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ZIRGAN ganciclovir 1.5 mg/g Gel — NDC 24208-0535-35 package photo

ZIRGAN ganciclovir 1.5 mg/g Gel

by Bausch & Lomb Incorporated · 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR
NDC 24208-0535-35
🏷️ FDA NDC (as labeled) 24208-535-35 billing pads the product segment with a zero
This package
Contains5 g in 1 tube, with applicator Cost per g$91.26 NADAC Per package$456.29 / 5 g Pack sizes2 compare ↓
Also priced by: Medicaid pays $93.38/unit · Part D plans $91.52/unit — full pricing hub ↓
Also comes in: 1.5 g 24208-0535-15
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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) 24208-535-35
Product NDC 24208-535
11-digit billing NDC 24208053535
NCPDP billing unit GM — per gram (weight)
RxCUI 388052, 864650
UNII P9G3CKZ4P5
Application # NDA022211
SPL Set ID ea25e7ac-7a93-4ec8-975b-2cec197e1c27
Established class (EPC) Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor; Nucleoside Analog Antiviral
Mechanism of action DNA Polymerase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-04-30
Route OPHTHALMIC
Dosage form GEL
Substance GANCICLOVIR
GPI-14 86103007004020
GPI class Zirgan
GCN Seq No 030938
GCN 33684
HICL code 009644
Ingredient (HICL) Ganciclovir
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6V
Therapeutic class — specific (HIC3) Eye Antivirals
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name ZIRGAN 0.15% OPHTHALMIC GEL
FDB brand name Zirgan
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 24208-535-35 — 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 → 24208-0535-35. 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 Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor class.

Pharmacologic class Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor, Nucleoside Analog Antiviral
Drug family (ATC) 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

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationNDA022211 (NDA)
Labeler code24208
First marketedApr 2010
Product typeHuman Prescription Drug
Portfolio92 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 ZIRGAN 0.15% OPHTHALMIC GEL Ingredient Ganciclovir
📖 What it is MedlinePlus · NLM

Ganciclovir ophthalmic is used to treat herpetic keratitis (dendritic ulcers; eye ulcers caused by a herpes simplex virus infection). Ganciclovir is in a class of medications called antivirals. It works by stopping the spread of the herpes virus in the eye.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Zirgan treats a specific type of eye infection caused by the herpes simplex virus — not the kind of pink eye you might get from a cold or bacteria. The herpes virus can infect the...
  • What exactly is Zirgan treating — is this just a regular eye infection?
  • Yes, please keep going. The first phase of treatment continues until your corneal ulcer is fully healed, and then you still take Zirgan three times a day for 7 more days after that...
  • I'm feeling much better after a few days — do I really need to finish the full course?
📖 Read our full Ganciclovir Ophthalmic 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII HHT01ZNK31
    Carbomer Homopolymer Type B is a synthetic polymer made from acrylic acid. It absorbs water and forms a gel, so it's used in medicines as a thickener, suspending agent, and to help create a smooth texture in creams, gels, and lotions.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients 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 $91.257 $456.29 / 5 g
Medicaid paysCMS SDUD · 12 mo $93.38 $466.89 / 5 g
Medicare drug plans payPart D · Q2 2026 $91.52 $457.59 / 5 g
NADAC price history (per g) — tap or hover for the price & month
Oct 2021 Jan 2024 Apr 2026 Aug 2026 $91.382 $75.588
▲ Up 21% over the last 12 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
Zirgan 1.5 mg/gthis 24208-0535-35 Bausch 1 tube $91.257 Availability likely
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2010
On the market since
Apr 2010
📍
2026
Currently FDA-listed
16 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 24208-0535-35, 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 – Q1 2026 · 5 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
1.8K
Units reimbursed last 4 qtrs
9.4K
Gross reimbursed last 4 qtrs
$877.8K
Avg / prescription
$479.39
Avg / unit
$93.3789
Latest quarter Q1 2026
479Rx
Medicaid pays / g
$93.3789
gross reimbursed
vs
NADAC / g
$91.2570
acquisition cost
=
Spread
+$2.1219
+2% 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
69% FFS 31% MCO
Fee-for-service · 1,272 Rx Managed care · 559 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 60 units · 0.8 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 230 units · 3.9 per 100k residents WI Michigan: no data reported MI New York: 2,860 units · 14.6 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: 530 units · 4.2 per 100k residents IL Indiana: no data reported IN Ohio: 55 units · 0.5 per 100k residents OH Pennsylvania: 315 units · 2.4 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 195 units · 2.8 per 100k residents MA California: 2,535 units · 6.5 per 100k residents CA Utah: no data reported UT Colorado: 340 units · 5.8 per 100k residents CO Nebraska: no data reported NE Missouri: 255 units · 4.1 per 100k residents MO Kentucky: 255 units · 5.6 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 315 units · 8.7 per 100k residents 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: 285 units · 2.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 60 units · 1.5 per 100k residents OK Louisiana: 320 units · 7.0 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 430 units · 1.4 per 100k residents TX Florida: 360 units · 1.6 per 100k residents FL
Units reimbursed · per 100k residents
0.514.6
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 New York 14.6 /100k
2 Connecticut 8.7 /100k
3 Louisiana 7.0 /100k
4 California 6.5 /100k
5 Colorado 5.8 /100k
6 Kentucky 5.6 /100k
7 Illinois 4.2 /100k
8 Missouri 4.1 /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 page24208-0535-35 1,831 Rx · $877,762
1 tube24208-0535-15 No Medicaid data
Drug total (last 4 qtrs): 1,831 Rx · 9,400 units · $877,762 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 Zirgan — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Zirgan. 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
$2.02M
Claims incl. refills
4.1K
Beneficiaries
3.1K
Spend / beneficiary
$654.48
Spend / claim
$488.01
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 Ganciclovir — the ingredient across all brands.

