HomeNDC LookupIngredientsAcyclovir › 72578-0082-06
acyclovir 50 mg/g Ointment — NDC 72578-0082-06 package photo

acyclovir 50 mg/g Ointment

by Viona Pharmaceuticals Inc · 1 TUBE in 1 CARTON (72578-082-06) / 30 g in 1 TUBE
NDC 72578-0082-06
🏷️ FDA NDC (as labeled) 72578-082-06 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Cost per g$0.3421 NADAC Per package$10.26 / 30 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.03/unit · Part D plans $1.40/unit — full pricing hub ↓
Also comes in: 15 g 72578-0082-01
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 72578-082-06
Product NDC 72578-082
11-digit billing NDC 72578008206
NCPDP billing unit GM — per gram (weight)
RxCUI 197312
UNII X4HES1O11F
UPC 0372578082017
Application # ANDA205974
SPL Set ID 12df1991-fb1c-45df-acf3-706b1e8ecfc3
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 2020-06-08
Route TOPICAL
Dosage form OINTMENT
Substance ACYCLOVIR
GPI-14 90350010004205
GPI class Acyclovir
GCN Seq No 007670
GCN 31640
HICL code 004183
Ingredient (HICL) Acyclovir
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5V
Therapeutic class — specific (HIC3) Topical Antivirals
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name ACYCLOVIR 5% OINTMENT
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 72578-082-06 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72578-0082-06. 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

LabelerViona Pharmaceuticals Inc
Application holderZYDUS LIFESCIENCES LTD
FDA applicationANDA205974 (ANDA)
Labeler code72578
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio94 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ACYCLOVIR 5% OINTMENT Ingredient Acyclovir
📖 What it is MedlinePlus · NLM

Acyclovir cream is used to treat cold sores (fever blisters; blisters that are caused by a virus called herpes simplex) on the face or lips. Acyclovir ointment is used to treat first outbreaks of genital herpes (a herpes virus infection that causes sores to form around the genitals and rectum from time to time) and to treat certain types of sores caused by the herpes simplex virus in people with weak immune systems. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the body. Acyclovir does not cure col...

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 White
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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.

