FDA.reportPublic FDA data

VIZZ

Product NDC
84226-100
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

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 Identifiers#

Field, Values table
FieldValues
Unii3B22O325Q6
Rxcui2721771, 2721776

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

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
84226-100-01842260100015 in 1 POUCHHistorical
84226-100-02842260100020.25 mL in 1 AMPULE0.25 mlHistorical
84226-100-11842260100115 POUCH in 1 CARTON (84226-100-11) / 5 AMPULE in 1 POUCH (84226-100-01) / .4 mL in 1 AMPULE5 pouch2025-07-31NoNoHistorical
84226-100-21842260100215 POUCH in 1 CARTON (84226-100-21) / 5 AMPULE in 1 POUCH (84226-100-02) / .25 mL in 1 AMPULE5 pouch2026-01-02NoNoHistorical