Prescription drug · ANDA
ofloxacin (ofloxacin otic) NDC 76420-749
Ofloxacin 3 mg/mL · Solution · Auricular (Otic) · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-749-10 | 76420074910 | 10 mL in 1 BOTTLE, DROPPER (76420-749-10)Marketed from Jun 12, 2024 |
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 otic
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution
- Route
- Auricular (Otic)
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216130
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 76420-749_1aaaf971-7d69-9422-e063-6394a90a2a69SPL ID 1aaaf971-7d69-9422-e063-6394a90a2a69SPL set ID ff2abdd2-f7ca-49cd-a2d6-cd2bbd980b0cRxCUI 242446UNII 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 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
N476420074910followed by a unit qualifier and the quantityPackage 76420-0749-10. 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 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 216130
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 |
|---|---|---|---|---|
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NorthStar RxLLC | 72603-186 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Sportpharm LLC | 85766-226 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Sportpharm LLC | 85766-227 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-3604 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Asclemed USA, Inc. | 76420-748 |
| Olfoxacin Otic Soln | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Direct_Rx | 72189-490 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Lifestar Pharma LLC | 70756-609 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | REMEDYREPACK INC. | 70518-3984 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Lifestar Pharma LLC | 70756-610 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | A-S Medication Solutions | 50090-7207 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Proficient Rx LP | 82804-061 |
| ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | REMEDYREPACK INC. | 70518-4147 |