NDC product

RHAPSIDO

NDC 0078-1483 · Novartis Pharmaceuticals Corporation

Key facts

Product NDC 0078-1483
Proprietary name RHAPSIDO
Nonproprietary name remibrutinib
Substances REMIBRUTINIB
Dosage form TABLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA218436
Pharmacologic classes Bruton's Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]
Marketing start Sep 30, 2025
Listing certified through Dec 31, 2027

At a glance

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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