Prescription drug · NDA
Cipro Hc NDC 66758-087
ciprofloxacin hydrochloride and hydrocortisone · Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL · Suspension/ drops · Auricular (Otic) · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66758-087-70 | 66758008770 | 1 BOTTLE in 1 CARTON (66758-087-70) / 10 mL in 1 BOTTLEMarketed from Nov 8, 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)
- Cipro HcSuffix: HC
- Generic name (nonproprietary)
- ciprofloxacin hydrochloride and hydrocortisone
- Active ingredients
- Ciprofloxacin hydrochloride — 2 mg/mLHydrocortisone — 10 mg/mL
- Dosage form
- Suspension/ drops
- Route
- Auricular (Otic)
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020805
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 66758-087_7c5775a8-2754-4652-b57a-75bbf32dfbe6SPL ID 7c5775a8-2754-4652-b57a-75bbf32dfbe6SPL set ID b26594a3-2adf-4954-8be0-5bd6f8de9671RxCUI 213320, 309305UNII 4BA73M5E37, WI4X0X7BPJ
- 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
N466758008770followed by a unit qualifier and the quantityPackage 66758-0087-70. 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 CIPRO ® HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020805
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 |
|---|---|---|---|---|
| Cipro Hcciprofloxacin hydrochloride and hydrocortisone | Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL | Suspension/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-7631 |
| Cipro Hcciprofloxacin hydrochloride and hydrocortisone | Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL | Suspension/ dropsAuricular (Otic) | Asclemed USA, Inc. | 76420-273 |
| Cipro Hcciprofloxacin hydrochloride and hydrocortisone | Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL | Suspension/ dropsAuricular (Otic) | A-S Medication Solutions | 50090-6043 |
| ciprofloxacin hydrochloride and hydrocortisone | Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL | Suspension/ dropsAuricular (Otic) | Sandoz Inc | 0781-6218 |