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NDC 55289-0168-03 Famciclovir 500 mg/1 Details
Famciclovir 500 mg/1
Famciclovir is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. The primary component is FAMCICLOVIR.
MedlinePlus Drug Summary
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.
Related Packages: 55289-0168-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Famciclovir
Product Information
| NDC | 55289-0168 |
|---|---|
| Product ID | 55289-168_05f3c9e6-4478-3507-e063-6294a90a36d5 |
| Associated GPIs | 12408040000320 |
| GCN Sequence Number | 021995 |
| GCN Sequence Number Description | famciclovir TABLET 500 MG ORAL |
| HIC3 | W5A |
| HIC3 Description | ANTIVIRALS, GENERAL |
| GCN | 14108 |
| HICL Sequence Number | 009007 |
| HICL Sequence Number Description | FAMCICLOVIR |
| Brand/Generic | Generic |
| Proprietary Name | Famciclovir |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Famciclovir |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | FAMCICLOVIR |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | DNA Polymerase Inhibitors [MoA], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077487 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 55289-0168-03 (55289016803)
| NDC Package Code | 55289-168-03 |
|---|---|
| Billing NDC | 55289016803 |
| Package | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-168-03) |
| Marketing Start Date | 2011-04-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |