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  4. NDC Product Code: 60429-360 Famciclovir

NDC 60429-360 Famciclovir

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Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 60429-360?
  4. Famciclovir Uses
  5. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory .
NDC Product Code:
60429-360
Proprietary Name:
Famciclovir
Product Type: [3]
Labeler Name: [5]
Golden State Medical Supply, Inc.
Labeler Code:
60429
FDA Application Number: [6]
ANDA091480
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
07-22-2011
End Marketing Date: [10]
03-31-2023
Listing Expiration Date: [11]
03-31-2023
Exclude Flag: [12]
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Patient Education

Famciclovir


Famciclovir is used to treat herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past). It is also used to treat repeat outbreaks of herpes virus cold sores or fever blisters in people with a normal immune system. Famciclovir is used to treat repeat outbreaks and to prevent further outbreaks of genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time) in people with a normal immune system. Famciclovir is also used to treat returning herpes simplex infections of the skin and mucus membranes (mouth, anus) in people with human immunodeficiency virus (HIV) infection. Famciclovir is in a class of medications called antivirals. It works by stopping the spread of the herpes virus in the body. Famciclovir does not cure herpes infections and may not stop the spread of herpes virus to other people. However, it may decrease the symptoms of pain, burning, tingling, tenderness, and itching; help sores to heal; and prevent new sores from forming.
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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.

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".