United States· US:0574-4031_7c012e78-01c6-4b9a-a971-62a64fe6885a
TOBRAMYCIN AND DEXAMETHASONE
A medicinal product containing dexamethasone; tobramycin, registered in United States by Padagis US 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
- DEXAMETHASONE; TOBRAMYCIN
- Manufacturer
- Padagis US LLC
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 26, 2026
Packs & prices · 6
- ndc1105744031055 mL in 1 BOTTLE, PLASTIC (0574-4031-05)
- ndc11057440311010 mL in 1 BOTTLE, PLASTIC (0574-4031-10)
- ndc1105744031252.5 mL in 1 BOTTLE, PLASTIC (0574-4031-25)
- ndc110574-4031-05
- ndc110574-4031-10
- ndc110574-4031-25
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dexamethasone; tobramycin in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- PolandBrazoflaminSynoptis Pharma Sp. z o.o.
- United KingdomDexamethasone 0.1% / Tobramycin 0.3% eye dropsAspire Pharma Ltd
- NetherlandsBradexa 3 mg/ml + 1 mg/ml oogdruppels, suspensieRockmed Pharma B.V.
- CzechiaTOBRADEXNovartis s.r.o., Praha
- SwedenTobrasone 3 mg/ml / 1 mg/ml Ögondroppar, suspensionNovartis Sverige AB
- NorwayTobrasoneNOVARTIS NORGE AS
- CanadaTOBRADEXNOVARTIS PHARMACEUTICALS CANADA INC
- FranceTOBRADEX, collyre en suspensionNOVARTIS PHARMA
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Tobradex
- Belgium · Tobradex
- Bulgaria · Декс-Тобрин, Медетром
- Cyprus · Lofoto, Tobradex
- Czechia · Tobradex
- Germany · Tobradex
- Denmark · Oridecin, Tobradex
- Estonia · Tobradex, Tobramycin/Dexamethasone Elvim
- Spain · Tobradex
- Finland · Tobrasone
- France · Tobradex, Todexal
- United Kingdom (Northern Ireland) · Tobradex, Tobramycin + Dexamethasone Blumont Pharma
- Greece · Lofoto, O-Biotic
- Croatia · Tobradex
- Hungary · Tobradex, Todep
- Iceland · Tobradex
- Italy · Iridina Infezioni E Infiammazioni, Luxabiotic
- Lithuania · Tobradex, Tobramycin/Dexamethasone Elvim
- Luxembourg · Tobradex
- Latvia · Tobradex, Tobramycin/Dexamethasone Elvim
- Malta · Tobradex
- Netherlands · Bradexa, Tobradex
- Norway · Tobrasone, Toflacort
- Poland · Brazoflamin, Mybracin
- Portugal · Dextob, Tobradex
- Romania · Dexatobrom, Tobradex
- Sweden · Tobrasone, Toflacort
- Slovenia · Tobradex
- Slovakia · Tobradex
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/7808b080-ea6d-4e27-a375-7ab8faa039a9 GET /v1/drugs/7808b080-ea6d-4e27-a375-7ab8faa039a9?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": "1; 3",
"substance": "DEXAMETHASONE; TOBRAMYCIN",
"productndc": "0574-4031",
"dosage_form": "SUSPENSION/ DROPS",
"dea_schedule": null,
"strength_unit": "mg/mL; mg/mL",
"application_number": "ANDA212715",
"marketing_category": "ANDA"
}See everything about dexamethasone; tobramycin.
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.