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  5. NDC Package Code: 77391-005-04 Valrubicin

NDC Package 77391-005-04 Valrubicin

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
77391-005-04
Package Description:
500 g in 1 BOTTLE, GLASS
Product Code:
77391-005
Non-Proprietary Name:
Valrubicin
Substance Name:
Valrubicin
Usage Information:
Valrubicin is used to treat bladder cancer. The usual treatment for bladder cancer is surgery. However, if you and your doctor decide that the risk of surgery is greater than its benefit or that surgery may be delayed, this medication may be used as part of your treatment. This medication belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells. This medication may not cure your cancer. Delaying surgery could lead to a more serious illness (metastatic cancer). Discuss the risks and benefits of this medication with your doctor.
11-Digit NDC Billing Format:
77391000504
Product Type:
Bulk Ingredient
Labeler Name:
Gemini Pharmchem Mannheim Gmbh
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):
  • VALRUBICIN 1 g/g
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    08-01-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    77391-005-0150 g in 1 BOTTLE, GLASS
    77391-005-02100 g in 1 BOTTLE, GLASS
    77391-005-03250 g in 1 BOTTLE, GLASS

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 77391-005-04?

    The NDC Packaged Code 77391-005-04 is assigned to an UNFINISHED drug package of 500 g in 1 bottle, glass of Valrubicin, a bulk ingredient labeled by Gemini Pharmchem Mannheim Gmbh. The product's dosage form is powder and is administered via form.

    Is NDC 77391-005 included in the NDC Directory?

    Yes, Valrubicin is an UNFINISHED PRODUCT with code 77391-005 that is active and included in the NDC Directory. The product was first marketed by Gemini Pharmchem Mannheim Gmbh on August 01, 2021 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 77391-005-04?

    The 11-digit format is 77391000504. 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 5-3-2 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
    5-3-277391-005-045-4-277391-0005-04