Cipro Hc
NDC Package 16590-053-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cipro Hc is a medication used to treat bacterial ear infections. Marketed by Stat Rx Usa, this product is identified by NDC 16590-053 and is authorized under FDA application NDA020805.

Identification & Billing

NDC Package Code
16590-053-10
Package Description
10 mL in 1 BOTTLE, GLASS
Product Code
16590-053
11-Digit Billing Format
16590005310
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
10 ML
RxNorm Crosswalk
  • RxCUI: 213320 - Cipro HC 0.2 % / 1 % Otic Suspension
  • RxCUI: 213320 - ciprofloxacin 2 MG/ML / hydrocortisone 10 MG/ML Otic Suspension [Cipro HC]
  • RxCUI: 213320 - Cipro HC (ciprofloxacin 0.2 % / hydrocortisone 1 % ) Otic Suspension
  • RxCUI: 213320 - Cipro HC 2/10 Otic Suspension
  • RxCUI: 309305 - ciprofloxacin 0.2 % / hydrocortisone 1 % Otic Suspension

Clinical Specifications

Proprietary Name
Cipro Hc
Dosage Form
-
Usage Information
This medication is used to treat bacterial ear infections. It is used to treat outer ear infections (also known as swimmer's ear) in children and adults. This medication contains a combination of ciprofloxacin (a quinolone-type antibiotic) and hydrocortisone (an anti-inflammatory corticosteroid). This ear drop works by stopping the growth of bacteria and reducing ear swelling and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Stat Rx Usa
FDA Application #
NDA020805
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-10-1998
Listing Expiration
12-31-2017
Exclude Flag
I
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 16590-053-10 identifies a specific commercial package of 10 ml in 1 bottle, glass of Cipro Hc, labeled by Stat Rx Usa. This product is billed per "ML" milliliter and contains an estimated amount of 10 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Stat Rx Usa on February 10, 1998. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication is used to treat bacterial ear infections. It is used to treat outer ear infections (also known as swimmer's ear) in children and adults. This medication contains a combination of ciprofloxacin (a quinolone-type antibiotic) and hydrocortisone (an anti-inflammatory corticosteroid). This ear drop works by stopping the growth of bacteria and reducing ear swelling and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How is this Stat Rx Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590005310. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 10 total billable units per package. 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 (5-3-2)
16590-053-10
11-Digit CMS (5-4-2)
16590-0053-10

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