Prescription medicine
Valacyclovir Brand names: Valtrex
Valacyclovir (Valtrex) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 40 generic labelers, and pharmacies paid $0.229 per valacyclovir HCl 500 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the valacyclovir FDA label on DailyMed (effective November 12, 2025, GlaxoSmithKline LLC); the NDA 20487 record on Drugs@FDA; every valacyclovir label on DailyMed.
Highlights of the record
FDA label of November 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageVALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 )
Cold Sores (Herpes Labialis)
Genital Herpes
Treatment in immunocompetent patients (initial or recurrent episode)
Suppression in immunocompetent or HIV-1−infected patients
Reduction of transmission
Herpes Zoster Pediatric Patients ( 1.2 )
Cold Sores (Herpes Labialis)
Chickenpox Limitations of Use ( 1.3
Forms and strengths
- 1 g
- 500 mg
- 1000 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- June 23, 1995 Valtrex, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first January 31, 2007; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 41 of which 40 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.229 per tablet Valacyclovir HCl 500 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest April 25, 2024
- FAERS reports
- 70,054 through July 30, 2026
What is valacyclovir used for?
From the label: indications and usageVALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 )
Cold Sores (Herpes Labialis)
Genital Herpes
Treatment in immunocompetent patients (initial or recurrent episode)
Suppression in immunocompetent or HIV-1−infected patients
Reduction of transmission
Herpes Zoster Pediatric Patients ( 1.2 )
Cold Sores (Herpes Labialis)
Chickenpox Limitations of Use ( 1.3 ) The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1−infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) VALTREX is indicated for treatment of cold sores (herpes labialis). […]
Conditions named in the indications of valacyclovir's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor and Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor.
Source: FDA drug label (VALTREX), GlaxoSmithKline LLC, effective November 12, 2025 (SPL set f8e0d8f8-cb73-4206-a484-88f5c4fbd719), via openFDA; the full label on DailyMed
Is there a generic for valacyclovir (Valtrex)?
The FDA approved the first generic valacyclovir on January 31, 2007. 16 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists valacyclovir from 40 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2007 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for valacyclovir (Valtrex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.229 per Valacyclovir HCl 500 mg tablet, down 2% from $0.234 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Valacyclovir HCl 500 mg tablet (generic)
- Valtrex 500 mg caplet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Valacyclovir HCl 1 gram tablet | Generic | $0.410 per tablet | $12.30 | -0.9% |
| Valacyclovir HCl 500 mg tablet | Generic | $0.229 per tablet | $6.87 | -2% |
| Valtrex 1 gram caplet | Brand | $20.24 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
| Valtrex 500 mg caplet | Brand | $12.81 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has valacyclovir been recalled?
The FDA's Enforcement Report lists 4 recalls naming valacyclovir since 2013: 0 Class I (the most serious), 3 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 25, 2024 | Class III | Viatris Inc | Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets. |
| February 13, 2018 | Class II | Hetero Labs Limited Unit V | Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same … |
| November 8, 2013 | Class II | Teva Pharmaceuticals USA, Inc. | Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. |
| August 2, 2013 | Class II | American Health Packaging | Subpotent |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the valacyclovir label say about other medicines?
The valacyclovir label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 17 other medicines name valacyclovir. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acyclovir | contraindications | CONTRAINDICATIONS VALTREX is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to valacyclovir, acyclovir, or any component of the formulation [see Warnings and Precautions ( 5.4 ), Adverse Reactions … |
Other labels that name valacyclovir
Source: FDA drug label (VALTREX), GlaxoSmithKline LLC, effective November 12, 2025 (SPL set f8e0d8f8-cb73-4206-a484-88f5c4fbd719), via openFDA; the full label on DailyMed
What do FAERS reports show for valacyclovir?
The FDA Adverse Event Reporting System holds 70,054 reports that list valacyclovir among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,662 are coded as a death and 26,096 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as valacyclovir?
2 other medicines are given the same way (oral) and in the same FDA class as valacyclovir or labeled mainly for the same use (herpes and shingles), the same class first. Herpes and shingles lists all 15 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acyclovir | Herpes and shingles | 48 labelers | $0.0962 per tablet 400 mg tablet | No current entry |
| Famciclovir | Herpes and shingles | 9 labelers | $0.214 per tablet 125 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does valacyclovir compare with medicines for the same use?
2 side-by-side pages set valacyclovir beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other herpes simplex virus nucleoside analog dna polymerase inhibitors
- the pharmacologic class, with prices and generics
- Valacyclovir side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other