Dapsone
NDC Package 47781-334-31

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 discontinued by the firm.

Dapsone is a medication used to treat a certain type of skin disorder (dermatitis herpetiformis). Marketed by Alvogen Inc., this product is identified by NDC 47781-334 and is authorized under FDA application ANDA205429.

Identification & Billing

NDC Package Code
47781-334-31
Package Description
2 BLISTER PACK in 1 CARTON / 15 TABLET in 1 BLISTER PACK
Product Code
47781-334
11-Digit Billing Format
47781033431
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA

Clinical Specifications

Proprietary Name
Dapsone
Dosage Form
-
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
Alvogen Inc.
FDA Application #
ANDA205429
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-13-2016
End Marketing Date
02-01-2021
Listing Expiration
02-01-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 47781-334-31 identifies a specific commercial package of 2 blister pack in 1 carton / 15 tablet in 1 blister pack of Dapsone, labeled by Alvogen 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 Alvogen Inc. on June 13, 2016. The current certification is valid through February 01, 2021.

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 Alvogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47781033431. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
47781-334-31
11-Digit CMS (5-4-2)
47781-0334-31

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