Home › NDC Lookup › Ingredients › Valacyclovir › 62135-0613-90
Valacyclovir 500 mg Tablet, 90-count — NDC 62135-0613-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Valacyclovir 500 mg Tablet, 90-count — NDC 62135-613-90 (Billing 62135-0613-90)

by Chartwell RX, LLC · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of Valacyclovir 500 mg Tablet from Chartwell RX, LLC, marketed since Oct 2018 and currently FDA-listed; retail pharmacies pay about $0.2289 per tablet (NADAC).

NDC 62135-0613-90
🏷️ FDA NDC (as labeled) 62135-613-90 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.2289 NADAC Per package$20.60 / 90 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $0.4291/unit — full pricing hub ↓
Product page 62135-0613-30 Also comes in: 30 tablets 62135-613-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62135-613-90
Product NDC 62135-613
11-digit billing NDC 62135061390
NCPDP billing unit EA — each (per item)
RxCUI 313564, 313565
UNII G447S0T1VC
UPC 0362135613303, 0362135614300, 0362135613907, 0362135614904
Application # ANDA209553
SPL Set ID e59f15d0-c32a-4848-bdd5-fc2542e561c0
Established class (EPC) Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor; Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor; Nucleoside Analog [
Mechanism of action DNA Polymerase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-10-01
Route ORAL
Dosage form TABLET
Substance VALACYCLOVIR HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 12405085100310
GCN Seq No 023989
GCN 13740
HICL code 010117
Ingredient (HICL) Valacyclovir Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5A
Therapeutic class — specific (HIC3) Antivirals, General
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name VALACYCLOVIR HCL 500 MG TABLET
FDB brand name Valacyclovir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 023989
  • GCN: 13740
  • GPI-14 (Medi-Span): 12405085100310
  • HICL (First Databank): 010117
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 313564
Why two NDCs? The FDA registers this code as 62135-613-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62135-0613-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
Drug family (ATC) Nucleosides and nucleotides excl. reverse transcriptase inhibitors
How it works DNA Polymerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name VALACYCLOVIR HCL 500 MG TABLET Ingredient Valacyclovir Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats herpes virus infections. That includes cold sores, genital herpes, and shingles in adults. Children can use it for cold sores (age 12 and older) and chickenpox (ages 2 to...
  • No, you can take it with or without food. Do try to drink plenty of fluids while you are on it, since good hydration helps protect your kidneys.
  • As early as you can. For cold sores, start at the first tingling, itching or burning. Treatment works best for genital herpes and shingles when started within a day or two of sympt...
  • The most common ones are headache, nausea and stomach pain. Some people also get vomiting or dizziness. These are usually mild, but tell me if they bother you.
📖 Read our full Valacyclovir guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.229 $20.60 / 90 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4291 $38.62 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Feb 2024 Feb 2026 May 2026 Sep 2026 $0.279 $0.223
▼ Down 18% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
62135-0613-30 62135-613-30 Main listing 30 TABLET in 1 BOTTLE $0.2289 / ea $6.87 2023-06-21 — Active
62135-0613-90 You're viewing this 90 TABLET in 1 BOTTLE $0.2289 / ea $20.60 2023-06-21 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.2289 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle.
How does this package differ from NDC 62135-0613-30?
Both are Valacyclovir 500 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 62135-0613-30 is the 30 tablets package.
What NDC number is used to bill for this package of Valacyclovir 500 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Valacyclovir Hydrochloride 500 mg 00378-4275-77 Mylan 90 tablets $0.229 AB Availability likely —
Valacyclovir Hydrochloride 500 mg 00904-6565-07 Major 1 tablet $0.229 AB Availability likely —
Valacyclovir Hydrochloride 500 mg 50268-0788-15 AvPAK 1 tablet $0.229 AB Availability likely —
Valacyclovir Hydrochloride 500 mg 51079-0093-03 Mylan 1 tablet $0.229 AB Availability likely —
Valacyclovir 500 mgthis 62135-0613-90 Chartwell 90 tablets $0.229 AB Availability likely —
Valacyclovir Hydrochloride 500 mg 68084-0215-01 American 1 tablet $0.229 AB Availability likely —
