VIZZ Aceclidine 14.66 mg/mL Solution/ Drops — NDC 84226-100-11 (Billing 84226-0100-11)
This is a package of VIZZ Aceclidine 14.66 mg/mL Solution/ Drops from LENZ Therapeutics, Inc., marketed since Jul 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 088076
- GCN: 58161
- HICL (First Databank): 010841
- AHFS class code: 52:40.20.00
- RxCUI (RxNorm): 2721771
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Parasympathomimetics class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 84226-0100-11 You're viewing this Main listing | 5 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / .4 mL in 1 AMPULE | 2025-07-31 | — | Active |
| 84226-0100-21 84226-100-21 | 5 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / .25 mL in 1 AMPULE | 2026-01-02 | — | Active |
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of VIZZ Aceclidine 14.66 mg/mL Solution/ Drops?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vizz 14.66 mg/mLthis 84226-0100-11 | LENZ | 5 pouches | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 12533347 ↗ | Method of use | U-3741 | Oct 8, 2039 |
| US 10052313 ↗ | Method of use | U-3741 | Mar 24, 2034 |
| US 9844537 ↗ | Method of use | U-3741 | Mar 24, 2034 |
| US 12128036 ↗ | Method of use | U-3741 | Oct 8, 2039 |
| US 11179328 ↗ | Method of use | U-3741 | Mar 24, 2034 |
| US 12414942 ↗ | Method of use | U-3741 | Mar 15, 2044 |
| US 12653779 ↗ | Method of use | U-3741 | Jun 18, 2035 |
| Code | What it grants | Expires |
|---|---|---|
| NCE | New Chemical Entity (5-year) | Jul 31, 2030 |
Is there a generic version of VIZZ 1.44% EYE DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE VIZZ is indicated for the treatment of presbyopia in adults. VIZZ is a cholinergic agonist indicated for the treatment of presbyopia in adults ( 1 ).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill one drop in each eye, wait 2 minutes and instill a second drop in each eye once daily ( 2 ).
2.1Recommended Dosage Instill one drop in each eye, wait 2 minutes and instill a second drop in each eye once daily from the same single-dose vial.
2.2Administration Instructions Contact lenses should be removed prior to the instillation of VIZZ and may be reinserted 10 minutes after instillation. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. To open vial, twist off top [see How Supplied/Storage and Handling (16.1) ] . Discard the opened single-dose vial after use.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS VIZZ is a clear to opalescent and colorless to slightly yellow ophthalmic solution containing 1.44% of aceclidine in a single-dose vial. Ophthalmic solution: aceclidine 1.44% in a single-dose vial ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Blurred Vision: Patients may experience temporary dim or dark vision after instillation. Do not drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination ( 5.1 ).
Risk of Retinal Tear/Detachment: Rare cases of retinal tears and detachments have been reported with miotics. Examination of the retina is advised in all patients prior to initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss ( 5.2 ).
Iritis : Caution is advised in patients with a history of iritis ( 5.3 ).
5.1Blurred Vision Miotics may cause accommodative spasm. Do not drive or operate machinery if vision is not clear (e.g., blurred vision). Patients may experience temporary dim or dark vision. Exercise caution in night driving and other hazardous activities in poor illumination.
5.2Risk of Retinal Tear/Detachment Rare cases of retinal tear and detachment have been reported with miotics when used in susceptible individuals and those with pre-existing retinal disease. Examination of the retina is advised in all patients prior to the initiation of treatment with VIZZ. Patients should be advised to seek immediate care with sudden onset of flashing lights, floaters, or vision loss.
5.3Iritis Sequelae of ocular inflammation, i.e., adhesions (synechiae) between the iris and the lens, may be exacerbated with miotic use in patients with a known history of iritis.
5.4Hypersensitivity VIZZ is not recommended for use in patients with a known hypersensitivity to aceclidine or any other ingredient in VIZZ.
5.5Use with Contact Lenses Contact lenses should be removed prior to the instillation of VIZZ and may be reinserted 10 minutes after instillation.
5.6Potential for Eye Injury or Contamination To prevent eye injury or contamination, care should be taken to avoid touching the single-dose vial to the eye or to any other surface.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions were instillation site irritation (20%), dim vision (16%), and headache (13%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact LENZ Therapeutics, Inc. at 1-888-711-LENZ 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. VIZZ dosed once daily was evaluated for safety and efficacy in 466 participants with presbyopia in 2 randomized, double-masked, controlled phase 3 studies for 42 days (CLARITY-1, NCT05656027 and CLARITY-2, NCT05728944). VIZZ dosed once daily was also evaluated for long term safety in 217 participants with presbyopia in a separate randomized, double-masked, controlled phase 3 study (CLARITY-3, NCT05753189) for a 6-month duration.
