What is NDC 83709-001?

83709-001 is the product NDC for Xtoro (finafloxacin), Finafloxacin 3 mg/mL suspension, listed with the FDA by Fonseca Biosciences, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Fonseca Biosciences, LLC, NDC labeler code 83709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Xtoro?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Xtoro NDC 83709-001 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83709-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83709-0001Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
83709-001-01	83709000101	1 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 1, 2026
83709-001-90	83709000190	1 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPERMarketed from May 1, 2026 · Sample package
83709-001-91	83709000191	1 BOTTLE, DROPPER in 1 CARTON (83709-001-91) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 1, 2026 · Sample package

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Xtoro
Generic name (nonproprietary): finafloxacin
Active ingredients: Finafloxacin — 3 mg/mL
Dosage form: Suspension
Route: Auricular (Otic)
Labeler: Fonseca Biosciences, LLCNDC labeler code 83709
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206307
Marketing start: May 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 83709-001_9db61e18-114c-46c5-bdc2-5f56c4b2f87fSPL ID 9db61e18-114c-46c5-bdc2-5f56c4b2f87fSPL set ID 5c628272-019e-4511-8d5c-dcf56023da25RxCUI 1598645, 1598650UNII D26OSN9Q4RUPC 0383709001906, 0383709001913, 0383709001012
Pharmacologic class: Quinolone Antimicrobial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N483709000101 followed by a unit qualifier and the quantity

Package 83709-0001-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 24, 2026.

Indications (excerpt from the label)

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. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus . ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83709-001

What is NDC 83709-001?: 83709-001 is the product NDC for Xtoro (finafloxacin), Finafloxacin 3 mg/mL suspension, listed with the FDA by Fonseca Biosciences, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Xtoro (Finafloxacin).
What is the active ingredient?: Finafloxacin.
Who is the labeler?: Fonseca Biosciences, LLC, NDC labeler code 83709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Xtoro?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Xtoro (Finafloxacin) NDC 83709-001