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  5. NDC Package Code: 76519-1147-9 Valacyclovir Hydrochloride

NDC Package 76519-1147-9 Valacyclovir Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
76519-1147-9
Package Description:
90 TABLET in 1 BOTTLE
Product Code:
76519-1147
Proprietary Name:
Valacyclovir Hydrochloride
Usage Information:
1.1 Adult PatientsCold 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.1.2 Pediatric PatientsCold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for the treatment of cold sores (herpes labialis) in pediatric patients ≥12 years of age. 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.Chickenpox: Valacyclovir tablets, USP are indicated for the treatment of chickenpox in immunocompetent pediatric patients 2 to <18 years of age. Based on efficacy data from clinical studies with oral acyclovir, treatment with valacyclovir tablets, USP should be initiated within 24 hours after the onset of rash [see CLINICAL STUDIES (14.4)].1.3 Limitations of UseThe efficacy and safety of valacyclovir tablets, USP have not been established in:Immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients with a CD4+ cell count ≥100 cells/mm3. Patients <12 years of age with cold sores (herpes labialis). Patients <2 years of age or ≥18 years of age with chickenpox. Patients <18 years of age with genital herpes. Patients <18 years of age with herpes zoster. Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.
11-Digit NDC Billing Format:
76519114709
NDC to RxNorm Crosswalk:
  • RxCUI: 313565 - valACYclovir 500 MG Oral Tablet
  • RxCUI: 313565 - valacyclovir 500 MG Oral Tablet
  • RxCUI: 313565 - valacyclovir (as valacyclovir HCl) 500 MG Oral Tablet
    • Labeler Name:
    H.j. Harkins Company, Inc.
    Sample Package:
    No
    Start Marketing Date:
    01-30-2017
    Listing Expiration Date:
    12-31-2021
    Exclude Flag:
    I
    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
    76519-1147-110 TABLET in 1 BOTTLE
    76519-1147-330 TABLET in 1 BOTTLE
    76519-1147-414 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 76519-1147-9?

    The NDC Packaged Code 76519-1147-9 is assigned to a package of 90 tablet in 1 bottle of Valacyclovir Hydrochloride, labeled by H.j. Harkins Company, Inc.. The product's dosage form is and is administered via form.

    Is NDC 76519-1147 included in the NDC Directory?

    No, Valacyclovir Hydrochloride with product code 76519-1147 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by H.j. Harkins Company, Inc. on January 30, 2017 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 76519-1147-9?

    The 11-digit format is 76519114709. 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 5-4-1 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
    5-4-176519-1147-95-4-276519-1147-09