Xtoro Suspension
NDC Package 83709-001-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Xtoro (finafloxacin) suspension is xTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. This formulation utilizes a suspension delivery system. Marketed by Fonseca Biosciences, Llc, this product is identified by NDC 83709-001 and is authorized under FDA application NDA206307.

Identification & Billing

NDC Package Code
83709-001-91
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
Product Code
83709-001
11-Digit Billing Format
83709000191
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Xtoro
Non-Proprietary Name
Finafloxacin
Substance Name
Finafloxacin
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
FINAFLOXACIN 3 mg/mL
Pharmacologic Class
Usage Information
XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older.

Regulatory & Marketing

Labeler Name
Fonseca Biosciences, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA206307
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83709-001). Click a package code to view its specific billing and regulatory data.

83709-001-01
1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER
83709-001-90
1 POUCH in 1 CARTON / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83709-001-91 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper of Xtoro, a human prescription drug labeled by Fonseca Biosciences, Llc. This suspension is formulated for auricular (otic) use and contains finafloxacin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fonseca Biosciences, Llc on May 01, 2026. The current certification is valid through December 31, 2027.

How is this Fonseca Biosciences, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83709000191. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83709-001-91
11-Digit CMS (5-4-2)
83709-0001-91

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.