dexmethylphenidate hydrochloride
dexmethylphenidate hydrochloride is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Focalin, Focalin XR, Dexmethylphenidate Hydrochloride Extended-Release. Available dosage forms: capsule, extended release, tablet.
Drug Details
- Generic Name
- dexmethylphenidate hydrochloride
- Brand Names
- Focalin, Focalin XR, Dexmethylphenidate Hydrochloride Extended-Release, DEXMETHYLPHENIDATE HYDROCHLORIDE, Dexmethylphenidate Hydrochloride
- Application Number
- NDA021278
- Sponsor
- Societal CDMO Gainesville, LLC
- NDC Codes
- 50
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET
- Routes
- ORAL
- Active Ingredients
- DEXMETHYLPHENIDATE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Dexmethylphenidate Hydrochloride Extended-release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14) ] . Dexmethylphenidate Hydrochloride Extended-release Capsules is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older