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

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fluocinolone Acetonide Topical Solution Usp, 0.01% solution is this shampoo is used to treat severe dandruff (seborrheic dermatitis). This formulation utilizes a solution delivery system. Marketed by Encube Ethicals, Inc., this product is identified by NDC 21922-003 and is authorized under FDA application ANDA209913.

Identification & Billing

NDC Package Code
21922-003-01
Package Description
1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE
Product Code
21922-003
11-Digit Billing Format
21922000301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluocinolone Acetonide Topical Solution Usp, 0.01%
Non-Proprietary Name
Fluocinolone Acetonide Topical Solution Usp, 0.01%
Substance Name
Fluocinolone Acetonide
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
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)
FLUOCINOLONE ACETONIDE .1 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Encube Ethicals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209913
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21922-003-01 identifies a specific commercial 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, Inc.. This solution is formulated for topical use and contains fluocinolone acetonide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Encube Ethicals, Inc. on March 20, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Encube Ethicals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21922000301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
21922-003-01
11-Digit CMS (5-4-2)
21922-0003-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.