methylphenidate hydrochloride
methylphenidate hydrochloride is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including QuilliChew ER, Quillivant XR, RELEXXII. Available dosage forms: tablet, chewable, extended release, capsule, extended release, suspension, extended release, tablet, extended release, tablet.
Drug Details
- Generic Name
- methylphenidate hydrochloride
- Brand Names
- QuilliChew ER, Quillivant XR, RELEXXII, METADATE CD, methylphenidate hydrochloride, methylphenidate hydrochloride CD, Ritalin, Methylphenidate Hydrochloride Extended-Release, Ritalin LA
- Application Number
- NDA207960
- Sponsor
- NextWave Pharmaceuticals, Inc
- NDC Codes
- 50
- Dosage Forms
- TABLET, CHEWABLE, EXTENDED RELEASE, CAPSULE, EXTENDED RELEASE, SUSPENSION, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, TABLET
- 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 ).