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IHEEZO chloroprocaine hydrochloride ophthalmic gel 24 mg/800mg Gel — NDC 82667-0300-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

IHEEZO chloroprocaine hydrochloride ophthalmic gel 24 mg/800mg Gel — NDC 82667-300-01 (Billing 82667-0300-01)

by Harrow Eye, LLC · 1 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL

This is a package of IHEEZO chloroprocaine hydrochloride ophthalmic gel 24 mg/800mg Gel from Harrow Eye, LLC, marketed since Sep 2022 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 82667-0300-01
🏷️ FDA NDC (as labeled) 82667-300-01 billing pads the product segment with a zero
This package
Contains800 mg in 1 vial Medicaid pays$382.39 / unit · 12 mo Pack sizes3 compare ↓
Main listing for product 82667-300 · Also comes in: 800 mg 82667-300-00 5 pouches 82667-300-05
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 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 82667-300-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
82667 labeler · 300 product · 01 package
Package marketed since
Sep 27, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0382667300007
Medicaid fills, this package
3,549 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82667-300-01
Product NDC 82667-300
11-digit billing NDC 82667030001
NCPDP billing unit EA — each (per item)
RxCUI 2613956, 2613961
UNII LT7Z1YW11H
UPC 0382667300007
Application # NDA216227
SPL Set ID ea3b2d2c-8b33-d199-e053-2995a90a699c
Established class (EPC) Ester Local Anesthetic
Physiologic effect Local Anesthesia
Chemical class Esters
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-09-27
Route OPHTHALMIC
Dosage form GEL
Substance CHLOROPROCAINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86750012104020
GCN Seq No 083890
GCN 52959
HICL code 037210
Ingredient (HICL) Chloroprocaine Hcl/Pf
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 Q6H
Therapeutic class — specific (HIC3) Eye Local Anesthetics
AHFS code 52:16.00.00
AHFS class Local Anesthetics (Eent)
FDB label name IHEEZO 3% GEL EYE DROP
FDB brand name Iheezo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 083890
  • GCN: 52959
  • GPI-14 (Medi-Span): 86750012104020
  • HICL (First Databank): 037210
  • AHFS class code: 52:16.00.00
  • RxCUI (RxNorm): 2613956
Why two NDCs? The FDA registers this code as 82667-300-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 82667-0300-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Ester Local Anesthetic class.

Pharmacologic class Ester Local Anesthetic
Drug family (ATC) Esters of aminobenzoic acid, Local anesthetics
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.

Clinical

Label name IHEEZO 3% GEL EYE DROP Ingredient Chloroprocaine Hcl/Pf
📗 Our plain-language guide HelloPharmacist
  • It numbs an area so a procedure doesn't hurt. The injection forms are used for nerve blocks and numbing tissue, and Iheezo is used to numb the surface of the eye. Your provider cho...
  • It works fast, usually in about 6 to 12 minutes. Numbness can last up to an hour, depending on how much is used and where it is given.
  • How long does it take to work and how long does it last?
  • No. A healthcare provider gives it. Iheezo in particular is not meant for self-administration, and it should never be injected.
📖 Read our full Chloroprocaine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $382.39 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2403 $0.721 / J2403 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)82667-300-01
11-digit billing NDC82667-0300-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2403
DescriptorChloroprocaine hcl ophthalmic, 3% gel, 1 mg
Billing units / pkg800 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 800 billing units.
Medicare Part B spend (2026 (Q1))$19,588,214 · 37,882 claims · $517.08 per claim (all NDCs under J2403)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
82667-0300-01 You're viewing this Main listing 1 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL 2022-09-27 — Active
82667-0300-00 82667-300-00 1 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL Sample 2023-03-15 — Active
82667-0300-05 82667-300-05 5 POUCH in 1 CARTON / 1 VIAL in 1 POUCH / 800 mg in 1 VIAL 2026-03-02 — 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 this package?
This package is listed by the FDA — 1 pouch in 1 carton / 1 vial in 1 pouch / 800 mg in 1 vial.
What NDC number is used to bill for this package of IHEEZO chloroprocaine hydrochloride ophthalmic gel 24 mg/800mg Gel?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Iheezo 24 mg/800mgthis 82667-0300-01 Harrow 1 pouch — — FDA listed —
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

