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acyclovir 200 mg Capsule, 100-count — NDC 72578-0002-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

acyclovir 200 mg Capsule, 100-count — NDC 72578-002-01 (Billing 72578-0002-01)

by Viona Pharmaceuticals Inc · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of acyclovir 200 mg Capsule from Viona Pharmaceuticals Inc, marketed since Aug 2019 and currently FDA-listed; retail pharmacies pay about $0.0977 per capsule (NADAC). It is the main listing for this product, which comes in 5 package sizes.

NDC 72578-0002-01
🏷️ FDA NDC (as labeled) 72578-002-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0977 NADAC Per package$9.77 / 100 capsules Pack sizes5 compare ↓
Also priced by: Medicaid pays $0.2145/unit · Part D plans $0.1791/unit — full pricing hub ↓
Main listing for product 72578-002 · Also comes in: 30 capsules 72578-002-06 90 capsules 72578-002-16 500 capsules 72578-002-05 1000 capsules 72578-002-10
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) 72578-002-01
Product NDC 72578-002
11-digit billing NDC 72578000201
NCPDP billing unit EA — each (per item)
RxCUI 197310
UNII X4HES1O11F
Application # ANDA204313
SPL Set ID e580b7e9-9060-43f5-9b58-33998078d7e4
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
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 2019-08-23
Route ORAL
Dosage form CAPSULE
Substance ACYCLOVIR
TE code (Orange Book) AB · RLD · RS

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

GPI-14 12405010000110
GPI class Acyclovir
GCN Seq No 009630
GCN 43790
HICL code 004183
Ingredient (HICL) Acyclovir
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 ACYCLOVIR 200 MG CAPSULE
FDB brand name Acyclovir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009630
  • GCN: 43790
  • GPI-14 (Medi-Span): 12405010000110
  • HICL (First Databank): 004183
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 197310
Why two NDCs? The FDA registers this code as 72578-002-01 — 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 → 72578-0002-01. 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) Antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Antivirals
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 ACYCLOVIR 200 MG CAPSULE Ingredient Acyclovir
📖 What it is MedlinePlus · NLM

Acyclovir is used to treat viral infections like chickenpox, herpes zoster (shingles) and genital herpes (a sexually transmitted disease). Acyclovir is in a class of medications called antivirals. It works by stopping the spread of the virus in the body.  Acyclovir will not cure herpes infections and may not stop the spread of herpes virus to other people.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Acyclovir treats infections caused by herpes-family viruses. Oral forms treat shingles, genital herpes and chickenpox. Creams, ointments, the eye ointment, the buccal tablet and th...
  • As early as possible. For cold sores, that means at the first tingling, itching or burning. For genital herpes recurrences, start at the first sign of an outbreak. Early treatment...
  • The most common ones are headache, nausea and belly pain. Some people also get vomiting, dizziness or fatigue. These are usually manageable, but tell me if they bother you.
  • Call right away for confusion, hallucinations, seizures or unusual drowsiness. Also call if you urinate much less than usual, which can signal kidney trouble. Any allergic reaction...
📖 Read our full Acyclovir 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 $0.098 $9.77 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $0.2145 $21.45 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $0.1791 $17.91 / 100 capsules
Medicare Part B allowsASP · J8499 No ASP payment limit on file for J8499 this quarter.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.122 $0.097
▼ Down 7% over the last 24 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.

Billing & reimbursement

FDA NDC (as labeled)72578-002-01
11-digit billing NDC72578-0002-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ8499
DescriptorPRESCRIPTION DRUG, ORAL, NON CHEMOTHERAPEUTIC, NOS
Billing units / pkg1 units
How the units are derivedThis package is 100 EA; the HCPCS unit is 1 EA, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
72578-0002-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE $0.0977 / ea $9.77 2019-08-23 — Active
72578-0002-05 72578-002-05 500 CAPSULE in 1 BOTTLE $0.0977 / ea $48.87 2019-08-23 — Active
72578-0002-06 72578-002-06 30 CAPSULE in 1 BOTTLE — — 2019-08-23 — Active
72578-0002-10 72578-002-10 1000 CAPSULE in 1 BOTTLE — — 2019-08-23 — Active
72578-0002-16 72578-002-16 90 CAPSULE in 1 BOTTLE — — 2019-08-23 — Active