Valacyclovir 500 mg 69367-0262-09 Westminster 90 tablets $0.229 AB Availability likely —
Valacyclovir 500 mg 82009-0040-30 Quallent 30 tablets $0.229 AB Discontinued —
Valacyclovir Hydrochloride 500 mg 16714-0698-01 NorthStar 30 tablets $0.277 AB Discontinued +21%
Valtrex 500 mg 00173-0933-08 GlaxoSmithKline 30 tablets $12.805 AB Availability likely +5494%
Valacyclovir 500 mg 31722-0704-01 Camber 100 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 43063-0730-10 PD-Rx 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 48433-0144-03 Safecor 1 tablet — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 49483-0690-03 TIME 30 tablets — AB FDA listed —
Valacyclovir 500 mg 50090-2510-00 A-S 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 50090-5852-00 A-S 10 tablets — AB FDA listed —
Valacyclovir 500 mg 50090-6581-00 A-S 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 50090-6918-00 A-S 90 tablets — AB FDA listed —
Valacyclovir 500 mg 50090-7702-00 A-S 90 tablets — AB FDA listed —
Valacyclovir 500 mg 51407-0107-30 Golden 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 51655-0633-21 Northwind 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 55154-7985-00 Cardinal 1 tablet — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 57237-0042-05 Rising 500 tablets — AB FDA listed —
valacyclovir hydrochloride 500 mg 59746-0324-01 Jubilant 100 tablets — AB FDA listed —
Valacyclovir 500 mg 61919-0066-20 Direct 20 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 63187-0832-04 Proficient 4 tablets — AB FDA listed —
Valacyclovir 500 mg 63304-0904-03 SUN 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 65862-0448-01 Aurobindo 100 tablets — AB FDA listed —
Valacyclovir 500 mg 67046-1071-03 Coupler 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 67296-2127-02 Redpharm 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 68071-2738-01 NuCare 10 tablets — AB FDA listed —
Valacyclovir 500 mg 68071-3747-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir 500 mg 68071-3749-04 NuCare 14 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 68071-4783-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 68071-4885-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir 500 mg 68788-4105-03 Preferred 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 68788-8482-03 Preferred 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 68788-8904-03 Preferred 30 tablets — AB FDA listed —
Valacyclovir 500 mg 69117-0010-01 Yiling 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 70518-2266-00 REMEDYREPACK 30 tablets — AB FDA listed —
Valacyclovir 500 mg 70518-4417-00 REMEDYREPACK 30 tablets — AB FDA listed —
Valacyclovir 500 mg 70518-4661-00 REMEDYREPACK 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 71335-0708-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 71335-1341-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir 500 mg 71335-2566-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 72162-2366-09 Bryant 90 tablets — AB FDA listed —
Valacyclovir 500 mg 72189-0630-20 Direct_Rx 20 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 72789-0263-10 PD-Rx 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 72789-0264-30 PD-Rx 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 76420-0053-12 Asclemed 12 tablets — AB FDA listed —
Valacyclovir 500 mg 82804-0009-06 Proficient 6 tablets — AB FDA listed —
Valacyclovir 500 mg 82804-0212-06 Proficient 6 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 82868-0055-21 Northwind 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 500 mg 85766-0054-01 Sportpharm 100 tablets — AB FDA listed —
Valacyclovir 500 mg 53401-0031-81 Aphena 1080 tablets — AB FDA listed —
Valacyclovir 500 mg 85766-0270-02 Sportpharm 2 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Oct 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color blue
ShapeCapsule
ImprintY132
Size23 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII RDH86HJV5Z
    Povidone K90 is a synthetic polymer made from a chemical called vinyl pyrrolidone. It acts as a binder to hold pill ingredients together and as a dispersant to help the medicine break down and dissolve properly in your body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerChartwell RX, LLC
Application holderYILING PHARMACEUTICAL LTD
FDA applicationANDA209553 (ANDA)
Labeler code62135
First marketedOct 2018
Product typeHuman Prescription Drug
Portfolio521 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Valacyclovir tablets are 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 valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.

