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Valacyclovir Hydrochloride 1 g Tablet, Film Coated, 21-count — NDC 72189-0037-21 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Valacyclovir Hydrochloride 1 g Tablet, Film Coated, 21-count — NDC 72189-037-21 (Billing 72189-0037-21)

by DIRECT RX · 21 TABLET, FILM COATED in 1 BOTTLE

This is a package of 21 tablets of Valacyclovir Hydrochloride 1 g Tablet, Film Coated from DIRECT RX, no longer marketed, no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 4 package sizes.

NDC 72189-0037-21
🏷️ FDA NDC (as labeled) 72189-037-21 billing pads the product segment with a zero
This package
Contains21-count Pack sizes4 compare ↓
Main listing for product 72189-037 · Also comes in: 30 tablets 72189-037-30 60 tablets 72189-037-60 90 tablets 72189-037-90
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 14, 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-037-21
Product NDC 72189-037
11-digit billing NDC 72189003721
NCPDP billing unit EA — each (per item)
Application # ANDA201506
SPL Set ID 97a10bb6-52c0-495d-e053-2995a90a60a4
Established class (EPC) DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route ORAL
Dosage form TABLET, FILM COATED
Substance VALACYCLOVIR HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-037-21 — 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 → 72189-0037-21. 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.

Clinical

📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets 60 tablets 90 tablets
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 Marketing startMarketing endStatus
72189-0037-21 You're viewing this Main listing 21 TABLET, FILM COATED in 1 BOTTLE 2019-11-18 — Inactivated by FDA
72189-0037-30 72189-037-30 30 TABLET, FILM COATED in 1 BOTTLE 2019-11-18 — Inactivated by FDA
72189-0037-60 72189-037-60 60 TABLET, FILM COATED in 1 BOTTLE 2019-11-18 — Inactivated by FDA
72189-0037-90 72189-037-90 90 TABLET, FILM COATED in 1 BOTTLE 2019-11-18 — Inactivated by FDA

