Mafenide Acetate
NDC Package 51125-400-05

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.

Mafenide Acetate is a medication used alone or with other medications to help prevent and treat wound infections in patients with severe burns. Marketed by Riconpharma Llc, this product is identified by NDC 51125-400 and is authorized under FDA application ANDA206716.

Identification & Billing

NDC Package Code
51125-400-05
Package Description
1 CARTON in 1 PACKET / 5 POWDER, FOR SOLUTION in 1 CARTON (51125-400-03)
Product Code
51125-400
11-Digit Billing Format
51125040005

Clinical Specifications

Proprietary Name
Mafenide Acetate
Dosage Form
-
Usage Information
This medication is used alone or with other medications to help prevent and treat wound infections in patients with severe burns. Mafenide is a drug applied to the skin that belongs to a class of drugs known as sulfa antibiotics. It works by killing bacteria that may infect an open wound. Killing bacteria helps to promote wound healing and to decrease the risk of the bacteria spreading to surrounding skin or to the blood, thereby helping to prevent a serious blood infection (sepsis).

Regulatory & Marketing

Labeler Name
Riconpharma Llc
FDA Application #
ANDA206716
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2017
End Marketing Date
10-22-2018
Listing Expiration
10-22-2018
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 51125-400-05 identifies a specific commercial package of 1 carton in 1 packet / 5 powder, for solution in 1 carton (51125-400-03) of Mafenide Acetate, labeled by Riconpharma Llc. 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 Riconpharma Llc on July 31, 2017. The current certification is valid through October 22, 2018.

What are the primary indications for this medication?

This medication is used alone or with other medications to help prevent and treat wound infections in patients with severe burns. Mafenide is a drug applied to the skin that belongs to a class of drugs known as sulfa antibiotics. It works by killing bacteria that may infect an open wound. Killing bacteria helps to promote wound healing and to decrease the risk of the bacteria spreading to surrounding skin or to the blood, thereby helping to prevent a serious blood infection (sepsis).

How is this Riconpharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51125040005. 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)
51125-400-05
11-Digit CMS (5-4-2)
51125-0400-05

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