Prescription drug · ANDA
Ofloxacin Ophth Soln NDC 72189-472
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-472-05 | 72189047205 | 5 mL in 1 CARTON (72189-472-05)Marketed from May 22, 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 Ophth Soln
- Generic name (nonproprietary)
- ofloxacin ophth soln
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215886
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 72189-472_4d3a583a-dad5-8766-e063-6394a90a525fSPL ID 4d3a583a-dad5-8766-e063-6394a90a525fSPL set ID fc4d4b14-1eeb-0fba-e053-6394a90a738eRxCUI 312075UNII 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 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
N472189047205followed by a unit qualifier and the quantityPackage 72189-0472-05. 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 .
Indications (excerpt from the label)
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: *Efficacy for this organism was studied in fewer than 10 infections CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens* Streptococcus pneumoniae Anaerobic species: Propionibacterium acnes
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215886
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-6794 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals, Inc. | 68071-3919 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-607 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Major Pharmaceuticals | 0904-7434 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7761 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3448 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-650 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NorthStar RxLLC | 72603-192 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8449 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 82804-101 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3710 |