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Zerviate Cetirizine 2.4 mg/mL Solution/ Drops — NDC 71776-024-05 (Billing 71776-0024-05)

by Eyevance Pharmaceuticals · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Zerviate Cetirizine 2.4 mg/mL Solution/ Drops from Eyevance Pharmaceuticals, no longer marketed, no longer in the FDA NDC Directory.

NDC 71776-0024-05
🏷️ FDA NDC (as labeled) 71776-024-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dropper Pack sizes3 compare ↓
Product page 71776-0024-30 Also comes in: 5 vials 71776-024-01 30 vials 71776-024-30
Rx only Brand Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 15, 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

NDC database record

One package, one record: these facts belong to NDC 71776-024-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
71776 labeler · 024 product · 05 package
Barcode (UPC-A, from the NDC)
3 7177602405 8
FDA record last changed
Jul 15, 2026
⚠️
Other active recalls for Cetirizine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0348-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71776-024-05
Product NDC 71776-024
11-digit billing NDC 71776002405
Application # NDA208694
SPL Set ID 3e6fecc1-df71-4c01-a654-f55635617a7f
Established class (EPC) Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2024)
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance CETIRIZINE
Why two NDCs? The FDA registers this code as 71776-024-05 — 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 → 71776-0024-05. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Zerviate is an antihistamine eye drop that treats itchy eyes caused by allergic conjunctivitis — basically, eye allergies. It works right where you need it, blocking the itch signa...
  • You need to take your contacts out first. The preservative in Zerviate can get soaked up by soft contact lenses, which isn't good for your eyes. After you put the drops in, wait at...
  • Can I put my contact lenses in before or after using these drops?
  • The most common ones are eye redness, a brief sting or pain when the drop goes in, and slightly blurry vision right after. These are usually mild and short-lived. If you notice wor...
📖 Read our full Cetirizine 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.

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 mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 vials 30 vials
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
71776-0024-01 71776-024-01 5 VIAL, SINGLE-USE in 1 CARTON / .2 mL in 1 VIAL, SINGLE-USE — — 2020-03-23 — Inactivated by FDA
71776-0024-05 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER — — 2019-02-19 — Inactivated by FDA
71776-0024-30 71776-024-30 Main listing 30 VIAL, SINGLE-USE in 1 CARTON / .2 mL in 1 VIAL, SINGLE-USE $7.35 / ea $220.61 2020-03-23 — Inactivated by FDA

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Zerviate Cetirizine 2.4 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Zerviate 2.4 mg/mL 82667-0015-24 Harrow 1 pouch $7.354 — Availability likely —
Zerviate 2.4 mg/mLthis 71776-0024-05 Eyevance 1 bottle — — Discontinued —
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

🏛️
2017
First FDA approval
May 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jan 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 30, 2017 RLD RS ⏳ ~6.3 yr to latest listed protection

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.

Patents & exclusivity — FDA Orange Book
US 9993471 — method of use (U-1680)
US 8829005 — method of use (U-1680)
US 9254286 — drug product
US 9750684 — drug product
US 8829005*PED — drug product
US 9254286*PED — drug product
2017 2019 2021 2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 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.

Listed patents (6)
PatentTypeUse codeExpires
US 9993471 ↗ Method of use U-1680 Mar 15, 2030
US 8829005 ↗ Method of use U-1680 Mar 15, 2030
US 9254286 ↗ Drug product — Jul 9, 2032
US 9750684 ↗ Drug product — Mar 15, 2030
US 8829005*PED ↗ Drug product — Sep 15, 2030
US 9254286*PED ↗ Drug product — Jan 9, 2033
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jan 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

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.

Manufacturer & labeler

LabelerEyevance Pharmaceuticals
Application holderHARROW EYE LLC
FDA applicationNDA208694 (NDA)
Labeler code71776
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Eyevance Pharmaceuticals labeler code 71776

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.

