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  5. NDC Package Code: 70069-810-01 Valganciclovir Hydrochloride

NDC Package 70069-810-01 Valganciclovir Hydrochloride

Valganciclovir For Solution 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:
70069-810-01
Package Description:
100 mL in 1 BOTTLE
Product Code:
70069-810
Proprietary Name:
Valganciclovir Hydrochloride
Non-Proprietary Name:
Valganciclovir
Substance Name:
Valganciclovir
Usage Information:
Valganciclovir hydrochloride is 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:
70069081001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
100 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 863559 - valGANciclovir 50 MG in 1 mL Oral Solution
  • RxCUI: 863559 - valganciclovir 50 MG/ML Oral Solution
  • RxCUI: 863559 - valganciclovir (as valganciclovir hydrochloride) 50 MG/ML Oral Solution
  • RxCUI: 863559 - valganciclovir 50 MG per 1 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Somerset Therapeutics, Llc
    Dosage Form:
    For Solution - A product, usually a solid, intended for solution prior to administration.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • VALGANCICLOVIR 50 mg/mL
    • Pharmacologic Class(es):
  • Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • DNA Polymerase Inhibitors - [MoA] (Mechanism of Action)
  • Nucleoside Analog - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    ANDA213306
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-15-2022
    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 70069-810-01?

    The NDC Packaged Code 70069-810-01 is assigned to a package of 100 ml in 1 bottle of Valganciclovir Hydrochloride, a human prescription drug labeled by Somerset Therapeutics, Llc. The product's dosage form is for solution and is administered via oral form.

    Is NDC 70069-810 included in the NDC Directory?

    Yes, Valganciclovir Hydrochloride with product code 70069-810 is active and included in the NDC Directory. The product was first marketed by Somerset Therapeutics, Llc on January 15, 2022 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 70069-810-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 70069-810-01?

    The 11-digit format is 70069081001. 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 5-3-2 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
    5-3-270069-810-015-4-270069-0810-01