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  5. NDC Package Code: 48087-0120-0 Sofosbuvir

NDC Package 48087-0120-0 Sofosbuvir

Powder - View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
48087-0120-0
Package Description:
50 kg in 1 DRUM
Product Code:
48087-0120
Non-Proprietary Name:
Sofosbuvir
Substance Name:
Sofosbuvir
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.
11-Digit NDC Billing Format:
48087012000
Product Type:
Bulk Ingredient
Labeler Name:
F.i.s. Fabbrica Italiana Sintetici S.p.a.
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
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    07-31-2015
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 48087-0120-0?

    The NDC Packaged Code 48087-0120-0 is assigned to an UNFINISHED drug package of 50 kg in 1 drum of Sofosbuvir, a bulk ingredient labeled by F.i.s. Fabbrica Italiana Sintetici S.p.a.. The product's dosage form is powder and is administered via form.

    Is NDC 48087-0120 included in the NDC Directory?

    Yes, Sofosbuvir is an UNFINISHED PRODUCT with code 48087-0120 that is active and included in the NDC Directory. The product was first marketed by F.i.s. Fabbrica Italiana Sintetici S.p.a. on July 31, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 48087-0120-0?

    The 11-digit format is 48087012000. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-148087-0120-05-4-248087-0120-00