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

1 INDICATIONS AND USAGE ZERVIATE™ (cetirizine ophthalmic solution) 0.24% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. ZERVIATE (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis. ( 1 )

⏱️ Dosage and Administration 82 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of ZERVIATE is to instill one drop in each affected eye twice daily (approximately 8 hours apart). │The single-use containers are to be used immediately after opening and can be used to dose both eyes. Discard the single-use container and any remaining contents after administration. The single-use │containers should be stored in the original foil pouch until ready to use.

The recommended dose is one drop in each affected eye twice daily. ( 2 )

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Cetirizine ophthalmic solution, 0.24% is a sterile, buffered, clear, colorless aqueous solution containing cetirizine 0.24% (equivalent to cetirizine hydrochloride 0.29%). Ophthalmic solution: 2.4 mg cetirizine in 1 mL sterile solution (0.24%). ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 172 words ▾

5 WARNINGS AND PRECAUTIONS Contamination of Tip and Solution. To prevent contaminating the dropper tip and solution, advise patients not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of single-use container. ( 5.1 )

5.1Contamination of Tip and Solution │As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of the single- use container in order to avoid injury to the eye and to prevent │contaminating the tip and solution. Keep the multi-dose bottle closed when not in use. Discard the single-use container after using in each eye.

5.2Contact Lens Wear Patients should be advised not to wear a contact lens if their eye is red. ZERVIATE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of ZERVIATE. The preservative in ZERVIATE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes following administration of ZERVIATE.

🤒 Adverse Reactions 141 words ▾

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates in practice. In seven clinical trials, patients with allergic conjunctivitis or those at a risk of developing allergic conjunctivitis received one drop of either cetirizine (N=511) or vehicle (N=329) in one or both eyes. The most commonly reported adverse reactions occurred in approximately 1–7% of patients treated with either ZERVIATE or vehicle.

These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced. The most common adverse reactions (1–7%) were ocular hyperemia, instillation site pain, and visual acuity reduced. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eyevance Pharmaceuticals, LLC at 1-844-390-0720 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There were no adequate or well-controlled studies with ZERVIATE™ (cetirizine ophthalmic solution) 0.24% in pregnant women. Cetirizine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data Cetirizine was not teratogenic in mice, rats, or rabbits at oral doses up to 96, 225, and 135 mg/kg, respectively (approximately 1300, 4930, and 7400 times the maximum recommended human ophthalmic dose (MRHOD), on a mg/m 2 basis).

8.2Lactation Risk Summary Cetirizine has been reported to be excreted in human breast milk following oral administration. Multiple doses of oral dose cetirizine (10 mg tablets once daily for 10 days) resulted in systemic levels (Mean C max = 311 ng/mL) that were 100 times higher than the observed human exposure (Mean C max = 3.1 ng/mL) following twice-daily administration of cetirizine ophthalmic solution 0.24% to both eyes for one week [see Clinical Pharmacology ( 12.3 )] . Comparable bioavailability has been found between the tablet and syrup dosage forms.

However, it is not known whether the systemic absorption resulting from topical ocular administration of ZERVIATE could produce detectable quantities in human breast milk. There is no adequate information regarding the effects of cetirizine on breastfed infants, or the effects on milk production to inform risk of ZERVIATE to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ZERVIATE and any potential adverse effects on the breastfed child from ZERVIATE.

8.4Pediatric Use The safety and effectiveness of ZERVIATE has been established in pediatric patients two years of age and older. Use of ZERVIATE in these pediatric patients is supported by evidence from adequate and well-controlled studies of ZERVIATE in pediatric and adult patients.

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

🤰 Pregnancy 78 words ▾

8.1Pregnancy Risk Summary There were no adequate or well-controlled studies with ZERVIATE™ (cetirizine ophthalmic solution) 0.24% in pregnant women. Cetirizine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data Cetirizine was not teratogenic in mice, rats, or rabbits at oral doses up to 96, 225, and 135 mg/kg, respectively (approximately 1300, 4930, and 7400 times the maximum recommended human ophthalmic dose (MRHOD), on a mg/m 2 basis).