1 inactive ingredient 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 DailyMedingredient 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 gPer package
Retail pharmacies payNADAC · weekly $0.342 $10.26 / 30 g
Medicaid paysCMS SDUD · 12 mo $1.03 $30.94 / 30 g
Medicare drug plans payPart D · Q2 2026 $1.40 $41.99 / 30 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.176 $0.306
▼ Down 66% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acyclovir 50 mg/g 00591-1159-30 ACTAVIS 1 tube $0.315 AB Availability likely save 8%
acyclovir 50 mg/gthis 72578-0082-06 Viona 1 tube $0.342 AB Availability likely
acyclovir 50 mg/g 13668-0515-01 Torrent 15 g $0.536 AB Availability likely +57%
acyclovir 50 mg/g 16714-0885-01 Northstar 1 tube $0.536 AB Availability likely +57%
Acyclovir 50 mg/g 51672-1360-01 Sun 1 tube $0.536 AB Availability likely +57%
Acyclovir 50 mg/g 65162-0835-94 Amneal 1 tube $0.536 AB Availability likely +57%
acyclovir 50 mg/g 68462-0746-17 Glenmark 1 tube $0.536 AB Availability likely +57%
Acyclovir 50 mg/g 70700-0107-15 Xiromed, 1 tube $0.536 AB Availability likely +57%
Acyclovir 50 mg/g 33342-0439-15 Macleods 1 tube $0.676 AB FDA listed +98%
Acyclovir 50 mg/g 51672-1361-05 Sun 1 tube $9.108 AB Availability likely +2562%
Acyclovir 50 mg/g 62332-0423-05 Alembic 1 tube $9.108 AB Availability likely +2562%
Acyclovir 50 mg/g 65162-0836-14 Amneal 1 tube $9.108 AB Availability likely +2562%
Acyclovir 50 mg/g 00093-3630-20 Teva 1 tube $9.108 AB Availability likely +2562%
Acyclovir 50 mg/g 45802-0044-75 Padagis 1 tube $9.108 AB Availability likely +2562%
Zovirax 50 mg/g 00187-0994-45 Bausch 1 tube $38.247 AB FDA listed +11079%
Zovirax 50 mg/g 00187-0993-95 Bausch 1 tube AB FDA listed
Acyclovir 50 mg/g 43547-0499-41 Solco 1 tube FDA listed
acyclovir 50 mg/g 50090-6561-00 A-S 1 tube AB FDA listed
Acyclovir 50 mg/g 62332-0248-05 Alembic 1 tube AB FDA listed
Acyclovir 50 mg/g 63629-2327-01 Bryant 30 g AB FDA listed
Acyclovir 50 mg/g 63629-2328-01 Bryant 15 g AB FDA listed
acyclovir 50 mg/g 68071-3909-05 NuCare 1 tube AB FDA listed
acyclovir 50 mg/g 68788-8247-01 Preferred 1 tube AB FDA listed
acyclovir 50 mg/g 70771-1371-01 Zydus 1 tube AB FDA listed
Acyclovir 50 mg/g 72162-1960-02 Bryant 15 g AB FDA listed
acyclovir 50 mg/g 85766-0115-15 Sportpharm 1 tube AB FDA listed
Acyclovir 50 mg/g 85957-0036-01 Aryeh 2 tubes AB FDA listed
Acyclovir 50 mg/g 72162-2327-02 Bryant 1 tube AB FDA listed
Acyclovir 50 mg/g 70771-1808-02 Zydus 1 tube BX FDA listed
Acyclovir 50 mg/g 72578-0101-04 Viona 1 tube BX FDA listed
acyclovir 50 mg/g 68788-4142-01 c 15 g 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
Jun 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 72578-0082-06, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.8K
Units reimbursed last 4 qtrs
89K
Gross reimbursed last 4 qtrs
$91.8K
Avg / prescription
$32.24
Avg / unit
$1.0314
Latest quarter Q4 2025
1.1KRx
Medicaid pays / g
$1.0314
gross reimbursed
vs
NADAC / g
$0.3421
acquisition cost
=
Spread
+$0.6893
+201% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
46% FFS 54% MCO
Fee-for-service · 1,303 Rx Managed care · 1,545 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 330 units · 5.8 per 100k residents MN Wisconsin: 1,365 units · 23.1 per 100k residents WI Michigan: 9,495 units · 94.6 per 100k residents MI New York: 6,285 units · 32.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 5,025 units · 42.6 per 100k residents OH Pennsylvania: 3,810 units · 29.4 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 26,610 units · 68.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 1,500 units · 24.2 per 100k residents MO Kentucky: 3,600 units · 79.5 per 100k residents KY West Virginia: 960 units · 54.2 per 100k residents WV Virginia: 2,765 units · 31.7 per 100k residents VA Maryland: no data reported MD Connecticut: 390 units · 10.8 per 100k residents CT Rhode Island: no data reported RI Arizona: 570 units · 7.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 3,705 units · 52.0 per 100k residents TN North Carolina: 4,515 units · 41.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 6,435 units · 141 per 100k residents LA Mississippi: no data reported MS Alabama: 1,830 units · 35.8 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 570 units · 1.9 per 100k residents TX Florida: 9,255 units · 40.9 per 100k residents FL
Units reimbursed · per 100k residents
1.9141
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 141 /100k
2 Michigan 94.6 /100k
3 Kentucky 79.5 /100k
4 California 68.3 /100k
5 West Virginia 54.2 /100k
6 Tennessee 52.0 /100k
7 Ohio 42.6 /100k
8 North Carolina 41.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 tube72578-0082-01 8,311 Rx · $189,105
1 tube this page72578-0082-06 2,848 Rx · $91,809
Drug total (last 4 qtrs): 11,159 Rx · 235,217 units · $280,914 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Acyclovir — the program that covers self-administered drugs. 29 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Acyclovir. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.1M
Claims incl. refills
517.4K
Beneficiaries
366.8K
Spend / beneficiary
$30.28
Spend / claim
$21.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

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

Age at onset

Neonate121
Infant157
Child436
Adolescent193
Adult8,482
Elderly12,300

Reporter sex

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

Serious outcomes

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

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
72578-0082-01 1 TUBE in 1 CARTON (72578-082-01) / 15 g in 1 TUBE $0.5362 / g $8.04 2020-06-08 Active
72578-0082-06 You're viewing this 1 TUBE in 1 CARTON (72578-082-06) / 30 g in 1 TUBE $0.3421 / g $10.26 2020-06-08 Active

This pack has the lowest per-g cost of the 2 priced pack sizes ($0.3421 NADAC).

