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  5. NDC Package Code: 13925-508-20 Fluocinolone Acetonide 0.01%

NDC Package 13925-508-20 Fluocinolone Acetonide 0.01%

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:
13925-508-20
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 20 mL in 1 BOTTLE, DROPPER
Product Code:
13925-508
Proprietary Name:
Fluocinolone Acetonide 0.01%
Non-Proprietary Name:
Fluocinolone Acetonide
Substance Name:
Fluocinolone Acetonide
Usage Information:
This shampoo is used to treat severe dandruff (seborrheic dermatitis). Fluocinolone reduces the swelling, itching, flaking, and redness that can occur with dandruff. This medication is a low- to medium-strength corticosteroid.
11-Digit NDC Billing Format:
13925050820
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:
    Seton 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 AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date:
    08-01-2013
    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 13925-508-20?

    The NDC Packaged Code 13925-508-20 is assigned to a package of 1 bottle, dropper in 1 carton / 20 ml in 1 bottle, dropper of Fluocinolone Acetonide 0.01%, a human prescription drug labeled by Seton Pharmaceuticals. The product's dosage form is oil and is administered via auricular (otic) form.

    Is NDC 13925-508 included in the NDC Directory?

    Yes, Fluocinolone Acetonide 0.01% with product code 13925-508 is active and included in the NDC Directory. The product was first marketed by Seton Pharmaceuticals on August 01, 2013 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 13925-508-20?

    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 13925-508-20?

    The 11-digit format is 13925050820. 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
    5-3-213925-508-205-4-213925-0508-20