NDC Package 21922-003-01 Fluocinolone Acetonide Topical Solution Usp, 0.01%

Solution Topical - View Billable Units, 11-Digit Format, RxNorm

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:
21922-003-01
Package Description:
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Fluocinolone Acetonide Topical Solution Usp, 0.01%
Non-Proprietary Name:
Fluocinolone Acetonide Topical Solution Usp, 0.01%
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:
21922000301
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1191310 - fluocinolone acetonide 0.01 % Topical Solution
  • RxCUI: 1191310 - fluocinolone acetonide 0.1 MG/ML Topical Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Encube Ethicals Private Limited
    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):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA209913
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-20-2019
    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 21922-003-01?

    The NDC Packaged Code 21922-003-01 is assigned to a package of 1 bottle in 1 carton / 60 ml in 1 bottle of Fluocinolone Acetonide Topical Solution Usp, 0.01%, a human prescription drug labeled by Encube Ethicals Private Limited. The product's dosage form is solution and is administered via topical form.

    Is NDC 21922-003 included in the NDC Directory?

    Yes, Fluocinolone Acetonide Topical Solution Usp, 0.01% with product code 21922-003 is active and included in the NDC Directory. The product was first marketed by Encube Ethicals Private Limited on March 20, 2019 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 21922-003-01?

    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 21922-003-01?

    The 11-digit format is 21922000301. 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
    5-3-221922-003-015-4-221922-0003-01