Dapsone Powder
NDC Package 45562-1120-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Dapsone powders is a medication used to treat acne. This formulation utilizes a powder delivery system. Marketed by Lundbeck Pharmaceuticals Italy S.p.a., this product is identified by NDC 45562-1120.

Identification & Billing

NDC Package Code
45562-1120-0
Package Description
50 kg in 1 DRUM
Product Code
45562-1120
11-Digit Billing Format
45562112000

Clinical Specifications

Proprietary Name
Dapsone
Non-Proprietary Name
Dapsone
Substance Name
Dapsone
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
DAPSONE 1 kg/kg
Usage Information
This medication is used to treat acne. It helps decrease the number and severity of acne pimples and helps pimples that do develop to heal more quickly. Dapsone is an antibiotic. It is not known how dapsone works to treat acne.

Regulatory & Marketing

Labeler Name
Lundbeck Pharmaceuticals Italy S.p.a.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
03-09-2001
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 45562-1120-0 identifies a specific commercial package of 50 kg in 1 drum of Dapsone (UNFINISHED drug), drug for further processing labeled by Lundbeck Pharmaceuticals Italy S.p.a.. This powder is formulated for 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 Lundbeck Pharmaceuticals Italy S.p.a. on March 09, 2001. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat acne. It helps decrease the number and severity of acne pimples and helps pimples that do develop to heal more quickly. Dapsone is an antibiotic. It is not known how dapsone works to treat acne.

How is this Lundbeck Pharmaceuticals Italy S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45562112000. 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)
45562-1120-0
11-Digit CMS (5-4-2)
45562-1120-00

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