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  5. NDC Package Code: 69097-153-02 Valacyclovir Hydrochloride

NDC Package 69097-153-02 Valacyclovir Hydrochloride

Tablet 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:
69097-153-02
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
69097-153
Proprietary Name:
Valacyclovir Hydrochloride
Non-Proprietary Name:
Valacyclovir Hydrochloride
Substance Name:
Valacyclovir Hydrochloride
Usage Information:
Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets, USP initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes: Initial Episode: Valacyclovir tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets, USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets, USP when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy: Valacyclovir tablets, USP are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults. The efficacy and safety of valacyclovir tablets, USP for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-infected patients have not been established. Reduction of Transmission: Valacyclovir tablets, USP are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines). Herpes Zoster: Valacyclovir tablets, USP are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets, USP when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets, USP for treatment of disseminated herpes zoster have not been established.
11-Digit NDC Billing Format:
69097015302
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
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:
    Cipla Usa Inc.
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    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:
    ANDA077135
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-24-2010
    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
    69097-153-0590 TABLET in 1 BOTTLE
    69097-153-12500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 69097-153-02?

    The NDC Packaged Code 69097-153-02 is assigned to a package of 30 tablet in 1 bottle of Valacyclovir Hydrochloride, a human prescription drug labeled by Cipla Usa Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 69097-153 included in the NDC Directory?

    Yes, Valacyclovir Hydrochloride with product code 69097-153 is active and included in the NDC Directory. The product was first marketed by Cipla Usa Inc. on May 24, 2010 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 69097-153-02?

    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 30.

    What is the 11-digit format for NDC 69097-153-02?

    The 11-digit format is 69097015302. 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
    5-3-269097-153-025-4-269097-0153-02