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acyclovir 50 mg/g Ointment

by Northstar Rx LLC · 1 TUBE in 1 CARTON (16714-885-01) / 15 g in 1 TUBE
NDC 16714-0885-01
🏷️ FDA NDC (as labeled) 16714-885-01 billing pads the product segment with a zero
This package
Contains15 g in 1 tube Cost per g$0.5362 NADAC Per package$8.04 / 15 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.23/unit · Part D plans $1.40/unit — full pricing hub ↓
Also comes in: 30 g 16714-0885-02
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) 16714-885-01
Product NDC 16714-885
11-digit billing NDC 16714088501
NCPDP billing unit GM — per gram (weight)
RxCUI 197312
UNII X4HES1O11F
UPC 0316714885018
Application # ANDA205510
SPL Set ID 6788f3c6-b79c-4f3f-9a73-10c8d3a38267
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 2017-07-31
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 16714-885-01 — 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 → 16714-0885-01. 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

LabelerNorthstar Rx LLC
Application holderGLENMARK SPECIALTY SA
FDA applicationANDA205510 (ANDA)
Labeler code16714
First marketedJul 2017
Product typeHuman Prescription Drug
Portfolio414 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
📗 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.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.536 $8.04 / 15 g
Medicaid paysCMS SDUD · 12 mo $1.23 $18.38 / 15 g
Medicare drug plans payPart D · Q2 2026 $1.40 $21.00 / 15 g
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.369 $0.515
▼ Down 45% 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 41%
acyclovir 50 mg/g 13668-0515-01 Torrent 15 g $0.536 AB Availability likely —
acyclovir 50 mg/gthis 16714-0885-01 Northstar 1 tube $0.536 AB Availability likely —
Acyclovir 50 mg/g 51672-1360-01 Sun 1 tube $0.536 AB Availability likely —
Acyclovir 50 mg/g 65162-0835-94 Amneal 1 tube $0.536 AB Availability likely —
acyclovir 50 mg/g 68462-0746-17 Glenmark 1 tube $0.536 AB Availability likely —
Acyclovir 50 mg/g 70700-0107-15 Xiromed, 1 tube $0.536 AB Availability likely —
acyclovir 50 mg/g 72578-0082-01 Viona 1 tube $0.536 AB Availability likely —
Acyclovir 50 mg/g 33342-0439-15 Macleods 1 tube $0.676 AB FDA listed +26%
Acyclovir 50 mg/g 51672-1361-05 Sun 1 tube $9.108 AB Availability likely +1599%
Acyclovir 50 mg/g 62332-0423-05 Alembic 1 tube $9.108 AB Availability likely +1599%
Acyclovir 50 mg/g 65162-0836-14 Amneal 1 tube $9.108 AB Availability likely +1599%
Acyclovir 50 mg/g 00093-3630-20 Teva 1 tube $9.108 AB Availability likely +1599%
Acyclovir 50 mg/g 45802-0044-75 Padagis 1 tube $9.108 AB Availability likely +1599%
Zovirax 50 mg/g 00187-0994-45 Bausch 1 tube $38.247 AB FDA listed +7033%
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

🏛️
2017
On the market since
Jul 2017
📍
2026
Currently FDA-listed
9 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 16714-0885-01, 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
1.3K
Units reimbursed last 4 qtrs
22.6K
Gross reimbursed last 4 qtrs
$27.6K
Avg / prescription
$21.35
Avg / unit
$1.2252
Latest quarter Q4 2025
374Rx
Medicaid pays / g
$1.2252
gross reimbursed
vs
NADAC / g
$0.5362
acquisition cost
=
Spread
+$0.6890
+128% 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 ⓘ
55% FFS 45% MCO
Fee-for-service · 713 Rx Managed care · 582 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 525 units · 6.7 per 100k residents WA Idaho: 870 units · 44.3 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 420 units · 7.3 per 100k residents MN Wisconsin: 1,035 units · 17.5 per 100k residents WI Michigan: 3,335 units · 33.2 per 100k residents MI New York: 1,625 units · 8.3 per 100k residents NY Vermont: 210 units · 32.5 per 100k residents 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: 885 units · 7.5 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 195 units · 2.1 per 100k residents NJ Massachusetts: no data reported MA California: 5,657 units · 14.5 per 100k residents CA Utah: no data reported UT Colorado: 1,290 units · 21.9 per 100k residents CO Nebraska: 180 units · 9.1 per 100k residents NE Missouri: 810 units · 13.1 per 100k residents MO Kentucky: 1,245 units · 27.5 per 100k residents KY West Virginia: no data reported WV Virginia: 515 units · 5.9 per 100k residents VA Maryland: 195 units · 3.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 300 units · 2.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,710 units · 37.4 per 100k residents LA Mississippi: no data reported MS Alabama: 1,035 units · 20.3 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 525 units · 2.3 per 100k residents FL
Units reimbursed · per 100k residents
2.144.3
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 Idaho 44.3 /100k
2 Louisiana 37.4 /100k
3 Michigan 33.2 /100k
4 Vermont 32.5 /100k
5 Kentucky 27.5 /100k
6 Colorado 21.9 /100k
7 Alabama 20.3 /100k
8 Wisconsin 17.5 /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 tube this page16714-0885-01 1,295 Rx · $27,643
1 tube16714-0885-02 762 Rx · $20,371
Drug total (last 4 qtrs): 2,057 Rx · 46,777 units · $48,014 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
16714-0885-01 You're viewing this 1 TUBE in 1 CARTON (16714-885-01) / 15 g in 1 TUBE $0.5362 / g $8.04 2018-12-31 Active
16714-0885-02 1 TUBE in 1 CARTON (16714-885-02) / 30 g in 1 TUBE $0.3421 / g $10.26 2018-12-31 Active

Per g, this pack runs about 57% above the cheapest pack (NDC 16714-0885-02, $0.3421 vs $0.5362 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 63% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 16714-0885-01?
NDC 16714-0885-01 is listed by the FDA — 1 tube in 1 carton / 15 g in 1 tube.
What NDC number is used to bill for this package of acyclovir 50 mg/g Ointment?
Bill NDC 16714-0885-01 — the 11-digit billing format is 16714088501. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage 28 words ▾

INDICATIONS AND USAGE Acyclovir ointment USP 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 199 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 110 words ▾

HOW SUPPLIED Each gram of acyclovir ointment USP, 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. Acyclovir ointment USP, 5% is a white to off-white translucent ointment. It is supplied as follows: NDC 16714-885-01 15 gram tubes (1 tube per carton) NDC 16714-885-02 30 gram tubes (1 tube per carton) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India To report SUSPECT ADVERSE REACTIONS, Contact NorthStar Rx LLC 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fdagov/medwatch December 2021

📋 Description 105 words ▾

DESCRIPTION Acyclovir 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, USP in a polyethylene glycol (PEG) base.

Acyclovir, USP 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 225.2 g/mol. 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, USP is 2-amino-1, 9-dihydro-9- [(2-hydroxyethoxy)methyl]-6 H purin-6-one; it has the following structural formula: acyclovir-structura-formula

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 16714-0878-01 · Northstar 16714-0886-01 · NorthStar →
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.