Prescription drug · ANDA
ciprofloxacin NDC 85534-0075
Ciprofloxacin hydrochloride 3 mg/mL · Solution · Ophthalmic · HAWAII REPACK, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0075-0 | 85534007500 | 1 BOTTLE, PLASTIC in 1 CARTON (85534-0075-0) / 2.5 mL in 1 BOTTLE, PLASTICMarketed from Jul 12, 2026 | |
| 85534-0075-1 | 85534007501 | 1 BOTTLE, PLASTIC in 1 CARTON (85534-0075-1) / 5 mL in 1 BOTTLE, PLASTICMarketed from Jul 12, 2026 | |
| 85534-0075-2 | 85534007502 | 1 BOTTLE, PLASTIC in 1 CARTON (85534-0075-2) / 10 mL in 1 BOTTLE, PLASTICMarketed from Jul 12, 2026 |
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)
- ciprofloxacin
- Generic name (nonproprietary)
- ciprofloxacin
- Active ingredients
- Ciprofloxacin hydrochloride — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- HAWAII REPACK, INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077568
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 85534-0075_566c6b87-1aa7-7ddc-e063-6394a90acd3bSPL ID 566c6b87-1aa7-7ddc-e063-6394a90acd3bSPL set ID 4caf49d9-b06f-4d57-aac3-cc64ae12cc95RxCUI 309307UNII 4BA73M5E37
- Pharmacologic class
- Fluoroquinolone Antibacterial
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
N485534007500followed by a unit qualifier and the quantityPackage 85534-0075-00. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Ciprofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group) * Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077568
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 |
|---|---|---|---|---|
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-308 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Advanced Rx of Tennessee, LLC | 80425-0499 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4672 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4679 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Preferred Pharmaceuticals, Inc. | 68788-7500 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Sportpharm LLC | 85766-023 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Redpharm Drug | 67296-1703 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-4217 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-588 |
| ciprofloxacin | Ciprofloxacin hydrochloride 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 71205-300 |