Clobetasol Propionate Cream Usp, 0.05%
NDC Package 68071-2671-3

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Clobetasol Propionate Cream Usp, 0.05% is clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-2671 and is authorized under FDA application ANDA212982.

Identification & Billing

NDC Package Code
68071-2671-3
Package Description
30 g in 1 TUBE
Product Code
68071-2671
11-Digit Billing Format
68071267103
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clobetasol Propionate Cream Usp, 0.05% Clobetasol Propionate Cream Usp, 0.05%
Dosage Form
-
Usage Information
Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals,inc.
FDA Application #
ANDA212982
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2020
Listing Expiration
12-31-2024
Exclude Flag
I
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 68071-2671-3 identifies a specific commercial package of 30 g in 1 tube of Clobetasol Propionate Cream Usp, 0.05% Clobetasol Propionate Cream Usp, 0.05%, labeled by Nucare 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 Nucare Pharmaceuticals,inc. on October 01, 2020. The current certification is valid through December 31, 2024.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071267103. 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 (5-4-1)
68071-2671-3
11-Digit CMS (5-4-2)
68071-2671-03

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