You're viewing one of 5 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0977 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 90% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 72578-0002-06?
Both are acyclovir 200 mg Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 72578-0002-06 is the 30 capsules package.
What NDC number is used to bill for this package of acyclovir 200 mg Capsule?
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
Acyclovir 200 mg 00904-5789-61 Major 100 capsules $0.097 AB Discontinued +0%
Acyclovir 200 mg 00904-7519-61 Major 100 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 23155-0229-01 Heritage 100 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 23155-0962-01 Avet 100 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 61442-0114-01 Carlsbad 100 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 62135-0039-50 Chartwell 50 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 69076-0146-01 Quinn 100 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 71921-0146-01 Florida 100 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 72241-0028-05 Modavar 100 capsules $0.098 AB Availability likely —
acyclovir 200 mgthis 72578-0002-01 Viona 100 capsules $0.098 AB Availability likely —
Acyclovir 200 mg 75834-0124-01 Nivagen 100 capsules $0.105 AB Discontinued +8%
Acyclovir 200 mg 50090-5610-00 A-S 25 capsules — AB FDA listed —
acyclovir 200 mg 50090-7216-00 A-S 25 capsules — AB FDA listed —
Acyclovir 200 mg 51407-0852-01 Golden 100 capsules — AB FDA listed —
acyclovir 200 mg 51655-0965-52 Northwind 30 capsules — AB FDA listed —
Acyclovir 200 mg 55154-0199-00 Cardinal 10 capsules — AB FDA listed —
Acyclovir 200 mg 55154-7629-00 Cardinal 10 capsules — AB Discontinued —
Acyclovir 200 mg 60505-0042-05 Apotex 500 capsules — AB Discontinued —
Acyclovir 200 mg 63629-2009-01 Bryant 500 capsules — AB FDA listed —
acyclovir 200 mg 65841-0829-01 Zydus 100 capsules — AB FDA listed —
Acyclovir 200 mg 68071-2299-03 NuCare 30 capsules — AB FDA listed —
Acyclovir 200 mg 68071-2526-03 NuCare 30 capsules — AB FDA listed —
Acyclovir 200 mg 69117-0039-01 YILING 100 capsules — AB FDA listed —
acyclovir 200 mg 70518-3436-00 REMEDYREPACK 30 capsules — AB FDA listed —
Acyclovir 200 mg 71205-0209-30 Proficient 30 capsules — AB FDA listed —
Acyclovir 200 mg 71205-0243-30 Proficient 30 capsules — AB FDA listed —
Acyclovir 200 mg 71205-0578-30 Proficient 30 capsules — AB FDA listed —
Acyclovir 200 mg 71209-0004-05 Cadila 100 capsules — AB FDA listed —
Acyclovir 200 mg 71335-0280-00 Bryant 90 capsules — AB FDA listed —
Acyclovir 200 mg 71335-0470-00 Bryant 90 capsules — AB FDA listed —
Acyclovir 200 mg 71335-1290-00 Bryant 90 capsules — AB FDA listed —
acyclovir 200 mg 71335-2261-00 Bryant 90 capsules — AB FDA listed —
Acyclovir 200 mg 72162-1704-00 Bryant 120 capsules — AB FDA listed —
Acyclovir 200 mg 72162-1908-00 Bryant 30 capsules — AB FDA listed —
acyclovir 200 mg 72789-0536-50 PD-Rx 50 capsules — AB FDA listed —
acyclovir 200 mg 82804-0245-30 Proficient 30 capsules — 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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 / White
ShapeCapsule
Imprint668
Size19 mm
ScoringNot scored
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 H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PN2ZH5LOQY
    A synthetic red dye approved by the FDA for use in foods, medicines, and cosmetics. It serves as a colorant to make tablets, capsules, and liquids visually distinctive for product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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

LabelerViona Pharmaceuticals Inc
Application holderCADILA HEALTHCARE LTD
FDA applicationANDA204313 (ANDA)
Labeler code72578
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio94 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 50 words ▾

INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir capsules are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir capsules are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir capsules are indicated for the treatment of chickenpox (varicella).

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Acute Treatment of Herpes Zoster: 800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes: Treatment of Initial Genital Herpes: 200 mg every 4 hours, 5 times daily for 10 days. Chronic Suppressive Therapy for Recurrent Disease: 400 mg 2 times daily for up to 12 months, followed by re-evaluation.

Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily. The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with acyclovir.

