Prescription drug · ANDA
Ciprofloxacin and Dexamethasone NDC 85766-245
Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL · Suspension/ drops · Auricular (Otic) · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-245-75 | 85766024575 | 1 BOTTLE, DROPPER in 1 CARTON (85766-245-75) / 7.5 mL in 1 BOTTLE, DROPPERMarketed from Jul 13, 2026 |
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)
- Ciprofloxacin and Dexamethasone
- Generic name (nonproprietary)
- ciprofloxacin and dexamethasone
- Active ingredients
- Ciprofloxacin hydrochloride — 3 mg/mLDexamethasone — 1 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Auricular (Otic)
- Labeler
- Sportpharm LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205548
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 85766-245_567b0c1f-2a68-ea09-e063-6394a90a4a9dSPL ID 567b0c1f-2a68-ea09-e063-6394a90a4a9dSPL set ID 780a5554-54ef-4294-b681-8c5300b028b6RxCUI 403908UNII 4BA73M5E37, 7S5I7G3JQL
- Pharmacologic class
- Corticosteroid; 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N485766024575followed by a unit qualifier and the quantityPackage 85766-0245-75. 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)
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa. Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is a combination of ciprofloxacin, a fluoroquinolone a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205548
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 and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Dr. Reddy's Laboratories, Inc. | 43598-326 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | Redpharm Drug | 67296-2257 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | NuCare Pharmaceuticals, Inc. | 68071-3804 |
| Ciprofloxacin and Dexamethasone | Ciprofloxacin hydrochloride 3 mg/mL; Dexamethasone 1 mg/mL | Suspension/ dropsAuricular (Otic) | NorthStar RxLLC | 16714-628 |