Sofosbuvir Powder
NDC Package 68554-0139-1

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Sofosbuvir powders is sofosbuvir is used with other antiviral medications (such as ribavirin, peginterferon, daclatasvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. This formulation utilizes a powder delivery system. Marketed by Hetero Labs Limited, this product is identified by NDC 68554-0139.

Identification & Billing

NDC Package Code
68554-0139-1
Package Description
1 kg in 1 DRUM
Product Code
68554-0139
11-Digit Billing Format
68554013901

Clinical Specifications

Proprietary Name
Sofosbuvir
Non-Proprietary Name
Sofosbuvir
Substance Name
Sofosbuvir
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
SOFOSBUVIR 1 kg/kg
Usage Information
Sofosbuvir is used with other antiviral medications (such as ribavirin, peginterferon, daclatasvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. Sofosbuvir in combination with other antiviral medications reduces the amount of hepatitis C virus in the body and helps the body's immune system fight the infection. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others. Sofosbuvir must be used in combination treatment to have the best effect. Do not use sofosbuvir alone to treat hepatitis C.

Regulatory & Marketing

Labeler Name
Hetero Labs Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-06-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 68554-0139-1 identifies a specific commercial package of 1 kg in 1 drum of Sofosbuvir (UNFINISHED drug), a bulk ingredient labeled by Hetero Labs Limited. This powder is formulated for use and contains sofosbuvir 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 Hetero Labs Limited on December 06, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sofosbuvir is used with other antiviral medications (such as ribavirin, peginterferon, daclatasvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. Sofosbuvir in combination with other antiviral medications reduces the amount of hepatitis C virus in the body and helps the body's immune system fight the infection. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others. Sofosbuvir must be used in combination treatment to have the best effect. Do not use sofosbuvir alone to treat hepatitis C.

How is this Hetero Labs Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68554013901. 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)
68554-0139-1
11-Digit CMS (5-4-2)
68554-0139-01

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