1.1Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes Initial Episode: Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults.

The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: Valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established.

Suppressive Therapy: Valacyclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-1-infected adults. The efficacy and safety of valacyclovir tablets for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-1-infected patients have not been established. Reduction of Transmission: Valacyclovir tablets are indicated for the reduction of transmission of genital herpes in immunocompetent adults.

The efficacy of valacyclovir tablets for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets for the reduction of transmission of genital herpes in individuals with multiple partners and non-heterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC] Sexually Transmitted Diseases Treatment Guidelines ).

Herpes Zoster Valacyclovir tablets are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets for treatment of disseminated herpes zoster have not been established.

1.2Pediatric Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12 years. The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Chickenpox Valacyclovir tablets are indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years.

Based on efficacy data from clinical trials with oral acyclovir, treatment with valacyclovir tablets should be initiated within 24 hours after the onset of rash [see Clinical Studies (14.4) ] .

1.3Limitations of Use The efficacy and safety of valacyclovir tablets have not been established in: Immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3 . Patients aged less than 12 years with cold sores (herpes labialis). Patients aged less than 2 years or greater than or equal to 18 years with chickenpox.

Pat… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from the 500-mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3) ] . Adult Dosage ( 2.1 ) Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients Alternate dose in patients with less than or equal to 9 recurrences/year HIV-1-infected patients 1 gram once daily 500 mg once daily 500 mg twice daily Reduction of transmission 500 mg once daily Herpes Zoster 1 gram 3 times daily for 7 days Pediatric Dosage ( 2.2 ) Cold Sores (aged greater than or equal to 12 years) 2 grams every 12 hours for 1 day Chickenpox (aged 2 to less than 18 years) 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the Valacyclovir Tablets 500 mg.

( 2.3 )

2.1Adult Dosing Recommendations Cold Sores (Herpes Labialis) The recommended dosage of valacyclovir tablets for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). Genital Herpes Initial Episode: The recommended dosage of valacyclovir tablets for treatment of initial genital herpes is 1 gram twice daily for 10 days.

Therapy was most effective when administered within 48 hours of the onset of signs and symptoms. Recurrent Episodes: The recommended dosage of valacyclovir tablets for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.

Suppressive Therapy: The recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily. In HIV-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3 , the recommended dosage of valacyclovir tablets for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

Reduction of Transmission: The recommended dosage of valacyclovir tablets for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner. Herpes Zoster The recommended dosage of valacyclovir tablets for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.

2.2Pediatric Dosing Recommendations Cold Sores (Herpes Labialis) The recommended dosage of valacyclovir tablets for the treatment of cold sores in pediatric patients aged greater than or equal to 12 years is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). Chickenpox The recommended dosage of valacyclovir tablets for treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years is 20 mg/kg administered 3 times daily for 5 days.

The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [see Use in Specific Populations (8.4) , Clinical Pharmacology (12.3) , Clinical Studies (14.4) ].

2.3Extemporaneous Preparation of Oral Suspension Ingredients and Preparation per USP-NF Valacyclovir tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL. Instructions for Preparing Suspension… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 81 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: Valacyclovir Tablets, USP 500-mg: Blue, film-coated, capsule-shaped tablets, debossed with “Y131” on one side contains 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg of the free base. Valacyclovir Tablets, USP 1-gram: Blue, film-coated, capsule-shaped tablets, with a partial score bar on both sides, debossed with "Y132" on one side contains 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of the free base. Tablets: 500 mg (unscored), 1 gram (partially scored) ( 3 )

⛔ Contraindications 48 words ▾

4 CONTRAINDICATIONS Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3) ]. Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV-1 disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of valacyclovir tablets in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. ( 5.1 ) Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir tablets for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients.

Use with caution in elderly patients and reduce dosage in patients with renal impairment. ( 2.4 , 5.2 ) Central nervous system adverse reactions (e.g., agitation, hallucinations, confusion, and encephalopathy): May occur in both adult and pediatric patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir tablets for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions.

Use with caution in elderly patients and reduce dosage in patients with renal impairment. (2.4 , 5.3 )

5.1Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS) TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV-1 disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of valacyclovir tablets at doses of 8 grams per day. Treatment with valacyclovir tablets should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur.

5.2Acute Renal Failure Cases of acute renal failure have been reported in: Elderly patients with or without reduced renal function. Caution should be exercised when administering valacyclovir tablets to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4) , Use in Specific Populations (8.5) ]. Patients with underlying renal disease who received higher-than-recommended doses of valacyclovir tablets for their level of renal function.

Dosage reduction is recommended when administering valacyclovir tablets to patients with renal impairment [see Dosage and Administration (2.4) , Use in Specific Populations (8.6) ]. Patients receiving other nephrotoxic drugs. Caution should be exercised when administering valacyclovir tablets to patients receiving potentially nephrotoxic drugs.

Patients without adequate hydration. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Adequate hydration should be maintained for all patients.

In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4) , Adverse Reactions (6.3) ] .

5.3Central Nervous System Effects Central nervous system adverse reactions, including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher-than-recommended doses of valacyclovir tablets for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. Valacyclovir tablets should be discontinued if central nervous system adverse reactions occur [see Adverse Reactions (6.3) , Use in Specific Populations (8.5 , 8.6) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1) ]. Acute Renal Failure [see Warnings and Precautions (5.2) ] . Central Nervous System Effects [see Warnings and Precautions (5.3) ] .

