Package 0078-1112-15

Brand: mekinist

Generic: trametinib
NDC Package

Package Facts

Identity

Package NDC 0078-1112-15
Digits Only 0078111215
Product NDC 0078-1112
Description

30 TABLET, FILM COATED in 1 BOTTLE (0078-1112-15)

Marketing

Marketing Status
Marketed Since 2021-12-22
Brand mekinist
Generic trametinib
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "79c3da5e-f442-46a6-8580-ffc85fad1a09", "openfda": {"unii": ["BSB9VJ5TUT"], "rxcui": ["1425116", "1425118", "2632560", "1425104", "2632564", "1425110"], "spl_set_id": ["0002ad27-779d-42ab-83b5-bc65453412a1"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0078-1112-15)", "package_ndc": "0078-1112-15", "marketing_start_date": "20211222"}, {"sample": true, "description": "14 TABLET, FILM COATED in 1 BOTTLE (0078-1112-94)", "package_ndc": "0078-1112-94", "marketing_start_date": "20211222"}], "brand_name": "Mekinist", "product_id": "0078-1112_79c3da5e-f442-46a6-8580-ffc85fad1a09", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0078-1112", "generic_name": "trametinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mekinist", "active_ingredients": [{"name": "TRAMETINIB DIMETHYL SULFOXIDE", "strength": "2 mg/1"}], "application_number": "NDA204114", "marketing_category": "NDA", "marketing_start_date": "20160317", "listing_expiration_date": "20271231"}