FDA.reportPublic FDA data

TEPMETKO

Product NDC
44087-5000
11-digit product format
440875000
Labeler code
44087
Product ID
44087-5000_d922de79-b0f0-4ed2-b551-c7a86ed72d7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tepotinib Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
EMD Serono, Inc.
Application
NDA214096
Marketing category
NDA
Marketing start
2021-02-03
Substance
TEPOTINIB HYDROCHLORIDE
Active strength
225 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Mesenchymal Epithelial Transition Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEPOTINIB HYDROCHLORIDE225 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVY5YX2TQ1F
Rxcui2477266, 2477272

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4545044d-7660-4513-8a33-dad91ffdcfbeProduct name120210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44087-5000-32021-09-27C16284748780-1c7ccaba7-23ca-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021
44087-5000-62021-09-27C16284748780-1c7ccaba7-23ca-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021
44087-5000-32021-07-23C16284748780-1c7ccaba7-23ca-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021
44087-5000-62021-07-23C16284748780-1c7ccaba7-23ca-fd44-e053-dadaa90aa01bThese highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-5000-3TEPMETKO3 in 1 CARTONTABLET38
44087-5000-3TEPMETKO10 in 1 BLISTER PACKTABLET108
44087-5000-6TEPMETKO10 in 1 BLISTER PACKTABLET108
44087-5000-6TEPMETKO6 in 1 CARTONTABLET68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-5000-3EA - Each44087-5000fc27d82d-e35d-4244-9616-f1d985af170b12021-03-02
44087-5000-6EA - Each44087-50001e11ed05-4e05-4d00-9021-6e5d0b21e36312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-5000TEPMETKO (TEPOTINIB HYDROCHLORIDE) TABLET [EMD SERONO, INC.]8Current NDC, Legacy NDC, 4 package rows20250422_80a0f1b9-071a-47f5-9e67-32d638a669dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2477272TEPMETKO 225 MG Oral TabletPSN80a0f1b9-071a-47f5-9e67-32d638a669dc8
2477266tepotinib 225 MG Oral TabletPSN80a0f1b9-071a-47f5-9e67-32d638a669dc8
2477272tepotinib 225 MG Oral Tablet [Tepmetko]SBD80a0f1b9-071a-47f5-9e67-32d638a669dc8
2477266tepotinib 225 MG Oral TabletSCD80a0f1b9-071a-47f5-9e67-32d638a669dc8
2477272Tepmetko 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral TabletSY80a0f1b9-071a-47f5-9e67-32d638a669dc8
2477272Tepmetko 225 MG Oral TabletSY80a0f1b9-071a-47f5-9e67-32d638a669dc8
2477266tepotinib 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral TabletSY80a0f1b9-071a-47f5-9e67-32d638a669dc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44087-5000-3440875000033 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK3 blister pack2021-02-030000-00-00NoNoCurrent
44087-5000-6440875000066 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACK6 blister pack2021-02-030000-00-00NoNoCurrent