Prescription drug · ANDA
Ofloxacin NDC 60505-0560
Ofloxacin 3 mg/mL · Solution · Ophthalmic · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0560-0 | 60505056000 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-0) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 1, 2019 | |
| 60505-0560-1 | 60505056001 | 1 BOTTLE, DROPPER in 1 CARTON (60505-0560-1) / 10 mL in 1 BOTTLE, DROPPERMarketed from Mar 1, 2019 |
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
- Generic name (nonproprietary)
- ofloxacin
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Apotex Corp.NDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076513
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 60505-0560_546dcc18-50b8-db4a-0a19-b06b0ba3a01fSPL ID 546dcc18-50b8-db4a-0a19-b06b0ba3a01f
- 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
N460505056000followed by a unit qualifier and the quantityPackage 60505-0560-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-0560
- What is NDC 60505-0560?
- 60505-0560 is the product NDC for 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.
- 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?
- 71 other product NDCs are listed under this name. See all Ofloxacin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ofloxacin 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 | Ofloxacin 3 mg/mL | SolutionAuricular (Otic) | REMEDYREPACK INC. | 70518-4752 | 70518-4752-00 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsAuricular (Otic) | Preferred Pharmaceuticals Inc. | 68788-4086 | 68788-4086-01 |
| Ofloxacin | Ofloxacin 200 mg/1 | Tablet, Film coatedOral | Modavar Pharmaceuticals LLC | 72241-072 | 72241-0072-0272241-0072-0572241-0072-10 |
| Ofloxacin | Ofloxacin 300 mg/1 | Tablet, Film coatedOral | Modavar Pharmaceuticals LLC | 72241-073 | 72241-0073-0272241-0073-0572241-0073-10 |
| Ofloxacin | Ofloxacin 400 mg/1 | Tablet, Film coatedOral | Modavar Pharmaceuticals LLC | 72241-074 | 72241-0074-0272241-0074-0572241-0074-10 |
| Ofloxacinofloxacin ophthalmic solution usp, 0.3% | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-141 | 65145-0141-01 |
| Ofloxacinofloxacin ophthalmic solution usp, 0.3% | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-142 | 65145-0142-01 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | St. Mary's Medical Park Pharmacy | 60760-917 | 60760-0917-05 |
| Ofloxacinofloxacin otic | Ofloxacin 3 mg/mL | Solution/ dropsAuricular (Otic) | Caplin Steriles Limited | 65145-143 | 65145-0143-01 |
| Ofloxacinofloxacin otic solution | Ofloxacin 3 mg/mL | Solution/ dropsAuricular (Otic) | Caplin Steriles Limited | 65145-144 | 65145-0144-01 |
Other NDCs under ANDA 076513
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 | Ofloxacin 3 mg/mL | SolutionOphthalmic | NuCare Pharmceuticals,Inc. | 68071-3566 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-5186 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-5209 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8761 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 71205-420 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | St. Mary's Medical Park Pharmacy | 60760-917 |