Prescription drug · ANDA
Ofloxacin Otic (Ofloxacin) NDC 70518-4226
Ofloxacin 3 mg/mL · Solution · Auricular (Otic) · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4226-0 | 7051842260070518422600 | 5 mL in 1 BOTTLE, DROPPER (70518-4226-0)Marketed from Oct 31, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-4226_5a5d2bd2-0d3c-764e-e063-6394a90a4013SPL ID 5a5d2bd2-0d3c-764e-e063-6394a90a4013SPL set ID 42366170-e536-46a1-9735-d76e5820a9deRxCUI 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
N470518422600followed by a unit qualifier and the quantityPackage 70518-4226-00. 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.
About NDC 70518-4226
- What is NDC 70518-4226?
- 70518-4226 is the product NDC for Ofloxacin Otic (ofloxacin), Ofloxacin 3 mg/mL solution, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ofloxacin Otic (Ofloxacin).
- What is the active ingredient?
- Ofloxacin.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ofloxacin Otic?
- 9 other product NDCs are listed under this name. See all Ofloxacin Otic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ofloxacin Otic products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | DIRECT RX | 72189-108 | 72189-0108-05 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | A-S Medication Solutions | 50090-1090 | 50090-1090-00 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Apotex Corp. | 60505-0363 | 60505-0363-0160505-0363-02 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Proficient Rx LP | 63187-184 | 63187-0184-05 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 63629-8716 | 63629-8716-01 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-1588 | 68071-1588-05 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | NuCare Pharmaceuticals,Inc. | 68071-1630 | 68071-1630-03 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 71335-2822 | 71335-2822-01 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 72162-1709 | 72162-1709-02 |
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) | A-S Medication Solutions | 50090-1090 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Apotex Corp. | 60505-0363 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Proficient Rx LP | 63187-184 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | Bryant Ranch Prepack | 63629-8716 |
| 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 |
| Ofloxacin Oticofloxacin | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | DIRECT RX | 72189-108 |