1. Home
  2. Labeler Index
  3. Genentech, Inc.
  4. 0004-0038
  5. NDC Package Code: 0004-0038-22 Valcyte

NDC Package 0004-0038-22 Valcyte

Valganciclovir Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
0004-0038-22
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
0004-0038
Proprietary Name:
Valcyte
Non-Proprietary Name:
Valganciclovir
Substance Name:
Valganciclovir Hydrochloride
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.
11-Digit NDC Billing Format:
00004003822
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 284587 - Valcyte 450 MG Oral Tablet
  • RxCUI: 284587 - valganciclovir 450 MG Oral Tablet [Valcyte]
  • RxCUI: 284587 - Valcyte 450 MG (valganciclovir hydrochloride 496.3 MG) Oral Tablet
  • RxCUI: 313566 - valGANciclovir HCl 450 MG Oral Tablet
  • RxCUI: 313566 - valganciclovir 450 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genentech, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • VALGANCICLOVIR HYDROCHLORIDE 450 mg/1
    • Pharmacologic Class(es):
  • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • DNA Polymerase Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Analog Antiviral - [EPC] (Established Pharmacologic Class)
  • Nucleoside Analog - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    NDA021304
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-29-2001
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    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.

    Frequently Asked Questions

    What is NDC 0004-0038-22?

    The NDC Packaged Code 0004-0038-22 is assigned to a package of 1 bottle, plastic in 1 carton / 60 tablet, film coated in 1 bottle, plastic of Valcyte, a human prescription drug labeled by Genentech, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0004-0038 included in the NDC Directory?

    Yes, Valcyte with product code 0004-0038 is active and included in the NDC Directory. The product was first marketed by Genentech, Inc. on March 29, 2001 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0004-0038-22?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0004-0038-22?

    The 11-digit format is 00004003822. 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 4-4-2 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
    4-4-20004-0038-225-4-200004-0038-22