Avaclyr ACYCLOVIR 30 mg/g Ointment, 1 tube
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ophthalmic acyclovir is used to treat an infection of the eye caused by herpes simplex virus. Acyclovir is in a class of antiviral medications called synthetic nucleoside analogues. It works by stopping the spread of the herpes virus in the eye.
Read the full MedlinePlus article ↗- Avaclyr treats a herpes simplex virus infection of the cornea — the clear surface at the front of your eye. This condition is called herpetic keratitis, and it can cause painful so...
- What exactly is this eye ointment treating?
- Gently pull your lower eyelid down to create a small pocket, then squeeze out about a 1 cm ribbon of ointment — roughly the length of your fingernail — into that pocket. Try not to...
- How do I actually use the ointment? It sounds tricky.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Acyclovir — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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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White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.
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.Inactive ingredient FAQ
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💲 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 | 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Avaclyr 30 mg/gthis 48102-0028-35 | Fera | 1 tube | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Code | What it grants | Expires |
|---|---|---|
| ODE-235 | Orphan Drug Exclusivity (7-year) | Mar 29, 2026 |
Is there a generic version of this drug?
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Why are there multiple patent dates?
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 48102-0028-35 You're viewing this | 1 TUBE in 1 CARTON (48102-028-35) / 3.5 g in 1 TUBE | 2026-01-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE AVACLYR is a sterile topical antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus. AVACLYR (acyclovir ophthalmic ointment) 3%, a herpes simplex virus nucleoside analog DNA polymerase inhibitor, is indicated in the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended dosing regimen is to apply a 1 cm ribbon of ointment in the lower cul-de-sac of the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals and then a 1 cm ribbon 3 times per day for 7 days. Apply a 1 cm ribbon in the lower cul-de-sac of the affected eye 5 times per day until healed then 3 times per day for 7 days. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS AVACLYR is an ophthalmic ointment containing 3% acyclovir. Ophthalmic ointment containing 3% acyclovir.
⛔ Contraindications ▾
4 CONTRAINDICATIONS AVACLYR is contraindicated for patients who develop sensitivity to acyclovir or valacyclovir. AVACLYR is contraindicated in patients with a known hypersensitivity to acyclovir or valacyclovir.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS AVACLYR is indicated for topical ophthalmic use. ( 5.1 ) Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR. ( 5.2 )
5.1Topical Ophthalmic Use AVACLYR is indicated for topical ophthalmic use.
5.2Avoidance of Contact Lenses Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR.
5.3Risk of Contamination This product is sterile when packaged. Patients should be advised to not allow the tip of the container to touch any surface, as this may contaminate the ointment. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (2-10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis. Rare reports of blepharitis and very rare reports of immediate hypersensitivity reactions including angioedema and urticaria have been observed post-marketing in patients taking AVACLYR. The most common adverse reactions (2 to 10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No clinically significant interactions have been identified resulting from topical administration of other drugs concomitantly with AVACLYR.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary A prospective epidemiologic registry of acyclovir use from 1984 to 1999 indicated that the occurrence rate of birth defects in women exposed to systemically administered acyclovir during the first trimester of pregnancy (period of organogenesis) approximated that found in the general population. Likewise, oral and subcutaneous administration of acyclovir to pregnant mice, rats, and rabbits during organogenesis did not produce teratogenicity at clinically relevant doses (see Animal Data ) .
Data Human Data 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 systemically administered 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. The human maternal plasma level of acyclovir following ocular administration is unknown. Animal Data In published animal reproduction studies, acyclovir was not maternally toxic and did not produce teratogenicity in the mouse at oral doses up to 450 mg/kg/day (1100 times the maximum recommended human ophthalmic dose [RHOD] on a mg/m 2 basis, assuming 100% absorption), or in the rat and rabbit at subcutaneous doses up to 50 mg/kg/day (approximately 250 and 500 times the RHOD, respectively) when administered throughout the period of organogenesis.
Administration of acyclovir from postnatal days 3 to 21 did not produce adverse effects in neonatal rats at subcutaneous doses less than or equal to 20 mg/kg/day (100 times the RHOD).
8.2Lactation Risk Summary Acyclovir concentrations have been documented in breast milk following oral administration of acyclovir. There is no information regarding the presence of acyclovir in human milk following ocular administration, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for acyclovir, and any potential adverse effects on the breast-fed child from acyclovir or from the underlying maternal condition.
8.4Pediatric Use Safety and efficacy of Acyclovir ophthalmic ointment in pediatric patients below the age of two years has not been established.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary A prospective epidemiologic registry of acyclovir use from 1984 to 1999 indicated that the occurrence rate of birth defects in women exposed to systemically administered acyclovir during the first trimester of pregnancy (period of organogenesis) approximated that found in the general population. Likewise, oral and subcutaneous administration of acyclovir to pregnant mice, rats, and rabbits during organogenesis did not produce teratogenicity at clinically relevant doses (see Animal Data ) .