Intermittent Therapy: 200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence. Treatment of Chickenpox: Children (2 years of age and older): 20 mg/kg per dose orally 4 times daily (80 mg/kg/day) for 5 days.

Children over 40 kg should receive the adult dose for chickenpox. Adults and Children over 40 kg: 800 mg 4 times daily for 5 days. Intravenous acyclovir is indicated for the treatment of varicella-zoster infections in immunocompromised patients.

When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms. Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of Acyclovir Capsules should be modified as shown in Table 3.

Table 3. Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m 2 ) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours >10 200 every 4 hours, 5x daily 0 to 10 200 every 12 hours 400 mg every 12 hours >10 400 every 12 hours 0 to 10 200 every 12 hours 800 mg every 4 hours >25 800 every 4 hours, 5x daily 10 to 25 800 every 8 hours 0 to 10 800 every 12 hours Hemodialysis: For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours.

This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis. Peritoneal Dialysis: No supplemental dose appears to be necessary after adjustment of the dosing interval.

⛔ Contraindications 38 words ▾

CONTRAINDICATIONS Acyclovir capsules are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to acyclovir, valacyclovir, or any component of the formulation (see WARNINGS and ADVERSE REACTIONS ).

⚠️ Warnings 147 words ▾

WARNINGS Acyclovir capsules are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE ). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.

Severe cutaneous adverse reactions (SCARs), including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme (EM) have been reported with acyclovir (see CONTRAINDICATIONS and ADVERSE REACTIONS ). Discontinue acyclovir capsules immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Closely monitor clinical status and initiate appropriate therapy.

Acyclovir capsules are contraindicated in patients who have developed SCARs with the use of acyclovir or valacyclovir, or any component of the formulation (see CONTRAINDICATIONS and ADVERSE REACTIONS ).

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Herpes Simplex: Short-Term Administration: The most frequent adverse events reported during clinical trials of treatment of genital herpes with acyclovir 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo. Long-Term Administration: The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with acyclovir were nausea (4.8%) and diarrhea (2.4%).

The 589 control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%). Herpes Zoster: The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral acyclovir 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).

Chickenpox: The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral acyclovir at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%). Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir.

Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to acyclovir, or a combination of these factors. General: Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.

Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS ). Digestive: Diarrhea, gastrointestinal distress, nausea.

Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia. Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. Musculoskeletal: Myalgia.

Skin and Subcutaneous Tissue Disorders: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme (EM), rashes including photosensitivity, alopecia, pruritus, urticaria (see CONTRAINDICATIONS and WARNINGS ). Special Senses: Visual abnormalities. Urogenital: Renal failure, renal pain (may be associated with renal failure), elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS ).

To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🆘 Overdosage 110 words ▾

OVERDOSAGE Overdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid.

Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION ).

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacokinetics: The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Acyclovir pharmacokinetic parameters are summarized in Table 1. Table 1.

Acyclovir Pharmacokinetic Characteristics (Range) * Bioavailability decreases with increasing dose. Parameter Range Plasma protein binding 9% to 33% Plasma elimination half-life 2.5 to 3.3 hr Average oral bioavailability 10% to 20% * In one multiple-dose, crossover study in healthy subjects (n = 23), it was shown that increases in plasma acyclovir concentrations were less than dose proportional with increasing dose, as shown in Table 2. The decrease in bioavailability is a function of the dose and not the dosage form.

Table 2. Acyclovir Peak and Trough Concentrations at Steady State Parameter 200 mg 400 mg 800 mg C S S m a x 0.83 mcg/mL 1.21 mcg/mL 1.61 mcg/mL C S S t r o u g h 0.46 mcg/mL 0.63 mcg/mL 0.83 mcg/mL There was no effect of food on the absorption of acyclovir (n = 6); therefore, Acyclovir Capsules may be administered with or without food. The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine.

Special Populations: Adults With Impaired Renal Function: The half-life and total body clearance of acyclovir are dependent on renal function. A dosage adjustment is recommended for patients with reduced renal function (see DOSAGE AND ADMINISTRATION ). Geriatrics: Acyclovir plasma concentrations are higher in geriatric patients compared with younger adults, in part due to age-related changes in renal function.

Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use ). Pediatrics: In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. Mean half-life after oral doses of 300 mg/m 2 and 600 mg/m 2 in pediatric patients aged 7 months to 7 years was 2.6 hours (range 1.59 to 3.74 hours).

