Sofosbuvir Tablet, Film Coated
NDC Package 63285-752-01

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 tablets 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 tablet, film coated delivery system. Marketed by Patheon Inc., this product is identified by NDC 63285-752.

Identification & Billing

NDC Package Code
63285-752-01
Package Description
80 BOTTLE in 1 CONTAINER / 28 TABLET, FILM COATED in 1 BOTTLE
Product Code
63285-752
11-Digit Billing Format
63285075201

Clinical Specifications

Proprietary Name
Sofosbuvir
Non-Proprietary Name
Sofosbuvir
Substance Name
Sofosbuvir
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Active Ingredient(s)
SOFOSBUVIR 400 mg/1
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
Patheon Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
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 63285-752-01 identifies a specific commercial package of 80 bottle in 1 container / 28 tablet, film coated in 1 bottle of Sofosbuvir (UNFINISHED drug), drug for further processing labeled by Patheon Inc.. This tablet, film coated 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 Patheon Inc. 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 Patheon Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63285075201. 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)
63285-752-01
11-Digit CMS (5-4-2)
63285-0752-01

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