armodafinil

FDA Drug Profile — Armodafinil

armodafinil is listed in the FDA National Drug Code directory with 12 NDC codes, marketed under brand name including Armodafinil. Available dosage form: tablet.

Drug Details

Generic Name
armodafinil
Brand Names
Armodafinil
Application Number
ANDA200043
Sponsor
Patheon Inc.
NDC Codes
12
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
ARMODAFINIL

Indications and Usage

1 INDICATIONS AND USAGE Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). ( 1 ) Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.