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  5. NDC Package Code: 45802-009-10 Fluocinolone Acetonide

NDC Package 45802-009-10 Fluocinolone Acetonide

Solution/ Drops 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:
45802-009-10
Package Description:
1 BOTTLE in 1 CARTON / 20 mL in 1 BOTTLE
Product Code:
45802-009
Proprietary Name:
Fluocinolone Acetonide
Non-Proprietary Name:
Fluocinolone Acetonide
Substance Name:
Fluocinolone Acetonide
Usage Information:
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Fluocinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.
11-Digit NDC Billing Format:
45802000910
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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    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:
    ANDA202849
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-04-2017
    Listing Expiration Date:
    12-31-2024
    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 45802-009-10?

    The NDC Packaged Code 45802-009-10 is assigned to a package of 1 bottle in 1 carton / 20 ml in 1 bottle of Fluocinolone Acetonide, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is solution/ drops and is administered via auricular (otic) form.

    Is NDC 45802-009 included in the NDC Directory?

    Yes, Fluocinolone Acetonide with product code 45802-009 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on October 04, 2017 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 45802-009-10?

    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 45802-009-10?

    The 11-digit format is 45802000910. 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
    5-3-245802-009-105-4-245802-0009-10