FDA.reportPublic FDA data

Klisyri

Product NDC
16110-391
11-digit product format
161100391
Labeler code
16110
Product ID
16110-391_89dd936d-4a69-4c60-b743-dfefb589ec1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tirbanibulin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Almirall, LLC
Application
NDA213189
Marketing category
NDA
Marketing start
2020-12-14
Substance
TIRBANIBULIN
Active strength
10 mg/g
Pharmacologic classes
Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIRBANIBULIN10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4V9848RS5G
Rxcui2471095, 2471100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ea0d3f2-ffbc-40ed-a599-5af865155babProduct name120210607

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16110-391-052024-01-30C16284748780-11030e365-63d2-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use KLISYRI safely and effectively. See full prescribing information for KLISYRI. KLISYRI (tirbanibulin) ointment, for topical use Initial U.S. Approval: 2020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16110-391-05Klisyri0.25 g in 1 PACKETOINTMENT0.2512
16110-391-05Klisyri5 in 1 CARTONOINTMENT512
16110-391-55Klisyri0.35 g in 1 PACKETOINTMENT0.3512
16110-391-55Klisyri5 in 1 CARTONOINTMENT512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-391-05EA - Each16110-39146845bce-1e0d-48c3-b2d8-fc21d01cbfce12021-02-05
16110-391-55EA - Each16110-3910ca5e2e2-2dfe-4888-a37a-232fb110c0aa12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-391KLISYRI (TIRBANIBULIN) OINTMENT [ALMIRALL, LLC]12Current NDC, Legacy NDC, 4 package rows20241109_589c8de8-b773-4d47-b60c-48471806cccc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2471100Klisyri 1 % Topical OintmentPSN589c8de8-b773-4d47-b60c-48471806cccc12
2471095tirbanibulin 1 % Topical OintmentPSN589c8de8-b773-4d47-b60c-48471806cccc12
2471100tirbanibulin 0.01 MG/MG Topical Ointment [Klisyri]SBD589c8de8-b773-4d47-b60c-48471806cccc12
2471095tirbanibulin 0.01 MG/MG Topical OintmentSCD589c8de8-b773-4d47-b60c-48471806cccc12
2471100Klisyri 0.01 MG/MG Topical OintmentSY589c8de8-b773-4d47-b60c-48471806cccc12
2471100Klisyri 1 % Topical OintmentSY589c8de8-b773-4d47-b60c-48471806cccc12
2471095tirbanibulin 1 % Topical OintmentSY589c8de8-b773-4d47-b60c-48471806cccc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16110-391-05161100391055 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET5 packet2020-12-140000-00-00NoNoCurrent
16110-391-55161100391555 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET5 packet2024-06-07NoNoHistorical