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Acyclovir 800 mg Tablet, 500-count — NDC 69367-0138-05 package photo

Acyclovir 800 mg Tablet, 500-count

by Westminster Pharmaceuticals, LLC · 500 TABLET in 1 BOTTLE (69367-138-05)
NDC 69367-0138-05
🏷️ FDA NDC (as labeled) 69367-138-05 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.1847 NADAC Per package$92.35 / 500 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.4031/unit · Part D plans $0.1848/unit — full pricing hub ↓
Also comes in: 100 tablets 69367-0138-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 69367-138-05
Product NDC 69367-138
11-digit billing NDC 69367013805
NCPDP billing unit EA — each (per item)
RxCUI 197311, 197313
UNII X4HES1O11F
UPC 0369367137010, 0369367138017
Application # ANDA210401
SPL Set ID f352a641-988e-4878-8016-2b69cd6ee548
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 2023-06-20
Route ORAL
Dosage form TABLET
Substance ACYCLOVIR
GPI-14 12405010000330
GCN Seq No 015979
GCN 13721
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 800 MG TABLET
FDB brand name Acyclovir
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 69367-138-05 — 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 → 69367-0138-05. 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.

🏭 Manufacturer & labeler

LabelerWestminster Pharmaceuticals, LLC
Application holderYILING PHARMACEUTICAL LTD
FDA applicationANDA210401 (ANDA)
Labeler code69367
First marketedJun 2023
Product typeHuman Prescription Drug
Portfolio186 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.

🩺 Clinical

Label name ACYCLOVIR 800 MG TABLET Ingredient Acyclovir
📗 Our plain-language guide HelloPharmacist
  • Acyclovir doesn't cure herpes — it can't eliminate the virus from your body. What it does is slow down the virus's ability to copy itself, which shortens outbreaks, eases symptoms,...
  • What exactly does acyclovir do — does it cure herpes?
  • Timing really does matter with acyclovir. For cold sores, you want to start at the very first warning sign — that tingling or itching feeling — before a sore even appears. For geni...
  • How soon do I need to start taking it for it to work?
📖 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.

