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  5. NDC Package Code: 65841-629-01 Valacyclovir

NDC Package 65841-629-01 Valacyclovir

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:
65841-629-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
65841-629
Proprietary Name:
Valacyclovir
Non-Proprietary Name:
Valacyclovir
Substance Name:
Valacyclovir Hydrochloride
Usage Information:
Valacyclovir is used to treat infections caused by certain types of viruses. In children, it is used to treat cold sores around the mouth (caused by herpes simplex) and chickenpox (caused by varicella zoster). In adults, it is used to treat shingles (caused by herpes zoster) and cold sores around the mouth. Valacyclovir is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, this medication is used to reduce the number of future episodes. Valacyclovir is an antiviral drug. It stops the growth of certain viruses. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Valacyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal.
11-Digit NDC Billing Format:
65841062901
NDC to RxNorm Crosswalk:
  • RxCUI: 313564 - valACYclovir 1 GM Oral Tablet
  • RxCUI: 313564 - valacyclovir 1000 MG Oral Tablet
  • RxCUI: 313564 - valacyclovir (as valacyclovir HCl) 1 GM Oral Tablet
  • RxCUI: 313564 - valacyclovir 1 GM Oral Tablet
  • RxCUI: 313565 - valACYclovir 500 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Lifesciences Limited
    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):
  • VALACYCLOVIR HYDROCHLORIDE 500 mg/1
    • Pharmacologic Class(es):
  • DNA Polymerase Inhibitors - [MoA] (Mechanism of Action)
  • Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor - [EPC] (Established Pharmacologic Class)
  • Nucleoside Analog - [EXT]
    • Sample Package:
    No
    FDA Application Number:
    ANDA079137
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-05-2018
    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
    65841-629-0630 TABLET, FILM COATED in 1 BOTTLE
    65841-629-101000 TABLET, FILM COATED in 1 BOTTLE
    65841-629-7710 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-629-30)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65841-629-01?

    The NDC Packaged Code 65841-629-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Valacyclovir, a human prescription drug labeled by Zydus Lifesciences Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 65841-629 included in the NDC Directory?

    Yes, Valacyclovir with product code 65841-629 is active and included in the NDC Directory. The product was first marketed by Zydus Lifesciences Limited on April 05, 2018 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 11-digit format for NDC 65841-629-01?

    The 11-digit format is 65841062901. 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
    5-3-265841-629-015-4-265841-0629-01