Top reported reactions

Cytomegalovirus Infection1,266
Drug Resistance731
Pyrexia620
Neutropenia598
Pancytopenia554
Diarrhoea470
Cytomegalovirus Viraemia438

Age at onset

Neonate32
Infant135
Child168
Adolescent75
Adult946
Elderly374

Reporter sex

10,879 reports
Male · 57%
Female · 42%
Unknown · 1%

Serious outcomes

Hospitalization4,436
Life-threatening1,178
Disabling213
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,042 0
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
24208-0535-15 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR 2010-04-30 Active
24208-0535-35 You're viewing this 1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR $91.26 / g $456.29 2010-04-30 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 24208-0535-35?
NDC 24208-0535-35 is listed by the FDA — 1 tube, with applicator in 1 carton / 5 g in 1 tube, with applicator.
What NDC number is used to bill for this package of ZIRGAN ganciclovir 1.5 mg/g Gel?
Bill NDC 24208-0535-35 — the 11-digit billing format is 24208053535. 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 55 words

1 INDICATIONS AND USAGE ZIRGAN is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ZIRGAN is a nucleoside analog antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older. ( 1 )

⏱️ Dosage and Administration 76 words

2 DOSAGE AND ADMINISTRATION The recommended dosage is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days. Apply 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days. ( 2 )

💊 Dosage Forms and Strengths 16 words

3 DOSAGE FORMS AND STRENGTHS Ophthalmic gel: 0.15% ganciclovir. Ophthalmic gel: 0.15% ganciclovir. ( 3 )

Contraindications 4 words

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions 124 words

5 WARNINGS AND PRECAUTIONS ZIRGAN is indicated for topical ophthalmic use only. ( 5.1 ) Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with ZIRGAN. ( 5.2 )

5.1Topical Ophthalmic Use Only ZIRGAN is indicated for topical ophthalmic use only.

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 ZIRGAN.

5.3Risk of Contamination Do 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 63 words

6 ADVERSE REACTIONS Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%). Most common adverse reactions were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated, at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available human data on use of ZIRGAN or ganciclovir during pregnancy to inform any drug-associated risk. Intravenous administration of ganciclovir to pregnant mice or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant doses ( see Data ). The background risk in the U.S. general population of major birth defects is 2 to 4% and the risk of miscarriage is 15 to 20% of clinically recognized pregnancies.

Data Animal Data Daily intravenous doses of ganciclovir were administered to pregnant mice [up to 108 mg/kg/day, approximately 1400 times the maximum recommended human ocular dose (RHOD) of 0.375 mg] and rabbits [up to 60 mg/kg/day, approximately 2400 times the maximum RHOD], and also to female mice [up to 90 mg/kg, approximately 1174 times the maximum RHOD] prior to mating, during gestation, and during lactation. Fetal resorptions were present in at least 85% of rabbits and mice. Additional effects observed in rabbits included fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity.

Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly and brachygnathia. A maternal no observed adverse effect level (NOAEL) was observed at 36 mg/kg/day (approximately 470 times higher than the maximum RHOD, based on body surface area) in mice and at 6 mg/kg/day (approximately 240 times higher than the maximum RHOD, based on body surface area) in rabbits. In pre/postnatal development studies in mice, there were maternal/fetal toxicity and embryolethality which included fetal effects of hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach.

A maternal no observed adverse effect level (NOAEL) was observed at 20 mg/kg/day (approximately 261 times higher than the maximum RHOD, based on body surface area).

8.2Lactation Risk Summary No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production. It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Animal data indicate that ganciclovir is excreted in the milk of lactating rats.

Caution should be exercised when ZIRGAN is administered to nursing mothers.

8.3Females and Males of Reproductive Potential Infertility It is not known whether topical ophthalmic ganciclovir administration could result in sufficient absorption to impair fertility in humans. Animal data indicate decreased fertility in female mice following intravenous doses at 90 mg/kg/day, approximately 1174 times the maximum RHOD (based on body surface area), and decreased fertility and hypospermatogenesis in male mice and dogs following intravenous doses at 10 mg/kg/day for mice, approximately 130 times the maximum RHOD (based on body surface area), and 3.6 mg/kg/day for dogs, approximately 240 times the maximum RHOD (based on body surface area).

