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  5. NDC Package Code: 0904-6796-10 Valganciclovir

NDC Package 0904-6796-10 Valganciclovir

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
0904-6796-10
Package Description:
20 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
0904-6796
Proprietary Name:
Valganciclovir
Non-Proprietary Name:
Valganciclovir
Substance Name:
Valganciclovir Hydrochloride
Usage Information:
Valganciclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see Adverse Reactions (6.1)].
11-Digit NDC Billing Format:
00904679610
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
20 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 313566 - valGANciclovir HCl 450 MG Oral Tablet
  • RxCUI: 313566 - valganciclovir 450 MG Oral Tablet
  • RxCUI: 313566 - valganciclovir 450 MG (as valganciclovir hydrochloride 496.3 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Major Pharmaceuticals
    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:
    ANDA205166
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-18-2016
    Listing Expiration Date:
    12-31-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0904-6796-0430 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0904-6796-10?

    The NDC Packaged Code 0904-6796-10 is assigned to a package of 20 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack of Valganciclovir, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0904-6796 included in the NDC Directory?

    Yes, Valganciclovir with product code 0904-6796 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on March 18, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0904-6796-10?

    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 20.

    What is the 11-digit format for NDC 0904-6796-10?

    The 11-digit format is 00904679610. 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
    4-4-20904-6796-105-4-200904-6796-10