Ciprodex
NDC Package 0065-8533-03
Package Information
Ciprodex is a medication used to treat bacterial ear infections. Marketed by Alcon Laboratories, Inc., this product is identified by NDC 0065-8533 and is authorized under FDA application NDA021537.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0065 - Alcon Laboratories, Inc.
- 0065-8533 - Ciprodex
- 0065-8533-03 - 1 BOTTLE, DROPPER in 1 CARTON / 1.5 mL in 1 BOTTLE, DROPPER
- 0065-8533 - Ciprodex
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.
Other Available Packages
The following commercial packages are registered under the same Product NDC (0065-8533). Click a package code to view its specific billing and regulatory data.
* 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 0065-8533-03 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 1.5 ml in 1 bottle, dropper of Ciprodex, labeled by Alcon Laboratories, Inc.. 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 Alcon Laboratories, Inc. on August 04, 2003. The current certification is valid through November 30, 2021.
What are the primary indications for this medication?
This medication is used to treat bacterial ear infections. It is used to treat middle ear infections in children with ear tubes, as well as 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 dexamethasone (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 Alcon Laboratories, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00065853303. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