8.4Pediatric Use The safety and effectiveness of ZIRGAN for the treatment of acute herpetic keratitis (dendritic ulcers) have been established in pediatric patients aged 2 years and older. Use of ZIRGAN for this indication is supported by evidence from adequate and well-controlled studies. The safety and effectiveness of ZIRGAN have not been established in pediatric patients below the age of 2 years.

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🤰 Pregnancy ~1 min read

8.1Pregnancy Risk Summary There are no available human data on use of ZIRGAN or ganciclovir during pregnancy to inform any drug-associated risk. Intravenous administration of ganciclovir to pregnant mice or rabbits during organogenesis or during the pre/postnatal period did not produce adverse embryofetal or offspring effects at clinically relevant doses ( see Data ). The background risk in the U.S. general population of major birth defects is 2 to 4% and the risk of miscarriage is 15 to 20% of clinically recognized pregnancies.

Data Animal Data Daily intravenous doses of ganciclovir were administered to pregnant mice [up to 108 mg/kg/day, approximately 1400 times the maximum recommended human ocular dose (RHOD) of 0.375 mg] and rabbits [up to 60 mg/kg/day, approximately 2400 times the maximum RHOD], and also to female mice [up to 90 mg/kg, approximately 1174 times the maximum RHOD] prior to mating, during gestation, and during lactation. Fetal resorptions were present in at least 85% of rabbits and mice. Additional effects observed in rabbits included fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity.

Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly and brachygnathia. A maternal no observed adverse effect level (NOAEL) was observed at 36 mg/kg/day (approximately 470 times higher than the maximum RHOD, based on body surface area) in mice and at 6 mg/kg/day (approximately 240 times higher than the maximum RHOD, based on body surface area) in rabbits. In pre/postnatal development studies in mice, there were maternal/fetal toxicity and embryolethality which included fetal effects of hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach.

A maternal no observed adverse effect level (NOAEL) was observed at 20 mg/kg/day (approximately 261 times higher than the maximum RHOD, based on body surface area).

🧒 Pediatric Use 63 words

8.4Pediatric Use The safety and effectiveness of ZIRGAN for the treatment of acute herpetic keratitis (dendritic ulcers) have been established in pediatric patients aged 2 years and older. Use of ZIRGAN for this indication is supported by evidence from adequate and well-controlled studies. The safety and effectiveness of ZIRGAN have not been established in pediatric patients below the age of 2 years.

🧓 Geriatric Use 18 words

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology 153 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ZIRGAN is an antiviral drug [ see Microbiology (12.4) ] .

12.3Pharmacokinetics The estimated maximum daily dose of ganciclovir administered as 1 drop, 5 times per day is 0.375 mg. Compared to maintenance doses of systemically administered ganciclovir of 900 mg (oral valganciclovir) and 5 mg/kg (IV ganciclovir), the ophthalmically administered daily dose is approximately 0.04% and 0.1% of the oral dose and IV doses, respectively, thus minimal systemic exposure is expected.

12.4Microbiology Mechanism of Action ZIRGAN contains ganciclovir, a guanosine derivative that upon phosphorylation inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which works as an antiviral agent by inhibiting the synthesis of viral DNA in 2 ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of replication.

🧬 Mechanism of Action 15 words

12.1Mechanism of Action ZIRGAN is an antiviral drug [ see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 57 words

16 HOW SUPPLIED/STORAGE AND HANDLING ZIRGAN (ganciclovir ophthalmic gel) 0.15% is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band (NDC 24208-535-35). Storage Store at 15°C to 25°C (59°F to 77°F). Do not freeze.

📋 Description 95 words

11 DESCRIPTION ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains ganciclovir, a nucleoside analog antiviral. ZIRGAN is a sterile, preserved, clear, colorless, ophthalmic gel for topical ophthalmic use. The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0).

Ganciclovir is represented by the following structural formula: Ganciclovir has a molecular weight of 255.23, and the empirical formula is C 9 H 13 N 5 O 4 . Each gram of gel contains: ACTIVE: ganciclovir 1.5 mg (0.15%). INACTIVES: carbomer homopolymer, water for injection, sodium hydroxide (to adjust the pH to 7.2-7.6), mannitol.

PRESERVATIVE: benzalkonium chloride 0.075 mg (0.0075%). ChemStructure

💬 Information for Patients 112 words

17 PATIENT COUNSELING INFORMATION When to Consult a Physician Advise patients to consult a physician if pain develops, or if redness, itching, or inflammation becomes aggravated. Risk of Contamination ZIRGAN is sterile when packaged. Advise patients to not allow the dropper tip to touch any surface, as this may contaminate the gel.

Avoidance of Contact Lenses Advise patients to not wear contact lenses when using ZIRGAN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by : Bausch & Lomb Incorporated Tampa, FL 33637 USA Zirgan is a trademark of Laboratoires Théa Corporation used under license. © 2026 Bausch & Lomb Incorporated or its affiliates 9224806 (Folded) 9224706 (Flat)

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.