FDA label
What is Prozac used for?
Prozac contains fluoxetine. 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: “PROZAC® is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder; Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD); Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa; Acute treatment of Panic Disorder, with or without a...”
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Prozac, capsule
Indications and Usage, quoted from the label by Dista Products Company (NDA018936). Cross-references to other label sections are left out.
PROZAC® is indicated for the treatment of:
- Acute and maintenance treatment of Major Depressive Disorder.
- Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD).
- Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa.
- Acute treatment of Panic Disorder, with or without agoraphobia.
PROZAC and Olanzapine in Combination is indicated for the treatment of:
- Acute treatment of depressive episodes associated with Bipolar I Disorder.
- Treatment resistant depression (Major Depressive Disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode).
PROZAC monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depression.
When using PROZAC and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax ®.
Source: DailyMed label, set id c88f33ed-6dfb-4c5e-bc01-d8e36dd97299, version 59, effective January 8, 2026. NDC 0777-3104, one of 3 listings for this product.
Questions
What is Prozac used for?
The FDA label says: “PROZAC® is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder; Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD); Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa; Acute treatment of Panic Disorder, with or without a...”
What drug class is Prozac?
FDA lists fluoxetine in the Serotonin Reuptake Inhibitor 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 Prozac
- Is Prozac a controlled substance?Federal schedule
- Generic for ProzacFDA Orange Book
- What is Fluoxetine used for?FDA label uses
- Is Fluoxetine a controlled substance?Federal schedule
- Generic for Prozac WeeklyFDA Orange Book
- Generic for SarafemFDA Orange Book
- Serotonin Reuptake Inhibitors listFDA drug class
- NDC 0777-3104Prozac NDC record
- NDC 0777-3105Prozac NDC record
- NDC 0777-3107Prozac NDC record