Ciprodex
NDC Package 54868-4928-0
Package Information
Ciprodex is a medication used to treat bacterial ear infections. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4928 and is authorized under FDA application NDA021537.
Identification & Billing
- RxCUI: 403908 - ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic Suspension
- RxCUI: 403908 - ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
- RxCUI: 403908 - ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
- RxCUI: 403908 - ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic Suspension
- RxCUI: 404630 - CIPRODEX 0.3 % / 0.1 % Otic Suspension
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 54868 - Physicians Total Care, Inc.
- 54868-4928 - Ciprodex
- 54868-4928-0 - 7.5 mL in 1 BOTTLE, PLASTIC
- 54868-4928 - 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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 54868-4928-0 identifies a specific commercial package of 7.5 ml in 1 bottle, plastic of Ciprodex, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 7.5 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 Physicians Total Care, Inc. on September 21, 2004. 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 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 Physicians Total Care, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868492800. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 7.5 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
