYL",
  "productndc": "84826-002",
  "dosage_form": "SOLUTION/ DROPS",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "NDA215092",
  "marketing_category": "NDA"
}

See everything about omidenepag isopropyl.

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.