modafinil
modafinil is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including Modafinil, Provigil, modafinil. Available dosage forms: tablet, powder.
Drug Details
- Generic Name
- modafinil
- Brand Names
- Modafinil, Provigil, modafinil
- Application Number
- ANDA077667
- Sponsor
- Apotex Corp.
- NDC Codes
- 16
- Dosage Forms
- TABLET, POWDER
- Routes
- ORAL
- Active Ingredients
- MODAFINIL
Indications and Usage
1 INDICATIONS AND USAGE Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil 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 and during treatment with modafinil tablets for excessive sleepiness. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). (1) Limitations of Use In OSA, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.