NDC 43063-771 Valacyclovir

Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
43063-771
Proprietary Name:
Valacyclovir
Non-Proprietary Name: [1]
Valacyclovir
Substance Name: [2]
Valacyclovir Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Pd-rx Pharmaceuticals, Inc.
    Labeler Code:
    43063
    FDA Application Number: [6]
    ANDA203047
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-25-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    CAPSULE (C48336)
    Size(s):
    23 MM
    Imprint(s):
    I;87
    Score:
    2

    Product Packages

    NDC Code 43063-771-06

    Package Description: 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    NDC Code 43063-771-14

    Package Description: 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    NDC Code 43063-771-20

    Package Description: 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    NDC Code 43063-771-21

    Package Description: 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 43063-771?

    The NDC code 43063-771 is assigned by the FDA to the product Valacyclovir which is a human prescription drug product labeled by Pd-rx Pharmaceuticals, Inc.. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 43063-771-06 6 tablet, film coated in 1 bottle, plastic , 43063-771-14 14 tablet, film coated in 1 bottle, plastic , 43063-771-20 20 tablet, film coated in 1 bottle, plastic , 43063-771-21 21 tablet, film coated in 1 bottle, plastic . 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?

    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.

    What are Valacyclovir Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • VALACYCLOVIR HYDROCHLORIDE 1 g/1 - A prodrug of acyclovir that is used in the treatment of HERPES ZOSTER and HERPES SIMPLEX VIRUS INFECTION of the skin and mucous membranes, including GENITAL HERPES.

    Which are Valacyclovir UNII Codes?

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

    Which are Valacyclovir 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?

    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:

    Which are the Pharmacologic Classes for Valacyclovir?

    * Please review the disclaimer below.

    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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [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".