Prescription drug · ANDA
Ofloxacin Otic (ofloxacin) NDC 63187-184
Ofloxacin 3 mg/mL · Solution · Auricular (Otic) · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-184-05 | 63187018405 | 5 mL in 1 BOTTLE, DROPPER (63187-184-05)Marketed from Jan 1, 2019 |
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 Otic
- Generic name (nonproprietary)
- ofloxacin
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution
- Route
- Auricular (Otic)
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076527
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 63187-184_494bc1d0-100f-46c4-b35f-8248fc20b727SPL ID 494bc1d0-100f-46c4-b35f-8248fc20b727SPL set ID 14e6e355-3a87-43dc-80a2-070b9df93bf1RxCUI 242446UNII A4P49JAZ9HUPC 0363187184056
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N463187018405followed by a unit qualifier and the quantityPackage 63187-0184-05. 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 otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa, and Staphylococcus aureus . Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis , Pseudomonas aeruginosa, Staphylococcu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076527
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 Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | REMEDYREPACK INC. | 70518-4226 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | DIRECT RX | 72189-108 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | A-S Medication Solutions | 50090-1090 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 63629-8716 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Apotex Corp. | 60505-0363 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-1588 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-1630 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 71335-2822 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 72162-1709 |