Clobetasol Propionate Solution
NDC Package 0168-0269-50

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

Package Information

Clobetasol Propionate solution is a medication used to treat a variety of skin conditions (e.g., eczema, psoriasis, dermatitis, allergies, rash). This formulation utilizes a solution delivery system. Marketed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc, this product is identified by NDC 0168-0269 and is authorized under FDA application ANDA075391.

Identification & Billing

NDC Package Code
0168-0269-50
Package Description
50 mL in 1 BOTTLE, PLASTIC
Product Code
0168-0269
11-Digit Billing Format
00168026950
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
50 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clobetasol Propionate
Non-Proprietary Name
Clobetasol Propionate
Substance Name
Clobetasol Propionate
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)
CLOBETASOL PROPIONATE .5 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat a variety of skin conditions (e.g., eczema, psoriasis, dermatitis, allergies, rash). Clobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid.

Regulatory & Marketing

Labeler Name
E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075391
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-08-1999
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 0168-0269-50 identifies a specific commercial package of 50 ml in 1 bottle, plastic of Clobetasol Propionate, a human prescription drug labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc. This solution is formulated for topical use and contains clobetasol propionate 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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc on February 08, 1999. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a variety of skin conditions (e.g., eczema, psoriasis, dermatitis, allergies, rash). Clobetasol reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid.

How is this E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00168026950. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 50 total billable units per package. 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 (4-4-2)
0168-0269-50
11-Digit CMS (5-4-2)
00168-0269-50

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