RHAPSIDO Film-coated tablet Ref.[116081] Active ingredients: Remibrutinib

Source: FDA, National Drug Code (US)  Revision Year: 2025 

Product description

RHAPSIDO (remibrutinib) is a kinase inhibitor.

Its empirical formula (remibrutinib) is C27H27F2N5O3. The chemical name for remibrutinib is N-(3-{6-Amino-5-[2-(N-methylprop-2-enamido)ethoxy]pyrimidin-4-yl}-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide. Its molecular weight is approximately 507.54 g/mol. The chemical structure of remibrutinib is:

Remibrutinib is white to pale yellow powder, and it is practically insoluble in water.

RHAPSIDO is supplied as film-coated tablets for oral administration, with each film-coated tablet containing 25 mg of remibrutinib. The tablet core inactive ingredients are copovidone, croscarmellose sodium, mannitol, microcrystalline cellulose, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet coating inactive ingredients are polyethylene glycol 4000, polyvinyl alcohol, red iron oxide (E172), talc, titanium dioxide (E171), and yellow iron oxide (E172).

Dosage Forms and Strengths

Tablets: 25 mg, light yellow, round, curved, unscored, film-coated tablet, debossed with "LV" on one side and Novartis logo on the other side. The tablet diameter is 7 mm.
How Supplied

RHAPSIDO tablets are supplied as described in Table 4:

Table 4. RHAPSIDO Tablets and Package Configuration:

StrengthTablet
Description		Package
Configuration		NDC
25 mglight yellow,
round,
curved,
unscored,
film-coated
tablet,
debossed
with "LV" on
one side and
Novartis
logo on the
other side.
Tablet
diameter is 7 mm.		40 mL HDPE
bottle
containing 60
tablets with 2
gm silica gel
and a child-
resistant
closure		0078-1483-20

Distributed by: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936

Drugs

Drug Countries
RHAPSIDO United States
 
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