🧒 Pediatric Use 44 words ▾

8.4Pediatric Use The safety and effectiveness of ZERVIATE has been established in pediatric patients two years of age and older. Use of ZERVIATE in these pediatric patients is supported by evidence from adequate and well-controlled studies of ZERVIATE in pediatric and adult patients.

🧓 Geriatric Use 58 words ▾

Animal Data Cetirizine was not teratogenic in mice, rats, or rabbits at oral doses up to 96, 225, and 135 mg/kg, respectively (approximately 1300, 4930, and 7400 times the maximum recommended human ophthalmic dose (MRHOD), on a mg/m 2 basis).

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

🧬 Clinical Pharmacology 128 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action ZERVIATE, an antihistamine, is a histamine-1 (H1) receptor antagonist. The antihistaminic activity of cetirizine has been documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors.

12.3Pharmacokinetics In healthy subjects, bilateral topical ocular dosing of one drop of ZERVIATE™ (cetirizine ophthalmic solution) 0.24% resulted in a mean cetirizine plasma C max of 1.7 ng/mL following a single dose and 3.1 ng/mL after twice-daily dosing for one week. The observed mean terminal half-life of cetirizine was 8.6 hours following a single dose and 8.2 hours after twice-daily dosing of ZERVIATE for one week.

🧬 Mechanism of Action 58 words ▾

12.1Mechanism of Action ZERVIATE, an antihistamine, is a histamine-1 (H1) receptor antagonist. The antihistaminic activity of cetirizine has been documented in a variety of animal and human models. In vivo and ex vivo animal models have shown negligible anticholinergic and antiserotonergic activity. In vitro receptor binding studies have shown no measurable affinity for other than H1 receptors.

📦 How Supplied / Storage and Handling 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING ZERVIATE is a sterile, buffered, clear, colorless aqueous solution containing cetirizine 0.24% (equivalent to cetirizine hydrochloride 0.29%) supplied in a white low-density polyethylene multi-dose ophthalmic bottle with a low-density polyethylene dropper tip and a white polypropylene cap. ZERVIATE is supplied in a 7.5 mL bottle that contains 5 mL and a 10 mL bottle that contains 7.5 mL cetirizine ophthalmic solution, 2.40 mg [equivalent to 2.85 mg cetirizine hydrochloride in one mL solution].

ZERVIATE is also supplied in 5 low-density polyethylene 0.2 mL single-use containers within a foil pouch. 5 mL fill in a 7.5 mL bottle NDC 71776-024-05 7.5 mL fill in a 10 mL bottle NDC 71776-024-08 Carton of 30 single-use containers NDC 71776-024-30 Storage: Store at 15°C to 25°C (59°F to 77°F). Single-use containers should be stored in the original foil pouch.

📋 Description 133 words ▾

11 DESCRIPTION ZERVIATE is a sterile opthalmic solution containing cetirizene, which is a histamine-1 (H1) receptor antagonist, for topical administration to the eyes. Cetirizine hydrochloride is a white, crystalline, water-soluble powder with a molecular weight of 461.8 and a molecular formula of C 21 H 25 ClN 2 0 3 •2HCl. The chemical structure is presented below: Chemical Name: ( RS )-2-[2-[4-[(4-Chlorophenyl) phenylmethyl] piperazin-1-yl] ethoxy] acetic acid, dihydrochloride Each mL of ZERVIATE contains an active ingredient [cetirizine 2.40 mg (equivalent to 2.85 mg of cetirizine hydrochloride)] and the following inactive ingredients: benzalkonium chloride 0.010% (preservative); glycerin; sodium phosphate, dibasic; edetate disodium; polyethylene glycol 400; polysorbate 80; hypromellose; hydrochloric acid/sodium hydroxide (to adjust pH); and water for injection.