This pack accounts for about 26% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 72578-0082-06?
NDC 72578-0082-06 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of acyclovir 50 mg/g Ointment?
Bill NDC 72578-0082-06 — the 11-digit billing format is 72578008206. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 27 words

INDICATIONS AND USAGE Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients.

⏱️ Dosage and Administration 91 words

DOSAGE AND ADMINISTRATION Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days. The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area. A finger cot or rubber glove should be used when applying Acyclovir Ointment to prevent autoinoculation of other body sites and transmission of infection to other persons.

Therapy should be initiated as early as possible following onset of signs and symptoms.

Contraindications 17 words

CONTRAINDICATIONS Acyclovir Ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.

⚠️ Warnings 18 words

WARNINGS Acyclovir Ointment 5% is intended for cutaneous use only and should not be used in the eye.

🤒 Adverse Reactions 151 words

ADVERSE REACTIONS In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings.

Observed During Clinical Practice Based on clinical practice experience in patients treated with Acyclovir Ointment in the US, spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process.

Voluntary reports of adverse events that have been received since market introduction include: General Edema and/or pain at the application site. Skin Pruritus, rash.

🔄 Drug Interactions 22 words

Drug Interactions Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Ointment 5%.

🤰 Pregnancy 144 words

Pregnancy Teratogenic Effects Pregnancy Category B Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled studies of systemic acyclovir 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.

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

🧒 Pediatric Use 12 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 56 words

Geriatric Use Clinical studies of Acyclovir Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal (see CLINICAL PHARMACOLOGY ).

🆘 Overdosage 20 words

OVERDOSAGE Overdosage by topical application of Acyclovir Ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY ).

🧬 Clinical Pharmacology 202 words

CLINICAL PHARMACOLOGY Two clinical pharmacology studies were performed with Acyclovir Ointment 5% in immunocompromised adults at risk of developing mucocutaneous Herpes simplex virus infections or with localized varicella-zoster infections. These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir. In 1 of these studies, which included 16 inpatients, the complete ointment or its vehicle were randomly administered in a dose of 1-cm strips (25 mg acyclovir) 4 times a day for 7 days to an intact skin surface area of 4.5 square inches.

No local intolerance, systemic toxicity, or contact dermatitis were observed. In addition, no drug was detected in blood and urine by radioimmunoassay (sensitivity, 0.01 mcg/mL). The other study included 11 patients with localized varicella-zoster infections.

In this uncontrolled study, acyclovir was detected in the blood of 9 patients and in the urine of all patients tested. Acyclovir levels in plasma ranged from < 0.01 to 0.28 mcg/mL in 8 patients with normal renal function, and from < 0.01 to 0.78 mcg/mL in 1 patient with impaired renal function. Acyclovir excreted in the urine ranged from < 0.02% to 9.4% of the daily dose.

Therefore, systemic absorption of acyclovir after topical application is minimal.

📦 How Supplied / Storage and Handling 93 words

HOW SUPPLIED Each gram of Acyclovir Ointment USP, 5% contains 50 mg acyclovir in a polyethylene glycol base. Acyclovir Ointment USP, 5% is supplied in 15 gram and 30 gram tubes. NDC 72578-082-01 in tube of 15 gm NDC 72578-082-06 in tube of 30 gm Storage Store at 15° to 25°C (59° to 77°F) in a dry place.

Keep this and all medications out of the reach of children. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

📋 Description 105 words

DESCRIPTION Acyclovir Ointment USP, 5% is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base.

Acyclovir is a white to off-white, crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/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: Acyclovir Ointment USP, 5%

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