SPL Set ID: 1e6bea44-57d6-4bac-9328-46e1ee59f83b

NUPLAZID contains pimavanserin, an atypical antipsychotic, which is present as pimavanserin tartrate salt with the chemical name, urea, N -[(4-fluorophenyl)methyl]- N -(1-methyl-4-piperidinyl)- N '-[[4-(2-methylpropoxy)phenyl]methyl]-,(2 R ,3 R )-2,3-dihydroxybutanedioate (2:1). Pimavanserin tartrate is freely soluble in water. Its molecular formula is (C 25 H 34 FN 3 O 2 ) 2 ∙C 4 H 6 O 6 and its molecular weight is 1005.20 (tartrate salt). The chemical structure is: The molecular formula of pimavanserin free base is C 25 H 34 FN 3 O 2 and its molecular weight is 427.55. NUPLAZID capsules are intended for oral administration only. Each capsule contains 40 mg of pimavanserin tartrate, which is equivalent to 34 mg of pimavanserin free base. Inactive ingredients include magnesium stearate and microcrystalline cellulose. Additionally, the following inactive ingredients are present as components of the capsule shell: black iron oxide, FD&C blue #1, hypromellose, titanium dioxide, and yellow iron oxide. NUPLAZID tablets are intended for oral administration only. Each round, orange, immediate-release, film coated tablet contains 11.8 mg of pimavanserin tartrate, which is equivalent to 10 mg pimavanserin free base. Inactive ingredients include magnesium stearate, pregelatinized starch, and silicified microcrystalline cellulose. Additionally, the following inactive ingredients are present as components of the film coat: polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow iron oxide. Chemical Structure