Otovel
NDC Package 24338-080-14

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.

Otovel is a medication used to treat ear infections for children who have a tube in their ears. Marketed by Arbor Pharmaceuticals, this product is identified by NDC 24338-080 and is authorized under FDA application NDA208251.

Identification & Billing

NDC Package Code
24338-080-14
Package Description
1 POUCH in 1 CARTON / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE (24338-080-25)
Product Code
24338-080
11-Digit Billing Format
24338008014
RxNorm Crosswalk
  • RxCUI: 1792386 - ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % Otic Solution
  • RxCUI: 1792386 - ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution
  • RxCUI: 1792391 - Otovel 0.3 % / 0.025 % Otic Solution
  • RxCUI: 1792391 - ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution [Otovel]
  • RxCUI: 1792391 - Otovel (ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % ) Otic Solution

Clinical Specifications

Proprietary Name
Otovel
Dosage Form
-
Usage Information
This medication is used to treat ear infections for children who have a tube in their ears. This medication contains ciprofloxacin (a quinolone antibiotic) and fluocinolone (a corticosteroid). This product works by stopping the growth of bacteria and reducing ear inflammation and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Arbor Pharmaceuticals
FDA Application #
NDA208251
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-29-2016
Listing Expiration
12-31-2021
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 24338-080-14 identifies a specific commercial package of 1 pouch in 1 carton / 14 vial, single-dose in 1 pouch / .25 ml in 1 vial, single-dose (24338-080-25) of Otovel, labeled by Arbor Pharmaceuticals. 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 Arbor Pharmaceuticals on April 29, 2016. The current certification is valid through December 31, 2021.

What are the primary indications for this medication?

This medication is used to treat ear infections for children who have a tube in their ears. This medication contains ciprofloxacin (a quinolone antibiotic) and fluocinolone (a corticosteroid). This product works by stopping the growth of bacteria and reducing ear inflammation and discomfort. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Arbor Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24338008014. 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)
24338-080-14
11-Digit CMS (5-4-2)
24338-0080-14

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