rhapsido

Generic: remibrutinib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rhapsido
Generic Name remibrutinib
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

remibrutinib 25 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-1483
Product ID 0078-1483_e5e89bff-6ced-4165-acc5-fb13136b3a3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218436
Listing Expiration 2026-12-31
Marketing Start 2025-09-30

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
bruton's tyrosine kinase inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00781483
Hyphenated Format 0078-1483

Supplemental Identifiers

RxCUI
2724392 2724398
UNII
I7MVZ8HDNU
NUI
N0000175605 N0000193934 N0000185503

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 rhapsido (source: ndc)
Generic Name remibrutinib (source: ndc)
Application Number NDA218436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (0078-1483-20)
  • 2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE (0078-1483-93)
source: ndc

Packages (2)

0078-1483-20 60 TABLET in 1 BOTTLE (0078-1483-20) 0078-1483-92 2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLE (0078-1483-93)

Ingredients (1)

remibrutinib (25 mg/1)

Linked Drug Pages (1)

RHAPSIDO ndc-match (0.9)

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"}