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  5. NDC Package Code: 68791-103-20 Dermotic

NDC Package 68791-103-20 Dermotic

Fluocinolone Acetonide Oil 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:
68791-103-20
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 20 mL in 1 BOTTLE, DROPPER
Product Code:
68791-103
Proprietary Name:
Dermotic
Non-Proprietary Name:
Fluocinolone Acetonide
Substance Name:
Fluocinolone Acetonide
Usage Information:
This medication is used to treat eczema of the outer ear (also known as chronic itchy ear). The main symptom is itchiness, but redness, flaking, or oozing may also occur. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.
11-Digit NDC Billing Format:
68791010320
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1191299 - fluocinolone acetonide 0.01 % Oil for Otic Solution
  • RxCUI: 1191299 - fluocinolone acetonide 0.1 MG/ML Otic Solution
  • RxCUI: 1191299 - fluocinolone acetonide 0.01 % Auricular Oil
  • RxCUI: 1191301 - DermOtic Oil 0.01 % Otic Solution
  • RxCUI: 1191301 - fluocinolone acetonide 0.1 MG/ML Otic Solution [Dermotic]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Royal Pharmaceuticals
    Dosage Form:
    Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
    Administration Route(s):
  • Auricular (otic) - Administration to or by way of the ear.
    • Active Ingredient(s):
  • FLUOCINOLONE ACETONIDE .11 mg/mL
    • Pharmacologic Class(es):
  • Corticosteroid Hormone Receptor Agonists - [MoA] (Mechanism of Action)
  • Corticosteroid - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA019452
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-09-2005
    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 68791-103-20?

    The NDC Packaged Code 68791-103-20 is assigned to a package of 1 bottle, dropper in 1 carton / 20 ml in 1 bottle, dropper of Dermotic, a human prescription drug labeled by Royal Pharmaceuticals. The product's dosage form is oil and is administered via auricular (otic) form.

    Is NDC 68791-103 included in the NDC Directory?

    Yes, Dermotic with product code 68791-103 is active and included in the NDC Directory. The product was first marketed by Royal Pharmaceuticals on November 09, 2005 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 68791-103-20?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 68791-103-20?

    The 11-digit format is 68791010320. 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
    5-3-268791-103-205-4-268791-0103-20