Clobetasol Propionate Spray
NDC Package 33342-326-87

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

Clobetasol Propionate sprays is a medication used to treat a variety of skin conditions (e.g., eczema, psoriasis, dermatitis, allergies, rash). This formulation utilizes a spray delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-326 and is authorized under FDA application ANDA214345.

Identification & Billing

NDC Package Code
33342-326-87
Package Description
1 BOTTLE, PUMP in 1 CARTON / 59 mL in 1 BOTTLE, PUMP
Product Code
33342-326
11-Digit Billing Format
33342032687
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clobetasol Propionate
Non-Proprietary Name
Clobetasol Propionate
Substance Name
Clobetasol Propionate
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA214345
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-03-2024
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33342-326). Click a package code to view its specific billing and regulatory data.

33342-326-88
1 BOTTLE, PUMP in 1 CARTON / 125 mL in 1 BOTTLE, PUMP

* 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 33342-326-87 identifies a specific commercial package of 1 bottle, pump in 1 carton / 59 ml in 1 bottle, pump of Clobetasol Propionate, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This spray 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 Macleods Pharmaceuticals Limited on December 03, 2024. The current certification is valid through December 31, 2026.

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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342032687. 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)
33342-326-87
11-Digit CMS (5-4-2)
33342-0326-87

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