NDC 42291-416 Famciclovir
Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
OVAL (C48345)
10 MM
18 MM
8118;93
8119;93
Code Structure Chart
Product Details
What is NDC 42291-416?
What are the uses for Famciclovir?
What are Famciclovir Active Ingredients?
- FAMCICLOVIR 500 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 Famciclovir UNII Codes?
The UNII codes for the active ingredients in this product are:
- FAMCICLOVIR (UNII: QIC03ANI02)
- PENCICLOVIR (UNII: 359HUE8FJC) (Active Moiety)
Which are Famciclovir 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:
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
- HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)
- HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
- HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)
- POLYDEXTROSE (UNII: VH2XOU12IE)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
- SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TRIACETIN (UNII: XHX3C3X673)
What is the NDC to RxNorm Crosswalk for Famciclovir?
- RxCUI: 198382 - famciclovir 500 MG Oral Tablet
- RxCUI: 199192 - famciclovir 125 MG Oral Tablet
- RxCUI: 199193 - famciclovir 250 MG Oral Tablet
Which are the Pharmacologic Classes for Famciclovir?
* Please review the disclaimer below.
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 disclaimer below.
[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".