The most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with valacyclovir tablets and observed more frequently with valacyclovir tablets compared with placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in greater than 10% of pediatric subjects aged less than 18 years was headache. The most common adverse reactions reported in at least one indication by greater than 10% of adult subjects treated with valacyclovir tablets and more commonly than in subjects treated with placebo are headache, nausea, and abdominal pain.

( 6.1 ) The only adverse reaction occurring in greater than 10% of pediatric subjects less than 18 years of age was headache. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Cold Sores (Herpes Labialis) In clinical trials for the treatment of cold sores, the adverse reactions reported by subjects receiving valacyclovir tablets 2 grams twice daily (n = 609) or placebo (n = 609) for 1 day, respectively, included headache (14%, 10%) and dizziness (2%, 1%).

The frequencies of abnormal ALT (greater than 2 x ULN) were 1.8% for subjects receiving valacyclovir tablets compared with 0.8% for placebo. Other laboratory abnormalities (hemoglobin, white blood cells, alkaline phosphatase, and serum creatinine) occurred with similar frequencies in the 2 groups. Genital Herpes Initial Episode: In a clinical trial for the treatment of initial episodes of genital herpes, the adverse reactions reported by greater than or equal to 5% of subjects receiving valacyclovir tablets 1 gram twice daily for 10 days (n = 318) or oral acyclovir 200 mg 5 times daily for 10 days (n = 318), respectively, included headache (13%, 10%) and nausea (6%, 6%).

For the incidence of laboratory abnormalities see Table 2. Recurrent Episodes: In 3 clinical trials for the episodic treatment of recurrent genital herpes, the adverse reactions reported by greater than or equal to 5% of subjects receiving valacyclovir tablets 500 mg twice daily for 3 days (n = 402), valacyclovir tablets 500 mg twice daily for 5 days (n = 1,136) or placebo (n = 259), respectively, included headache (16%, 11%, 14%) and nausea (5%, 4%, 5%). For the incidence of laboratory abnormalities see Table 2.

Suppressive Therapy: Suppression of Recurrent Genital Herpes in Immunocompetent Adults: In a clinical trial for the suppression of recurrent genital herpes infections, the adverse reactions reported by subjects receiving valacyclovir tablets 1 gram once daily (n = 269), valacyclovir tablets 500 mg once daily (n = 266), or placebo (n = 134), respectively, included headache (35%, 38%, 34%), nausea (11%, 11%, 8%), abdominal pain (11%, 9%, 6%), dysmenorrhea (8%, 5%, 4%), depression (7%, 5%, 5%), arthralgia (6%, 5%, 4%), vomiting (3%, 3%, 2%), and dizziness (4%, 2%, 1%).

For the incidence of laboratory abnormalities see Table 2. Suppression of Recurrent Genital Herpes in HIV-1-Infected Subjects: In HIV-1-infected subjects, frequently reported adverse reactions for valacyclovir tablets (500 mg twice daily; n = 194, median days on therapy = 172) and placebo (n = 99, median days on therapy = 59), respectively, included headache (13%, 8%), fatigue (8%, 5%)… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 20 words ▾

7 DRUG INTERACTIONS No clinically significant drug-drug or drug-food interactions with valacyclovir tablets are known [see Clinical Pharmacology (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Clinical data over several decades with valacyclovir and its metabolite, acyclovir, in pregnant women, have not identified a drug associated risk of major birth defects. There are insufficient data on the use of valacyclovir regarding miscarriage or adverse maternal or fetal outcomes (see Data) . There are risks to the fetus associated with untreated herpes simplex during pregnancy (see Clinical Considerations).

In animal reproduction studies, no evidence of adverse developmental outcomes was observed with valacyclovir when administered to pregnant rats and rabbits at system exposures (AUC) 4 (rats) and 7 (rabbits) times the human exposure at the maximum recommended human dose (MRHD) (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: The risk of neonatal HSV infection varies from 30% to 50% for genital HSV acquired in late pregnancy (third trimester), whereas with HSV acquisition in early pregnancy, the risk of neonatal infection is about 1%. A primary herpes occurrence during the first trimester of pregnancy has been associated with neonatal chorioretinitis, microcephaly, and, in rare cases, skin lesions.

