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  5. NDC Package Code: 66992-128-14 Otovel

NDC Package 66992-128-14 Otovel

Ciprofloxacin And Fluocinolone Acetonide Solution Auricular (otic) - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
66992-128-14
Package Description:
1 POUCH in 1 CARTON / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE
Product Code:
66992-128
Proprietary Name:
Otovel
Non-Proprietary Name:
Ciprofloxacin And Fluocinolone Acetonide
Substance Name:
Ciprofloxacin; Fluocinolone Acetonide
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.
11-Digit NDC Billing Format:
66992012814
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Wraser Llc
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s):
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
NDA208251
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
10-04-2021
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 66992-128-14?

The NDC Packaged Code 66992-128-14 is assigned to a package of 1 pouch in 1 carton / 14 vial, single-dose in 1 pouch / .25 ml in 1 vial, single-dose of Otovel, a human prescription drug labeled by Wraser Llc. The product's dosage form is solution and is administered via auricular (otic) form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 66992-128 included in the NDC Directory?

Yes, Otovel with product code 66992-128 is active and included in the NDC Directory. The product was first marketed by Wraser Llc on October 04, 2021 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 66992-128-14?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 66992-128-14?

The 11-digit format is 66992012814. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-266992-128-145-4-266992-0128-14