Sitavig
NDC 71403-049

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 71403-049?
  5. Sitavig Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

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

Sitavig is a NDA-approved product labeled by Epi Health, Inc. This medication is used to treat cold sores around the mouth (caused by herpes virus) that keep coming back. It is supplied as a white product. This product entry covers the primary NDC 71403-049 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
71403-049
Proprietary Name:
Sitavig
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Epi Health, Inc
Labeler Code:
71403
Product Label ID:
cd6e902d-5753-49ec-bec8-b27176ed978e
FDA Application Number: [6]
NDA203791
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-20-2014
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
AL21
Score:
1

Code Structure Chart

Product Details

What is NDC 71403-049?

The NDC code 71403-049 is assigned by the FDA to the product Sitavig. This pharmaceutical product is labeled by Epi Health, Inc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 71403-049-02. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to treat cold sores around the mouth (caused by herpes virus) that keep coming back. Acyclovir is an antiviral drug. However, it is not a cure for the infection. The virus that causes infection continues to live in the body between outbreaks. Acyclovir makes outbreaks shorter and less severe. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain lasts after the sores heal.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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

Acyclovir


Acyclovir is used to decrease pain and speed the healing of sores or blisters in people who have varicella (chickenpox), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), and first-time or repeat outbreaks of genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time). Acyclovir is also sometimes used to prevent outbreaks of genital herpes in people who are infected with the virus. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body. Acyclovir will not cure genital herpes and may not stop the spread of genital herpes to other people.
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Acyclovir Buccal


Acyclovir buccal is used to treat herpes labialis (cold sores or fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".