FDA.reportPublic FDA data

XDEMVY

Product NDC
81942-125
11-digit product format
819420125
Labeler code
81942
Product ID
81942-125_1f574fcb-3810-2e5c-e063-6394a90aafd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lotilaner ophthalmic solution
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Tarsus Pharmaceuticals, Inc.
Application
NDA217603
Marketing category
NDA
Marketing start
2023-08-14
Substance
LOTILANER
Active strength
2.5 mg/mL
Pharmacologic classes
Ectoparasiticide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XDEMVY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTILANER2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHEH4938D7K
Rxcui2644507, 2644512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
373dd329-965c-4df5-9985-c01fbf324eacProduct name120231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81942-125-012024-08-10C16284748780-11030e365-4c07-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-992024-08-10C16284748780-11030e365-4c07-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-012024-07-30C16284748780-11030e365-4c07-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-992024-07-30C16284748780-11030e365-4c07-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-012024-01-30C16284748780-11030e365-4c07-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-992024-01-30C16284748780-11030e365-4c07-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81942-125-01XDEMVY10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS103
81942-125-01XDEMVY1 in 1 CARTONSOLUTION/ DROPS13
81942-125-99XDEMVY1 in 1 CARTONSOLUTION/ DROPS13
81942-125-99XDEMVY1.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1.53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81942-125-01ML - Milliliter81942-125625c397d-185f-4af9-97a0-4a9be1b78eb512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81942-125XDEMVY (LOTILANER OPHTHALMIC SOLUTION) SOLUTION/ DROPS [TARSUS PHARMACEUTICALS, INC.]3Current NDC, 4 package rows20240811_ccd9e37c-654e-4e84-8c85-6523457df979.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2644507lotilaner 0.25 % Ophthalmic SolutionPSNccd9e37c-654e-4e84-8c85-6523457df9793
2644512xdemvy 0.25 % Ophthalmic SolutionPSNccd9e37c-654e-4e84-8c85-6523457df9793
2644512lotilaner 2.5 MG/ML Ophthalmic Solution [Xdemvy]SBDccd9e37c-654e-4e84-8c85-6523457df9793
2644507lotilaner 2.5 MG/ML Ophthalmic SolutionSCDccd9e37c-654e-4e84-8c85-6523457df9793
2644507lotilaner 0.25 % Ophthalmic SolutionSYccd9e37c-654e-4e84-8c85-6523457df9793
2644512Xdemvy 0.25 % Ophthalmic SolutionSYccd9e37c-654e-4e84-8c85-6523457df9793
2644512Xdemvy 2.5 MG/ML Ophthalmic SolutionSYccd9e37c-654e-4e84-8c85-6523457df9793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
81942-125-01819420125011 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPER2023-08-14NoNoHistorical
81942-125-99819420125991 BOTTLE, DROPPER in 1 CARTON (81942-125-99) / 1.5 mL in 1 BOTTLE, DROPPER2023-08-14NoNoHistorical