Silver Sulfadiazine Cream
NDC Package 50090-0607-0

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

Package Information

Silver Sulfadiazine cream is a medication used with other treatments to help prevent and treat wound infections in patients with serious burns. This formulation utilizes a cream delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-0607 and is authorized under FDA application NDA018810.

Identification & Billing

NDC Package Code
50090-0607-0
Package Description
50 g in 1 JAR
Product Code
50090-0607
11-Digit Billing Format
50090060700
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Silver Sulfadiazine
Non-Proprietary Name
Silver Sulfadiazine
Substance Name
Silver Sulfadiazine
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)
SILVER SULFADIAZINE 10 mg/g
Pharmacologic Class
Usage Information
This medication is used with other treatments to help prevent and treat wound infections in patients with serious burns. Silver sulfadiazine works by stopping the growth of bacteria that may infect an open wound. This helps to decrease the risk of the bacteria spreading to surrounding skin, or to the blood where it can cause a serious blood infection (sepsis). Silver sulfadiazine belongs to a class of drugs known as sulfa antibiotics. Silver sulfadiazine must not be used on premature babies or on newborns during the first 2 months of life because of the risk of serious side effects.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Human Prescription Drug
FDA Application #
NDA018810
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-23-1985
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 50090-0607-0 identifies a specific commercial package of 50 g in 1 jar of Silver Sulfadiazine, a human prescription drug labeled by A-s Medication Solutions. This product is billed per "GM" gram and contains an estimated amount of 50 billable units per package. This cream is formulated for topical use and contains silver sulfadiazine 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 A-s Medication Solutions on December 23, 1985. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used with other treatments to help prevent and treat wound infections in patients with serious burns. Silver sulfadiazine works by stopping the growth of bacteria that may infect an open wound. This helps to decrease the risk of the bacteria spreading to surrounding skin, or to the blood where it can cause a serious blood infection (sepsis). Silver sulfadiazine belongs to a class of drugs known as sulfa antibiotics. Silver sulfadiazine must not be used on premature babies or on newborns during the first 2 months of life because of the risk of serious side effects.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090060700. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 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 (5-4-1)
50090-0607-0
11-Digit CMS (5-4-2)
50090-0607-00

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