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 21-count package — 21 tablet, film coated in 1 bottle.
How does this package differ from NDC 72189-0037-30?
Both are Valacyclovir Hydrochloride 1 g Tablet, Film Coated — the drug itself is identical. This page's package is the 21-count one, while NDC 72189-0037-30 is the 30 tablets package.
What NDC number is used to bill for this package of Valacyclovir Hydrochloride 1 g Tablet, Film Coated?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Valacyclovir Hydrochloride 1 g 00378-4276-77 Mylan 90 tablets $0.410 AB Availability likely —
Valacyclovir Hydrochloride 1 g 50268-0789-15 AvPAK 1 tablet $0.410 AB Availability likely —
Valacyclovir 1 g 62135-0614-30 Chartwell 30 tablets $0.410 AB Availability likely —
Valacyclovir Hydrochloride 1 g 68084-0309-21 American 1 tablet $0.410 AB Availability likely —
Valacyclovir 1000 mg 69367-0263-09 Westminster 90 tablets $0.410 AB Availability likely —
Valacyclovir 1 g 82009-0041-90 Quallent 90 tablets $0.410 AB Availability likely —
Valacyclovir Hydrochloride 1 g 16714-0697-01 NorthStar 30 tablets $0.506 AB Discontinued —
Valtrex 1 g 00173-0565-04 GlaxoSmithKline 30 tablets $20.244 AB Availability likely —
Valacyclovir 1 g 31722-0705-01 Camber 100 tablets — AB FDA listed —
Valacyclovir 1 g 43063-0771-06 PD-Rx 6 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 49483-0691-01 TIME 100 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 50090-1173-00 A-S 15 tablets — AB FDA listed —
Valacyclovir 1 g 50090-2575-00 A-S 15 tablets — AB FDA listed —
Valacyclovir 1000 mg 50090-7270-00 A-S 15 tablets — AB FDA listed —
Valacyclovir 1000 mg 50090-7484-00 A-S 21 tablets — AB FDA listed —
Valacyclovir 1 g 51407-0108-30 Golden 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 51655-0703-21 Northwind 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 57237-0043-05 Rising 500 tablets — AB FDA listed —
valacyclovir hydrochloride 1 g 59746-0325-01 Jubilant 100 tablets — AB FDA listed —
Valacyclovir 1 g 60760-0469-42 St 42 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 60760-0757-42 St. 42 tablets — AB FDA listed —
valacyclovir hydrochloride 1 g 63187-0538-04 Proficient 4 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 63187-0776-04 Proficient 4 tablets — AB FDA listed —
Valacyclovir 1 g 63187-0950-04 Proficient 4 tablets — AB FDA listed —
Valacyclovir 1 g 63304-0905-03 SUN 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 65862-0449-01 Aurobindo 100 tablets — AB FDA listed —
Valacyclovir 1 g 67046-1347-03 Coupler 30 tablets — AB FDA listed —
Valacyclovir 1 g 67296-1297-01 RedPharm 21 tablets — AB Discontinued —
Valacyclovir 1000 mg 67296-2146-01 Redpharm 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68071-1548-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir 1000 mg 68071-3624-03 NuCare 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68071-4727-02 NuCare 2 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68071-4728-01 NuCare 21 tablets — AB FDA listed —
Valacyclovir 1 g 68071-4805-01 NuCare 90 tablets — AB FDA listed —
Valacyclovir 1 g 68788-7587-00 Preferred 6 tablets — AB FDA listed —
Valacyclovir 1000 mg 68788-8705-00 Preferred 6 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 68788-8820-00 Preferred 6 tablets — AB FDA listed —
Valacyclovir 1 g 69117-0011-01 Yiling 30 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 70518-0541-01 REMEDYREPACK 14 tablets — AB FDA listed —
Valtrex 1 g 70518-2039-01 REMEDYREPACK 14 tablets — AB FDA listed —
Valacyclovir 1 g 70518-2402-01 REMEDYREPACK 4 tablets — AB Discontinued —
Valacyclovir Hydrochloride 1 g 70518-3359-00 REMEDYREPACK 4 tablets — AB Discontinued —
Valacyclovir 1000 mg 70518-4100-00 REMEDYREPACK 30 tablets — AB FDA listed —
Valacyclovir 1 g 71335-0630-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 71335-1862-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir 1000 mg 71335-2534-00 Bryant 60 tablets — AB FDA listed —
Valacyclovir 1000 mg 72189-0594-04 Direct 4 tablets — AB FDA listed —
Valacyclovir 1 g 72789-0452-21 PD-Rx 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 76420-0600-02 Asclemed 2 tablets — AB FDA listed —
Valacyclovir 1000 mg 82804-0006-06 Proficient 6 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 82804-0093-10 Proficient 10 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 82868-0106-21 Northwind 21 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 g 85766-0026-01 Sportpharm 100 tablets — AB FDA listed —
Valacyclovir Hydrochloride 1 gthis 72189-0037-21 DIRECT 21 tablets — AB Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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.

8 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

LabelerDIRECT RX
Application holderJUBILANT GENERICS LTD
FDA applicationANDA201506 (ANDA)
Labeler code72189
Product typeHuman Prescription Drug
Portfolio204 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. 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
🎯 Indications and Usage ~2 min read ▾

1.1Adult Patients Cold Sores (Herpes Labialis): Valacyclovir tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets, USP 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, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults.

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

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

The efficacy of valacyclovir tablets, USP for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets, USP 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, USP are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets, USP when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets, USP for treatment of disseminated herpes zoster have not been established.

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

Based on efficacy data from clinical studies with oral acyclovir, treatment with valacyclovir tablets, USP 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, USP have not been established in: Immunocompromised patients other than for the suppression of genital herpes in HIV‑infected patients with a CD4+ cell count ≥100 cells/mm3. Patients <12 years of age with cold sores (herpes labialis). Patients <2 years of age or ≥18 years of age with chickenpox.

Patients <18 years of age with genital herpes. Patients <18 years of age with herpes zoster. Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.

⏱️ Dosage and Administration ~3 min read ▾

Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from valacyclovir tablets 500 mg for use in pediatric patients for whom a solid dosage form is not appropriate [see DOSAGE AND ADMINISTRATION (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‑infected patients with a CD4+ cell count ≥100 cells/mm3, 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 ≥12 years of age 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 2 to <18 years of age 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. Prepare Suspension at Time of Dispensing as Follows: Prepare SSV according to the USP-NF.

Using a pestle and mortar, grind the required number of valacyclovir 500 mg tablets until a fine powder is produced (5 valacyclovir tablets for 25 mg/mL suspension; 10 valacyclovir tablets for 50 mg/mL suspension). Gradually add approximately 5 mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted.

