Package 0078-1483-92

Brand: rhapsido

Generic: remibrutinib
NDC Package Sample

Package Facts

Identity

Package NDC 0078-1483-92
Digits Only 0078148392
Product NDC 0078-1483
Description

2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE (0078-1483-93)

Marketing

Marketing Status
Marketed Since 2025-09-30
Brand rhapsido
Generic remibrutinib
Sample Package Yes

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "e5e89bff-6ced-4165-acc5-fb13136b3a3d", "openfda": {"nui": ["N0000175605", "N0000193934", "N0000185503"], "unii": ["I7MVZ8HDNU"], "rxcui": ["2724392", "2724398"], "spl_set_id": ["e5e89bff-6ced-4165-acc5-fb13136b3a3d"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Bruton's Tyrosine Kinase Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (0078-1483-20)", "package_ndc": "0078-1483-20", "marketing_start_date": "20250930"}, {"sample": true, "description": "2 BOTTLE in 1 CARTON (0078-1483-92)  / 30 TABLET in 1 BOTTLE (0078-1483-93)", "package_ndc": "0078-1483-92", "marketing_start_date": "20250930"}], "brand_name": "RHAPSIDO", "product_id": "0078-1483_e5e89bff-6ced-4165-acc5-fb13136b3a3d", "dosage_form": "TABLET", "product_ndc": "0078-1483", "generic_name": "remibrutinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RHAPSIDO", "active_ingredients": [{"name": "REMIBRUTINIB", "strength": "25 mg/1"}], "application_number": "NDA218436", "marketing_category": "NDA", "marketing_start_date": "20250930", "listing_expiration_date": "20261231"}