NUPLAZID Capsule Ref.[10166] Active ingredients: Pimavanserin

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

NUPLAZID contains pimavanserin, an atypical antipsychotic, which is present as pimavanserin tartrate salt with the chemical name, urea, N-N(1-methyl-4-piperidinyl)N'[[4-(2-methylpropoxy)phenyl]methyl]-,(2R,3R)-2,3-dihydroxybutanedioate (2:1). Pimavanserin tartrate is freely soluble in water. Its molecular formula is (C25H34FN3O2)2∙C4H6O6 and its molecular weight is 1005.20 (tartrate salt).

The chemical structure is:

The molecular formula of pimavanserin free base is C25H34FN3O2 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.

Dosage Forms and Strengths

NUPLAZID (pimavanserin) is available as:

  • 34 mg strength capsules. The capsules are opaque white and light green with “PIMA” and “34” printed in black.
  • 10 mg strength tablets. The orange, round, coated tablets are debossed on one side with a “P” and “10” on the reverse side.
How Supplied

NUPLAZID (pimavanserin) is available as:

34 mg Capsule: Opaque white and light green capsule with “PIMA” and “34” printed in black.

Bottle of 30: NDC 63090-340-30

10 mg Tablet: Orange, round, coated tablet debossed with “P” on one side and “10” on the reverse.

Bottle of 30: NDC 63090-100-30

Drugs

Drug Countries
NUPLAZID United States

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