Silvadene
NDC Package 76413-124-20

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 inactivated by the FDA.

Silvadene is a medication used with other treatments to help prevent and treat wound infections in patients with serious burns. Marketed by Central Texas Community Health Centers, this product is identified by NDC 76413-124 and is authorized under FDA application NDA017381.

Identification & Billing

NDC Package Code
76413-124-20
Package Description
1 TUBE in 1 CARTON / 20 g in 1 TUBE
Product Code
76413-124
11-Digit Billing Format
76413012420
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Silvadene
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
Central Texas Community Health Centers
FDA Application #
NDA017381
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-26-1973
Listing Expiration
12-31-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76413-124-20 identifies a specific commercial package of 1 tube in 1 carton / 20 g in 1 tube of Silvadene, labeled by Central Texas Community Health Centers. 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 Central Texas Community Health Centers on November 26, 1973. The current certification is valid through December 31, 2019.

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 Central Texas Community Health Centers product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76413012420. 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)
76413-124-20
11-Digit CMS (5-4-2)
76413-0124-20

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