Continue to add approximately 5 mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25 mg/mL and 50 mg/mL suspensions. Transfer the mixture to a suitable 100 mL measuring flask. Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV.

Once dissolved, add to the…

💊 Dosage Forms and Strengths 55 words ▾

Valacyclovir Tablets, USP: 500 mg: blue colored, capsule shaped, film coated tablets debossed with "C324 500" on one side and plain on the other side. 1 gram: blue colored, capsule shaped, film coated tablets with partial score bar on both sides and debossed with "C325 1000" on one side and plain on the other side.

⛔ Contraindications 30 words ▾

Valacyclovir hydrochloride is 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)].

⚠️ Warnings and Cautions ~1 min read ▾

5.1Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS) TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of valacyclovir hydrochloride at doses of 8 grams per day. Treatment with valacyclovir hydrochloride 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 hydrochloride 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 hydrochloride for their level of renal function.

Dosage reduction is recommended when administering valacyclovir hydrochloride 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 hydrochloride 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 hydrochloride for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. Valacyclovir hydrochloride 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 ▾

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 >10% of adult patients treated with valacyclovir hydrochloride and observed more frequently with valacyclovir hydrochloride compared to placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in >10% of pediatric patients <18 years of age was headache.

6.1Clinical Trials Experience in Adult Patients 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 studies for the treatment of cold sores, the adverse reactions reported by patients receiving valacyclovir hydrochloride 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 (>2 x ULN) were 1.8% for patients receiving valacyclovir hydrochloride 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 study for the treatment of initial episodes of genital herpes, the adverse reactions reported by ≥5% of patients receiving valacyclovir hydrochloride 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 studies for the episodic treatment of recurrent genital herpes, the adverse reactions reported by ≥5% of patients receiving valacyclovir hydrochloride 500 mg twice daily for 3 days (n = 402), valacyclovir hydrochloride 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 study for the suppression of recurrent genital herpes infections, the adverse reactions reported by patients receiving valacyclovir hydrochloride 1 gram once daily (n = 269), valacyclovir hydrochloride 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-Infected Patients: In HIV-infected patients, frequently reported adverse reactions for valacyclovir hydrochloride (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%), and rash (8%, 1%). Post-randomization laboratory abnormalities that were reported more frequently in valacyclovir hydrochloride subjects versus placebo included elevated alkaline phosphatase (4%, 2%), elevated ALT (14%, 10%), elevated AST (16%, 11%), decreased neutrophil counts (18%, 10%), and decreased platelet counts (3%, 0%), respectively.

Reduction of Transmission: In a clinical study for the reduction of transmission of genital herpes, the adverse reactions reported by patients receiving valacyclovir hydrochloride 500 mg once daily (n = 743) or placebo…

🔄 Drug Interactions 16 words ▾

No clinically significant drug-drug or drug-food interactions with valacyclovir hydrochloride are known [see CLINICAL PHARMACOLOGY (12.3)].

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Pregnancy Category B. There are no adequate and well-controlled studies of valacyclovir hydrochloride or acyclovir in pregnant women. Based on prospective pregnancy registry data on 749 pregnancies, the overall rate of birth defects in infants exposed to acyclovir in-utero appears similar to the rate for infants in the general population.

Valacyclovir hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes.

The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Animal reproduction studies performed at oral doses that provided up to 10 and 7 times the human plasma levels during the period of major organogenesis in rats and rabbits, respectively, revealed no evidence of teratogenicity.

8.3Nursing Mothers Following oral administration of a 500 mg dose of valacyclovir hydrochloride to 5 nursing mothers, peak acyclovir concentrations (Cmax) in breast milk ranged from 0.5 to 2.3 times (median 1.4) the corresponding maternal acyclovir serum concentrations. The acyclovir breast milk AUC ranged from 1.4 to 2.6 times (median 2.2) maternal serum AUC. A 500 mg maternal dosage of valacyclovir hydrochloride twice daily would provide a nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day.

This would result in less than 2% of the exposure obtained after administration of a standard neonatal dose of 30 mg/kg/day of intravenous acyclovir to the nursing infant. Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Caution should be exercised when valacyclovir hydrochloride is administered to a nursing woman.

