The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Xtoro
finafloxacin · FINAFLOXACIN 3 mg/mL · Suspension · Auricular (Otic) · Fonseca Biosciences, LLC
NDC 83709-0001-01 · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Estimated fill cost
WAC per package, as filed
$695.00
Reported to Texas DSHS · 2026 annual filing · Fonseca Biosciences LLC
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- manufacture
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- NDA206307
- TE code
- —
- Approval date
- Dec 17, 2014
- Patents / exclusivity
- 4 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 9504691 | Nov 21, 2033 |
| patent | 8536167 | Aug 8, 2031 |
| patent | 9119859 | Jul 2, 2030 |
| patent | 9993483 | Jul 2, 2030 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of finafloxacin (Suspension)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Fonseca Biosciences, LLC | FINAFLOXACIN 3 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Xtoro — NDC 83709-0001-01," retrieved September 3, 2026, https://drugdashboards.com/drug/83709000101.
Free to cite with attribution — see how the data is put together.