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Acyclovir 400 mg Tablet, 15-count — NDC 71335-0323-05 package photo

Acyclovir 400 mg Tablet, 15-count

by Bryant Ranch Prepack · 15 TABLET in 1 BOTTLE (71335-0323-5)
NDC 71335-0323-05
🏷️ FDA NDC (as labeled) 71335-0323-5 billing pads the package segment with a zero
This package
Contains15-count Pack sizes10 compare ↓
Also priced by: Part D plans $0.1848/unit — full pricing hub ↓
Also comes in: 10 tablets 71335-0323-08 20 tablets 71335-0323-01 25 tablets 71335-0323-07 28 tablets 71335-0323-02 30 tablets 71335-0323-03 40 tablets 71335-0323-09 50 tablets 71335-0323-04 60 tablets 71335-0323-06 120 tablets 71335-0323-00
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) 71335-0323-5
Product NDC 71335-0323
11-digit billing NDC 71335032305
NCPDP billing unit EA — each (per item)
RxCUI 197311
UNII X4HES1O11F
Application # ANDA203834
SPL Set ID 0e78d5e8-ae2d-4e84-b8c2-6765b1299c12
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 2013-11-29
Route ORAL
Dosage form TABLET
Substance ACYCLOVIR
GPI-14 12405010000320
GPI class Acyclovir
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-0323-5 — 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 → 71335-0323-05. 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

LabelerBryant Ranch Prepack
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA203834 (ANDA)
Labeler code71335
First marketedNov 2013
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

📖 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 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 pink
ShapeHEXAGON (6 sided)
ImprintJ;49
Size12 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 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

6 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.

