tepmetko

Generic: tepotinib hydrochloride

Labeler: emd serono, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tepmetko
Generic Name tepotinib hydrochloride
Labeler emd serono, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tepotinib hydrochloride 225 mg/1

Manufacturer
EMD Serono, Inc.

Identifiers & Regulatory

Product NDC 44087-5000
Product ID 44087-5000_d922de79-b0f0-4ed2-b551-c7a86ed72d7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214096
Listing Expiration 2026-12-31
Marketing Start 2021-02-03

Pharmacologic Class

Classes
kinase inhibitor [epc] mesenchymal epithelial transition inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 440875000
Hyphenated Format 44087-5000

Supplemental Identifiers

RxCUI
2477266 2477272
UNII
VY5YX2TQ1F

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tepmetko (source: ndc)
Generic Name tepotinib hydrochloride (source: ndc)
Application Number NDA214096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 225 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK
  • 6 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

44087-5000-3 3 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK 44087-5000-6 6 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

tepotinib hydrochloride (225 mg/1)

Linked Drug Pages (1)

TEPMETKO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d922de79-b0f0-4ed2-b551-c7a86ed72d7d", "openfda": {"unii": ["VY5YX2TQ1F"], "rxcui": ["2477266", "2477272"], "spl_set_id": ["80a0f1b9-071a-47f5-9e67-32d638a669dc"], "manufacturer_name": ["EMD Serono, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (44087-5000-3)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "44087-5000-3", "marketing_start_date": "20210203"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (44087-5000-6)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "44087-5000-6", "marketing_start_date": "20210203"}], "brand_name": "TEPMETKO", "product_id": "44087-5000_d922de79-b0f0-4ed2-b551-c7a86ed72d7d", "dosage_form": "TABLET", "pharm_class": ["Kinase Inhibitor [EPC]", "Mesenchymal Epithelial Transition Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "44087-5000", "generic_name": "Tepotinib Hydrochloride", "labeler_name": "EMD Serono, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TEPMETKO", "active_ingredients": [{"name": "TEPOTINIB HYDROCHLORIDE", "strength": "225 mg/1"}], "application_number": "NDA214096", "marketing_category": "NDA", "marketing_start_date": "20210203", "listing_expiration_date": "20261231"}