Valrubicin Powder
NDC Package 77391-005-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Valrubicin powders is valrubicin is used to treat bladder cancer. This formulation utilizes a powder delivery system. Marketed by Gemini Pharmchem Mannheim Gmbh, this product is identified by NDC 77391-005.

Identification & Billing

NDC Package Code
77391-005-01
Package Description
50 g in 1 BOTTLE, GLASS
Product Code
77391-005
11-Digit Billing Format
77391000501

Clinical Specifications

Proprietary Name
Valrubicin
Non-Proprietary Name
Valrubicin
Substance Name
Valrubicin
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
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.

Regulatory & Marketing

Labeler Name
Gemini Pharmchem Mannheim Gmbh
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-01-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (77391-005). Click a package code to view its specific billing and regulatory data.

77391-005-02
100 g in 1 BOTTLE, GLASS
77391-005-03
250 g in 1 BOTTLE, GLASS
77391-005-04
500 g in 1 BOTTLE, GLASS

* 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 77391-005-01 identifies a specific commercial package of 50 g in 1 bottle, glass of Valrubicin (UNFINISHED drug), a bulk ingredient labeled by Gemini Pharmchem Mannheim Gmbh. This powder is formulated for use and contains valrubicin 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 Gemini Pharmchem Mannheim Gmbh on August 01, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Gemini Pharmchem Mannheim Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77391000501. 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)
77391-005-01
11-Digit CMS (5-4-2)
77391-0005-01

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