Prescription drug · ANDA
Ofloxacin NDC 68788-7693
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7693-5 | 68788769305 | 1 BOTTLE, DROPPER in 1 CARTON (68788-7693-5) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 1, 2020 |
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/ drops
- Route
- Ophthalmic
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076622
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 68788-7693_7743f352-5f73-4768-89eb-b81017aa8bc1SPL ID 7743f352-5f73-4768-89eb-b81017aa8bc1SPL set ID 0c01de7a-a885-4bf0-8df0-7c62170b7850RxCUI 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
N468788769305followed by a unit qualifier and the quantityPackage 68788-7693-05. 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: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections…
Excerpt only. Read the full label for complete information.
About NDC 68788-7693
- What is NDC 68788-7693?
- 68788-7693 is the product NDC for Ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by Preferred Pharmaceuticals, Inc.. 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 | 65145-142 | 65145-0142-01 |
| Ofloxacinofloxacin ophthalmic solution usp, 0.3% | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Caplin Steriles Limited | 65145-141 | 65145-0141-01 |
| 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 076622
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 | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3573 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7264 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1744 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-268 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-434 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2254 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2265 |