Serdexmethylphenidate and Dexmethylphenidate
Serdexmethylphenidate and Dexmethylphenidate is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including AZSTARYS. Available dosage form: capsule.
Drug Details
- Generic Name
- Serdexmethylphenidate and Dexmethylphenidate
- Brand Names
- AZSTARYS
- Application Number
- NDA212994
- Sponsor
- Commave Sub, LLC
- NDC Codes
- 3
- Dosage Forms
- CAPSULE
- Routes
- ORAL
- Active Ingredients
- SERDEXMETHYLPHENIDATE CHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS 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 ), Use in Specific Populations ( 8.4 )]. AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. ( 1 ) Limitations of Use The use of AZSTARYS 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 (5.7, 8.4).