NDC 64679-153 Valacyclovir Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
64679-153
Proprietary Name:
Valacyclovir Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Wockhardt Usa Llc.
Labeler Code:
64679
Start Marketing Date: [9]
05-24-2010
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
23 MM
Imprint(s):
W152
W153
Score:
1
2

Product Packages

NDC Code 64679-153-01

Package Description: 21 TABLET, FILM COATED in 1 BOTTLE

NDC Code 64679-153-02

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.75842 per EA

NDC Code 64679-153-03

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.75842 per EA

NDC Code 64679-153-04

Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

Price per Unit: $0.75842 per EA

NDC Code 64679-153-05

Package Description: 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

NDC Code 64679-153-06

Package Description: 250 TABLET, FILM COATED in 1 BOTTLE

Product Details

What is NDC 64679-153?

The NDC code 64679-153 is assigned by the FDA to the product Valacyclovir Hydrochloride which is product labeled by Wockhardt Usa Llc.. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 64679-153-01 21 tablet, film coated in 1 bottle , 64679-153-02 30 tablet, film coated in 1 bottle , 64679-153-03 90 tablet, film coated in 1 bottle , 64679-153-04 500 tablet, film coated in 1 bottle , 64679-153-05 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 64679-153-06 250 tablet, film coated in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Valacyclovir Hydrochloride?

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.

Which are Valacyclovir Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Valacyclovir Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Valacyclovir Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Valacyclovir


Valacyclovir is used to treat herpes zoster (shingles) and genital herpes. It does not cure herpes infections but decreases pain and itching, helps sores to heal, and prevents new ones from forming. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".