💊 What it looks like

Color White
ShapeOval
ImprintY213
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 $0.185 $92.35 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.4031 $201.55 / 500 tablets
Medicare drug plans payPart D · Q2 2026 $0.1848 $92.40 / 500 tablets
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
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.202 $0.161
▼ Down 9% over the last 12 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)69367-138-05
11-digit billing NDC69367-0138-05
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
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acyclovir 800 mg 23155-0228-01 Heritage 100 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 31722-0778-01 Camber 100 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 50268-0062-15 AvPAK 50 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 59651-0966-01 Aurobindo 100 tablets $0.185 AB Availability likely —
acyclovir 800 mg 60505-5307-01 Apotex 100 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 60687-0867-01 American 100 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 61442-0113-01 Carlsbad 100 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 62135-0019-50 Chartwell 50 tablets $0.185 AB Availability likely —
acyclovir 800 mg 68382-0792-01 Zydus 100 tablets $0.185 AB Availability likely —
Acyclovir 800 mgthis 69367-0138-05 Westminster 500 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 69452-0291-20 Bionpharma 100 tablets $0.185 AB Availability likely —
Acyclovir 800 mg 69117-0019-01 YILING 100 tablets $0.190 AB FDA listed +3%
Acyclovir 800 mg 43063-0589-10 PD-Rx 10 tablets — AB FDA listed —
Acyclovir 800 mg 50090-6335-00 A-S 35 tablets — AB FDA listed —
Acyclovir 800 mg 50090-6578-00 A-S 35 tablets — AB FDA listed —
Acyclovir 800 mg 51407-0146-01 Golden 100 tablets — AB FDA listed —
Acyclovir 800 mg 51655-0679-35 Northwind 35 tablets — AB FDA listed —
Acyclovir 800 mg 54348-0624-10 PharmPak, 10 tablets — AB FDA listed —
Acyclovir 800 mg 60760-0778-35 St. 35 tablets — AB FDA listed —
acyclovir 800 mg 63187-0192-30 Proficient 30 tablets — AB FDA listed —
acyclovir 800 mg 63187-0366-30 Proficient 30 tablets — AB FDA listed —
Acyclovir 800 mg 63187-0574-06 Proficient 6 tablets — AB FDA listed —
Acyclovir 800 mg 63629-1678-00 Bryant 500 tablets — AB FDA listed —
acyclovir 800 mg 63629-9174-01 Bryant 50 tablets — AB FDA listed —
acyclovir 800 mg 65841-0803-01 Zydus 100 tablets — AB FDA listed —
acyclovir 800 mg 66267-0399-15 NuCare 15 tablets — AB FDA listed —
acyclovir 800 mg 67046-1487-03 Coupler 30 tablets — AB FDA listed —
Acyclovir 800 mg 67296-2254-04 Redpharm 35 tablets — AB FDA listed —
Acyclovir 800 mg 68071-2408-01 NuCare 21 tablets — AB FDA listed —
Acyclovir 800 mg 68071-3222-00 NuCare 50 tablets — AB FDA listed —
acyclovir 800 mg 68071-5100-03 NuCare 30 tablets — AB FDA listed —
Acyclovir 800 mg 68788-7575-02 Preferred 21 tablets — AB FDA listed —
acyclovir 800 mg 70518-1614-00 REMEDYREPACK 30 tablets — AB FDA listed —
Acyclovir 800 mg 70518-2518-00 REMEDYREPACK 30 tablets — AB Discontinued —
Acyclovir 800 mg 70518-4186-00 REMEDYREPACK 10 tablets — AB FDA listed —
Acyclovir 800 mg 70518-4450-00 REMEDYREPACK 30 tablets — AB FDA listed —
Acyclovir 800 mg 71205-0053-30 Proficient 30 tablets — AB FDA listed —
Acyclovir 800 mg 71205-0388-30 Proficient 30 tablets — AB FDA listed —
Acyclovir 800 mg 71209-0006-05 Cadila 100 tablets — AB FDA listed —
Acyclovir 800 mg 71335-0695-00 Bryant 500 tablets — AB Discontinued —
Acyclovir 800 mg 71335-1222-00 Bryant 500 tablets — AB FDA listed —
acyclovir 800 mg 71335-1381-00 Bryant 500 tablets — AB FDA listed —
Acyclovir 800 mg 71335-2555-00 Bryant 500 tablets — AB FDA listed —
Acyclovir 800 mg 71335-9721-00 Bryant 500 tablets — AB FDA listed —
acyclovir 800 mg 72162-1724-00 Bryant 40 tablets — AB FDA listed —
Acyclovir 800 mg 72241-0027-05 Modavar 100 tablets — AB FDA listed —
Acyclovir 800 mg 75834-0123-01 Nivagen 100 tablets — AB Discontinued —
Acyclovir 800 mg 76483-0042-00 SQUARE 30 tablets — AB FDA listed —
Acyclovir 800 mg 82804-0012-30 Proficient 30 tablets — AB FDA listed —
acyclovir 800 mg 82868-0107-35 Northwind 35 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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.

🗺️ 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 69367-0138-05, 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
144
Units reimbursed last 4 qtrs
6.2K
Gross reimbursed last 4 qtrs
$2.5K
Avg / prescription
$17.31
Avg / unit
$0.4031
Latest quarter Q1 2026
25Rx
Medicaid pays / ea
$0.4031
gross reimbursed
vs
NADAC / ea
$0.1847
acquisition cost
=
Spread
+$0.2184
+118% 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 ⓘ
100% FFS
Fee-for-service · 144 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 4,657 units · 23.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,525 units · 3.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.923.8
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 New York 23.8 /100k
2 California 3.9 /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 tablets69367-0138-01 2,796 Rx · $29,612
500 tablets this page69367-0138-05 144 Rx · $2,492
Drug total (last 4 qtrs): 2,940 Rx · 104,088 units · $32,104 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acyclovir — the ingredient across all brands.

Top reported reactions

Fatigue8,029
Diarrhoea7,348
Pneumonia5,700
Nausea5,643
Pyrexia4,989
Death4,896
Rash4,296

Age at onset

Neonate121
Infant157
Child436
Adolescent193
Adult8,482
Elderly12,300

Reporter sex

114,761 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization42,634
Life-threatening6,235
Disabling1,985
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 8,378 3,543
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
69367-0138-01 100 TABLET in 1 BOTTLE (69367-138-01) $0.1847 / ea $18.47 2023-06-20 Active
69367-0138-05 You're viewing this 500 TABLET in 1 BOTTLE (69367-138-05) $0.1847 / ea $92.35 2023-06-20 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 ($0.1847 NADAC).

This pack accounts for about 4.9% of this product's recent Medicaid fills; most go to the 100 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 69367-0138-05?
NDC 69367-0138-05 is a 500-count package — 500 tablet in 1 bottle.
What is the difference between NDC 69367-0138-05 and NDC 69367-0138-01?
Both are Acyclovir 800 mg Tablet — the drug itself is identical. NDC 69367-0138-05 is the 500-count package, while NDC 69367-0138-01 is the 100 tablets package.
What NDC number is used to bill for this package of Acyclovir 800 mg Tablet?
Bill NDC 69367-0138-05 — the 11-digit billing format is 69367013805. 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.

