Dapsone Tablet
NDC Package 62135-965-30

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

Package Information

Dapsone tablets is a medication used to treat a certain type of skin disorder (dermatitis herpetiformis). This formulation utilizes a tablet delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-965 and is authorized under FDA application ANDA204074.

Identification & Billing

NDC Package Code
62135-965-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
62135-965
11-Digit Billing Format
62135096530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dapsone
Non-Proprietary Name
Dapsone
Substance Name
Dapsone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DAPSONE 25 mg/1
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
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204074
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-10-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62135-965-30 identifies a specific commercial package of 30 tablet in 1 bottle of Dapsone, a human prescription drug labeled by Chartwell Rx, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet is formulated for oral 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 Chartwell Rx, Llc on May 10, 2016. 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 Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135096530. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
62135-965-30
11-Digit CMS (5-4-2)
62135-0965-30

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