Sulfamylon Cream
NDC Package 16571-723-60

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

Sulfamylon (mafenide acetate) cream is a medication used alone or with other medications to help prevent and treat wound infections in patients with severe burns. This formulation utilizes a cream delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 16571-723 and is authorized under FDA application NDA016763.

Identification & Billing

NDC Package Code
16571-723-60
Package Description
1 TUBE in 1 CARTON / 56.7 g in 1 TUBE
Product Code
16571-723
11-Digit Billing Format
16571072360
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
56.7 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sulfamylon
Non-Proprietary Name
Mafenide Acetate
Substance Name
Mafenide Acetate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
MAFENIDE ACETATE 85 mg/g
Pharmacologic Class
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
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA016763
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-18-2020
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 (16571-723). Click a package code to view its specific billing and regulatory data.

16571-723-12
1 TUBE in 1 CARTON / 113.4 g in 1 TUBE
16571-723-48
453.6 g in 1 JAR

* 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 16571-723-60 identifies a specific commercial package of 1 tube in 1 carton / 56.7 g in 1 tube of Sulfamylon, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This cream is formulated for topical use and contains mafenide acetate 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 Rising Pharma Holdings, Inc. on May 18, 2020. The current certification is valid through December 31, 2026.

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 Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16571072360. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 56.7 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)
16571-723-60
11-Digit CMS (5-4-2)
16571-0723-60

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