📄 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 47 words ▾

INDICATIONS AND USAGE Herpes Zoster Infections Acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox Acyclovir is 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 immunocompro-mised 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 and tablets should be modified as shown in Table 3.

Table 3. Dosage Modification for Renal Impairment Normal Dosage Regimen Creatinine Clearance (mL/min/1.73 m2 ) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours >10 0-10 200 200 every 4 hours, 5× daily every 12 hours 400 mg every 12 hours >10 0-10 400 200 every 12 hours every 12 hours 800 mg every 4 hours >25 10-25 0-10 800 800 800 every 4 hours, 5× daily every 8 hours 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.

Bioequivalence of Dosage Forms 1 acyclovir 800 mg tablet was shown to be bioequivalent to 4 acyclovir 200 mg capsules (n = 24).

⛔ Contraindications 37 words ▾

CONTRAINDICATIONS Acyclovir is 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 Tablets and 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 immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Closely monitor clinical status and initiate appropriate therapy.

Acyclovir is 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 ).

🔄 Drug Interactions 7 words ▾

Drug Interactions See CLINICAL PHARMACOLOGY: Pharmacokinetics .

🤰 Pregnancy 166 words ▾

Pregnancy Teratogenic Effects Pregnancy Category B Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o.), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day, s.c.). These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively, human levels. There are no adequate and well-controlled studies in pregnant women.

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. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 23 words ▾

Pediatric Use Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established.

🧓 Geriatric Use 149 words ▾

Geriatric Use Of 376 subjects who received acyclovir in a clinical study of herpes zoster treatment in immunocompetent subjects ≥50 years of age, 244 were 65 and over while 111 were 75 and over. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. The duration of pain after healing was longer in patients 65 and over.

Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events.

With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY , ADVERSE REACTIONS: Observed During Clinical Practice , and DOSAGE AND ADMINISTRATION ).

🆘 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. Table1.

Acyclovir Pharmacokinetic Characteristics (Range) Parameter Range Plasma protein binding 9% to 33% Plasma elimination half-life 2.5 to 3.3 hr Average oral bioavailability 10% to 20% Bioavailability decreases with increasing dose. 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.

Table2. Acyclovir Peak and Trough Concentrations at Steady State Parameter 200 mg 400 mg 800 mg C SS max 0.83 mcg/mL 1.21 mcg/mL 1.61 mcg/mL C SS trough 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 and Tablets 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 if started w…

📦 How Supplied / Storage and Handling 166 words ▾

HOW SUPPLIED Acyclovir Capsules, USP 200 mg are available for oral administration as white opaque body, powder blue opaque cap with black 'Y211'. They are supplied as follows: Bottle of 100 (NDC 69367-136-01) Bottle of 500 (NDC 69367-136-05) Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture.

Acyclovir Tablets, USP 400 mg are available for oral administration as white round tablets, engraved Y212 on one side and plain on other. They are supplied as follows: Bottle of 100 (NDC 69367-137-01) Bottle of 500 (NDC 69367-137-05) Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture.

Acyclovir Tablets, USP 800 mg are available for oral administration as white capsule-shaped tablets, engraved Y213 on one side and plain on other side. They are supplied as follows: Bottle of 100 (NDC 69367-138-01) Bottle of 500 (NDC 69367-138-05) Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture.

📦 Storage and Handling 17 words ▾

Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Protect from light and moisture.

📋 Description 197 words ▾

DESCRIPTION Acyclovir, USP is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Capsules, USP and Acyclovir Tablets, USP are formulations for oral administration. Each capsule contains 200 mg of acyclovir, USP and the inactive ingredients corn starch, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate.

The capsule shell consists of gelatin, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No.

6 and titanium dioxide. Printed with edible black ink. Each 800 mg tablet of acyclovir contains 800 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes).

Each 400 mg tablet of acyclovir contains 400 mg of acyclovir, USP and the inactive ingredients magnesium stearate, microcrystalline cellulose PH101, povidone K30, and sodium starch glycolate (Type A) (Starch from Non GMO potatoes). Acyclovir, USP is a white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5mg/mL.

The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula: Chemical Structure

💬 Information for Patients ~1 min read ▾

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 ).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69367-0137-01 · Westminster 69367-0174-01 · Westminster →
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.