Prescription drug · ANDA
Ofloxacin (Ofloxacin ophthalmic solution usp, 0.3%) NDC 70512-793
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · SOLA Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70512-793-05 | 7051207930570512079305 | 1 BOTTLE, DROPPER in 1 BOX (70512-793-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 30, 2024 | |
| 70512-793-10 | 7051207931070512079310 | 1 BOTTLE, DROPPER in 1 BOX (70512-793-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Apr 30, 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 ophthalmic solution usp, 0.3%
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- SOLA Pharmaceuticals, LLCNDC labeler code 70512
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217904
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 70512-793_4572865e-3ba3-c17b-e063-6294a90a97fdSPL ID 4572865e-3ba3-c17b-e063-6294a90a97fdSPL set ID 4ca27244-ed70-4868-b2d8-8f97c3a52148RxCUI 312075UNII A4P49JAZ9HUPC 0370512793104, 0370512793050
- 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
N470512079305followed by a unit qualifier and the quantityPackage 70512-0793-05. 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 & 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 Efficacy for this organism was studied in fewer than 10 infections Streptococcus pneumoniae Anaerobic species: Propionibacterium acnes
Excerpt only. Read the full label for complete information.
About NDC 70512-793
- What is NDC 70512-793?
- 70512-793 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by SOLA Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ofloxacin (Ofloxacin Ophthalmic Solution USP, 0.3%).
- What is the active ingredient?
- Ofloxacin.
- Who is the labeler?
- SOLA Pharmaceuticals, LLC, NDC labeler code 70512. 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?
- 72 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 217904
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 ophthalmic solution usp, 0.3% | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-141 |
| Ofloxacinofloxacin ophthalmic solution usp, 0.3% | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-142 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals, Inc. | 68071-5337 |
| Ofloxacin | Ofloxacin 3 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-327 |