Drug Interactions: Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced. Clinical Trials: Initial Genital Herpes: Double-blind, placebo-controlled studies have demonstrated that orally administered acyclovir significantly reduced the duration of acute infection and duration of lesion healing.

The duration of pain and new lesion formation was decreased in some patient groups. Recurrent Genital Herpes: Double-blind, placebo-controlled studies in patients with frequent recurrences (6 or more episodes per year) have shown that orally administered acyclovir given daily for 4 months to 10 years prevented or reduced the frequency and/or severity of recurrences in greater than 95% of patients. In a study of patients who received acyclovir 400 mg twice daily for 3 years, 45%, 52%, and 63% of patients remained free of recurrences in the first, second, and third years, respectively.

Serial analyses of the 3-month recurrence rates for the patients showed that 71% to 87% were recurrence free in each quarter. Herpes Zoster Infections: In a double-blind, placebo-controlled study of immunocompetent patients with localized cutaneous zoster infection, acyclovir (800 mg 5 times daily for 10 days) shortened the times to lesion scabbing, healing, and complete cessation of pain, and reduced the duration of viral shedding and the duration of new lesion formation. In a similar double-blind, placebo-controlled study, acyclovir (800 mg 5 times daily for 7 days) shortened the times to complete lesion scabbing, healing, and cessation of pain; reduced the duration of new lesion formation; and reduced the prevalence of localized zoster-associated neurologic symptoms (paresthesia, dysesthesia, or hyperesthesia).

Treatment was begun within 72 hours of rash onset and was most effective i… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 137 words ▾

HOW SUPPLIED Acyclovir Capsules USP, 200 mg are white to off-white powder filled in size "1" empty hard gelatin capsules with blue opaque colored cap imprinted with '668' in black ink and white opaque colored body and are supplied as follows: NDC 72578-002-06 in bottles of 30 capsules NDC 72578-002-16 in bottles of 90 capsules NDC 72578-002-01 in bottles of 100 capsules NDC 72578-002-05 in bottles of 500 capsules NDC 72578-002-10 in bottles of 1000 capsules Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] .

Protect from light and moisture. Dispense in a tight, light-resistant container (USP). Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. Manufactured by: Zydus Lifesciences Ltd., India Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 Rev.: 11/25

📋 Description 157 words ▾

DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir capsules are formulation for oral administration. Acyclovir is a white or almost white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.20.

It is soluble in diluted hydrochloric acid; slightly soluble in water and insoluble in alcohol. The pka’s of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]- 6H- purin-6-one; it has the following structural formula: Each acyclovir capsule intended for oral administration contains 200 mg of acyclovir.

In addition, each capsule contains the following inactive ingredients: corn starch, FD & C blue # 1, FD & C red # 3, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate and titanium dioxide. Each capsule is printed with black pharmaceutical ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. figure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS Dosage adjustment is recommended when administering acyclovir to patients with renal impairment (see DOSAGE AND ADMINISTRATION ). Caution should also be exercised when administering acyclovir to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.

Information for Patients: Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered acyclovir, or they have any other questions. Patients should be advised to maintain adequate hydration. 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. Genital Herpes Infections: Patients should be informed that acyclovir is not a cure for genital herpes. There are no data evaluating whether acyclovir will prevent transmission of infection to others.

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 can also be transmitted in the absence of symptoms through asymptomatic viral shedding. 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.

Chickenpox: Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course.

Severe Cutaneous Adverse Reactions: Inform patients that severe skin reactions including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme (EM) have been reported with acyclovir. Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct patients to immediately stop taking acyclovir and seek medical attention if a painful rash with mucosal involvement develops (see CONTRAINDICATIONS and WARNINGS ).

Drug Interactions: See CLINICAL PHARMACOLOGY: Pharmacokinetics . Carcinogenesis , Mutagenesis , Impairment of Fertility: The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with 800 mg given orally 5 times a day (dosing appropriate for treatment of herpes zoster) or 200 mg given orally 5 times a day (dosing appropriate for treatment of genital herpes). Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics ).

Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to 450 mg/kg administered by gavage. There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Maximum plasma concentrations were 3 to 6 times human levels in the mouse bioassay and 1 to 2 times human levels in the rat bioassay.

Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in 5 of the assays. Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, p.o.) or in rats (25 mg/kg/day, s.c.).

