Ciprofloxacin Hydrochloride And Hydrocortisone Suspension/ Drops
NDC Package 0713-0851-09

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ciprofloxacin Hydrochloride And Hydrocortisone suspension/ dropses is 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. This formulation utilizes a suspension/ drops delivery system. Marketed by Cosette Pharmaceuticals, Inc., this product is identified by NDC 0713-0851 and is authorized under FDA application ANDA218273.

Identification & Billing

NDC Package Code
0713-0851-09
Package Description
1 BOTTLE in 1 CARTON / 10 mL in 1 BOTTLE
Product Code
0713-0851
11-Digit Billing Format
00713085109
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 309305 - ciprofloxacin 0.2 % / hydrocortisone 1 % Otic Suspension
  • RxCUI: 309305 - ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension

Clinical Specifications

Proprietary Name
Ciprofloxacin Hydrochloride And Hydrocortisone
Non-Proprietary Name
Ciprofloxacin Hydrochloride And Hydrocortisone
Substance Name
Ciprofloxacin Hydrochloride; Hydrocortisone
Dosage Form
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Cosette Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218273
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-04-2025
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0713-0851-09 identifies a specific commercial package of 1 bottle in 1 carton / 10 ml in 1 bottle of Ciprofloxacin Hydrochloride And Hydrocortisone, a human prescription drug labeled by Cosette Pharmaceuticals, Inc.. This suspension/ drops is formulated for auricular (otic) use and contains ciprofloxacin hydrochloride; hydrocortisone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Cosette Pharmaceuticals, Inc. on December 04, 2025. The current certification is valid through December 31, 2026.

How is this Cosette Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00713085109. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0713-0851-09
11-Digit CMS (5-4-2)
00713-0851-09

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.