United States· US:61314-630_c28e6969-112d-49ae-b037-f09954e99f3e
Neomycin and Polymyxin B Sulfates and Dexamethasone
A medicinal product containing dexamethasone; neomycin sulfate; polymyxin b sulfate, registered in United States by Sandoz 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
- DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Manufacturer
- Sandoz Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- July 12, 2026
Packs & prices · 2
- ndc1161314630065 mL in 1 BOTTLE, PLASTIC (61314-630-06)
- ndc1161314-630-06
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Dexamethasone; neomycin sulfate; polymyxin b sulfate in 5 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaMAXITROLNovartis s.r.o., Praha
- GermanyIsopto-MaxNovartis Pharma Gmbh
- FinlandMaxitrolNovartis Finland Oy
- IrelandMaxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspensionNovartis Ireland Limited
- NorwayMaxitrolNOVARTIS NORGE AS
Authorised across Europe · EMA
The same active substance is authorised in 19 EEA countries. Names it is sold under:
- Belgium · Maxitrol
- Bulgaria · Макситрол, Неладекс
- Cyprus · Isopto Maxitrol
- Czechia · Maxitrol
- Germany · Isopto-Max
- Estonia · Maxitrol
- Spain · Maxitrol
- France · Maxidrol
- United Kingdom (Northern Ireland) · Maxitrol
- Croatia · Maxitrol
- Ireland · Maxitrol
- Iceland · Maxitrol
- Lithuania · Maxitrol
- Luxembourg · Maxitrol
- Latvia · Maxitrol
- Norway · Maxitrol
- Poland · Maxitrol
- Romania · Maxitrol
- Slovenia · Maxitrol
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/ffc3c09f-7967-4997-bd5e-53765d80cf45 GET /v1/drugs/ffc3c09f-7967-4997-bd5e-53765d80cf45?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; 3.5; 10000",
"substance": "DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"productndc": "61314-630",
"dosage_form": "SUSPENSION",
"dea_schedule": null,
"strength_unit": "mg/mL; mg/mL; [USP'U]/mL",
"application_number": "ANDA062341",
"marketing_category": "ANDA"
}See everything about dexamethasone; neomycin sulfate; polymyxin b sulfate.
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.