Ganciclovir Powder
NDC Package 12869-803-01

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.

Ganciclovir powders is ganciclovir is used to treat herpes infection of the eye. This formulation utilizes a powder delivery system. Marketed by Corden Pharma Colorado, Inc., this product is identified by NDC 12869-803.

Identification & Billing

NDC Package Code
12869-803-01
Package Description
50 kg in 1 DRUM
Product Code
12869-803
11-Digit Billing Format
12869080301

Clinical Specifications

Proprietary Name
Ganciclovir
Non-Proprietary Name
Ganciclovir
Substance Name
Ganciclovir
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)
GANCICLOVIR 1 kg/kg
Usage Information
Ganciclovir is used to treat herpes infection of the eye. Although ganciclovir stops the growth of the virus, it is not a cure for the herpes infection. Herpes virus continues to live in the body even between outbreaks of infection. However, treating an outbreak may help the sores in the eye to heal faster and lower the risk of complications (such as decreased vision, blindness). Ganciclovir is an anti-viral drug. This medication treats only herpes eye infections. It will not work for other types of eye infections, such as those caused by bacteria. Unnecessary use or misuse of any anti-infective drug can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Corden Pharma Colorado, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-22-2003
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 12869-803-01 identifies a specific commercial package of 50 kg in 1 drum of Ganciclovir (UNFINISHED drug), a bulk ingredient labeled by Corden Pharma Colorado, Inc.. This powder is formulated for use and contains ganciclovir 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 Corden Pharma Colorado, Inc. on April 22, 2003. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Ganciclovir is used to treat herpes infection of the eye. Although ganciclovir stops the growth of the virus, it is not a cure for the herpes infection. Herpes virus continues to live in the body even between outbreaks of infection. However, treating an outbreak may help the sores in the eye to heal faster and lower the risk of complications (such as decreased vision, blindness). Ganciclovir is an anti-viral drug. This medication treats only herpes eye infections. It will not work for other types of eye infections, such as those caused by bacteria. Unnecessary use or misuse of any anti-infective drug can lead to its decreased effectiveness.

How is this Corden Pharma Colorado, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12869080301. 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)
12869-803-01
11-Digit CMS (5-4-2)
12869-0803-01

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