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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N220142-001YUVEZZIBRIMONIDINE TARTRATE; CARBACHOL0.1%;2.75%SOLUTION/DROPS / OPHTHALMICRLD, RS2026-01-28

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220142-00184554942030-05-24U-37412026-02-24
N220142-00184554942030-05-24U-44192026-02-24
N220142-00184554942030-05-24U-44202026-02-24
N220142-001122686622042-11-10U-3741Drug product2026-02-24
N220142-001122686622042-11-10U-4419Drug product2026-02-24
N220142-001122686622042-11-10U-4420Drug product2026-02-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220142-001NP2029-01-28

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
2026-02-19 14:30 UTC2026-02N220142-001YUVEZZI0.1%;2.75%SOLUTION/DROPS / OPHTHALMICRLD, RS2026-01-28011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-001YUVEZZI0.1%;2.75%SOLUTION/DROPS / OPHTHALMICRLD, RS2026-01-28a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-00184554942030-05-24U-37412026-02-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-00184554942030-05-24U-44192026-02-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-00184554942030-05-24U-44202026-02-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-001122686622042-11-10U-3741Drug product2026-02-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-001122686622042-11-10U-4419Drug product2026-02-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-001122686622042-11-10U-4420Drug product2026-02-24a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220142-001NP2029-01-28a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBACHOL1 mg/mL
BRIMONIDINE TARTRATE27.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8Y164V895YInternal UNII lookup
4S9CL2DY2HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2736933Internal RxNorm lookup
2736939Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
68198098-0f33-458f-83b8-eb2a5ec69012Available on FDA.report

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

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
YUVEZZICARBACHOL AND BRIMONIDINE TARTRATEVisus Therapeutics, Inc.68198098-0f33-458f-83b8-eb2a5ec690122026-05-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 220142
application number: NDA220142
ndc (product): 84892-275

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