Package 44087-5000-3
Brand: tepmetko
Generic: tepotinib hydrochloridePackage Facts
Identity
Package NDC
44087-5000-3
Digits Only
4408750003
Product NDC
44087-5000
Description
3 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK
Marketing
Marketing Status
Brand
tepmetko
Generic
tepotinib hydrochloride
Sample Package
No
Linked Drug Pages (1)
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"}