The most common reported adverse reactions of participants were instillation site irritation (20%), dim vision (16%), and headache (13%). Adverse reactions reported in > 5% of participants were conjunctival hyperemia (8%) and ocular hyperemia (7%). The majority of adverse reactions were mild, transient, and self-resolving.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well controlled studies of VIZZ administration in pregnant women to inform a drug associated risk. In animal reproduction studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis and lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. Data Animal Data In embryofetal development studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis produced no maternal toxicity, skeletal anomalies, nor reduction in fetal body weight at 1.5 mg/kg/day (approximately 110-fold and 70-fold the human plasma exposure to the metabolite, 3-quinuclidinol, in rats and rabbits, respectively, at the MRHOD, assuming administration of 2 drops/eye/day).
In a pre-/postnatal development study in rats, oral administration of aceclidine during organogenesis through lactation produced no adverse maternal, fetal, or neonatal effects at doses up to 1.5 mg/kg/day (approximately 110-fold higher than the MHOD based on body surface area, assuming administration of 2 drops/eye/day).
8.2Lactation Risk Summary There is no information regarding the presence of VIZZ or its metabolite in human or animal milk, the effects on breastfed infants or the effects on milk production to inform the risk of VIZZ to an infant during lactation. Systemic levels of aceclidine and its metabolites following topical ocular administration are low [see Clinical Pharmacology (12.3) ] , and it is not known whether measurable levels of aceclidine or its metabolites would be present in human milk following topical ocular administration.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VIZZ and any potential adverse effects on the breastfed child from VIZZ or from the underlying maternal condition.
8.4Pediatric Use Presbyopia does not occur in the pediatric population.
8.5Geriatric Use No overall differences in safety or effectiveness of VIZZ have been observed between patients 65 years of age and older and younger adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well controlled studies of VIZZ administration in pregnant women to inform a drug associated risk. In animal reproduction studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis and lactation did not produce adverse maternal, fetal or neonatal effects at clinically relevant doses. Data Animal Data In embryofetal development studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis produced no maternal toxicity, skeletal anomalies, nor reduction in fetal body weight at 1.5 mg/kg/day (approximately 110-fold and 70-fold the human plasma exposure to the metabolite, 3-quinuclidinol, in rats and rabbits, respectively, at the MRHOD, assuming administration of 2 drops/eye/day).
In a pre-/postnatal development study in rats, oral administration of aceclidine during organogenesis through lactation produced no adverse maternal, fetal, or neonatal effects at doses up to 1.5 mg/kg/day (approximately 110-fold higher than the MHOD based on body surface area, assuming administration of 2 drops/eye/day).
🧒 Pediatric Use ▾
8.4Pediatric Use Presbyopia does not occur in the pediatric population.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness of VIZZ have been observed between patients 65 years of age and older and younger adult patients.
🆘 Overdosage ▾
10 OVERDOSAGE Systemic toxicity following topical ocular administration of miotics is rare, but occasionally patients who are sensitive may develop increased salivation, sweating, gastrointestinal overactivity, and slowing of the pulse. Accidental ingestion can produce sweating, salivation, nausea, tremors, slowing of the pulse, and a decrease in blood pressure. In moderate overdosage, spontaneous recovery is to be expected and is aided by intravenous fluids to compensate for dehydration.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Aceclidine is a cholinergic muscarinic agonist that stimulates muscarinic receptors located on smooth muscles. VIZZ is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision.
12.3Pharmacokinetics Aceclidine undergoes hydrolysis in the eye to acetate and 3-quinuclidinol (3-Q) with one mole of aceclidine hydrolyzed to one mole of 3-Q. Pharmacokinetic studies are performed on the analysis of 3-Q, which is a metabolite formed from the hydrolysis of aceclidine. Systemic exposure of aceclidine hydrochloride was evaluated in 16 subjects with presbyopia following once daily VIZZ administration (one drop of VIZZ in each eye followed by a second drop in each eye two minutes later) for 8 days.
