Dapsone Gel
NDC Package 68308-342-60

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

Dapsone gel is a medication used to treat a certain type of skin disorder (dermatitis herpetiformis). This formulation utilizes a gel delivery system. Marketed by Mayne Pharma Commercial Llc, this product is identified by NDC 68308-342 and is authorized under FDA application ANDA214722.

Identification & Billing

NDC Package Code
68308-342-60
Package Description
1 BOTTLE, PUMP in 1 CARTON / 60 g in 1 BOTTLE, PUMP
Product Code
68308-342
11-Digit Billing Format
68308034260
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dapsone
Non-Proprietary Name
Dapsone
Substance Name
Dapsone
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
DAPSONE 75 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat a certain type of skin disorder (dermatitis herpetiformis). It is also used with other drugs to treat Hansen's disease. Dapsone belongs to a class of drugs known as sulfones. It works by decreasing swelling (inflammation) and stopping the growth of bacteria. This medication will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Mayne Pharma Commercial Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA214722
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-11-2022
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 (68308-342). Click a package code to view its specific billing and regulatory data.

68308-342-90
1 BOTTLE, PUMP in 1 CARTON / 90 g 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 68308-342-60 identifies a specific commercial package of 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump of Dapsone, a human prescription drug labeled by Mayne Pharma Commercial Llc. This gel is formulated for topical use and contains dapsone 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 Mayne Pharma Commercial Llc on February 11, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain type of skin disorder (dermatitis herpetiformis). It is also used with other drugs to treat Hansen's disease. Dapsone belongs to a class of drugs known as sulfones. It works by decreasing swelling (inflammation) and stopping the growth of bacteria. This medication will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

How is this Mayne Pharma Commercial Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308034260. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 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 (5-3-2)
68308-342-60
11-Digit CMS (5-4-2)
68308-0342-60

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