FDA.reportPublic FDA data

YUVEZZI

Product NDC
84892-275
11-digit product format
848920275
Labeler code
84892
Product ID
84892-275_4d630a35-0473-5b82-e063-6294a90a3f4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbachol and brimonidine tartrate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Visus Therapeutics, Inc.
Application
NDA220142
Marketing category
NDA
Marketing start
2026-02-18
Substance
BRIMONIDINE TARTRATE; CARBACHOL
Active strength
1; 27.5 mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], alpha-Adrenergic 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
YUVEZZI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BRIMONIDINE TARTRATE1 mg/mL
CARBACHOL27.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4S9CL2DY2H, 8Y164V895Y
Rxcui2736933, 2736939

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
76dbb916-cd7f-7147-fbde-e858c08e0e3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84892-275-01YUVEZZI0.16 mL in 1 VIAL, SINGLE-DOSESOLUTION/ DROPS0.164
84892-275-02YUVEZZI5 in 1 POUCHSOLUTION/ DROPS54
84892-275-30YUVEZZI6 in 1 CARTONSOLUTION/ DROPS64
84892-275-99YUVEZZI1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84892-275-02EA - Each84892-2751b3cc6f2-de1c-4271-95ad-14d1715a888b12026-03-17
84892-275-30EA - Each84892-275c3d300c3-702c-45ab-9251-9d3fb37f77ea12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2736933brimonidine tartrate 0.1 % / carbachol 2.75 % Ophthalmic SolutionPSN68198098-0f33-458f-83b8-eb2a5ec690124
2736939YUVEZZI 2.75 % / 0.1 % Ophthalmic SolutionPSN68198098-0f33-458f-83b8-eb2a5ec690124
2736939brimonidine tartrate 1 MG/ML / carbachol 27.5 MG/ML Ophthalmic Solution [Yuvezzi]SBD68198098-0f33-458f-83b8-eb2a5ec690124
2736933brimonidine tartrate 1 MG/ML / carbachol 27.5 MG/ML Ophthalmic SolutionSCD68198098-0f33-458f-83b8-eb2a5ec690124
2736933brimonidine tartrate 0.1 % / carbachol 2.75 % Ophthalmic SolutionSY68198098-0f33-458f-83b8-eb2a5ec690124
2736939Yuvezzi (brimonidine tartrate 0.1 % / carbachol 2.75 % ) Ophthalmic SolutionSY68198098-0f33-458f-83b8-eb2a5ec690124

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84892-275-01848920275010.16 mL in 1 VIAL, SINGLE-DOSE0.16 mlHistorical
84892-275-02848920275025 in 1 POUCHHistorical
84892-275-30848920275306 POUCH in 1 CARTON (84892-275-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (84892-275-02) / .16 mL in 1 VIAL, SINGLE-DOSE (84892-275-01) 6 pouch2026-02-18NoNoCurrent
84892-275-99848920275991 POUCH in 1 CARTON (84892-275-99) / 5 VIAL, SINGLE-DOSE in 1 POUCH (84892-275-02) / .16 mL in 1 VIAL, SINGLE-DOSE (84892-275-01) 1 pouch2026-02-18YesNoCurrent