Ofloxacin (ofloxacin otic) NDC 65145-143

NDC codes

FDA NDC Directory

Product NDC (as listed)65145-143Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65145-0143Add 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
65145-143-01	65145014301	1 BOTTLE, DROPPER in 1 CARTON (65145-143-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Dec 16, 2024

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): Ofloxacin
Generic name (nonproprietary): ofloxacin otic
Active ingredients: Ofloxacin — 3 mg/mL
Dosage form: Solution/ drops
Route: Auricular (Otic)
Labeler: Caplin Steriles Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217903
Marketing start: Dec 16, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 65145-143_47f838f6-cc86-41f5-924a-f6f5c4ddc43eSPL ID 47f838f6-cc86-41f5-924a-f6f5c4ddc43eSPL set ID 2bb61a24-87a6-4e74-a319-fc5e7c483bbbRxCUI 242446UNII A4P49JAZ9HUPC 0365145143013, 0365145144010
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

N465145014301 followed by a unit qualifier and the quantity

Package 65145-0143-01. 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 Dec 16, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217903

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

FDA NDC Directory listings under ANDA 217903
Product	Strength	Form · route	Labeler	Product NDC
Ofloxacin	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Redpharm Drug	67296-2159
Ofloxacin	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	Leading Pharma, LLC	69315-320
Ofloxacinofloxacin otic solution	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Caplin Steriles Limited	65145-144