🏛️
2022
First FDA approval
Sep 2022
📍
2026
Currently FDA-listed
4 years listed
🛡️
2039
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 May 2039. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Sep 27, 2022 RLD RS ⏳ ~12.6 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 10792271 — method of use (U-3457)
US 11969403 — drug product
2022 2024 2026 2028 2030 2032 2034 2036 2038
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 (2)
PatentTypeUse codeExpires
US 10792271 ↗ Method of use U-3457 Sep 15, 2038
US 11969403 ↗ Drug product — May 14, 2039
Common questions
Is there a generic version of IHEEZO 3% GEL EYE DROP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for IHEEZO 3% GEL EYE DROP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2039 — 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.

🧪 Avoiding an ingredient? See Chloroprocaine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • 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.

3 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 DailyMed — 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

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

LabelerHarrow Eye, LLC
Application holderHARROW EYE LLC
FDA applicationNDA216227 (NDA)
Labeler code82667
First marketedSep 2022
Product typeHuman Prescription Drug
Portfolio17 products on file

More NDCs from Harrow Eye, LLC labeler code 82667

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

1 INDICATIONS AND USAGE IHEEZO TM is indicated for ocular surface anesthesia. IHEEZO TM is an ester anesthetic indicated for ocular surface anesthesia. ( 1 )

⏱️ Dosage and Administration 76 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose of IHEEZO TM is 3 drops applied topically to the ocular surface in the area of the planned procedure. IHEEZO TM may be reapplied as needed to maintain anesthetic effect. The recommended dose of IHEEZO TM is 3 drops applied topically to the ocular surface in the area of the planned procedure. ( 2 ) IHEEZO TM may be reapplied as needed to maintain anesthetic effect. ( 2 )

💊 Dosage Forms and Strengths 53 words ▾

3 DOSAGE FORMS AND STRENGTHS IHEEZO TM (chloroprocaine hydrochloride ophthalmic gel) 3% contains 24 mg of chloroprocaine hydrochloride per vial (800 mg of gel). IHEEZO TM (chloroprocaine hydrochloride ophthalmic gel) 3% contains 24 mg of chloroprocaine hydrochloride per vial (800 mg). Clear, colorless to light yellow gel in single‑patient‑use vial. ( 3 )

⛔ Contraindications 39 words ▾

4 CONTRAINDICATIONS IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation. IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Not for Injection or Intraocular Administration ( 5.1 ). Corneal Injury Due to Insensitivity ( 5.2 ). Corneal Opacification ( 5.3 ) For Administration by Healthcare Provider : IHEEZO TM is not intended for patient self-administration ( 5.5 ).

5.1Not for Injection or Intraocular Administration IHEEZO TM should not be injected or intraocularly administered.

5.2Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.

5.3Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

5.4Risk of Contamination Do not touch the dropper tip to any surface as this may contaminate the gel.

5.5For Administration by Healthcare Provider IHEEZO TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO TM is not intended for patient self-administration.

5.1Not for Injection or Intraocular Administration IHEEZO TM should not be injected or intraocularly administered.

5.2Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.

5.3Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss.

5.4Risk of Contamination Do not touch the dropper tip to any surface as this may contaminate the gel.

5.5For Administration by Healthcare Provider IHEEZO TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO TM is not intended for patient self-administration.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reaction is mydriasis (approximately 25%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 844.446.6979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect 201 patients undergoing various surgical ocular procedures in two placebo-controlled trials (Study 1 and Study 2). Patients in Study 1 were randomized to receive a single instillation of 3 drops of IHEEZO TM or placebo.

Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO TM or placebo. The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TM administration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1.

Adverse Reactions in 5% or more of IHEEZO TM Treated Patients in Studies 1 and 2 IHEEZO TM Placebo Preferred Term N=151 n (%) N=50 n (%) Mydriasis 39 (26%) 1 (2%) Conjunctival hyperemia 16 (11%) 6 (12%) Eye irritation 9 (6%) 2 (4%)

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect 201 patients undergoing various surgical ocular procedures in two placebo-controlled trials (Study 1 and Study 2). Patients in Study 1 were randomized to receive a single instillation of 3 drops of IHEEZO TM or placebo.

Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO TM or placebo. The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TM administration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1.

Adverse Reactions in 5% or more of IHEEZO TM Treated Patients in Studies 1 and 2 IHEEZO TM Placebo Preferred Term N=151 n (%) N=50 n (%) Mydriasis 39 (26%) 1 (2%) Conjunctival hyperemia 16 (11%) 6 (12%) Eye irritation 9 (6%) 2 (4%)

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of IHEEZO TM use in pregnant women to inform a drug associated risk. There are no animal reproduction studies for chloroprocaine.

8.2Lactation Risk Summary There are no data on the presence of chloroprocaine in human milk, 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 IHEEZO TM and any potential adverse effects on the breastfed infant from IHEEZO TM .

8.4Pediatric Use The safety and effectiveness of IHEEZO TM have not been established in pediatric patients.

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

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of IHEEZO TM use in pregnant women to inform a drug associated risk. There are no animal reproduction studies for chloroprocaine.

8.2Lactation Risk Summary There are no data on the presence of chloroprocaine in human milk, 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 IHEEZO TM and any potential adverse effects on the breastfed infant from IHEEZO TM .

8.4Pediatric Use The safety and effectiveness of IHEEZO TM have not been established in pediatric patients.

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

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.1Mechanism of Action Chloroprocaine, like other local anesthetics, blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

12.3Pharmacokinetics The systemic exposure to chloroprocaine following topical ocular administration of IHEEZO TM has not been studied. Elimination Metabolism Chloroprocaine is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues. Chloroprocaine is rapidly metabolized in plasma by hydrolysis of the ester linkage by pseudocholinesterase.

The hydrolysis of chloroprocaine results in the production of ß-diethylaminoethanol and 2-chloro-4-aminobenzoic acid, which inhibits the action of the sulfonamides. Excretion Chloroprocaine plasma half-life in vitro is approximately 25 seconds in adults and approximately 43 seconds in neonates. The kidney is the main excretory organ for most local anesthetics and their metabolites.

Urinary excretion is affected by urinary perfusion and factors affecting urinary pH.

12.1 Mechanism of Action

12.1Mechanism of Action Chloroprocaine, like other local anesthetics, blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

12.3Pharmacokinetics The systemic exposure to chloroprocaine following topical ocular administration of IHEEZO TM has not been studied. Elimination Metabolism Chloroprocaine is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues. Chloroprocaine is rapidly metabolized in plasma by hydrolysis of the ester linkage by pseudocholinesterase.

The hydrolysis of chloroprocaine results in the production of ß-diethylaminoethanol and 2-chloro-4-aminobenzoic acid, which inhibits the action of the sulfonamides. Excretion Chloroprocaine plasma half-life in vitro is approximately 25 seconds in adults and approximately 43 seconds in neonates. The kidney is the main excretory organ for most local anesthetics and their metabolites.

Urinary excretion is affected by urinary perfusion and factors affecting urinary pH.

📦 How Supplied / Storage and Handling 99 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING IHEEZO TM (chloroprocaine hydrochloride ophthalmic gel) 3% is supplied as a sterile, clear, colorless to light yellow gel in a single-patient‑use vial. Each single‑patient‑use vial contains 24 mg chloroprocaine in 800 mg of gel. Aluminum pouch containing 1 LDPE single-patient‑use vial of IHEEZO TM .

The outer surface of the vial is not sterile. NDC 82667-300-01 Package of 1 unit of 1.25 mL single-patient‑use vial (800 mg filled) NDC 82667-300-05 Package of 5 units of 1.25 mL single-patient‑use vials (800 mg filled) Storage Store at 15°C to 25°C (59°F to 77°F). Discard after use.

📋 Description 120 words ▾

11 DESCRIPTION IHEEZO TM is a sterile, single-patient‑use ophthalmic gel preparation for topical ocular anesthesia containing chloroprocaine hydrochloride as the active pharmaceutical ingredient. Chloroprocaine hydrochloride is an ester anesthetic. It is a water-soluble white crystalline powder and its chemical name is 2-(Diethylamino)ethyl 4‑amino-2-chlorobenzoate monohydrochloride.

