Prescription drug · ANDA
Ofloxacin NDC 63187-662
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-662-05 | 63187066205 | 1 BOTTLE, DROPPER in 1 CARTON (63187-662-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Dec 1, 2018 | |
| 63187-662-10 | 63187066210 | 1 BOTTLE, DROPPER in 1 CARTON (63187-662-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Dec 1, 2018 |
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 076407
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 63187-662_78fd4254-2047-414b-ab00-68d3427a3261SPL ID 78fd4254-2047-414b-ab00-68d3427a3261SPL set ID 2d2807a8-19d5-4922-8270-a8885d61e851RxCUI 312075UNII A4P49JAZ9HUPC 0363187662059
- 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
N463187066205followed by a unit qualifier and the quantityPackage 63187-0662-05. 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 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: Anaerobic species: Staphylococcus aureus Pseudomonas aeruginosa Propionibacterium acnes Staphylococcus epidermidis Serratia marcescens* Streptococcus pneumoniae
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.