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  5. NDC Package Code: 55111-553-30 Valacyclovir Hydrochloride

NDC Package 55111-553-30 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:
55111-553-30
Package Description:
30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
55111-553
Proprietary Name:
Valacyclovir Hydrochloride
Usage Information:
Cold Sores (Herpes Labialis): Valacyclovir hydrochloride tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir hydrochloride 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 hydrochloride tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride when initiated more than 72 hours after the onset of signs and symptoms has not been established.Recurrent Episodes: Valacyclovir hydrochloride tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride when initiated more than 24 hours after the onset of signs and symptoms has not been established. Suppressive Therapy: Valacyclovir hydrochloride tablets 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 hydrochloride 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 hydrochloride tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir hydrochloride for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir hydrochloride 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 hydrochloride tablets are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir hydrochloride when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir hydrochloride for treatment of disseminated herpes zoster have not been established.
11-Digit NDC Billing Format:
55111055330
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:
Labeler Name:
Dr. Reddys Laboratories Limited
Sample Package:
No
FDA Application Number:
ANDA079012
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
12-06-2010
Listing Expiration Date:
12-31-2023
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
55111-553-01100 TABLET, FILM COATED in 1 BOTTLE
55111-553-05500 TABLET, FILM COATED in 1 BOTTLE
55111-553-7810 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-553-79)
55111-553-9090 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 55111-553-30?

The NDC Packaged Code 55111-553-30 is assigned to a package of 30 tablet, film coated in 1 bottle of Valacyclovir Hydrochloride, labeled by Dr. Reddys Laboratories Limited. The product's dosage form is and is administered via form.

Is NDC 55111-553 included in the NDC Directory?

No, Valacyclovir Hydrochloride with product code 55111-553 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Dr. Reddys Laboratories Limited on December 06, 2010 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 55111-553-30?

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 55111-553-30?

The 11-digit format is 55111055330. 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
5-3-255111-553-305-4-255111-0553-30