Valcyte Powder, For Solution
NDC Package 61269-485-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Valcyte (valganciclovir hydrochloride) powders is valganciclovir is an anti-viral drug. This formulation utilizes a powder, for solution delivery system. Marketed by H2-pharma, Llc, this product is identified by NDC 61269-485 and is authorized under FDA application NDA022257.

Identification & Billing

NDC Package Code
61269-485-10
Package Description
1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS
Product Code
61269-485
11-Digit Billing Format
61269048510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valcyte
Non-Proprietary Name
Valganciclovir Hydrochloride
Substance Name
Valganciclovir Hydrochloride
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VALGANCICLOVIR HYDROCHLORIDE 50 mg/mL
Pharmacologic Class
Usage Information
Valganciclovir is an anti-viral drug. It is changed in the body to the active form of the drug called ganciclovir. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Valganciclovir works by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body. Valganciclovir is also used to treat CMV retinitis in people with advanced HIV disease (AIDS). This medication helps control CMV retinitis and decrease the risk of blindness. Valganciclovir 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
H2-pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022257
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-28-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 61269-485-10 identifies a specific commercial package of 1 bottle, glass in 1 carton / 100 ml in 1 bottle, glass of Valcyte, a human prescription drug labeled by H2-pharma, Llc. This powder, for solution is formulated for oral use and contains valganciclovir hydrochloride 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 H2-pharma, Llc on August 28, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Valganciclovir is an anti-viral drug. It is changed in the body to the active form of the drug called ganciclovir. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Valganciclovir works by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body. Valganciclovir is also used to treat CMV retinitis in people with advanced HIV disease (AIDS). This medication helps control CMV retinitis and decrease the risk of blindness. Valganciclovir 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 H2-pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61269048510. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
61269-485-10
11-Digit CMS (5-4-2)
61269-0485-10

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