FDA.reportPublic FDA data

VEVYE

Product NDC
82667-900
11-digit product format
826670900
Labeler code
82667
Product ID
82667-900_4bc25aeb-44ca-06b2-e063-6294a90a03c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine ophthalmic solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA217469
Marketing category
NDA
Marketing start
2023-12-01
Substance
CYCLOSPORINE
Active strength
1 mg/mL
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui2639936, 2639941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1be408a0-e15a-4092-b35e-4e294e65196fProduct name320240216
b3fdee3e-0c46-442f-aad5-aa71941d5621Product name120231023
78fb0708-fce5-decd-6611-5a9fbe3e3decProduct name320230327
54840517-000d-4fcb-b976-a6ddd102faa0Product name120220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633aProduct name120181029
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
b1c0d609-8b97-06ee-2cd0-5652a4b1d019Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82667-900-002024-01-30C16284748780-11030e365-280f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-002024-01-30C16284748780-11030e365-280f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-002024-01-30C16284748780-11030e365-280f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-022024-01-30C16284748780-11030e365-280f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-022024-01-30C16284748780-11030e365-280f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
82667-900-022024-01-30C16284748780-11030e365-280f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use VEVYE ® safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-900-00VEVYE2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS24
82667-900-00VEVYE1 in 1 CARTONSOLUTION/ DROPS14
82667-900-02VEVYE1 in 1 CARTONSOLUTION/ DROPS14
82667-900-02VEVYE2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-900-02ML - Milliliter82667-9005721caa8-a8d9-47d5-a448-bd6658e2f3de12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-900VEVYE (CYCLOSPORINE OPHTHALMIC SOLUTION) SOLUTION/ DROPS [HARROW EYE, LLC]1Current NDC, 4 package rows20231201_0a60fccf-7e1b-44fe-e063-6394a90aadd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639936cycloSPORINE 0.1 % Ophthalmic SolutionPSN0a60fccf-7e1b-44fe-e063-6394a90aadd54
2639941vevye 0.1 % Ophthalmic SolutionPSN0a60fccf-7e1b-44fe-e063-6394a90aadd54
2639941cyclosporine 1 MG/ML Ophthalmic Solution [Vevye]SBD0a60fccf-7e1b-44fe-e063-6394a90aadd54
2639936cyclosporine 1 MG/ML Ophthalmic SolutionSCD0a60fccf-7e1b-44fe-e063-6394a90aadd54
2639936cyclosporine 0.1 % Ophthalmic SolutionSY0a60fccf-7e1b-44fe-e063-6394a90aadd54
2639941Vevye 0.1 % Ophthalmic SolutionSY0a60fccf-7e1b-44fe-e063-6394a90aadd54
2639941Vevye 1 MG/ML Ophthalmic SolutionSY0a60fccf-7e1b-44fe-e063-6394a90aadd54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82667-900-00826670900001 BOTTLE, DROPPER in 1 CARTON (82667-900-00) / 2 mL in 1 BOTTLE, DROPPER2026-02-24YesNoHistorical
82667-900-02826670900021 BOTTLE, DROPPER in 1 CARTON (82667-900-02) / 2 mL in 1 BOTTLE, DROPPER2023-12-01NoNoHistorical