Silver Sulfadiazine
NDC Package 54868-0375-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Silver Sulfadiazine is a medication used with other treatments to help prevent and treat wound infections in patients with serious burns. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0375 and is authorized under FDA application NDA018578.

Identification & Billing

NDC Package Code
54868-0375-2
Package Description
400 g in 1 JAR
Product Code
54868-0375
11-Digit Billing Format
54868037502
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
400 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Silver Sulfadiazine
Dosage Form
-
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
Physicians Total Care, Inc.
FDA Application #
NDA018578
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-20-1993
Listing Expiration
12-31-2017
Exclude Flag
I
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 (54868-0375). Click a package code to view its specific billing and regulatory data.

54868-0375-1
50 g in 1 TUBE
54868-0375-4
85 g in 1 TUBE
54868-0375-5
25 g in 1 TUBE

* 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 54868-0375-2 identifies a specific commercial package of 400 g in 1 jar of Silver Sulfadiazine, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 400 billable units per package. 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 Physicians Total Care, Inc. on May 20, 1993. The current certification is valid through December 31, 2017.

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 Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868037502. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 400 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)
54868-0375-2
11-Digit CMS (5-4-2)
54868-0375-02

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