ZERVIATE solution has a pH of approximately 7.0 and osmolality of approximately 300 mOsm/kg. image description

💬 Information for Patients 191 words ▾

17 PATIENT COUNSELING INFORMATION Risk of Contamination: Advise patients not to touch dropper tip to eyelids or surrounding areas, as this may contaminate the dropper tip and ophthalmic solution. Advise patients to keep the bottle closed when not in use. Advise patients to discard single-use containers after each use.

Concomitant Use of Contact Lenses: Advise patients not to wear contact lenses if their eyes are red. Advise patients that ZERVIATE should not be used to treat contact lens-related irritation. Advise patients to remove contact lenses prior to instillation of ZERVIATE.

The preservative in ZERVIATE solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted ten minutes following administration of ZERVIATE. Administration: Advise patients that the solution from one single-use container is to be used immediately after opening.

Advise patients that the single-use container can be used to dose both eyes. Discard the single-use container and remaining contents immediately after administration. Storage of Single-use Containers: Instruct patients to store single-use containers in the original foil pouch until ready to use.

ZPI0000 Rev 02/2020 Distributed by: Eyevance Pharmaceuticals, LLC. Fort Worth, TX 76102 U.S. Patents: 8,829,005; 9,254,286; 9,750,684; 9,993,471

🧬 Pharmacokinetics 67 words ▾

12.3Pharmacokinetics In healthy subjects, bilateral topical ocular dosing of one drop of ZERVIATE™ (cetirizine ophthalmic solution) 0.24% resulted in a mean cetirizine plasma C max of 1.7 ng/mL following a single dose and 3.1 ng/mL after twice-daily dosing for one week. The observed mean terminal half-life of cetirizine was 8.6 hours following a single dose and 8.2 hours after twice-daily dosing of ZERVIATE for one week.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES The efficacy of ZERVIATE was established in three randomized, double-masked, placebo-controlled, conjunctival allergen challenge (CAC) clinical trials in patients with a history of allergic conjunctivitis. Onset and duration of action were evaluated in two of these trials in which patients were randomized to receive ZERVIATE or vehicle ophthalmic solutions. Patients were evaluated with an ocular itching severity score ranging from 0 (no itching) to 4 (incapacitating itch) at several time points after CAC administration.

Table 1 displays data from the mean ocular itching severity scores after ocular administration of an antigen using the CAC model. A one unit difference compared to vehicle is considered a clinically meaningful change in the ocular itching severity score. Patients treated with ZERVIATE demonstrated statistically and clinically significantly less ocular itching compared to vehicle at 15 minutes and 8 hours after treatment.

Table 1 Itching Scores in the ITT Population by Treatment Group and Treatment Difference Study 1 Study 2 Statistics 15 minutes post-treatment 8 hours post-treatment 15 minutes post-treatment 8 hours post-treatment ZERVIATE N=50 Vehicle N=50 ZERVIATE N=50 Vehicle N=50 ZERVIATE N=51 Vehicle N=50 ZERVIATE N=51 Vehicle N=50 1 Treatment difference values shown are the group mean active minus the group mean vehicle at each post-CAC time point. * p<0.05 3 Minute Post-CAC Mean 1.00 2.38 1.76 2.69 1.01 2.54 1.94

2.86Treatment Difference (95% CI) 1 -1.38 (-1.72, -1.05)* -0.93 (-1.26, -0.61)* -1.53 (-1.92, -1.15)* -0.92 (-1.25, -0.58)* 5 Minute Post-CAC Mean 1.18 2.43 1.85 2.74 1.17 2.51 2.03

2.94Treatment Difference (95% CI) 1 -1.25 (-1.58, -0.91)* -0.89 (-1.24, -0.54)* -1.34 (-1.71, -0.97)* -0.90 (-1.23, -0.57)* 7 Minute Post-CAC Mean 1.11 2.11 1.54 2.53 1.15 2.23 1.82

