Prescription drug · ANDA
ofloxacin NDC 70756-650
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-650-30 | 70756065030 | 1 BOTTLE, DROPPER in 1 CARTON (70756-650-30) / 10 mL in 1 BOTTLE, DROPPERMarketed from Aug 25, 2023 |
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/ drops
- Route
- Ophthalmic
- Labeler
- Lifestar Pharma LLCNDC labeler code 70756
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215886
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 70756-650_a68adde3-7458-4a12-9aea-537d6ce5f144SPL ID a68adde3-7458-4a12-9aea-537d6ce5f144SPL set ID 871d63f4-41c1-4b30-903c-11fbf0d4c1f8RxCUI 312075UNII A4P49JAZ9HUPC 0370756607304
- 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
N470756065030followed by a unit qualifier and the quantityPackage 70756-0650-30. 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: *Efficacy for this organism was studied in fewer than 10 infections 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
Excerpt only. Read the full label for complete information.
About NDC 70756-650
- What is NDC 70756-650?
- 70756-650 is the product NDC for ofloxacin, Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by Lifestar Pharma LLC. 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?
- Lifestar Pharma LLC, NDC labeler code 70756. 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 215886
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 | Major Pharmaceuticals | 0904-7434 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-6794 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-7761 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3448 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals, Inc. | 68071-3919 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8449 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3710 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-607 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NorthStar RxLLC | 72603-192 |
| ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 82804-101 |
| Ofloxacin Ophth Soln | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Direct_Rx | 72189-472 |