Prescription drug · ANDA
Ofloxacin Otic (Ofloxacin) NDC 60505-0363
Ofloxacin 3 mg/mL · Solution · Auricular (Otic) · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0363-1 | 6050503630160505036301 | 5 mL in 1 BOTTLE, DROPPER (60505-0363-1)Marketed from May 14, 2004 | |
| 60505-0363-2 | 6050503630260505036302 | 10 mL in 1 BOTTLE, DROPPER (60505-0363-2)Marketed from May 14, 2004 |
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
- Apotex Corp.NDC labeler code 60505
- 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 60505-0363_face4268-6008-b5da-8227-eed609bef124SPL ID face4268-6008-b5da-8227-eed609bef124
- 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
N460505036301followed by a unit qualifier and the quantityPackage 60505-0363-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-0363
- What is NDC 60505-0363?
- 60505-0363 is the product NDC for Ofloxacin Otic (ofloxacin), Ofloxacin 3 mg/mL solution, listed with the FDA by Apotex Corp.. It has 2 package NDCs, 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?
- Apotex Corp., NDC labeler code 60505. 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) | REMEDYREPACK INC. | 70518-4226 | 70518-4226-00 |
| 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) | 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) | 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) | REMEDYREPACK INC. | 70518-4226 |
| 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 |