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Acyclovir 400 mg Tablet, 14-count — NDC 72189-0631-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acyclovir 400 mg Tablet, 14-count — NDC 72189-631-14 (Billing 72189-0631-14)

by Direct_Rx · 14 TABLET in 1 BOTTLE

This is a package of 14 tablets of Acyclovir 400 mg Tablet from Direct_Rx, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 72189-0631-14
🏷️ FDA NDC (as labeled) 72189-631-14 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-631-14
Product NDC 72189-631
11-digit billing NDC 72189063114
NCPDP billing unit EA — each (per item)
RxCUI 197311
UNII X4HES1O11F
Application # ANDA209366
SPL Set ID 387d33ed-45e5-42d6-e063-6294a90afbb7
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 2025-06-26
Route ORAL
Dosage form TABLET
Substance ACYCLOVIR
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 016408
GCN 13724
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 400 MG TABLET
FDB brand name Acyclovir
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 016408
  • GCN: 13724
  • HICL (First Databank): 004183
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 197311
Why two NDCs? The FDA registers this code as 72189-631-14 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0631-14. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor
Drug family (ATC) Antivirals, Nucleosides and nucleotides excl. reverse transcriptase inhibitors, Antivirals
How it works DNA Polymerase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ACYCLOVIR 400 MG TABLET Ingredient Acyclovir
📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Acyclovir treats infections caused by herpes-family viruses. Oral forms treat shingles, genital herpes and chickenpox. Creams, ointments, the eye ointment, the buccal tablet and th...
  • As early as possible. For cold sores, that means at the first tingling, itching or burning. For genital herpes recurrences, start at the first sign of an outbreak. Early treatment...
  • The most common ones are headache, nausea and belly pain. Some people also get vomiting, dizziness or fatigue. These are usually manageable, but tell me if they bother you.
  • Call right away for confusion, hallucinations, seizures or unusual drowsiness. Also call if you urinate much less than usual, which can signal kidney trouble. Any allergic reaction...
📖 Read our full Acyclovir guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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 $2.59 / 14 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72189-0631-14 You're viewing this Main listing 14 TABLET in 1 BOTTLE 2025-06-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acyclovir 400 mg 00904-7507-61 Major 100 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 23155-0227-01 Heritage 100 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 31722-0777-01 Camber 100 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 50268-0061-15 AvPAK 50 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 59651-0965-01 Aurobindo 100 tablets $0.096 AB Availability likely —
acyclovir 400 mg 60505-5306-01 Apotex 100 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 60687-0856-01 American 100 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 61442-0112-01 Carlsbad 100 tablets $0.096 AB Availability likely —
acyclovir 400 mg 68382-0791-01 Zydus 100 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 69367-0137-01 Westminster 100 tablets $0.096 AB Availability likely —
Acyclovir 400 mg 69452-0290-20 Bionpharma 100 tablets $0.096 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 mg 71335-0323-00 Bryant 120 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 mgthis 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

🏛️
2025
On the market since
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintS047
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.

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.

Manufacturer & labeler

LabelerDirect_Rx
Application holderSQUARE PHARMACEUTICALS LTD
FDA applicationANDA209366 (ANDA)
Labeler code72189
First marketedJun 2025
Product typeHuman Prescription Drug
Portfolio355 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 44 words ▾

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 ▾

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 m2) 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 12 words ▾

Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

⚠️ Warnings and Cautions 50 words ▾

Acyclovir Tablets is 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.v

🤒 Adverse Reactions ~2 min read ▾

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).

🆘 Overdosage 106 words ▾

Overdoses involving ingestion of up to 100 capsules (20g) 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 (2.5mg/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 70 words ▾

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 87 words ▾

Acyclovir tablets, USP (white to off white, round) containing 400mg acyclovir, USP and engraved "S047" on one side and plain on the other side. Bottle of 14 (72189-631-14) Bottle of 500 (69452-290-30) 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. 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)

📦 Storage and Handling 69 words ▾

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. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured By: Distributed by: Square Pharmaceuticals Ltd. Bionpharma Inc.

Dhaka Unit, Kaliakoir, Gazipur-1750, Princeton, NJ 08540, USA Bangladesh Mfg.Lic.No: 235 & 460 Rev.: April, 2023, V-03

📋 Description 121 words ▾

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: [structure]

⚠️ Precautions ~3 min read ▾

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

Information for Patients: Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered acyclovir, or they have any other questions. Patients should be advised to maintain adequate hydration. Herpes Zoster: There are no data on treatment initiated more than 72 hours after onset of the zoster rash.

Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster. Genital Herpes Infections: Patients should be informed that acyclovir is not a cure for genital herpes. There are no data evaluating whether acyclovir will prevent transmission of infection to others.

Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.

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

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

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

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

In the mouse study, plasma levels were 9 to 18 times human levels, while in the rat study, they were 8 to 15 times human levels. At higher doses (50mg/kg/day, s.c.) in rats and rabbits (11 to 22 and 16 to 31 times human levels, respectively) implantation efficacy, but not litter size, was decreased. In a rat peri- and post-natal study at 50mg/kg/day, s.c., there was a statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses.

No testicular abnormalities were seen in dogs given 50mg/kg/day, IV for 1 month (21 to 41 times human levels) or in dogs given 60mg/kg/day orally for 1 year (6 to 12 times hum… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 1 words ▾

72189-631-14

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

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.

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) — 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Direct_Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct_Rx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
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.
← 72189-0630-20 · Direct_Rx 72189-0632-30 · Direct_Rx →
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.