Pegintron
NDC Package 54868-5036-0

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 discontinued by the firm.

Pegintron is peginterferon alfa-2b is used alone or in combination with ribavirin to treat chronic hepatitis C, a viral infection of the liver. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5036 and is authorized under FDA application BLA103949.

Identification & Billing

NDC Package Code
54868-5036-0
Package Description
1 CARTRIDGE in 1 CARTON / .5 mL in 1 CARTRIDGE
Product Code
54868-5036
11-Digit Billing Format
54868503600

Clinical Specifications

Proprietary Name
Pegintron
Dosage Form
-
Usage Information
Peginterferon alfa-2b is used alone or in combination with ribavirin to treat chronic hepatitis C, a viral infection of the liver. It works by decreasing the amount of hepatitis virus in the body and helps your body's natural defense (immune system) fight the infection. If untreated, chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if peginterferon can cure hepatitis C infection or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
BLA103949
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-31-2004
End Marketing Date
06-30-2011
Listing Expiration
06-30-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-5036). Click a package code to view its specific billing and regulatory data.

54868-5036-1
4 CARTRIDGE in 1 CARTON / .5 mL in 1 CARTRIDGE

* 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 54868-5036-0 identifies a specific commercial package of 1 cartridge in 1 carton / .5 ml in 1 cartridge of Pegintron, labeled by Physicians Total Care, Inc.. 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 March 31, 2004. The current certification is valid through June 30, 2011.

What are the primary indications for this medication?

Peginterferon alfa-2b is used alone or in combination with ribavirin to treat chronic hepatitis C, a viral infection of the liver. It works by decreasing the amount of hepatitis virus in the body and helps your body's natural defense (immune system) fight the infection. If untreated, chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if peginterferon can cure hepatitis C infection or can prevent you from passing the virus to others. Practice "safer sex" (such as the use of latex condoms) to lower the risk of passing the virus to others.

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: 54868503600. 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)
54868-5036-0
11-Digit CMS (5-4-2)
54868-5036-00

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