In very rare cases, transplacental transmission can occur resulting in congenital infection, including microcephaly, hepatosplenomegaly, intrauterine growth restriction, and stillbirth. Co-infection with HSV increases the risk of perinatal HIV transmission in women who had a clinical diagnosis of genital herpes during pregnancy. Data Human Data: Clinical data over several decades with valacyclovir and its metabolite, acyclovir, in pregnant women, based on published literature, have not identified a drug-associated risk of major birth defects.

There are insufficient data on the use of valacyclovir regarding miscarriage or adverse maternal or fetal outcomes. The Acyclovir and the Valacyclovir Pregnancy Registries, both population-based international prospective studies, collected pregnancy data through April 1999. The Acyclovir Registry documented outcomes of 1,246 infants and fetuses exposed to acyclovir during pregnancy (756 with earliest exposure during the first trimester, 197 during the second trimester, 291 during the third trimester, and 2 unknown).

The occurrence of major birth defects during first-trimester exposure to acyclovir was 3.2% (95% CI: 2.0% to 5.0%) and during any trimester of exposure was 2.6% (95% CI: 1.8% to 3.8%). The Valacyclovir Pregnancy Registry documented outcomes of 111 infants and fetuses exposed to valacyclovir during pregnancy (28 with earliest exposure in the first trimester, 31 during the second trimester, and 52 during the third trimester). The occurrence of major birth defects during first-trimester exposure to valacyclovir was 4.5% (95% CI: 0.24% to 24.9%) and during any trimester of exposure was 3.9% (95% CI: 1.3% to 10.7%).

Available studies have methodological limitations including insufficient sample size to support conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Animal Data: Valacyclovir was administered orally to pregnant rats and rabbits (up to 400 mg/kg/day) during organogenesis (Gestation Days 6 through 15, and 6 through 18, respectively). No adverse embryo-fetal effects were observed in rats and rabbits at acyclovir exposures (AUC) of up to approximately 4 (rats) and 7 (rabbits) times the exposure in humans at the MRHD.

Early embryo death, fetal growth retardation (weight and length), and variations in fetal skeletal development (primarily extra… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 66 words ▾

10 OVERDOSAGE Caution should be exercised to prevent inadvertent overdose [see Use in Specific Populations (8.5 , 8.6) ] . Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4) ] .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Valacyclovir is an antiviral drug active against α-herpes viruses [see Microbiology (12.4) ].

12.3Pharmacokinetics The pharmacokinetics of valacyclovir and acyclovir after oral administration of valacyclovir tablets have been investigated in 14 volunteer trials involving 283 adults and in 3 trials involving 112 pediatric subjects aged 1 month to less than 12 years. Pharmacokinetics in Adults Absorption and Bioavailability: After oral administration, valacyclovir hydrochloride is rapidly absorbed from the gastrointestinal tract and nearly completely converted to acyclovir and L- valine by first-pass intestinal and/or hepatic metabolism.

The absolute bioavailability of acyclovir after administration of valacyclovir tablets is 54.5% ± 9.1% as determined following a 1-gram oral dose of valacyclovir tablets and a 350-mg intravenous acyclovir dose to 12 healthy volunteers. Acyclovir bioavailability from the administration of valacyclovir tablets is not altered by administration with food (30 minutes after an 873 Kcal breakfast, which included 51 grams of fat). Acyclovir pharmacokinetic parameter estimates following administration of valacyclovir tablets to healthy adult volunteers are presented in Table 3.

There was a less than dose-proportional increase in acyclovir maximum concentration (C max ) and area under the acyclovir concentration-time curve (AUC) after single-dose and multiple-dose administration (4 times daily) of valacyclovir tablets from doses between 250 mg to 1 gram. There is no accumulation of acyclovir after the administration of valacyclovir at the recommended dosage regimens in adults with normal renal function. Table 3.

Mean (±SD) Plasma Acyclovir Pharmacokinetic Parameters Following Administration of Valacyclovir Tablets to Healthy Adult Volunteers Dose Single-Dose Administration (N = 8) Multiple-Dose Administration a (N = 24, 8 per treatment arm) C max (±SD) (mcg/mL) AUC (±SD) (h•mcg/mL) C max (±SD) (mcg/mL) AUC (±SD) (h•mcg/mL) 100 mg 0.83 (±0.14) 2.28 (±0.40) ND ND 250 mg 2.15 (±0.50) 5.76 (±0.60) 2.11 (±0.33) 5.66 (±1.09) 500 mg 3.28 (±0.83) 11.59 (±1.79) 3.69 (±0.87) 9.88 (±2.01) 750 mg 4.17 (±1.14) 14.11 (±3.54) ND ND 1,000 mg 5.65 (±2.37) 19.52 (±6.04) 4.96 (±0.64) 15.70 (±2.27) a Administered 4 times daily for 11 days.

