Clobetasol Propionate
NDC Package 0378-8167-50

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Clobetasol Propionate is a medication used to treat a variety of skin conditions (e.g., eczema, psoriasis, dermatitis, allergies, rash). Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-8167 and is authorized under FDA application NDA021142.

Identification & Billing

NDC Package Code
0378-8167-50
Package Description
50 g in 1 CAN
Product Code
0378-8167
11-Digit Billing Format
00378816750
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM

Clinical Specifications

Proprietary Name
Clobetasol Propionate
Dosage Form
-
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
Mylan Pharmaceuticals Inc.
FDA Application #
NDA021142
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
12-11-2018
End Marketing Date
01-31-2023
Listing Expiration
01-31-2023
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0378-8167). Click a package code to view its specific billing and regulatory data.

0378-8167-01
100 g in 1 CAN

* 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 0378-8167-50 identifies a specific commercial package of 50 g in 1 can of Clobetasol Propionate, labeled by Mylan Pharmaceuticals Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mylan Pharmaceuticals Inc. on December 11, 2018. The current certification is valid through January 31, 2023.

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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378816750. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
0378-8167-50
11-Digit CMS (5-4-2)
00378-8167-50

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