💲 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 $2.77 / 15 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 400 mg 00904-7507-61 Major 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 23155-0227-01 Heritage 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 31722-0777-01 Camber 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 50268-0061-15 AvPAK 50 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 59651-0965-01 Aurobindo 100 tablets $0.099 AB Availability likely —
acyclovir 400 mg 60505-5306-01 Apotex 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 60687-0856-01 American 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 61442-0112-01 Carlsbad 100 tablets $0.099 AB Availability likely —
acyclovir 400 mg 68382-0791-01 Zydus 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 69367-0137-01 Westminster 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 69452-0290-20 Bionpharma 100 tablets $0.099 AB Availability likely —
Acyclovir 400 mg 69117-0018-01 YILING 100 tablets $0.109 AB FDA listed —
Acyclovir 400 mg 43063-0928-04 PD-Rx 4 tablets — AB FDA listed —
acyclovir 400 mg 50090-3250-00 A-S 2 tablets — AB FDA listed —
acyclovir 400 mg 50090-3254-00 A-S 90 tablets — AB FDA listed —
Acyclovir 400 mg 50090-6844-00 A-S 90 tablets — AB FDA listed —
Acyclovir 400 mg 50090-7275-02 A-S 25 tablets — AB FDA listed —
Acyclovir 400 mg 50090-7276-00 A-S 90 tablets — AB FDA listed —
Acyclovir 400 mg 50090-7277-00 A-S 90 tablets — AB FDA listed —
Acyclovir 400 mg 51407-0145-01 Golden 100 tablets — AB FDA listed —
Acyclovir 400 mg 51655-0300-23 Northwind 25 tablets — AB FDA listed —
Acyclovir 400 mg 54348-0627-10 PharmPak, 10 tablets — AB FDA listed —
Acyclovir 400 mg 55154-4332-00 Cardinal 10 tablets — AB FDA listed —
Acyclovir 400 mg 63187-0253-15 Proficient 15 tablets — AB FDA listed —
acyclovir 400 mg 65841-0802-01 Zydus 100 tablets — AB FDA listed —
acyclovir 400 mg 67296-1707-02 RedPharm 20 tablets — AB Discontinued —
Acyclovir 400 mg 67296-2162-02 Redpharm 20 tablets — AB FDA listed —
Acyclovir 400 mg 68071-1841-01 NuCare 100 tablets — AB FDA listed —
acyclovir 400 mg 68071-2247-01 NuCare 100 tablets — AB FDA listed —
Acyclovir 400 mg 68071-2279-08 NuCare 15 tablets — AB FDA listed —
acyclovir 400 mg 68071-2287-04 NuCare 4 tablets — AB FDA listed —
Acyclovir 400 mg 68071-2447-01 NuCare 21 tablets — AB FDA listed —
Acyclovir 400 mg 68071-2811-05 NuCare 25 tablets — AB FDA listed —
Acyclovir 400 mg 68071-3573-04 NuCare 4 tablets — AB FDA listed —
Acyclovir 400 mg 68071-4799-05 NuCare 25 tablets — AB FDA listed —
Acyclovir 400 mg 68788-8203-01 Preferred 100 tablets — AB FDA listed —
Acyclovir 400 mg 68788-8724-01 Preferred 100 tablets — AB FDA listed —
acyclovir 400 mg 70518-0427-01 REMEDYREPACK 30 tablets — AB Discontinued —
acyclovir 400 mg 70518-1363-00 REMEDYREPACK 15 tablets — AB FDA listed —
Acyclovir 400 mg 70518-2117-00 REMEDYREPACK 30 tablets — AB FDA listed —
Acyclovir 400 mg 70518-2455-01 REMEDYREPACK 15 tablets — AB Discontinued —
Acyclovir 400 mg 70518-4414-00 REMEDYREPACK 30 tablets — AB FDA listed —
Acyclovir 400 mg 71205-0056-30 Proficient 30 tablets — AB FDA listed —
Acyclovir 400 mg 71205-0371-30 Proficient 30 tablets — AB FDA listed —
acyclovir 400 mg 71205-0391-25 Proficient 25 tablets — AB FDA listed —
Acyclovir 400 mg 71205-0472-15 Proficient 15 tablets — AB FDA listed —
Acyclovir 400 mg 71209-0005-05 Cadila 100 tablets — AB FDA listed —
Acyclovir 400 mgthis 71335-0323-05 Bryant 15 tablets — AB FDA listed —
Acyclovir 400 mg 71335-1053-00 Bryant 120 tablets — AB FDA listed —
Acyclovir 400 mg 71335-1645-00 Bryant 120 tablets — AB FDA listed —
Acyclovir 400 mg 71335-1757-01 Bryant 35 tablets — AB FDA listed —
Acyclovir 400 mg 71335-2229-01 Bryant 35 tablets — AB FDA listed —
Acyclovir 400 mg 71335-2619-01 Bryant 35 tablets — AB FDA listed —
Acyclovir 400 mg 71335-3103-00 Bryant 120 tablets — AB FDA listed —
Acyclovir 400 mg 71335-9620-00 Bryant 120 tablets — AB FDA listed —
Acyclovir 400 mg 72162-1735-01 Bryant 120 tablets — AB FDA listed —
Acyclovir 400 mg 72189-0631-14 Direct_Rx 14 tablets — AB FDA listed —
Acyclovir 400 mg 72241-0026-05 Modavar 100 tablets — AB FDA listed —
Acyclovir 400 mg 75834-0122-01 Nivagen 100 tablets — AB Discontinued —
acyclovir 400 mg 76420-0050-15 Asclemed 15 tablets — AB FDA listed —
Acyclovir 400 mg 76483-0047-00 SQUARE 30 tablets — AB FDA listed —
Acyclovir 400 mg 80425-0270-01 Advanced 40 tablets — AB FDA listed —
Acyclovir 400 mg 82804-0005-06 Proficient 6 tablets — AB FDA listed —
Acyclovir 400 mg 72789-0587-30 PD-Rx 30 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