ND = not done. Distribution: The binding of valacyclovir to human plasma proteins ranges from 13.5% to 17.9%. The binding of acyclovir to human plasma proteins ranges from 9% to 33%.

Metabolism: Valacyclovir is converted to acyclovir and L-valine by first-pass intestinal and/or hepatic metabolism. Acyclovir is converted to a small extent to inactive metabolites by aldehyde oxidase and by alcohol and aldehyde dehydrogenase. Neither valacyclovir nor acyclovir is metabolized by cytochrome P450 enzymes.

Plasma concentrations of unconverted valacyclovir are low and transient, generally becoming non-quantifiable by 3 hours after administration. Peak plasma valacyclovir concentrations are generally less than 0.5 mcg/mL at all doses. After single-dose administration of 1 gram of valacyclovir tablets, average plasma valacyclovir concentrations observed were 0.5, 0.4, and 0.8 mcg/mL in subjects with hepatic dysfunction, renal insufficiency, and in healthy subjects who received concomitant cimetidine and probenecid, respectively.

Elimination: The pharmacokinetic disposition of acyclovir delivered by valacyclovir is consistent with previous experience from intravenous and oral acyclovir. Following the oral administration of a single 1-gram dose of radiolabeled valacyclovir to 4 healthy subjects, 46% and 47% of administered radioactivity was recovered in urine and feces, respectively, over 96 hours. Acyclovir accounted for 89% of the radioactivity excreted in the urine.

Renal clearance of acyclovir following the administration of a single 1-gram dose of valacyclovir tablets to 12 healthy subjects was approximately 255 ± 86 mL/min which represents 42% o… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 98 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Valacyclovir Tablets, USP 500 mg (blue, film-coated, capsule-shaped tablets debossed with "Y131" on one side) containing 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg valacyclovir. Bottle of 30 (NDC 62135-613-30). Bottle of 90 (NDC 62135-613-90).

Valacyclovir Tablets, USP 1 gram (blue, film-coated, capsule-shaped tablets, with a partial scorebar on both sides, debossed with "Y132" on one side) containing 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram valacyclovir. Bottle of 30 (NDC 62135-614-30). Bottle of 90 (NDC 62135-614-90).

Storage: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

📋 Description 146 words ▾

11 DESCRIPTION Valacyclovir Tablets, USP is the hydrochloride salt of the L -valyl ester of the antiviral drug acyclovir. Valacyclovir Tablets, USP are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, hypromellose, magnesium stearate, polyethylene glycol 400, polysorbate 80, povidone K90, and titanium dioxide.

The chemical name of valacyclovir hydrochloride is L -valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H- purin- 9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula: Valacyclovir hydrochloride is a white to off-white powder with the molecular formula C 13 H 20 N 6 O 4 •HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL.

The pkas for valacyclovir hydrochloride are 1.90, 7.47, and 9.43. "Image Description"

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling (Patient Information). Importance of Adequate Hydration Patients should be advised to maintain adequate hydration. Missed Dose Instruct patients that if they miss a dose of valacyclovir tablets, to take it as soon as they remember.

Advise patients not to double their next dose or take more than the prescribed dose. Cold Sores (Herpes Labialis) Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer).

Patients should be instructed that treatment for cold sores should not exceed 1 day (2 doses) and that their doses should be taken about 12 hours apart. Patients should be informed that valacyclovir tablets is not a cure for cold sores. Genital Herpes Patients should be informed that valacyclovir tablets is not a cure for genital herpes.

Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices in combination with suppressive therapy with valacyclovir tablets.

Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists. Valacyclovir tablets has not been shown to reduce transmission of sexually transmitted infections other than HSV-2.

If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode. There are no data on the effectiveness of treatment initiated more than 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours after the onset of signs and symptoms of a recurrent episode. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 1 year’s duration in otherwise healthy patients.

There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 months’ duration in HIV-1-infected patients. Herpes Zoster There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

Chickenpox Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox. Manufactured by: Yiling Pharmaceutical Ltd No.36 Zhujiang Road, Shijiazhuang, 050035, China Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71508 Revised:06/2023 Pharmacist: Print Patient Information at: www.chartwellpharma.com/our-products/

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Cold Sores (Herpes Labialis) Two double-blind, placebo-controlled clinical trials were conducted in 1,856 healthy adults and adolescents (aged greater than or equal to 12 years) with a history of recurrent cold sores. Subjects self-initiated therapy at the earliest symptoms and prior to any signs of a cold sore. The majority of subjects initiated treatment within 2 hours of onset of symptoms.