8.4Pediatric Use Valacyclovir hydrochloride is indicated for treatment of cold sores in pediatric patients ≥12 years of age and for treatment of chickenpox in pediatric patients 2 to <18 years of age [see INDICATIONS AND USAGE (1.2), DOSAGE AND ADMINISTRATION (2.2)]. The use of valacyclovir hydrochloride for treatment of cold sores is based on 2 double-blind, placebo-controlled clinical trials in healthy adults and adolescents (≥12 years of age) with a history of recurrent cold sores [see CLINICAL STUDIES (14.1)]. The use of valacyclovir hydrochloride for treatment of chickenpox in pediatric patients 2 to <18 years of age is based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by efficacy and safety data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox [see DOSAGE AND ADMINISTRATION (2.2), ADVERSE REACTIONS (6.2), CLINICAL PHARMACOLOGY (12.3), CLINICAL STUDIES (14.4)].

The efficacy and safety of valacyclovir have not been established in pediatric patients: <12 years of age with cold sores <18 years of age with genital herpes <18 years of age with herpes zoster < 2 years of age with chickenpox for suppressive therapy following neonatal HSV infection. The pharmacokinetic profile and safety of valacyclovir oral suspension in children <12 years of age were studied in 3 open-label studies. No efficacy evaluations were conducted in any of the 3 studies.

Study 1 was a single-dose pharmacokinetic,multiple-dose safety study in 27 pediatric patients 1 to <12 years of age with clinically suspected varicella-zoster virus (VZV) infection [see DOSAGEANDADMINISTRATION(2.2), ADVERSE REACTIONS (6.2), CLINICAL PHARMACOLOGY (12.3), CLINICAL STUDIES (14.4)]. Study 2…

🆘 Overdosage 59 words ▾

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 ▾

12.1Mechanism of Action Valacyclovir is an antiviral drug [see CLINICAL PHARMACOLOGY (12.4)].

12.3Pharmacokinetics The pharmacokinetics of valacyclovir and acyclovir after oral administration of valacyclovir hydrochloride have been investigated in 14 volunteer studies involving 283 adults and in 3 studies involving 112 pediatric subjects from 1 month to <12 years of age. 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 hydrochloride is 54.5% ± 9.1% as determined following a 1 gram oral dose of valacyclovir hydrochloride and a 350 mg intravenous acyclovir dose to 12 healthy volunteers. Acyclovir bioavailability from the administration of valacyclovir hydrochloride 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 hydrochloride to healthy adult volunteers are presented in TABLE 3.

There was a less than dose-proportional increase in acyclovir maximum concentration (Cmax) and area under the acyclovir concentration-time curve (AUC) after single-dose and multiple-dose administration (4 times daily) of valacyclovir hydrochloride 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 Hydrochloride to Healthy Adult Volunteers Dose Single-Dose Administration (N = 8) Multiple‑Dose Administration* (N = 24, 8 per treatment arm) Cmax (±SD) (mcg/mL) AUC (±SD) (hr●mcg/mL) Cmax (±SD) (mcg/mL) AUC (±SD) (hr●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) *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 hydrochloride, average plasma valacyclovir concentrations observed were 0.5, 0.4, and 0.8 mcg/mL in patients with hepatic dysfunction, renal insufficiency, and in healthy volunteers 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 hydrochloride to 12 healthy volunteers was approximately 255 ± 86 mL/min which represents…

📦 How Supplied / Storage and Handling 98 words ▾

Valacyclovir tablets, USP 500 mg (blue colored, capsule shaped, film coated tablets debossed with "C324 500" on one side and plain on the other side) containing valacyclovir hydrochloride equivalent to 500 mg valacyclovir. Valacyclovir tablets, USP 1 gram (blue colored, capsule shaped, film coated tablets with partial score bar on both sides and debossed with "C325 1000" on one side and plain on the other) containing valacyclovir hydrochloride equivalent to 1 gram valacyclovir. Storage: Store at 20ºC-25°C (68ºF-77ºF), excursions permitted to 15°C-30°C (59ºF-86ºF) [See USP Controlled Room Temperature].

Dispense in a well-closed container as defined in the USP.

📋 Description 115 words ▾

Valacyclovir hydrochloride,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 valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C Blue No.

2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula: [Structure] Valacyclovir hydrochloride, USP is a white to off-white powder with the molecular formula C13H20N6O4•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.

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

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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NDC identity (package / product / labeler codes) ✓ Available
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (72189-0037-30), 60 tablets (72189-0037-60), 90 tablets (72189-0037-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
DIRECT RX is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
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← 72189-0033-30 · Direct_Rx 72189-0039-80 · Direct_Rx →
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