FDA.reportPublic FDA data

NDC 44087-5000-06 - TEPMETKO

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
44087-5000
Requested NDC
44087-5000-06
Package NDCs from labels
44087-5000-3, 44087-5000-6, 44087-5000-06
Manufacturer
EMD Serono, Inc.
Effective date
2025-04-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TEPMETKO - EMD Serono, Inc.EMD Serono, Inc.2025-04-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
44087-5000-32021-09-27These 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
44087-5000-62021-09-27These 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
44087-5000-32021-07-23These 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
44087-5000-62021-07-23These 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 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 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

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 46 of 132 · 2,639 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Deluxe Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC37657895-5fec-82d0-e063-6294a90acf672025-12-15Exact identifier
unii: 15FIX9V2JP
Facial Mineral FusionTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC35944621-e6fb-cd98-e063-6294a90aa6412025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral MousseTITANIUM DIOXIDE, ZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d00778-3857-ce8f-e063-6394a90ab3752025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.35933039-8beb-9f98-e063-6394a90a60bb2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38046e71-f171-7e96-e063-6294a90a1f0b2025-12-15Exact identifier
unii: 15FIX9V2JP
Barrier Plus Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38038beb-d0f0-ced2-e063-6294a90ac4232025-12-15Exact identifier
unii: 15FIX9V2JP
Happy Mineral Sunscreen Primer SPFTITANIUM DIOXIDE, ZINC OXIDEACNE CLINIC LAS VEGAS BY JUSTINA37d9c5f2-f414-6efa-e063-6294a90a927f2025-12-15Exact identifier
unii: 15FIX9V2JP
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
unii: 15FIX9V2JP
Prime And Protect MatteTITANIUM DIOXIDE, ZINC OXIDEKalon Skin Studio, LLC35939630-1166-1c70-e063-6294a90aac6b2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Lip BalmTITANIUM DIOXIDE, ZINC OXIDEGoldberg, Howard S MD Inc3598205d-2e87-9292-e063-6294a90a1f2a2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3981c878-826d-f685-e063-6294a90acb242025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984c4b7-94ee-2a8e-e063-6294a90ac24f2025-12-15Exact identifier
unii: 15FIX9V2JP
Ultra Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc833d-f231-5f52-e063-6394a90a37a62025-12-15Exact identifier
unii: 15FIX9V2JP
Ultra Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bc4586-5e62-c9e7-e063-6294a90a276b2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula Non-TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.39821730-f6d1-c01a-e063-6394a90a026b2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Formula TintedTITANIUM DIOXIDE, ZINC OXIDECR KEEFE ENTERPRISES, INC.3984920a-feb9-169c-e063-6394a90a95682025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC35bdf417-45ba-f81a-e063-6394a90a74712025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd148c-43c7-aa93-e063-6394a90abc8b2025-12-15Exact identifier
unii: 15FIX9V2JP
Sheer Tinted ProtectionTITANIUM DIOXIDE, ZINC OXIDECLEAR SKIN SOLUTIONS, LLC35bd62d8-ebe3-b3fd-e063-6394a90a827c2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.