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United States · US · US:44087-5000_d922de79-b0f0-4ed2-b551-c7a86ed72d7d
TEPMETKO
Orange BookUNIISPLATC L01EX21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEMD Serono, Inc.
CountryUS (United States)
ATC codeL01EX21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1144087500033 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK
- ndc1144087500066 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
VY5YX2TQ1F
TEPOTINIB HYDROCHLORIDE
RxCUI 2477104
Orange Book
N214096
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "VY5YX2TQ1F",
"rxcui": "2477104",
"inchikey": "KZVOMLRKFJUTLK-UHFFFAOYSA-N",
"display_name": "TEPOTINIB HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"80a0f1b9-071a-47f5-9e67-32d638a669dc": {
"match": "brand_token",
"title": "TEPMETKO (TEPOTINIB HYDROCHLORIDE) TABLET [EMD SERONO, INC.]",
"spl_version": "8",
"published_date": "2025-04-22"
}
},
"productid": "44087-5000_d922de79-b0f0-4ed2-b551-c7a86ed72d7d",
"productndc": "44087-5000",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214096",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 225MG BASE",
"product_no": "001",
"approval_date": "Feb 3, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TEPOTINIB HYDROCHLORIDE",
"proprietary_name": "TEPMETKO",
"active_ingred_unit": "mg/1",
"application_number": "NDA214096",
"marketing_category": "NDA",
"nonproprietary_name": "Tepotinib Hydrochloride",
"start_marketing_date": "20210203",
"active_numerator_strength": "225"
}Related drugs
Other records sharing ATC code L01EX21.
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