FDA label
What is Focalin used for?
Focalin contains dexmethylphenidate. 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: “Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).”
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Focalin, capsule, extended release
Indications and Usage, quoted from the label by Novartis Pharmaceuticals Corporation (NDA021802). Cross-references to other label sections are left out.
Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Limitations of Use
The use of Focalin XR 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.
Source: DailyMed label, set id 1a1da905-42a0-4748-9c39-67eca45deccc, version 36, effective September 23, 2025. NDC 0078-0430, one of 16 listings for this product.
Focalin, tablet
Indications and Usage, quoted from the label by Sandoz Inc (NDA021278). Cross-references to other label sections are left out.
Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Source: DailyMed label, set id 2016f5c2-95d2-4655-af65-c588c2bf5e6d, version 2, effective May 30, 2024. NDC 66758-250, one of 3 listings for this product.
Questions
What is Focalin used for?
The FDA label says: “Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).”
What drug class is Focalin?
FDA lists dexmethylphenidate 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 Focalin
- Is Focalin a controlled substance?Schedule II
- Generic for FocalinFDA Orange Book
- What is Dexmethylphenidate used for?FDA label uses
- Is Dexmethylphenidate a controlled substance?Schedule II
- Generic for Focalin XRFDA Orange Book
- Central Nervous System Stimulants listFDA drug class
- NDC 0078-0430Focalin NDC record
- NDC 0078-0431Focalin NDC record
- NDC 0078-0432Focalin NDC record
- Schedule II drugs listDEA schedule