Prescription medicine
Amoxapine First approved as Asendin
Amoxapine (Asendin) is a prescription medicine with an FDA approval on record since 1980. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the amoxapine FDA label on DailyMed (effective December 18, 2024, Chartwell RX, LLC); the NDA 18021 record on Drugs@FDA; every amoxapine label on DailyMed.
Highlights of the record
FDA label of December 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amoxapine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amoxapine is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use )
Used for
From the label: indications and usageAmoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions.
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
- 150 mg
Tablet.
On the market
- Earliest approval on file
- September 22, 1980 Asendin, Lederle; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first May 11, 1989; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 475 through July 30, 2026
What is amoxapine used for?
From the label: indications and usageAmoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.
Conditions named in the indications of amoxapine's FDA labels, with every medicine labeled for each:
From other amoxapine labelsDepression: INDICATIONS AND USAGE Amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions.
FDA pharmacologic class: Tricyclic Antidepressant.
Source: FDA drug label (Amoxapine), Chartwell RX, LLC, effective December 18, 2024 (SPL set eed5e856-dd7b-4eaa-9dad-508f2bef9328), via openFDA; the full label on DailyMed
Is there a generic for amoxapine (Asendin)?
The FDA approved the first generic amoxapine on May 11, 1989. 6 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists amoxapine from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1980 earliest approval on file
- 1989 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the amoxapine label say about other medicines?
The amoxapine label names no other medicine on this site. The labels of 6 other medicines name amoxapine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name amoxapine
Source: FDA drug label (Amoxapine), Chartwell RX, LLC, effective December 18, 2024 (SPL set eed5e856-dd7b-4eaa-9dad-508f2bef9328), via openFDA; the full label on DailyMed
What do FAERS reports show for amoxapine?
The FDA Adverse Event Reporting System holds 475 reports that list amoxapine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 181 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amoxapine?
32 other medicines are given the same way (oral) and in the same FDA class as amoxapine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Doxepin | Depression, Anxiety | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
| Nortriptyline | Depression | 27 labelers | $0.113 per capsule 10 mg capsule | No current entry |
| Desipramine | Depression | 9 labelers | $0.276 per tablet 75 mg tablet | No current entry |
| Imipramine | Depression | 14 labelers | $0.0698 per tablet 10 mg tablet | No current entry |
| Trimipramine | Depression | 3 labelers | n/a | No current entry |
| Amitriptyline and perphenazine | Anxiety | 1 labeler | n/a | No current entry |
| Protriptyline | Depression | 2 labelers | $2.71 per tablet 10 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amoxapine
- 32 medicines for the same use
- Other tricyclic antidepressants
- the pharmacologic class, with prices and generics
- Amoxapine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other