FDA label

What is alprazolam used for?

The FDA-approved uses of alprazolam, 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 for alprazolam (tablet, orally disintegrating) lists 2 uses: Generalized Anxiety Disorder; Panic Disorder.

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Alprazolam, tablet

Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA203346). Cross-references to other label sections are left out.

Alprazolam tablets are indicated for the:

  • acute treatment of generalized anxiety disorder (GAD) in adults.
  • treatment of panic disorder (PD), with or without agoraphobia in adults.

Source: DailyMed label, set id d2fd0b3e-9b78-44d0-82a6-96d6c6238750, version 10, effective December 11, 2025. NDC 65862-676, one of 83 listings for this product.

Alprazolam, tablet, extended release

Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA090871). Cross-references to other label sections are left out.

Alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults.

Source: DailyMed label, set id 326fa31a-5420-429b-9f7f-170cb38f64bd, version 16, effective December 11, 2025. NDC 65862-454, one of 18 listings for this product.

Alprazolam, tablet, orally disintegrating

Indications and Usage, quoted from the label by Par Health USA, LLC (ANDA078088). Cross-references to other label sections are left out.

Generalized Anxiety Disorder

Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder.

The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials.

Panic Disorder

Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia.

The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials.

Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months in duration for generalized anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.

Source: DailyMed label, set id ff1630b4-2044-433c-96bc-0bb4ae8d42a0, version 22, effective April 15, 2026. NDC 49884-110, one of 9 listings for this product.

Questions

What is alprazolam used for?

The FDA label for alprazolam (tablet, orally disintegrating) lists 2 uses: Generalized Anxiety Disorder; Panic Disorder.

What drug class is alprazolam?

FDA lists alprazolam in the Benzodiazepine 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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