What is NDC 72189-490?

72189-490 is the product NDC for Olfoxacin Otic Soln, Ofloxacin 3 mg/mL solution, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Olfoxacin Otic Soln?

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.

Olfoxacin Otic Soln NDC 72189-490 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-490Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0490Add 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	Copy
72189-490-05	7218904900572189049005	5 mL in 1 BOTTLE, DROPPER (72189-490-05)Marketed from Jun 8, 2023

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): Olfoxacin Otic Soln
Generic name (nonproprietary): olfoxacin otic soln
Active ingredients: Ofloxacin — 3 mg/mL
Dosage form: Solution
Route: Auricular (Otic)
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216130
Marketing start: Jun 8, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 72189-490_4d3aa53c-878c-d447-e063-6394a90a6a31SPL ID 4d3aa53c-878c-d447-e063-6394a90a6a31SPL set ID fda35d37-f36a-efc8-e053-6294a90a2bb8RxCUI 242446UNII A4P49JAZ9H
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

N472189049005 followed by a unit qualifier and the quantity

Package 72189-0490-05. 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 17, 2026.

Indications (excerpt from the label)

Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-490

What is NDC 72189-490?: 72189-490 is the product NDC for Olfoxacin Otic Soln, Ofloxacin 3 mg/mL solution, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Olfoxacin Otic Soln.
What is the active ingredient?: Ofloxacin.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Olfoxacin Otic Soln?: 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.

Other NDCs under ANDA 216130

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 216130
Product	Strength	Form · route	Labeler	Product NDC
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Lifestar Pharma LLC	70756-609
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Lifestar Pharma LLC	70756-610
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	REMEDYREPACK INC.	70518-4147
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Proficient Rx LP	82804-061
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	NuCare Pharmaceuticals,Inc.	68071-3604
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Sportpharm LLC	85766-226
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Sportpharm LLC	85766-227
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	NorthStar RxLLC	72603-186
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	A-S Medication Solutions	50090-7207
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Asclemed USA, Inc.	76420-748
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Asclemed USA, Inc.	76420-749
ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	REMEDYREPACK INC.	70518-3984