FDA label
What is dexmethylphenidate used for?
The FDA-approved uses of dexmethylphenidate, 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: “Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).”
Run it in Rivvi
Which 2027 plans near you dropped or restricted dexmethylphenidate?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Dexmethylphenidate Hydrochloride, capsule, extended release
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA202731). Cross-references to other label sections are left out.
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Limitations of Use
The use of dexmethylphenidate hydrochloride extended-release capsules 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 dd659d39-41f5-4612-8f17-bad602b4784d, version 25, effective July 1, 2026. NDC 0093-5045, one of 62 listings for this product.
Dexmethylphenidate Hydrochloride, tablet
Indications and Usage, quoted from the label by KVK-TECH, INC (ANDA206931). Cross-references to other label sections are left out.
Dexmethylphenidate hydrochloride tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Source: DailyMed label, set id 0c717ae4-ec27-47db-ac1b-e504dbb379be, version 14, effective November 24, 2025. NDC 10702-106, one of 25 listings for this product.
Questions
What is dexmethylphenidate used for?
The FDA label says: “Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).”
What drug class is dexmethylphenidate?
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 Dexmethylphenidate
- Is Dexmethylphenidate a controlled substance?Schedule II
- Generic for Focalin XRFDA Orange Book
- Generic for FocalinFDA Orange Book
- What is Focalin used for?FDA label uses
- Is Focalin a controlled substance?Schedule II
- Central Nervous System Stimulants listFDA drug class
- NDC 0078-0430Dexmethylphenidate NDC record
- NDC 0078-0431Dexmethylphenidate NDC record
- NDC 0078-0432Dexmethylphenidate NDC record
- Schedule II drugs listDEA schedule