Data Human Data 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 systemically administered 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. The human maternal plasma level of acyclovir following ocular administration is unknown. Animal Data In published animal reproduction studies, acyclovir was not maternally toxic and did not produce teratogenicity in the mouse at oral doses up to 450 mg/kg/day (1100 times the maximum recommended human ophthalmic dose [RHOD] on a mg/m 2 basis, assuming 100% absorption), or in the rat and rabbit at subcutaneous doses up to 50 mg/kg/day (approximately 250 and 500 times the RHOD, respectively) when administered throughout the period of organogenesis.
Administration of acyclovir from postnatal days 3 to 21 did not produce adverse effects in neonatal rats at subcutaneous doses less than or equal to 20 mg/kg/day (100 times the RHOD).
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and efficacy of Acyclovir ophthalmic ointment in pediatric patients below the age of two years has not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of topical application of acyclovir 3% is unlikely because of minimal absorption.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Acyclovir is an antiviral drug [see Microbiology ( 12.4 )] .
12.3Pharmacokinetics It has not been possible to detect acyclovir concentrations in the blood by existing bioanalytical methods after topical application to the eye. Trace quantities are detectable in the urine but are not therapeutically relevant.
12.4Microbiology Acyclovir is a synthetic purine nucleoside analogue that is phosphorylated intracellularly by the viral encoded thymidine kinase (TK) of HSV 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 a biochemical reaction, acyclovir triphosphate inhibits replication of herpes viral DNA by competing with nucleotides for binding to the viral DNA polymerase and by incorporation into and termination of the growing viral DNA chain.
The cellular thymidine kinase of normal, uninfected cells does not use acyclovir effectively as a substrate, hence toxicity to mammalian host cells is low. Antiviral Activities : The quantitative relationship between the cell culture susceptibility of herpes virus 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 (EC 50 ), vary greatly depending upon a number of factors.
Using plaque-reduction assays, on Vero cells, the median EC 50 value of acyclovir against clinical herpes simplex virus isolates (subjects receiving placebo) was 1.3 μM (range: < 0.56 to 3.3 μM). Drug Resistance : Resistance of HSV to acyclovir can result from qualitative and quantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection.
While most of the acyclovir resistant mutant isolates thus far from such patients have been found to be TK deficient, other mutant isolates involving the viral TK gene (TK partial and TK altered) or DNA polymerase have been identified. TK negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in immunocompromised patients who show poor clinical response during therapy.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Acyclovir is an antiviral drug [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING AVACLYR is available in a 3.5 g aluminum tube with a white high density polyethylene cap as a clear, colorless, sterile ophthalmic ointment for topical use containing 3% acyclovir active drug. Each tube is packaged in an individual carton. 3.5 g tube (NDC 48102-028-35) Store at 15°C to 25°C (59°F to 77°F).
📋 Description ▾
11 DESCRIPTION Acyclovir is a synthetic herpes simplex virus nucleoside analog DNA polymerase inhibitor. The drug substance is a white crystalline powder with the molecular formula of C 8 H 11 N 5 O 3 and a molecular weight of 225.2. The maximum solubility in water at 25°C is 1.41 mg/mL.
The pka's of acyclovir are 2.52 and 9.35. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]6H-purin-6-one, it has the following chemical structure: AVACLYR is a sterile ointment for topical administration in eyes. Each gram of ointment contains 30 mg of acyclovir in a white petrolatum base.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Advise patients to wash hands well and pull down lower lid of the affected eye to form a pocket. Instruct the patient to apply a 1 cm (1/2 inch) ribbon of ointment in the pocket formed by the lower lid 5 times per day (approximately every 3 hours while awake). After application of the ointment, the patient should be advised to close their eye for 1-2 minutes.
Excess ointment can be wiped away. Continue this dosing 5 times per day until the patient is advised by their physician that the corneal ulcer is healed. Once healed, instruct the patient to continue use of a 1 cm (1/2 inch) ribbon of ointment 3 times per day for 7 more days. [see Dosage and Administration ( 2 )].
Risk of Contamination This product is sterile when packaged. Advise patients to not allow the tip of the container to touch any surface, as this may contaminate the ointment. When to Consult a Physician Advise patients to consult a physician if pain develops, or if redness, itching, or inflammation becomes aggravated.
Avoidance of Contact Lenses Advise patients to not wear contact lenses when using AVACLYR. Manufactured in Canada for: Fera Pharmaceuticals, LLC Locust Valley, N.Y. 11560 PF028 P-622V1