Prescription drug · ANDA
ciprofloxacin hydrochloride and hydrocortisone NDC 0713-0851
Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL · Suspension/ drops · Auricular (Otic) · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0851-09 | 0071308510900713085109 | 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLEMarketed from Dec 4, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrochloride and hydrocortisone
- 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
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218273
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Fluoroquinolones (Chemical structure)
- Identifiers
- Product ID 0713-0851_44ea2018-99d5-8f97-e063-6294a90ab0f2SPL ID 44ea2018-99d5-8f97-e063-6294a90ab0f2SPL set ID 6848cb55-7ca4-40ca-9751-f1fc262b8336RxCUI 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
N400713085109followed by a unit qualifier and the quantityPackage 00713-0851-09. 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 hydrochloride and hydrocortisone otic suspension 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.
About NDC 0713-0851
- What is NDC 0713-0851?
- 0713-0851 is the product NDC for ciprofloxacin hydrochloride and hydrocortisone, Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL suspension/ drops, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ciprofloxacin hydrochloride and hydrocortisone.
- What is the active ingredient?
- Ciprofloxacin hydrochloride, Hydrocortisone.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for ciprofloxacin hydrochloride and hydrocortisone?
- 1 other product NDC are listed under this name. See all ciprofloxacin hydrochloride and hydrocortisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other ciprofloxacin hydrochloride and hydrocortisone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ciprofloxacin hydrochloride and hydrocortisone | Ciprofloxacin hydrochloride 2 mg/mL; Hydrocortisone 10 mg/mL | Suspension/ dropsAuricular (Otic) | Sandoz Inc | 0781-6218 | 00781-6218-70 |