FDA.reportPublic FDA data

VIZZ

Product NDC
84226-100
Requested package NDC
84226-100-21
11-digit product format
842260100
Labeler code
84226
Product ID
84226-100_485ee479-310b-1721-e063-6394a90aed7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aceclidine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
LENZ Therapeutics, Inc.
Application
NDA218585
Marketing category
NDA
Marketing start
2025-07-31
Substance
ACECLIDINE HYDROCHLORIDE
Active strength
14.66 mg/mL
Pharmacologic classes
Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218585-001VIZZACECLIDINE HYDROCHLORIDEEQ 1.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-07-31

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218585-001100523132034-03-24U-3741Drug product2025-08-22
N218585-001111793282034-03-24U-37412025-08-22
N218585-00198445372034-03-24U-3741Drug product2025-08-22
N218585-001126537792035-06-18U-37412026-07-13
N218585-001121280362039-10-08U-37412025-08-22
N218585-001125333472039-10-08U-37412026-02-17
N218585-001124149422044-03-15U-37412025-10-01

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218585-001NCE2030-07-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N218585-001VIZZEQ 1.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-07-3184e616aacf4f…
2026-08-18 06:07:402026-07N218585-001VIZZEQ 1.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218585-001VIZZEQ 1.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218585-001VIZZEQ 1.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N218585-001VIZZEQ 1.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-07-316a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-001VIZZEQ 1.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2025-07-31a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218585-001100523132034-03-24U-3741Drug product2025-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218585-001111793282034-03-24U-37412025-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218585-00198445372034-03-24U-3741Drug product2025-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218585-001126537792035-06-18U-37412026-07-1384e616aacf4f…
2026-09-14 22:38:342026-08N218585-001121280362039-10-08U-37412025-08-2284e616aacf4f…
2026-09-14 22:38:342026-08N218585-001125333472039-10-08U-37412026-02-1784e616aacf4f…
2026-09-14 22:38:342026-08N218585-001124149422044-03-15U-37412025-10-0184e616aacf4f…
2026-08-18 06:07:402026-07N218585-001100523132034-03-24U-3741Drug product2025-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218585-001111793282034-03-24U-37412025-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218585-00198445372034-03-24U-3741Drug product2025-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218585-001126537792035-06-18U-37412026-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07N218585-001121280362039-10-08U-37412025-08-22caaa826d4ba7…
2026-08-18 06:07:402026-07N218585-001125333472039-10-08U-37412026-02-17caaa826d4ba7…
2026-08-18 06:07:402026-07N218585-001124149422044-03-15U-37412025-10-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218585-001100523132034-03-24U-3741Drug product2025-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218585-001111793282034-03-24U-37412025-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218585-00198445372034-03-24U-3741Drug product2025-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218585-001121280362039-10-08U-37412025-08-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218585-001124149422044-03-15U-37412025-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218585-001100523132034-03-24U-3741Drug product2025-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218585-001111793282034-03-24U-37412025-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218585-00198445372034-03-24U-3741Drug product2025-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218585-001121280362039-10-08U-37412025-08-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218585-001124149422044-03-15U-37412025-10-0131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-001100523132034-03-24U-3741Drug product2025-08-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-001111793282034-03-24U-37412025-08-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-00198445372034-03-24U-3741Drug product2025-08-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-001121280362039-10-08U-37412025-08-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-001125333472039-10-08U-37412026-02-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-001124149422044-03-15U-37412025-10-01a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218585-001NCE2030-07-3184e616aacf4f…
2026-08-18 06:07:402026-07N218585-001NCE2030-07-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218585-001NCE2030-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218585-001NCE2030-07-3131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218585-001NCE2030-07-31a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
VIZZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACECLIDINE HYDROCHLORIDE14.66 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3B22O325Q6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2721771Internal RxNorm lookup
2721776Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7aed8024-ad30-44d6-8f3b-63338ad3ce52Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84226-100-01VIZZ5 in 1 POUCHSOLUTION/ DROPS56
84226-100-01VIZZ0.4 mL in 1 AMPULESOLUTION/ DROPS0.46
84226-100-02VIZZ0.25 mL in 1 AMPULESOLUTION/ DROPS0.256
84226-100-02VIZZ5 in 1 POUCHSOLUTION/ DROPS56
84226-100-11VIZZ5 in 1 CARTONSOLUTION/ DROPS56
84226-100-21VIZZ5 in 1 CARTONSOLUTION/ DROPS56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84226-100-01EA - Each84226-100d2655396-bf3d-4184-b24a-97bb1c66f4b612025-09-12
84226-100-02EA - Each84226-10088cf11bc-6551-4535-b786-8439731aad8912026-04-20
84226-100-11EA - Each84226-100a30cccbf-471a-4209-8551-f3e39587160812025-09-12
84226-100-21EA - Each84226-10070f285a3-04ef-40f3-9540-d01b1d63e77e12026-04-20

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VIZZACECLIDINELENZ Therapeutics, Inc.7aed8024-ad30-44d6-8f3b-63338ad3ce522026-01-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 218585
application number: NDA218585
ndc (package): 84226-100-21
ndc (product): 84226-100
ndc11 (package): 84226010021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2721771aceclidine 1.44 % Ophthalmic SolutionPSN7aed8024-ad30-44d6-8f3b-63338ad3ce526
2721776VIZZ 1.44 % Ophthalmic SolutionPSN7aed8024-ad30-44d6-8f3b-63338ad3ce526
2721776aceclidine 14.4 MG/ML Ophthalmic Solution [Vizz]SBD7aed8024-ad30-44d6-8f3b-63338ad3ce526
2721771aceclidine 14.4 MG/ML Ophthalmic SolutionSCD7aed8024-ad30-44d6-8f3b-63338ad3ce526
2721771aceclidine 1.44 % (as aceclidine hydrochloride 1.75 % ) Ophthalmic SolutionSY7aed8024-ad30-44d6-8f3b-63338ad3ce526
2721771aceclidine 1.44 % Ophthalmic SolutionSY7aed8024-ad30-44d6-8f3b-63338ad3ce526
2721776Vizz 1.44 % Ophthalmic SolutionSY7aed8024-ad30-44d6-8f3b-63338ad3ce526
2721776Vizz 14.4 MG/ML Ophthalmic SolutionSY7aed8024-ad30-44d6-8f3b-63338ad3ce526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84226-100-21842260100215 POUCH in 1 CARTON (84226-100-21) / 5 AMPULE in 1 POUCH (84226-100-02) / .25 mL in 1 AMPULE5 pouch2026-01-02NoNoCurrent