methylphenidate hydrochloride
methylphenidate hydrochloride is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including methylphenidate hydrochloride CD, METADATE CD, QuilliChew ER. Available dosage forms: capsule, extended release, tablet, chewable, extended release, tablet, tablet, extended release, suspension, extended release.
Drug Details
- Generic Name
- methylphenidate hydrochloride
- Brand Names
- methylphenidate hydrochloride CD, METADATE CD, QuilliChew ER, Ritalin, Methylphenidate Hydrochloride Extended-Release, RELEXXII, Ritalin LA, Quillivant XR, methylphenidate hydrochloride
- Application Number
- NDA021259
- Sponsor
- Lannett Company, LLC
- NDC Codes
- 50
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET, CHEWABLE, EXTENDED RELEASE, TABLET, TABLET, EXTENDED RELEASE, SUSPENSION, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- 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 ).