Subjects were randomized to valacyclovir tablets 2 grams twice daily on Day 1 followed by placebo on Day 2, valacyclovir tablets 2 grams twice daily on Day 1 followed by 1 gram twice daily on Day 2, or placebo on Days 1 and 2. The mean duration of cold sore episodes was about 1 day shorter in treated subjects as compared with placebo. The 2-day regimen did not offer additional benefit over the 1-day regimen.

No significant difference was observed between subjects receiving valacyclovir tablets or placebo in the prevention of progression of cold sore lesions beyond the papular stage.

14.2Genital Herpes Infections Initial Episode Six hundred forty-three immunocompetent adults with first-episode genital herpes who presented within 72 hours of symptom onset were randomized in a double-blind trial to receive 10 days of valacyclovir tablets 1 gram twice daily (n = 323) or oral acyclovir 200 mg 5 times a day (n = 320). For both treatment groups the median time to lesion healing was 9 days, the median time to cessation of pain was 5 days, and the median time to cessation of viral shedding was 3 days. Recurrent Episodes Three double-blind trials (2 of them placebo-controlled) in immunocompetent adults with recurrent genital herpes were conducted.

Subjects self-initiated therapy within 24 hours of the first sign or symptom of a recurrent genital herpes episode. In 1 trial, subjects were randomized to receive 5 days of treatment with either valacyclovir tablets 500 mg twice daily (n = 360) or placebo (n = 259). The median time to lesion healing was 4 days in the group receiving valacyclovir tablets 500 mg versus 6 days in the placebo group, and the median time to cessation of viral shedding in subjects with at least 1 positive culture (42% of the overall trial population) was 2 days in the group receiving valacyclovir tablets 500 mg versus 4 days in the placebo group.

The median time to cessation of pain was 3 days in the group receiving valacyclovir tablets 500 mg versus 4 days in the placebo group. Results supporting efficacy were replicated in a second trial. In a third trial, subjects were randomized to receive valacyclovir tablets 500 mg twice daily for 5 days (n = 398) or valacyclovir tablets 500 mg twice daily for 3 days (and matching placebo twice daily for 2 additional days) (n = 402).

The median time to lesion healing was about 4½ days in both treatment groups. The median time to cessation of pain was about 3 days in both treatment groups. Suppressive Therapy Two clinical trials were conducted, one in immunocompetent adults and one in HIV-1-infected adults.

A double-blind, 12-month, placebo and active-controlled trial enrolled immunocompetent adults with a history of 6 or more recurrences per year. Outcomes for the overall trial population are shown in Table 8. Table 8.

Recurrence Rates in Immunocompetent Adults at 6 and 12 Months Outcome 6 Months 12 Months Valacyclovir Tablets 1 gram Once Daily (n = 269) Oral Acyclovir 400 mg Twice Daily (n = 267) Placebo (n = 134) Valacyclovir Tablets 1 gram Once Daily (n = 269) Oral Acyclovir 400 mg Twice Daily (n = 267) Placebo (n = 134) Recurrence free Recurrences Unknown a 55% 35% 10% 54% 36% 10% 7% 83% 10% 34% 46% 19% 34% 46% 19% 4% 85% 10% a Includes lost to follow-up, discontinuations due to adverse events, and consent withdrawn. Subjects with 9 or fewer recurrences per year showed comparable results with valacyclovir tablets 500 mg once daily.

In a second trial, 293 HIV-1-infected adults on stable antiretroviral therapy with a history of 4 or more recurrences of anogenit… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The data presented below include references to the steady-state acyclovir AUC observed in humans treated with 1-gram of valacyclovir tablets given orally 3 times a day to treat herpes zoster. Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir [see Clinical Pharmacology (12.3) ]. Carcinogenesis Valacyclovir was noncarcinogenic in lifetime carcinogenicity bioassays at single daily doses (gavage) of valacyclovir giving plasma acyclovir concentrations equivalent to human levels in the mouse bioassay and 1.4 to 2.3 times human levels in the rat bioassay.

There was no significant difference in the incidence of tumors between treated and control animals, nor did valacyclovir shorten the latency of tumors. Mutagenesis Valacyclovir was tested in 5 genetic toxicity assays. An Ames assay was negative in the absence or presence of metabolic activation.

