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Acyclovir 800 mg Tablet, 35-count

by Bryant Ranch Prepack · 35 TABLET in 1 BOTTLE (71335-2555-2)
NDC 71335-2555-02
🏷️ FDA NDC (as labeled) 71335-2555-2 billing pads the package segment with a zero
This package
Contains35-count Pack sizes10 compare ↓
Also priced by: Part D plans $0.1848/unit — full pricing hub ↓
Also comes in: 10 tablets 71335-2555-06 21 tablets 71335-2555-08 25 tablets 71335-2555-01 30 tablets 71335-2555-03 40 tablets 71335-2555-07 50 tablets 71335-2555-05 60 tablets 71335-2555-04 90 tablets 71335-2555-09 500 tablets 71335-2555-00
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 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) 71335-2555-2
Product NDC 71335-2555
11-digit billing NDC 71335255502
RxCUI 197313
UNII X4HES1O11F
Application # ANDA209366
SPL Set ID 713960c2-8278-4778-b781-08ec89a9cfce
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 2020-08-15
Route ORAL
Dosage form TABLET
Substance ACYCLOVIR
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 71335-2555-2 — a 5-4-1 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 package segment → 71335-2555-02. 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

LabelerBryant Ranch Prepack
Application holderSQUARE PHARMACEUTICALS LTD
FDA applicationANDA209366 (ANDA)
Labeler code71335
First marketedAug 2020
Product typeHuman Prescription Drug
Portfolio4,433 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 Blue
ShapeCapsule
ImprintS042
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 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 · Q2 2026 $0.1848 $6.47 / 35 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.

🔁 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 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 mg 69367-0138-01 Westminster 100 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 —
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 59651-0966-01 Aurobindo 100 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 mgthis 71335-2555-02 Bryant 35 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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.

📊 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 Marketing startStatus
71335-2555-00 500 TABLET in 1 BOTTLE (71335-2555-0) 2025-01-23 Active
71335-2555-01 25 TABLET in 1 BOTTLE (71335-2555-1) 2025-01-23 Active
71335-2555-02 You're viewing this 35 TABLET in 1 BOTTLE (71335-2555-2) 2025-01-23 Active
71335-2555-03 30 TABLET in 1 BOTTLE (71335-2555-3) 2025-01-23 Active
71335-2555-04 60 TABLET in 1 BOTTLE (71335-2555-4) 2025-01-23 Active
71335-2555-05 50 TABLET in 1 BOTTLE (71335-2555-5) 2025-01-23 Active
71335-2555-06 10 TABLET in 1 BOTTLE (71335-2555-6) 2025-01-23 Active
71335-2555-07 40 TABLET in 1 BOTTLE (71335-2555-7) 2025-01-23 Active
71335-2555-08 21 TABLET in 1 BOTTLE (71335-2555-8) 2025-01-23 Active
71335-2555-09 90 TABLET in 1 BOTTLE (71335-2555-9) 2025-01-23 Active

You're viewing one of 10 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-2555-02?
NDC 71335-2555-02 is a 35-count package — 35 tablet in 1 bottle.
What is the difference between NDC 71335-2555-02 and NDC 71335-2555-06?
Both are Acyclovir 800 mg Tablet — the drug itself is identical. NDC 71335-2555-02 is the 35-count package, while NDC 71335-2555-06 is the 10 tablets package.
What NDC number is used to bill for this package of Acyclovir 800 mg Tablet?
Bill NDC 71335-2555-02 — the 11-digit billing format is 71335255502. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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.
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 FDA registers it as 71335-2555-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-2555-02, written without dashes as 71335255502. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-2555-02, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2555) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 9 other package presentations of this same product, including 10 tablets (71335-2555-06), 21 tablets (71335-2555-08), 25 tablets (71335-2555-01). 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?
Bryant Ranch Prepack 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.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

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

Alternative regimens have included doses ranging from 200mg 3 times daily to 200mg 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: 200mg 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): 20mg/kg per dose orally 4 times daily (80mg/kg/day) for 5 days.

Children over 40kg should receive the adult dose for chickenpox. Adults and Children over 40 kg: 800mg 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 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 m 2 ) Adjusted Dosage Regimen Dose (mg) Dosing Interval 200 mg every 4 hours >10 0-10 200 200 every 4 hours, 5x 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, 5x 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.

⛔ Contraindications 1 words ▾

CONTRAINDICATIONS

⚠️ Warnings 1 words ▾

WARNINGS

🤒 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 200mg 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 400mg (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 800mg 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 20mg/kg 4 times daily for 5 to 7 days or 800mg 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: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

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 39 words ▾

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.

Drug Interactions: See CLINICAL PHARMACOLOGY: Pharmacokinetics .

🤰 Pregnancy 163 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category B. Acyclovir administered during organogenesis was not teratogenic in the mouse (450mg/kg/day, p.o.), rabbit (50mg/kg/day, s.c. and IV), or rat (50mg/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 1 words ▾

OVERDOSAGE

🧬 Clinical Pharmacology 74 words ▾

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) Parameter Range Plasma protein binding 9 % to 33% Plasma elimination half-life 2.5 to 3.3 hr Average oral bio availability 10 % to 20 % * * Bio availability decreases with increasing dose.

📦 How Supplied / Storage and Handling 64 words ▾

Acyclovir tablets, USP (light blue, caplet) containing 800mg acyclovir, USP and engraved "S042" on one side and plain on the other side. Bottle of 100 (69452-291-20) Bottle of 500 (69452-291-30) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 122 words ▾

DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir Tablets are formulations for oral administration. Each 800-mg tablet of acyclovir contains 800mg of acyclovir and the inactive ingredients FD&C Blue No.

2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Each 400-mg tablet of acyclovir contains 400mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 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 is 2-amino -1, 9 -dihydro -9 - [(2-hydroxyethoxy) methyl]-6 H -purin-6 -one; it has the following structural formula:

💬 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.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-2554-01 · Bryant 71335-2556-01 · Bryant →
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