Acyclovir 50 mg/g Ointment — NDC 33342-439-15 (Billing 33342-0439-15)
This is a package of Acyclovir 50 mg/g Ointment from Macleods Pharmaceuticals Limited, marketed since Aug 2018 and currently FDA-listed; retail pharmacies pay about $0.6759 per g (NADAC).
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007670
- GCN: 31640
- GPI-14 (Medi-Span): 90350010004205
- HICL (First Databank): 004183
- AHFS class code: 08:18.32.00
- RxCUI (RxNorm): 197312
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
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 ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Acyclovir — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.676 | $10.14 / 15 g |
| 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 | $1.40 | $21.00 / 15 g |
Where does this data come from?
- CMS NADAC weekly file · file of Feb 21, 2024
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 3, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 33342-0439-15 You're viewing this | 1 TUBE in 1 CARTON / 15 g in 1 TUBE | $0.6759 / g | $10.14 | 2021-08-05 | — | Active |
| 33342-0439-30 33342-439-30 Main listing | 1 TUBE in 1 CARTON / 30 g in 1 TUBE | $0.3459 / g | $10.38 | 2018-08-13 | — | Active |
Per g, this pack runs about 95% above the cheapest pack (NDC 33342-0439-30, $0.3459 vs $0.6759 NADAC).
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Acyclovir 50 mg/g Ointment?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Acyclovir 50 mg/g 00591-1159-30 | ACTAVIS | 1 tube | $0.315 | AB | Availability likely | save 53% |
| acyclovir 50 mg/g 13668-0515-01 | Torrent | 15 g | $0.522 | AB | Availability likely | save 23% |
| acyclovir 50 mg/g 16714-0885-01 | Northstar | 1 tube | $0.522 | AB | Availability likely | save 23% |
| Acyclovir 50 mg/g 51672-1360-01 | Sun | 1 tube | $0.522 | AB | Availability likely | save 23% |
| Acyclovir 50 mg/g 65162-0835-94 | Amneal | 1 tube | $0.522 | AB | Availability likely | save 23% |
| acyclovir 50 mg/g 68462-0746-17 | Glenmark | 1 tube | $0.522 | AB | Availability likely | save 23% |
| Acyclovir 50 mg/g 70700-0107-15 | Xiromed, | 1 tube | $0.522 | AB | Availability likely | save 23% |
| acyclovir 50 mg/g 72578-0082-01 | Viona | 1 tube | $0.522 | AB | Availability likely | save 23% |
| Acyclovir 50 mg/gthis 33342-0439-15 | Macleods | 1 tube | $0.676 | AB | FDA listed | — |
| Acyclovir 50 mg/g 51672-1361-05 | Sun | 1 tube | $8.992 | AB | Availability likely | +1230% |
| Acyclovir 50 mg/g 62332-0423-05 | Alembic | 1 tube | $8.992 | AB | Availability likely | +1230% |
| Acyclovir 50 mg/g 65162-0836-14 | Amneal | 1 tube | $8.992 | AB | Availability likely | +1230% |
| Acyclovir 50 mg/g 00093-3630-20 | Teva | 1 tube | $8.992 | AB | Availability likely | +1230% |
| Acyclovir 50 mg/g 45802-0044-75 | Padagis | 1 tube | $8.992 | AB | Availability likely | +1230% |
| Zovirax 50 mg/g 00187-0994-45 | Bausch | 1 tube | $38.247 | AB | FDA listed | +5558% |
| 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 | — |
| acyclovir 50 mg/g 50090-8074-00 | A-S | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Feb 21, 2024
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
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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?
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-life threatening mucocutaneous HSV infections in immunocompromised patients.
⏱️ Dosage and Administration ▾
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 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 ▾
CONTRAINDICATIONS Acyclovir Ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
⚠️ Warnings ▾
WARNINGS Acyclovir Ointment 5% is intended for cutaneous use only and should not be used in the eye.
🤒 Adverse Reactions ▾
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 two 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 U.S., 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. To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🆘 Overdosage ▾
OVERDOSAGE Overdosage by topical application of acyclovir ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Two clinical pharmacology studies were performed with acyclovir ointment 5% in immunocompromised adults at risk of developing mucocutaneous HSV infections or with localized varicella-zoster infections. These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir. In one 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 one 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. CLINICAL TRIALS In clinical trials of initial genital herpes infections, acyclovir ointment 5% has shown a decrease in healing time and, in some cases, a decrease in duration of viral shedding and duration of pain. In studies in immunocompromised patients primarily with herpes labialis, there was a decrease in duration of viral shedding and a slight decrease in duration of pain.
In studies of recurrent genital herpes and of herpes labialis in non-immunocompromised patients, there was no evidence of clinical benefit; there was some decrease in duration of viral shedding.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Each gram of acyclovir ointment USP, 5% contains 50 mg acyclovir, USP in a polyethylene glycol base. It is supplied as follows: 15 g tubes NDC 33342-439-15 30 g tubes NDC 33342-439-30 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]. Store in a dry place.
Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 05/2021 PM00256302
📋 Description ▾
DESCRIPTION Acyclovir USP 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, 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]-6H-purin-6-one; it has the following structural formula: VIROLOGY Mechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue.
The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in three ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase.
The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC50), vary greatly depending upon a number of factors.
Using plaque-reduction assays, the IC50 against HSV isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to 10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC50 of 1.35 mcg/mL.
Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated.
TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy. str
⚠️ Precautions ▾
PRECAUTIONS General: The recommended dosage, frequency of applications, and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION ). There are no data to support the use of acyclovir ointment 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms. Acyclovir ointment 5% should not be used for the prevention of recurrent HSV infections.
Although clinically significant viral resistance associated with the use of acyclovir ointment 5% has not been observed, this possibility exists. Drug Interactions: Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with acyclovir ointment 5%. Carcinogenesis, Mutagenesis, Impairment of Fertility: Systemic exposure following topical administration of acyclovir is minimal.
Dermal carcinogenicity studies were not conducted. Results from the studies of carcinogenesis, mutagenesis, and fertility are not included in the full prescribing information for acyclovir ointment 5% due to the minimal exposures of acyclovir that result from dermal application. Information on these studies is available in the full prescribing information for Acyclovir Capsules, Tablets, and Suspension and Acyclovir for Injection.
Pregnancy: Teratogenic Effects: 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. Nursing Mothers: It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following topical administration is minimal.
After oral administration of acyclovir, acyclovir concentrations have been documented in breast milk in two women and ranged from 0.6 to 4.1 times the corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day. Nursing mothers who have active herpetic lesions near or on the breast should avoid nursing.
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 ).
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Acyclovir Topical Ointment USP, 5% Pack Type: 30 gms Tube label NDC: 33342-439-30 Acyclovir Topical Ointment USP, 5% Pack Type: 30 gms Carton label NDC: 33342-439-30 Acyclovir Topical Ointment USP, 5% Pack Type: 15 gms Tube label NDC: 33342-439-15 Acyclovir Topical Ointment USP, 5% Pack Type: 15 gms Carton label NDC: 33342-439-15 acyclovir-tube.jpg acyclovir-carton.jpg acyclovir-tube-15gm.jpg acyclovir-carton-15gm.jpg