Also negative were an in vitro cytogenetic study with human lymphocytes and a rat cytogenetic study. In the mouse lymphoma assay, valacyclovir was not mutagenic in the absence of metabolic activation. In the presence of metabolic activation (76% to 88% conversion to acyclovir), valacyclovir was mutagenic.

Valacyclovir was mutagenic in a mouse micronucleus assay. Impairment of Fertility Valacyclovir did not impair fertility or reproduction in male or female rats at acyclovir exposures (AUC) 6 times higher than in humans given the MRHD. Testicular atrophy occurred in male rats (orally dosed for 97 days at 18 times the MRHD) and was reversible.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Valacyclovir (val-a-SYE-kloe-veer) Tablets, USP What is valacyclovir tablets? Valacyclovir tablets is a prescription medicine used in adults: to treat cold sores (herpes labialis). to treat or control genital herpes outbreaks in adults with normal immune systems. to control genital herpes outbreaks in adults with human immunodeficiency virus-1 (HIV-1). with safer sex practices to lower the chance of spreading genital herpes to others, in adults with normal immune systems. Even with safer sex practices, it is still possible to spread genital herpes.

Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes. Use a condom made of latex or polyurethane whenever you have sexual contact. Ask your healthcare provider for more information about safer sex practices. to treat shingles (herpes zoster) in adults with normal immune systems.

Valacyclovir tablets is used in children to treat: cold sores in children 12 years of age and older. chickenpox in children with normal immune systems 2 years of age to less than 18 years of age. Valacyclovir tablets does not cure cold sores, chickenpox, shingles, or genital herpes. It is not known if valacyclovir tablets is safe and effective in people with weakened immune systems, other than for control of outbreaks of genital herpes in people with HIV-1.

It is not known if valacyclovir tablets is safe and effective in people 18 years of age and older with chickenpox. It is not known if valacyclovir tablets is safe and effective in children: less than 12 years of age with cold sores less than 2 years of age with chickenpox less than 18 years of age with genital herpes or shingles Do not take valacyclovir tablets if you are allergic to valacyclovir, acyclovir, or any of the ingredients in valacyclovir tablets. See the end of this leaflet for a complete list of ingredients in valacyclovir tablets.

Before you take valacyclovir tablets, tell your healthcare provider about all of your medical conditions, including if you: have had a bone marrow transplant or kidney transplant, or if you have advanced HIV-1 infection or acquired immune deficiency syndrome (AIDS). have kidney problems, including if you receive dialysis. are pregnant or plan to become pregnant. It is not known if valacyclovir tablets will harm your unborn baby. You and your healthcare provider will decide if you will take valacyclovir tablets if you are pregnant. are breastfeeding or plan to breastfeed. valacyclovir tablets may pass into your breastmilk.

Talk with your healthcare provider about the best way to feed your child if you take valacyclovir tablets. Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. How should I take valacyclovir tablets?

Take valacyclovir tablets exactly as your healthcare provider tells you to take it. Your dose of valacyclovir tablets and length of treatment will depend on the type of infection that you have and any other medical problems that you have. Do not stop valacyclovir tablets or change your treatment without talking to your healthcare provider.

Take valacyclovir tablets with or without food. Tell your healthcare provider if your child cannot swallow valacyclovir tablets. Your healthcare provider can prescribe valacyclovir tablets as an oral suspension for your child.

If you are taking valacyclovir tablets to treat outbreaks of cold sores, chickenpox, shingles, or genital herpes, take valacyclovir tablets as soon as you have the first symptoms of infection such as tingling, itching, or burning, or when the sore appears. It is important for you to stay well hydrated during treatment with valacyclovir tablets. Be sure to drink plenty of fluids during this time.

If you miss a dose of valacyclovir tablets, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 52 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Valacyclovir Tablets, USP 500 MG - NDC 62135-613-90- 90's Bottle Label Valacyclovir Tablets, USP 500 MG - NDC 62135-613-30- 30's Bottle Label Valacyclovir Tablets, USP 1gm- NDC 62135-614-90- 90's Bottle Label Valacyclovir Tablets, USP 1gm- NDC 62135-614-30- 30's Bottle Label "Image Description" "Image Description" "Image Description" "Image Description"

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Valacyclovir — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Valacyclovir. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$28.02M
Claims incl. refills
952.8K
Beneficiaries
727.1K
Spend / beneficiary
$38.54
Spend / claim
$29.41
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 62135-0612-60 · Chartwell 62135-0614-30 · Chartwell →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.