Ganciclovir Sodium Injection
NDC Package 46014-1054-0

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.

Ganciclovir Sodium injection is ganciclovir is an anti-viral drug. This formulation utilizes a injection delivery system. Marketed by Excella Gmbh Co. Kg, this product is identified by NDC 46014-1054.

Identification & Billing

NDC Package Code
46014-1054-0
Package Description
50 kg in 1 BOX
Product Code
46014-1054
11-Digit Billing Format
46014105400

Clinical Specifications

Proprietary Name
Ganciclovir Sodium
Non-Proprietary Name
Ganciclovir Sodium
Substance Name
Ganciclovir Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s)
GANCICLOVIR SODIUM 1 kg/kg
Usage Information
Ganciclovir is an anti-viral drug. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ or bone marrow transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Ganciclovir is also used to treat people with weakened immune systems (including people with AIDS) who have CMV retinitis. Ganciclovir works by slowing the growth of the CMV virus. It helps control CMV retinitis and decrease the risk of blindness. It also helps prevent the spread of infection to other areas of the body. Ganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.

Regulatory & Marketing

Labeler Name
Excella Gmbh Co. Kg
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
06-16-2005
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 46014-1054-0 identifies a specific commercial package of 50 kg in 1 box of Ganciclovir Sodium (UNFINISHED drug), a bulk ingredient labeled by Excella Gmbh Co. Kg. This injection is formulated for use and contains ganciclovir sodium 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 Excella Gmbh Co. Kg on June 16, 2005. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ganciclovir is an anti-viral drug. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ or bone marrow transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Ganciclovir is also used to treat people with weakened immune systems (including people with AIDS) who have CMV retinitis. Ganciclovir works by slowing the growth of the CMV virus. It helps control CMV retinitis and decrease the risk of blindness. It also helps prevent the spread of infection to other areas of the body. Ganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.

How is this Excella Gmbh Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46014105400. 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)
46014-1054-0
11-Digit CMS (5-4-2)
46014-1054-00

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