OJJAARA Tablet Ref.[107232] Active ingredients: Momelotinib

Source: FDA, National Drug Code (US)  Revision Year: 2023 

Product description

OJJAARA contains momelotinib dihydrochloride monohydrate, which is a kinase inhibitor with the chemical name Nā€‘(Cyanomethyl)4(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide dihydrochloride monohydrate. It has a molecular formula of C23H22N6O2 ā—2HCl ā—H2O, molecular weight of 505.40 and the following structural formula:

Momelotinib dihydrochloride monohydrate is a light yellow to brown to reddish-brown solid and is slightly soluble in water and insoluble in aqueous buffers across a pH range of 2.1 to 9. Momelotinib free base has a molecular formula of C23H22N6O2 and a molecular weight of 414.47.

OJJAARA (momelotinib) tablets are for oral administration. Each tablet contains 100 mg, 150 mg, or 200 mg of momelotinib, which is equivalent to 121.94 mg, 182.91 mg, or 243.88 mg, respectively, of momelotinib dihydrochloride monohydrate as the active ingredient. The core of each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate, silicon dioxide, and sodium starch glycolate. The film coating of each tablet contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow iron oxide.

Dosage Forms and Strengths

100 mg round tablet – brown with an underlined “M” debossed on one side and “100” on the other side.

150 mg triangular tablet – brown with an underlined “M” debossed on one side and “150” on the other side.

200 mg capsule-shaped tablet – brown with an underlined “M” debossed on one side and “200” on the other side.

How Supplied

OJJAARA (momelotinib) tablets are available as follows:

Table 6. OJJAARA Presentations:

NDC Number StrengthDescriptionTablets per Bottle
NDC 81864-103-30 100 mg Round-shaped brown film-coated tablet
with "M" on one side and “100” on the other side.
30
NDC 81864-102-30 150 mg Triangular-shaped brown film-coated tablet
with "M" on one side and “150” on the other side.
30
NDC 81864-101-30 200 mg Capsule-shaped brown film-coated tablet
with "M" on one side and “200” on the other side.
30

GlaxoSmithKline, Durham, NC 27701

Drugs

Drug Countries
OJJAARA United States

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