NUVIGIL Tablet Ref.[9991] Active ingredients: Armodafinil

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

Product description

NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

The chemical structure is:

Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol.

NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

Dosage Forms and Strengths
  • 50 mg – round, white to off-white tablet with “C” on one side and “205” on the other
  • 150 mg – oval, white to off-white tablet with “C” on one side and “215” on the other
  • 200 mg – rounded, rectangular, white to off-white tablet with “C” on one side and “220” on the other
  • 250 mg – oval, white to off-white tablet with “C” on one side and “225” on the other
How Supplied

NUVIGIL (armodafinil) tablets are available as follows:

50 mg: Each round, white to off-white tablet is debossed with “C” on one side and “205” on the other. NDC 63459-205-30 – Bottles of 30.

150 mg: Each oval, white to off-white tablet is debossed with “C” on one side and “215” on the other. NDC 63459-215-30 - Bottles of 30.

200 mg: Each rounded, rectangular, white to off-white tablet is debossed with “C” on one side and “220” on the other. NDC 63459-220-30 – Bottles of 30.

250 mg: Each oval, white to off-white tablet is debossed with “C” on one side and “225” on the other. NDC 63459-225-30 – Bottles of 30.

Drugs

Drug Countries
NUVIGIL Australia, Brazil, Israel, Turkey, United States

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