2.66Treatment Difference (95% CI) 1 -1.00 (-1.35, -0.65)* -0.99 (-1.40, -0.59)* -1.07 (-1.46, -0.69)* -0.84 (-1.21, -0.48)*

🧪 Nonclinical Toxicology 185 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity In a 2-year carcinogenicity study in rats, orally administered cetirizine was not carcinogenic at dietary doses up to 20 mg/kg (approximately 550 times the MRHOD, on a mg/m 2 basis). In a 2-year carcinogenicity study in mice, cetirizine caused an increased incidence of benign liver tumors in males at a dietary dose of 16 mg/kg (approximately 220 times the MRHOD, on a mg/m 2 basis). No increase in the incidence of liver tumors was observed in mice at a dietary dose of 4 mg/kg (approximately 55 times the MRHOD, on a mg/m 2 basis).

The clinical significance of these findings during long-term use of cetirizine is not known. Mutagenesis Cetirizine was not mutagenic in the Ames test or in an in vivo micronucleus test in rats. Cetirizine was not clastogenic in the human lymphocyte assay or the mouse lymphoma assay.

Impairment of Fertility In a fertility and general reproductive performance study in mice, cetirizine did not impair fertility at an oral dose of 64 mg/kg (approximately 875 times the MRHOD on a mg/m 2 basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 182 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity In a 2-year carcinogenicity study in rats, orally administered cetirizine was not carcinogenic at dietary doses up to 20 mg/kg (approximately 550 times the MRHOD, on a mg/m 2 basis). In a 2-year carcinogenicity study in mice, cetirizine caused an increased incidence of benign liver tumors in males at a dietary dose of 16 mg/kg (approximately 220 times the MRHOD, on a mg/m 2 basis). No increase in the incidence of liver tumors was observed in mice at a dietary dose of 4 mg/kg (approximately 55 times the MRHOD, on a mg/m 2 basis).

The clinical significance of these findings during long-term use of cetirizine is not known. Mutagenesis Cetirizine was not mutagenic in the Ames test or in an in vivo micronucleus test in rats. Cetirizine was not clastogenic in the human lymphocyte assay or the mouse lymphoma assay.

Impairment of Fertility In a fertility and general reproductive performance study in mice, cetirizine did not impair fertility at an oral dose of 64 mg/kg (approximately 875 times the MRHOD on a mg/m 2 basis).

📄 Recent Major Changes 13 words ▾

RECENT MAJOR CHANGES Dosage and Administration (2) 2/2020 Warnings and Precautions (5.1) 2/2020

📄 Package Label / Principal Display Panel 12 words ▾

image description image description image description image description image description image description

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

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.
30 vials71776-0024-30 13 Rx · $2,992
5 vials71776-0024-01 No Medicaid data
1 bottle this page71776-0024-05 No Medicaid data
Drug total (last 4 qtrs): 13 Rx · 78 units · $2,992 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 Zerviate — the program that covers self-administered drugs. 2 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 Zerviate. 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
$131.1K
Claims incl. refills
410
Beneficiaries
254
Spend / beneficiary
$516.12
Spend / claim
$319.74
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 Cetirizine — the ingredient across all brands.

Top reported reactions

Fatigue19,511
Pain16,352
Rash13,831
Headache13,198
Pruritus13,034
Nausea12,436
Dyspnoea11,675

Age at onset

Neonate198
Infant371
Child2,705
Adolescent1,799
Adult23,548
Elderly10,519

Reporter sex

174,062 reports
Male · 29%
Female · 71%
Unknown · 0%

Serious outcomes

Hospitalization40,117
Death11,199
Disabling11,152
Life-threatening9,911
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 15,402 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.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 5 vials (71776-0024-01), 30 vials (71776-0024-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Eyevance Pharmaceuticals is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71776-0005-15 · Eyevance 71776-0035-01 · Eyevance →
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.