What is NDC 72485-613?

72485-613 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by ARMAS PHARMACEUTICALS INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ARMAS PHARMACEUTICALS INC., NDC labeler code 72485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ofloxacin?

72 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ofloxacin NDC 72485-613 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72485-613Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72485-0613Add 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
72485-613-10	7248506131072485061310	1 BOTTLE, DROPPER in 1 CARTON (72485-613-10) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 14, 2023
72485-613-11	7248506131172485061311	1 BOTTLE, DROPPER in 1 CARTON (72485-613-11) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 14, 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): Ofloxacin
Generic name (nonproprietary): ofloxacin
Active ingredients: Ofloxacin — 3 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: ARMAS PHARMACEUTICALS INC.NDC labeler code 72485
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076407
Marketing start: Oct 14, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Quinolones (Chemical structure)
Identifiers: Product ID 72485-613_086cc6db-b800-dc8f-e063-6294a90a4196SPL ID 086cc6db-b800-dc8f-e063-6294a90a4196SPL set ID 07ac850b-a983-fc21-e063-6394a90a21b2RxCUI 312075UNII A4P49JAZ9HUPC 0372485613113
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

N472485061310 followed by a unit qualifier and the quantity

Package 72485-0613-10. 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 Oct 23, 2023.

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:

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72485-613

What is NDC 72485-613?: 72485-613 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by ARMAS PHARMACEUTICALS INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ofloxacin.
What is the active ingredient?: Ofloxacin.
Who is the labeler?: ARMAS PHARMACEUTICALS INC., NDC labeler code 72485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ofloxacin?: 72 other product NDCs are listed under this name. See all Ofloxacin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ofloxacin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ofloxacin	Ofloxacin 3 mg/mL	SolutionAuricular (Otic)	REMEDYREPACK INC.	70518-4752	70518-4752-00
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Preferred Pharmaceuticals Inc.	68788-4086	68788-4086-01
Ofloxacin	Ofloxacin 200 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-072	72241-0072-0272241-0072-0572241-0072-10
Ofloxacin	Ofloxacin 300 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-073	72241-0073-0272241-0073-0572241-0073-10
Ofloxacin	Ofloxacin 400 mg/1	Tablet, Film coatedOral	Modavar Pharmaceuticals LLC	72241-074	72241-0074-0272241-0074-0572241-0074-10
Ofloxacinofloxacin ophthalmic solution usp, 0.3%	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-141	65145-0141-01
Ofloxacinofloxacin ophthalmic solution usp, 0.3%	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Caplin Steriles Limited	65145-142	65145-0142-01
Ofloxacin	Ofloxacin 3 mg/mL	SolutionOphthalmic	St. Mary's Medical Park Pharmacy	60760-917	60760-0917-05
Ofloxacinofloxacin otic	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Caplin Steriles Limited	65145-143	65145-0143-01
Ofloxacinofloxacin otic solution	Ofloxacin 3 mg/mL	Solution/ dropsAuricular (Otic)	Caplin Steriles Limited	65145-144	65145-0144-01

All 73 Ofloxacin NDCs

Other NDCs under ANDA 076407

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

FDA NDC Directory listings under ANDA 076407
Product	Strength	Form · route	Labeler	Product NDC
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	63187-662
Ofloxacin	Ofloxacin 3 mg/mL	Solution/ dropsOphthalmic	NuCare Pharmaceuticals, Inc.	68071-1607