🏛️
2013
On the market since
Nov 2013
📍
2026
Currently FDA-listed
13 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
71335-0323-00 120 TABLET in 1 BOTTLE (71335-0323-0) 2018-05-02 Active
71335-0323-01 20 TABLET in 1 BOTTLE (71335-0323-1) 2021-12-27 Active
71335-0323-02 28 TABLET in 1 BOTTLE (71335-0323-2) 2021-12-27 Active
71335-0323-03 30 TABLET in 1 BOTTLE (71335-0323-3) 2018-03-20 Active
71335-0323-04 50 TABLET in 1 BOTTLE (71335-0323-4) 2021-12-27 Active
71335-0323-05 You're viewing this 15 TABLET in 1 BOTTLE (71335-0323-5) 2018-04-17 Active
71335-0323-06 60 TABLET in 1 BOTTLE (71335-0323-6) 2019-07-29 Active
71335-0323-07 25 TABLET in 1 BOTTLE (71335-0323-7) 2018-03-28 Active
71335-0323-08 10 TABLET in 1 BOTTLE (71335-0323-8) 2021-12-27 Active
71335-0323-09 40 TABLET in 1 BOTTLE (71335-0323-9) 2021-12-27 Active

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

Pack size FAQ

What quantity is in NDC 71335-0323-05?
NDC 71335-0323-05 is a 15-count package — 15 tablet in 1 bottle.
What is the difference between NDC 71335-0323-05 and NDC 71335-0323-08?
Both are Acyclovir 400 mg Tablet — the drug itself is identical. NDC 71335-0323-05 is the 15-count package, while NDC 71335-0323-08 is the 10 tablets package.
What NDC number is used to bill for this package of Acyclovir 400 mg Tablet?
Bill NDC 71335-0323-05 — the 11-digit billing format is 71335032305. 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 ✓ Available
Inactive ingredients (structured) ✓ 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 71335-0323-5, 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: 71335-0323-05, written without dashes as 71335032305. 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 71335-0323-05, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (0323) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 (71335-0323-08), 20 tablets (71335-0323-01), 25 tablets (71335-0323-07). 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 53 words ▾

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

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE & 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 tablets.

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 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 14 words ▾

CONTRAINDICATIONS Acyclovir tablets are contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

⚠️ Warnings 52 words ▾

WARNINGS Acyclovir tablets 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.

🤒 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 tablets 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 tablets were nausea (4.8%) and diarrhea (2.4%).

The 589 control patients receiving intermittent treatment of recurrences with acyclovir tablets 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 tablets 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 tablets 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 tablets.

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 tablets 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 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 150 words ▾

Geriatric Use Of 376 subjects who received acyclovir tablets 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. Table 1.

Acyclovir Pharmacokinetic Characteristics (Range) Parameter Range Plasma protein binding 9% to 33% Plasma elemination 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.

Table 2. 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 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 tablets 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 tablets 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 tablets 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 tablets (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 tablets (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…

📦 How Supplied / Storage and Handling 125 words ▾

HOW SUPPLIED Acyclovir tablets USP, 400 mg containing 400 mg of acyclovir USP are pink, shield shaped, flat tablets debossed with 'J' on one side and '49' in triangle on the other. They are supplied as follows: NDC 71335-0323-1: 20 Tablets in a BOTTLE NDC 71335-0323-2: 28 Tablets in a BOTTLE NDC 71335-0323-3: 30 Tablets in a BOTTLE NDC 71335-0323-4: 50 Tablets in a BOTTLE NDC 71335-0323-5: 15 Tablets in a BOTTLE NDC 71335-0323-6: 60 Tablets in a BOTTLE NDC 71335-0323-7: 25 Tablets in a BOTTLE NDC 71335-0323-8: 10 Tablets in a BOTTLE NDC 71335-0323-9: 40 Tablets in a BOTTLE NDC 71335-0323-0: 120 Tablets in a BOTTLE Store between 15º and 25ºC.

Protect from light and moisture. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504

📋 Description 133 words ▾

DESCRIPTION Acyclovir is a synthetic nucleoside analogue active against herpesviruses. Acyclovir tablets, USP is a formulation for oral administration. Each Acyclovir Tablet contains 400 mg or 800 mg of acyclovir.

In addition, each tablet contains the inactive ingredients colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate. The 400 mg and 800 mg tablet also contains ferric oxide and FD&C blue lake # 2 Indigo carmine AL, respectively. Acyclovir USP is a white to off white crystalline powder, slightly hygroscopic with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.20.

The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-.

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 tablets 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 tablets is not a cure for genital herpes. There are no data evaluating whether acyclovir tablets 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 ↗
← 71335-0322-01 · Bryant 71335-0324-00 · Bryant →
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.