Quick answers
- What is Valacyclovir used for?
- The FDA-approved label (Valtrex, GlaxoSmithKline LLC, November 12, 2025) says: “VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients • 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 • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use The efficacy and …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Valacyclovir have a boxed warning?
- No. None of the 86 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Valacyclovir?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Valacyclovir been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 25, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Valacyclovir?
- 36 companies list prescription products of Valacyclovir in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., A-S Medication Solutions and Proficient Rx LP.
What Valacyclovir is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients • 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 • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use The efficacy and …
— FDA label: Valtrex, GlaxoSmithKline LLC, effective November 12, 2025. Read the full label on DailyMed →
The FDA has 86 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 86 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 114 in the FDA NDC Directory |
| Brand names | Valtrex |
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 |
|---|---|---|
| valacyclovir hydrochloride 1 g tablet | Generic | $0.4238 per tablet |
| valacyclovir hydrochloride 1 g tablet, film coated | Generic | $0.4238 per tablet |
| valacyclovir hydrochloride 1 g tablet, film coated | Brand: Valtrex | $20.24 per tablet |
| valacyclovir hydrochloride 1000 mg tablet | Generic | $0.4238 per tablet |
| valacyclovir hydrochloride 500 mg tablet | Generic | $0.2289 per tablet |
| valacyclovir hydrochloride 500 mg tablet, film coated | Generic | $0.2289 per tablet |
| valacyclovir hydrochloride 500 mg tablet, film coated | Brand: Valtrex | $12.81 per tablet |
NADAC list of November 4, 2026; these prices took effect between May 20, 2026 and 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.
- NuCare Pharmaceuticals, Inc.11 products
- A-S Medication Solutions9 products
- Proficient Rx LP8 products
- Remedyrepack Inc.8 products
- Bryant Ranch Prepack7 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Northwind Health Company, LLC5 products
- Sportpharm LLC4 products
- Preferred Pharmaceuticals Inc.4 products
- Asclemed USA, Inc.4 products
- St. Mary's Medical Park Pharmacy3 products
- Redpharm Drug3 products
- Direct_Rx3 products
- Camber Pharmaceuticals, Inc.2 products
- GlaxoSmithKline LLC2 products
- Time Cap Laboratories, Inc2 products
- Chartwell RX, LLC2 products
- Coupler LLC2 products
- AvPAK2 products
- Golden State Medical Supply, Inc.2 products
- Jubilant Cadista Pharmaceuticals Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- American Health Packaging2 products
- Yiling Pharmaceutical, Inc.2 products
- Quallent Pharmaceuticals Health LLC2 products
- Rising Pharma Holdings, Inc.2 products
- Aurobindo Pharma Limited2 products
- NorthStar Rx LLC2 products
- Mylan Pharmaceuticals Inc.2 products
- Westminster Pharmaceuticals, LLC2 products
- Cardinal Health 107, LLC1 product
- Safecor Health LLC1 product
- Mylan Institutional Inc.1 product
- NuCare Pharmacuticals, Inc.1 product
- Major Pharmaceuticals1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020487 VALTREX | Glaxosmithkline | June 23, 1995 | 11, latest November 12, 2025 2025: Labeling · 2021: Labeling · 2019: Labeling |
Generic approvals (7)
- ANDA076588Sun Pharm Inds Ltd · January 31, 2007
- ANDA078518Mylan Pharms Inc · May 24, 2010
- ANDA079012Rising · May 24, 2010
- ANDA090682Aurobindo Pharma · May 24, 2010
- ANDA201506Jubilant Generics · April 3, 2012
- ANDA203047Hetero Labs Ltd V · April 8, 2015
- ANDA209553Yiling · March 18, 2020
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.
-
April 25, 2024 · Class III · Completed · D-0481-2024
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77 — Viatris Inc
-
February 13, 2018 · Class II · Terminated · D-0602-2018
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 consignment of Famciclovir complaint batch (D-0415-2018).
Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India NDC # — 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) | 108780, 212448, 313564, 313565 |
|---|---|
| SPL set ID of the quoted label | f8e0d8f8-cb73-4206-a484-88f5c4fbd719 |
| FDA labels (SPL) | 86 |
| FDA applications | NDA020487, 7 ANDA |
| Active ingredients (FDA) | VALACYCLOVIR |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Valtrex, GlaxoSmithKline LLC, effective November 12, 2025; 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 →