Pegasys
NDC Package 0004-0357-30

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 discontinued by the firm.

Pegasys is peginterferon alfa-2a is used alone or in combination with other medications to treat chronic hepatitis B and chronic hepatitis C, viral infections of the liver. Marketed by Genentech, Inc., this product is identified by NDC 0004-0357 and is authorized under FDA application BLA103964.

Identification & Billing

NDC Package Code
0004-0357-30
Package Description
1 PACKET in 1 BOX / 4 SYRINGE, GLASS in 1 PACKET / .5 mL in 1 SYRINGE, GLASS
Product Code
0004-0357
11-Digit Billing Format
00004035730
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Pegasys
Dosage Form
-
Usage Information
Peginterferon alfa-2a is used alone or in combination with other medications to treat chronic hepatitis B and chronic hepatitis C, viral infections 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. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if peginterferon can cure hepatitis B or hepatitis C infections 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
Genentech, Inc.
FDA Application #
BLA103964
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-29-2011
End Marketing Date
06-30-2024
Listing Expiration
06-30-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0004-0357-30 identifies a specific commercial package of 1 packet in 1 box / 4 syringe, glass in 1 packet / .5 ml in 1 syringe, glass of Pegasys, labeled by Genentech, 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 Genentech, Inc. on March 29, 2011. The current certification is valid through June 30, 2024.

What are the primary indications for this medication?

Peginterferon alfa-2a is used alone or in combination with other medications to treat chronic hepatitis B and chronic hepatitis C, viral infections 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. Chronic hepatitis infection can lead to serious liver damage (cirrhosis) and liver cancer. It is not known if peginterferon can cure hepatitis B or hepatitis C infections 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 Genentech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00004035730. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0004-0357-30
11-Digit CMS (5-4-2)
00004-0357-30

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