Prescription drug · ANDA
Ofloxacin NDC 72485-613
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · ARMAS PHARMACEUTICALS INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-613-10 | 72485061310 | 1 BOTTLE, DROPPER in 1 CARTON (72485-613-10) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 14, 2023 | |
| 72485-613-11 | 72485061311 | 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.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076407
- Marketing start
- Listing expires
- 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
N472485061310followed by a unit qualifier and the quantityPackage 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 .
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.
Other NDCs under ANDA 076407
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.