In the mouse study, plasma levels were 9 to 18 t… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 17 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 72578-002-01 Acyclovir Capsules, USP 200 mg Rx only 100 Capsules Viona figure

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
18K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$226.5K
Avg / prescription
$12.56
Avg / unit
$0.2145
Latest quarter Q1 2026
4.1KRx
Medicaid pays / ea
$0.2145
gross reimbursed
vs
NADAC / ea
$0.0977
acquisition cost
=
Spread
+$0.1168
+120% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 7,456 Rx Managed care · 10,576 Rx
State Medicaid map
Alaska: 685 units · 93.5 per 100k residents AK Maine: 17,656 units · 1,266 per 100k residents ME Washington: 26,421 units · 338 per 100k residents WA Idaho: 5,717 units · 291 per 100k residents ID Montana: 5,407 units · 478 per 100k residents MT North Dakota: 379 units · 48.4 per 100k residents ND Minnesota: 16,028 units · 279 per 100k residents MN Wisconsin: 31,127 units · 527 per 100k residents WI Michigan: 82,509 units · 822 per 100k residents MI New York: 97,361 units · 497 per 100k residents NY Vermont: 3,670 units · 567 per 100k residents VT New Hampshire: 420 units · 30.0 per 100k residents NH Oregon: 33,738 units · 797 per 100k residents OR Nevada: 6,575 units · 206 per 100k residents NV Wyoming: no data reported WY South Dakota: 330 units · 35.9 per 100k residents SD Iowa: 16,271 units · 507 per 100k residents IA Illinois: 44,119 units · 352 per 100k residents IL Indiana: 22,893 units · 334 per 100k residents IN Ohio: 42,948 units · 364 per 100k residents OH Pennsylvania: 42,628 units · 329 per 100k residents PA New Jersey: 18,371 units · 198 per 100k residents NJ Massachusetts: 10,905 units · 156 per 100k residents MA California: 139,095 units · 357 per 100k residents CA Utah: 2,500 units · 73.2 per 100k residents UT Colorado: 20,105 units · 342 per 100k residents CO Nebraska: 5,507 units · 278 per 100k residents NE Missouri: 40,796 units · 658 per 100k residents MO Kentucky: 31,453 units · 695 per 100k residents KY West Virginia: 2,617 units · 148 per 100k residents WV Virginia: 20,458 units · 235 per 100k residents VA Maryland: 15,630 units · 253 per 100k residents MD Connecticut: 9,116 units · 252 per 100k residents CT Rhode Island: 272 units · 24.8 per 100k residents RI Arizona: 14,238 units · 192 per 100k residents AZ New Mexico: 13,285 units · 628 per 100k residents NM Kansas: 3,196 units · 109 per 100k residents KS Arkansas: 12,197 units · 398 per 100k residents AR Tennessee: 21,404 units · 300 per 100k residents TN North Carolina: 45,048 units · 416 per 100k residents NC South Carolina: 4,129 units · 76.8 per 100k residents SC Delaware: no data reported DE Oklahoma: 20,631 units · 509 per 100k residents OK Louisiana: 18,768 units · 410 per 100k residents LA Mississippi: 12,560 units · 427 per 100k residents MS Alabama: 6,038 units · 118 per 100k residents AL Georgia: 12,946 units · 117 per 100k residents GA D.C.: no data reported DC Hawaii: 1,361 units · 94.8 per 100k residents HI Texas: 26,792 units · 87.8 per 100k residents TX Florida: 23,395 units · 103 per 100k residents FL
Units reimbursed · per 100k residents
24.81,266
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maine 1,266 /100k
2 Michigan 822 /100k
3 Oregon 797 /100k
4 Kentucky 695 /100k
5 Missouri 658 /100k
6 New Mexico 628 /100k
7 Vermont 567 /100k
8 Wisconsin 527 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 capsules this page72578-0002-01 18,032 Rx · $226,521
500 capsules72578-0002-05 2,062 Rx · $27,875
30 capsules72578-0002-06 No Medicaid data
1000 capsules72578-0002-10 No Medicaid data
90 capsules72578-0002-16 No Medicaid data
Drug total (last 4 qtrs): 20,094 Rx · 1,186,950 units · $254,396 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Acyclovir — the program that covers self-administered drugs. 29 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 Acyclovir. 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
$11.1M
Claims incl. refills
517.4K
Beneficiaries
366.8K
Spend / beneficiary
$30.28
Spend / claim
$21.46
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.
← 72578-0001-01 · Viona 72578-0003-01 · Viona →
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.