methylphenidate
methylphenidate is listed in the FDA National Drug Code directory with 16 NDC codes, marketed under brand names including Methylphenidate Transdermal System, Daytrana, Methylphenidate. Available dosage forms: patch, capsule, extended release.
Drug Details
- Generic Name
- methylphenidate
- Brand Names
- Methylphenidate Transdermal System, Daytrana, Methylphenidate
- Application Number
- NDA021514
- Sponsor
- PADAGIS US LLC
- NDC Codes
- 16
- Dosage Forms
- PATCH, CAPSULE, EXTENDED RELEASE
- Routes
- TRANSDERMAL, ORAL
- Active Ingredients
- METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), and Use in Specific Populations ( 8.4 )]. Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old ( 1 ). Limitations of Use The use of methylphenidate hydrochloride extended-release tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).