The molecular weight is 307.22 and the molecular formula is C 13 H 19 ClN 2 O 2 ·HCl. It is represented by the following structural formula: IHEEZO TM contains: Active: 30 mg of chloroprocaine hydrochloride (equivalent to 26 mg of chloroprocaine) per gram of gel. Inactive ingredients: Hydroxyethyl Cellulose (HEC), and Water for Injection.

The pH may be adjusted to 3.0 to 5.0 with Hydrochloric Acid. This product does not contain an antimicrobial preservative. chemstru

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Study 1 and 2 Study 1 (NCT04779606) and Study 2 (NCT04753710) were randomized, double-blinded placebo-controlled studies conducted to evaluate the efficacy, safety, and local tolerability of IHEEZO TM in 145 healthy volunteers. In Study 1 , 85 healthy male and female were randomized in a 4:1 ratio to receive a single ocular instillation of IHEEZO TM (N=68) or placebo (N=17). The double blinded treatment included a IHEEZO TM or a placebo dose of 3 drops instilled at 1 minute ± 15 seconds intervals in the right eye of each volunteer.

The median age was 39 years (range 19 to 55 years); 59% female and 41% male. In Study 2 , 60 healthy male and female were randomized (40:20) to receive single or multiple ocular instillations of IHEEZO TM dose of 3 drops in the right eye. The median age was 25 years (range 18 to 59 years); 54% female ad 46% male.

The efficacy in Study 1 and 2 was determined by proportion of patients achieving full conjunctival anesthesia evaluated by conjunctival pinching, 5 minutes after administration. Efficacy results of Study 1 The proportion of subjects with successful anesthesia was 90% in IHEEZO TM group and 12% in the placebo group (p<0.01). The median time for the IHEEZO TM group achieving anesthesia was 0.67 minutes.

The median duration of anesthesia was 14.3 minutes. Efficacy results of Study 2 The proportion of subjects with successful anesthesia was 95% in the IHEEZO TM group and 20% in the placebo group (p<0.01). The median time for the IHEEZO TM group achieving anesthesia was 0.67 minutes.

The median duration of anesthesia was 19.3 minutes.

14.2Study 3 Study 3 (NCT04685538) was a randomized, prospective, multi-center, active-controlled, observer-masked study conducted to evaluate the efficacy and safety of IHEEZO TM (N=166) versus tetracaine ophthalmic solution 0.5% (N=172) in patients undergoing cataract surgery. The primary endpoint was defined as the proportion of patients in each treatment group gaining successful anesthesia without any supplementation. On average, patients needed 1-1.5 minutes to obtain sufficient anesthesia to successfully perform the surgical procedure which lasted on average 22 minutes.

No patient treated with IHEEZO TM required supplemental treatment to complete the intended surgical procedure.

14.1Study 1 and 2 Study 1 (NCT04779606) and Study 2 (NCT04753710) were randomized, double-blinded placebo-controlled studies conducted to evaluate the efficacy, safety, and local tolerability of IHEEZO TM in 145 healthy volunteers. In Study 1 , 85 healthy male and female were randomized in a 4:1 ratio to receive a single ocular instillation of IHEEZO TM (N=68) or placebo (N=17). The double blinded treatment included a IHEEZO TM or a placebo dose of 3 drops instilled at 1 minute ± 15 seconds intervals in the right eye of each volunteer.

The median age was 39 years (range 19 to 55 years); 59% female and 41% male. In Study 2 , 60 healthy male and female were randomized (40:20) to receive single or multiple ocular instillations of IHEEZO TM dose of 3 drops in the right eye. The median age was 25 years (range 18 to 59 years); 54% female ad 46% male.

The efficacy in Study 1 and 2 was determined by proportion of patients achieving full conjunctival anesthesia evaluated by conjunctival pinching, 5 minutes after administration. Efficacy results of Study 1 The proportion of subjects with successful anesthesia was 90% in IHEEZO TM group and 12% in the placebo group (p<0.01). The median time for the IHEEZO TM group achieving anesthesia was 0.67 minutes.

