Prescription drug · ANDA
Ofloxacin ophthalmic (ofloxacin) NDC 59390-140
Ofloxacin 3 mg/mL · Solution · Ophthalmic · Altaire Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59390-140-05 | 59390014005 | 5 mL in 1 BOTTLE, DROPPER (59390-140-05)Marketed from May 31, 2013 |
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 ophthalmic
- Generic name (nonproprietary)
- ofloxacin
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Altaire Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202692
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 59390-140_28125c1a-d1b0-4763-9b5e-07b4cfc2d889SPL ID 28125c1a-d1b0-4763-9b5e-07b4cfc2d889SPL set ID fe564e33-8f5d-4b57-87a9-7afae02eaf97RxCUI 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
N459390014005followed by a unit qualifier and the quantityPackage 59390-0140-05. 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)
INDICATIONS AND USAGE Ofloxacin ophthalmic solution, USP is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Enterobacter cloacae Haemophilus influenza Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Pseudomonas aeruginosa Serratia marcascens ' Anaerobic species: Propionibacterium acnes * Efficacy for this organism was studied in fewer than 10 infec…
Excerpt only. Read the full label for complete information.