Quick answers
- What is Famciclovir used for?
- The FDA-approved label (Famciclovir, AvKARE, July 21, 2026) says: “Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients • Treatment of recurrent …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Famciclovir have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Famciclovir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Famciclovir been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 11, 2025 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Famciclovir?
- 9 companies list prescription products of Famciclovir in the FDA NDC Directory, including AvKARE, Teva Pharmaceuticals USA, Inc. and Rising Pharma Holdings, Inc..
What Famciclovir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients • Treatment of recurrent …
— FDA label: Famciclovir, AvKARE, effective July 21, 2026. Read the full label on DailyMed →
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 26 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| famciclovir 125 mg tablet, film coated | Generic | $0.2120 per tablet |
| famciclovir 250 mg tablet, film coated | Generic | $0.4184 per tablet |
| famciclovir 500 mg tablet, film coated | Generic | $0.8041 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- AvKARE6 products
- Teva Pharmaceuticals USA, Inc.3 products
- Rising Pharma Holdings, Inc.3 products
- Camber Pharmaceuticals, Inc.3 products
- Aurobindo Pharma Limited3 products
- Macleods Pharmaceuticals Limited3 products
- Bryant Ranch Prepack2 products
- Proficient Rx LP2 products
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (4)
- ANDA077487Teva Pharms · August 24, 2007
- ANDA091114Aurobindo Pharma Ltd · March 21, 2011
- ANDA201022Macleods Pharms Ltd · January 12, 2012
- ANDA202438Hetero Labs Ltd V · September 10, 2014
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 11, 2025 · Class III · Ongoing · D-0509-2025
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07. — Macleods Pharmaceuticals Ltd
-
December 22, 2017 · Class II · Terminated · D-0415-2018
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. ND — Hetero Labs Limited Unit V
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 198382, 199192, 199193 |
|---|---|
| SPL set ID of the quoted label | 5723f50e-b0fa-65f0-e063-6294a90a350f |
| FDA labels (SPL) | 12 |
| FDA applications | 4 ANDA |
| Active ingredients (FDA) | FAMCICLOVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Famciclovir, AvKARE, effective July 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →