MODEYSO Capsule Ref.[115554] Active ingredients: Dordaviprone

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

Product description

Dordaviprone is a protease activator.

Dordaviprone is present as dordaviprone hydrochloride with the molecular formula C24H26N4O•2HCl. The molecular weight is 459.41. The full chemical name for dordaviprone hydrochloride is 7-benzyl-4- (2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo[1,2-a]pyrido[3,4-e]pyrimidin-5(4H)-one dihydrochloride.

Dordaviprone hydrochloride has the following chemical structure:

Dordaviprone hydrochloride is a white to off-white solid that is freely soluble in water. The 1% solution of dordaviprone hydrochloride is measured as pH 3.3.

MODEYSO (dordaviprone) capsules are supplied as 125 mg strength capsules in an immediate-release oral formulation. Each MODEYSO capsule contains 125 mg of dordaviprone (equivalent to 148.8 mg of dordaviprone hydrochloride).

The inactive ingredients in the capsule include magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell consists of hypromellose and titanium dioxide. The black printing ink contains alcohol, D&C yellow #10, FD&C blue #1, FD&C blue #2, FD&C red #40, ferrosoferric oxide, methyl alcohol, N-butyl alcohol, propylene glycol, and shellac glaze (20% esterified).

Dosage Forms and Strengths

Capsules: 125 mg, white, opaque, hard capsules printed with "DDP" and "125" on the body and "CMRX" on the cap of the capsule. Each capsule contains 125 mg dordaviprone.

How Supplied
StrengthDescriptionPackage ConfigurationNDC Number
125 mgWhite, opaque, hard capsules
printed with "DDP" and "125" on
the body and "CMRX" on the cap
of the capsule.
Each bottle contains 10 capsules
and desiccant with a
child-resistant closure.
68727-250-01

Distributed by: Jazz Pharmaceuticals, Inc., Palo Alto, CA 94306

Drugs

Drug Countries
MODEYSO United States

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