The mean C max and AUC 0-t values for 3-Q after Day 8 dosing were 2.114 ng/mL and 4.899 hr*ng/mL, respectively. There was little to no accumulation of 3-Q after repeat once daily dosing of VIZZ. After 8 days, the mean (SD) RAUC 0-t and RC max values were 1.189 (0.770) and 0.996 (0.314), respectively.
T 1/2 could not be estimated at any timepoint due to the limited amount of quantifiable 3-Q concentrations after ocular dosing.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Aceclidine is a cholinergic muscarinic agonist that stimulates muscarinic receptors located on smooth muscles. VIZZ is a predominantly pupil selective miotic that interacts with the iris with minimal ciliary muscle stimulation. VIZZ causes contraction of the iris sphincter muscle, resulting in a pinhole effect that extends depth of focus to improve vision.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied VIZZ (aceclidine ophthalmic solution) 1.44% is supplied as a sterile, clear to opalescent, colorless to slightly yellow, and viscous ophthalmic solution in configurations of 5 single-dose vials. VIZZ does not include antimicrobial preservatives. Each single-dose vial is comprised of transparent low-density polyethylene (LDPE).
5 single-dose vials are packaged in a foil pouch. VIZZ is supplied in: NDC Number Description Vial Configuration 84226-100-11 carton box of 25 single-dose vials (5 pouches x five vials of 0.4 mL each) 84226-100-21 carton box of 25 single-dose vials (5 pouches x five vials of 0.25 mL each) Figure Figure
16.2Storage and Handling Store refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. When stored in refrigerated conditions, VIZZ can be used until the expiration date.
Once pouch or vial(s) are removed from refrigeration, VIZZ may be stored at room temperature [up to 77°F (25°C)] but must be used within 30 days. Discard the opened single-dose vial after use. During shipment, VIZZ may be maintained at temperatures up to 104°F (40°C) for a period not exceeding 8 days.
📦 Storage and Handling ▾
16.2Storage and Handling Store refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. When stored in refrigerated conditions, VIZZ can be used until the expiration date.
Once pouch or vial(s) are removed from refrigeration, VIZZ may be stored at room temperature [up to 77°F (25°C)] but must be used within 30 days. Discard the opened single-dose vial after use. During shipment, VIZZ may be maintained at temperatures up to 104°F (40°C) for a period not exceeding 8 days.
📋 Description ▾
11 DESCRIPTION VIZZ (aceclidine ophthalmic solution) 1.44% is a cholinergic muscarinic receptor agonist supplied as a sterile, clear to opalescent, colorless to slightly yellow, and viscous ophthalmic solution containing 1.75% of aceclidine hydrochloride (equivalent to 1.44% aceclidine). The chemical names for aceclidine hydrochloride are: 1) 3-Acetoxyquinuclidine Hydrochloride; 2) 3-Quinuclidinyl Acetate Hydrochloride. Its molecular weight is 205.68 g/mol and its molecular formula is C 9 H 15 NO 2 ∙ HCl.
Each mL of VIZZ contains aceclidine hydrochloride 1.75% (17.82 mg) as the active ingredient. Inactive ingredients in the ophthalmic solution are: polysorbate 80, mannitol, hypromellose, edetate disodium dihydrate, sodium citrate dihydrate, water for injection, and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 4.5 and 5.5, if necessary. VIZZ does not contain antimicrobial preservatives.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Night Driving Advise patients that they may experience temporary dim or dark vision. Advise patients to exercise caution with night driving and when hazardous activities are undertaken in poor illumination [see Warnings and Precautions (5.1) ]. Blurred Vision Temporary problems when changing focus between near and distant objects may occur.
Advise patients not to drive or use machinery if vision is not clear (e.g., blurred vision) [see Warnings and Precautions (5.1) ] . When to Seek Physician Advice Advise patients to seek immediate medical care with sudden onset of flashing lights, floaters, or vision loss [see Warnings and Precautions (5.2) ]. Contact Lens Wear Advise patients to remove contact lenses prior to the instillation of VIZZ.
Wait 10 minutes after instillation before reinserting their contact lenses [see Warnings and Precautions (5.5) ]. Potential for Eye Injury or Contamination Advise patients to avoid touching the tip of the single-dose vial to the eye or to any other surface in order to prevent eye injury or contamination [see Warnings and Precautions (5.6) ]. Advise patients to discard the opened single-dose vial and any remaining contents after use.
Concomitant Topical Ocular Therapy Advise patients if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart [see Dosage and Administration (2) ] .
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — 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. |