The median duration of anesthesia was 14.3 minutes. Efficacy results of Study 2 The proportion of subjects with successful anesthesia was 95% in the IHEEZO TM group and 20% in the placebo group (p<0.01). The median time for the IHEEZO TM group achieving anesthesia was 0.67 minutes.

The median duration of anesthesia was 19.3 minutes.

14.2Study 3 Study 3 (NCT04685538) was a randomized, prospective, multi-center, active-c… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 133 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate carcinogenic potential of chloroprocaine have not been conducted. Mutagenesis 2-chloroprocaine and the main metabolite, ACBA, were negative in the in vitro bacterial reverse mutation test (Ames assay) and the in vitro chromosome aberrations assay. Impairment of Fertility Studies in animals to evaluate the impairment of fertility have not been conducted with chloroprocaine.

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals to evaluate carcinogenic potential of chloroprocaine have not been conducted. Mutagenesis 2-chloroprocaine and the main metabolite, ACBA, were negative in the in vitro bacterial reverse mutation test (Ames assay) and the in vitro chromosome aberrations assay. Impairment of Fertility Studies in animals to evaluate the impairment of fertility have not been conducted with chloroprocaine.

📄 Package Label / Principal Display Panel 107 words ▾

PRINCIPAL DISPLAY PANEL: CARTON 1PK NDC 82667-300-01 Sterile Rx Only Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% For topical ophthalmic use Contains no preservatives. 1 Vial 800 mg each HARROW ® carton

PRINCIPAL DISPLAY PANEL - Sample Carton NDC 82667-300-00 Professional sample - Not for sale Sterile Rx Only Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% For topical ophthalmic use Contains no preservatives. 1 Vial 800 mg each HARROW ® Sample Carton

PRINCIPAL DISPLAY PANEL: CARTON - 5PK NDC 82667-300-05 Sterile Rx Only Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% For topical ophthalmic use Contains no preservatives. 1 Vial 800 mg each HARROW ® Iheezo carton 5pk

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

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 this package alone, 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
3.5K
Units reimbursed last 4 qtrs
4.7K
Gross reimbursed last 4 qtrs
$1.78M
Avg / prescription
$502.53
Avg / unit
$382.35
Latest quarter Q1 2026
962Rx
Fee-for-service vs managed care ⓘ
51% FFS 49% MCO
Fee-for-service · 1,814 Rx Managed care · 1,735 Rx
State Medicaid map
Alaska: no data reported AK Maine: 394 units · 28.2 per 100k residents ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 108 units · 1.1 per 100k residents MI New York: 1,166 units · 6.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 514 units · 16.1 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 30 units · 0.2 per 100k residents IL Indiana: no data reported IN Ohio: 6 units · 0.1 per 100k residents OH Pennsylvania: 555 units · 4.3 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 90 units · 0.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 477 units · 7.7 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 421 units · 6.8 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 10 units · 0.5 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 593 units · 5.5 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 233 units · 7.9 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 69 units · 0.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.128.2
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 Maine 28.2 /100k
2 Nevada 16.1 /100k
3 Mississippi 7.9 /100k
4 Missouri 7.7 /100k
5 Maryland 6.8 /100k
6 New York 6.0 /100k
7 North Carolina 5.5 /100k
8 Pennsylvania 4.3 /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 pouch this page82667-0300-01 3,549 Rx · $1,783,475
1 pouch82667-0300-00 No Medicaid data
5 pouches82667-0300-05 No Medicaid data
Drug total (last 4 qtrs): 3,549 Rx · 4,664 units · $1,783,475 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 IHEEZO (this brand).

Top reported reactions

Underdose54
Eye Pain19
Eye Irritation18
Ocular Hyperaemia8
Lacrimation Increased7
Ocular Discomfort7
Product Temperature Excursion Issue7

Reporter sex

104 reports
Male · 23%
Female · 77%
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 90 2
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
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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Harrow Eye, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 pouch (82667-0300-00), 5 pouches (82667-0300-05). 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?
Harrow Eye, LLC 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2403 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 82667-0200-01 · Harrow 82667-0400-03 · Harrow →
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.