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  4. NDC Product Code: 54868-3993 Valtrex

NDC 54868-3993 Valtrex

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-3993?
  5. Valtrex Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.
NDC Product Code:
54868-3993
Proprietary Name:
Valtrex
Product Type: [3]
EXPIRED PRODUCT and EXCLUDED from the NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
b4450539-78ec-4e8a-8cfc-56dcde7984a0
FDA Application Number: [6]
NDA020487
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
04-25-2003
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
E
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
23 MM
Imprint(s):
VALTREX;500;MG
VALTREX;1;GRAM
Score:
1
2

Code Structure Chart

Product Details

What is NDC 54868-3993?

The NDC code 54868-3993 is assigned by the FDA to the product Valtrex which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 54868-3993-0 15 tablet, film coated in 1 bottle , 54868-3993-1 10 tablet, film coated in 1 bottle , 54868-3993-2 21 tablet, film coated in 1 bottle , 54868-3993-5 20 tablet, film coated in 1 bottle , 54868-3993-6 30 tablet, film coated in 1 bottle , 54868-3993-8 3 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 Valtrex?

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.

Which are Valtrex UNII Codes?

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

Which are Valtrex 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 Valtrex?

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:

* Please review the disclaimer below.

Product Footnotes

[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".