United States· US:83709-001_9db61e18-114c-46c5-bdc2-5f56c4b2f87f

XTORO

A medicinal product containing finafloxacin, registered in United States by Fonseca Biosciences, LLC.

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…normalisedXTOROATC—REGISTER NO.US:83709-001_9db61e18…PACKS LISTED6CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
FINAFLOXACIN
Manufacturer
Fonseca Biosciences, 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 · 6

  • ndc11
    83709-001-01
  • ndc11
    83709-001-90
  • ndc11
    83709-001-91
  • ndc11
    8370900101
    1 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    8370900190
    1 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    8370900191
    1 BOTTLE, DROPPER in 1 CARTON (83709-001-91) / 5 mL in 1 BOTTLE, DROPPER

Regulatory notes

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

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/b1dad3a0-bc6e-4266-b4e9-f0c5f673576d
GET /v1/drugs/b1dad3a0-bc6e-4266-b4e9-f0c5f673576d?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": "AURICULAR (OTIC)",
  "source": "ndc",
  "strength": "3",
  "substance": "FINAFLOXACIN",
  "productndc": "83709-001",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "strength_unit": "mg/mL",
  "application_number": "NDA206307",
  "marketing_category": "NDA"
}

See everything about finafloxacin.

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.