methylphenidate

FDA Drug Profile — Methylphenidate, Daytrana, Methylphenidate Transdermal System

Drug Details

Generic Name
methylphenidate
Brand Names
Methylphenidate, Daytrana, Methylphenidate Transdermal System
Application Number
NDA021284
Sponsor
Sandoz Inc
NDC Codes
16
Dosage Forms
CAPSULE, EXTENDED RELEASE, PATCH
Routes
ORAL, TRANSDERMAL
Active Ingredients
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE

Indications and Usage

1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).