Prescription drug · ANDA
Ofloxacin NDC 60760-970
Ofloxacin 3 mg/mL · Solution · Ophthalmic · ST. MARY'S MEDICAL PARK PHARMACY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60760-970-05 | 60760097005 | 1 BOTTLE, PLASTIC in 1 CARTON (60760-970-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Nov 22, 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
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACYNDC labeler code 60760
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078559
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 60760-970_54de693a-498b-ce48-e063-6394a90af5ebSPL ID 54de693a-498b-ce48-e063-6394a90af5ebSPL set ID 27c247e5-ef93-e9a5-e063-6394a90a2e1eRxCUI 312075UNII 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 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
N460760097005followed by a unit qualifier and the quantityPackage 60760-0970-05. 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 ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS : Gram - positive bacteria : Gram - negative bacteria : Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS : Gram - positive bacteria : Gram - negative bacteria : Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens * Streptococcus pneumoniae Anaerobic species : Propionibacterium acnes * Efficacy for this organism was studied in fewer t…
Excerpt only. Read the full label for complete information.
About NDC 60760-970
- What is NDC 60760-970?
- 60760-970 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution, listed with the FDA by ST. MARY'S MEDICAL PARK PHARMACY. It has 1 package NDC, 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?
- ST. MARY'S MEDICAL PARK PHARMACY, NDC labeler code 60760. 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 400 mg/1 | Tablet, Film coatedOral | Modavar Pharmaceuticals LLC | 72241-074 | 72241-0074-0272241-0074-0572241-0074-10 |
| 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 |
| 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 078559
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 | Rising Pharma Holdings, Inc. | 64980-515 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-5425 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 63187-734 |