FDA label
What is methylphenidate used for?
The FDA-approved uses of methylphenidate, 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: “Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults; Narcolepsy.”
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Methylphenidate Hydrochloride, tablet
Indications and Usage, quoted from the label by KVK-TECH, INC. (ANDA206932). Cross-references to other label sections are left out.
Methylphenidate hydrochloride tablets are indicated for the treatment of:
- Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
- Narcolepsy
Source: DailyMed label, set id 1bf37f9f-29cf-4b09-9c81-eb369e35a042, version 14, effective January 2, 2026. NDC 10702-100, one of 50 listings for this product.
Methylphenidate Hydrochloride, tablet, extended release
Indications and Usage, quoted from the label by Lannett Company, Inc. (ANDA211918). Cross-references to other label sections are left out.
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.
Source: DailyMed label, set id 44737c1d-fe75-409e-8a58-591696d3d7aa, version 13, effective May 28, 2026. NDC 0527-3310, one of 42 listings for this product.
Methylphenidate Hydrochloride, capsule, extended release
Indications and Usage, quoted from the label by Amneal Pharmaceuticals of New York LLC (ANDA205105). Cross-references to other label sections are left out.
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.
Limitations of Use
The use of methylphenidate 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 10aa0dc0-bd0e-4927-a19a-8722d78ad67d, version 11, effective May 27, 2026. NDC 0115-1736, one of 29 listings for this product.
Questions
What is methylphenidate used for?
The FDA label says: “Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults; Narcolepsy.”
What drug class is methylphenidate?
FDA lists methylphenidate 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.
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