Diflorasone Diacetate
NDC Package 0168-0243-15

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.

Diflorasone Diacetate is diflorasone is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Marketed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc., this product is identified by NDC 0168-0243 and is authorized under FDA application ANDA075374.

Identification & Billing

NDC Package Code
0168-0243-15
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE
Product Code
0168-0243
11-Digit Billing Format
00168024315
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
15 GM

Clinical Specifications

Proprietary Name
Diflorasone Diacetate
Dosage Form
-
Usage Information
Diflorasone is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Diflorasone reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a strong (high-potency) corticosteroid.

Regulatory & Marketing

Labeler Name
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
FDA Application #
ANDA075374
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-27-1999
End Marketing Date
10-31-2011
Listing Expiration
10-31-2011
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 (0168-0243). Click a package code to view its specific billing and regulatory data.

0168-0243-30
1 TUBE in 1 CARTON / 30 g in 1 TUBE
0168-0243-60
1 TUBE in 1 CARTON / 60 g in 1 TUBE

* 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 0168-0243-15 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube of Diflorasone Diacetate, labeled by E. Fougera & Co. A Division Of Fougera 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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. on April 27, 1999. The current certification is valid through October 31, 2011.

What are the primary indications for this medication?

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

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00168024315. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 15 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)
0168-0243-15
11-Digit CMS (5-4-2)
00168-0243-15

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