Famciclovir Tablet, Film Coated
NDC 33342-024

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 33342-024?
  5. Famciclovir Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Famciclovir is a ANDA-approved product labeled by Macleods Pharmaceuticals Limited. Famciclovir is used to treat infections caused by certain types of viruses. It is supplied as a white tablet, film coated for oral administration. This product entry covers the primary NDC 33342-024 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
33342-024
Proprietary Name:
Famciclovir
Non-Proprietary Name: [1]
Famciclovir
Substance Name: [2]
Famciclovir
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Macleods Pharmaceuticals Limited
Labeler Code:
33342
Product Label ID:
eeeee9c4-8566-4100-8ca4-3df936a3365d
FDA Application Number: [6]
ANDA201022
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
01-13-2012
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
ML67
Score:
1

Code Structure Chart

Product Details

What is NDC 33342-024?

The NDC code 33342-024 is assigned by the FDA to the product Famciclovir. This pharmaceutical product is labeled by Macleods Pharmaceuticals Limited and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 33342-024-07. 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?

Famciclovir is used to treat infections caused by certain types of viruses. It treats shingles caused by herpes zoster. It also treats outbreaks of herpes simplex that cause cold sores around the mouth, sores around the anus, and genital herpes. In people with frequent outbreaks of genital herpes, famciclovir is used to help reduce the number of future episodes. Famciclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Famciclovir 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. In addition, in people with a weakened immune system, famciclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.

What are Active Ingredients of this product?

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.
  • FAMCICLOVIR 125 mg/1 - An aminopurine derivative and prodrug of penciclovir which is a competitive inhibitor of herpes simplex 2 DNA polymerase. It is used to treat HERPES SIMPLEX VIRUS INFECTION.

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:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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".