FDA label
What is Zenzedi used for?
Zenzedi contains dextroamphetamine. 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: “Zenzedi ®(Dextroamphetamine Sulfate Tablets, USP) is indicated for: Narcolepsy; Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of ...”
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Zenzedi, tablet
Indications and Usage, quoted from the label by Azurity Pharmaceuticals, Inc. (ANDA090533). Cross-references to other label sections are left out.
Zenzedi ®(Dextroamphetamine Sulfate Tablets, USP) is indicated for:
- Narcolepsy.
- Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Source: DailyMed label, set id d6394df5-f2c9-47eb-b57e-f3e9cfd94f84, version 14, effective November 26, 2025. NDC 24338-850, one of 7 listings for this product.
Questions
What is Zenzedi used for?
The FDA label says: “Zenzedi ®(Dextroamphetamine Sulfate Tablets, USP) is indicated for: Narcolepsy; Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of ...”
What drug class is Zenzedi?
FDA lists dextroamphetamine 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 Zenzedi
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- Schedule II drugs listDEA schedule