FDA label
What is Azstarys used for?
Azstarys contains dexmethylphenidate and serdexmethylphenidate chloride. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.”
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Azstarys, capsule
Indications and Usage, quoted from the label by Commave Sub, LLC (NDA212994). Cross-references to other label sections are left out.
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, Use in Specific Populations].
Source: DailyMed label, set id 00b5e716-5564-4bbd-acaf-df2bc45a5663, version 9, effective May 11, 2026. NDC 65038-286, one of 3 listings for this product.
Questions
What is Azstarys used for?
The FDA label says: “AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.”
What drug class is Azstarys?
FDA lists dexmethylphenidate and serdexmethylphenidate chloride in the Central Nervous System Stimulant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Azstarys
- Is Azstarys a controlled substance?Schedule II
- Generic for AzstarysFDA Orange Book
- Is Dexmethylphenidate and Serdexmethylphenidate Chloride a controlled substance?Schedule II
- Central Nervous System Stimulants listFDA drug class
- NDC 65038-286Azstarys NDC record
- NDC 65038-429Azstarys NDC record
- NDC 65038-561Azstarys NDC record
- Schedule II drugs listDEA schedule