Ofloxacin NDC 63187-268

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-268Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0268Add 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
63187-268-05	63187026805	1 BOTTLE, DROPPER in 1 CARTON (63187-268-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Jan 1, 2019

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
Active ingredients: Ofloxacin — 3 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076622
Marketing start: May 14, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 63187-268_331a9c17-9946-48a6-bc37-af84ecdea26aSPL ID 331a9c17-9946-48a6-bc37-af84ecdea26aSPL set ID c8020ad4-ac74-4ceb-863e-94da605cf23fRxCUI 312075UNII A4P49JAZ9HUPC 0363187268053
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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N463187026805 followed by a unit qualifier and the quantity

Package 63187-0268-05. 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 Apr 1, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076622

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

FDA NDC Directory listings under ANDA 076622
Product	Strength	Form · route	Labeler	Product NDC
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-1744
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Bausch & Lomb Incorporated	24208-434
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals,Inc.	68071-2254
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals,Inc.	68071-2265
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Preferred Pharmaceuticals, Inc.	68788-7693
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-7264
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	REMEDYREPACK INC.	70518-3573