dexmethylphenidate hydrochloride

FDA Drug Profile — Dexmethylphenidate Hydrochloride Extended-Release, Dexmethylphenidate Hydrochloride, Focalin XR, Focalin, DEXMETHYLPHENIDATE HYDROCHLORIDE

dexmethylphenidate hydrochloride is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Dexmethylphenidate Hydrochloride Extended-Release, Dexmethylphenidate Hydrochloride, Focalin XR. Available dosage forms: capsule, extended release, tablet.

Drug Details

Generic Name
dexmethylphenidate hydrochloride
Brand Names
Dexmethylphenidate Hydrochloride Extended-Release, Dexmethylphenidate Hydrochloride, Focalin XR, Focalin, DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
ANDA210279
Sponsor
Lannett Company, Inc.
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