Drugplain

Nortriptyline Hydrochloride 50 mg/1

Nortriptyline Hydrochloride · CAPSULE · Coupler LLC

No Recall History
Plain English

Nortriptyline Hydrochloride is a capsule containing nortriptyline hydrochloride at 50 mg/1, taken oral. Manufactured by Coupler LLC.

Key Facts

Brand Name
Nortriptyline Hydrochloride
Generic Name
Nortriptyline Hydrochloride
NDC Code (Product)
67046-1530
Manufacturer
Coupler LLC
Strength
50 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA073556
Marketing Start
03/10/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use669 reports
drug ineffective660 reports
pain555 reports
headache550 reports
hyperhidrosis492 reports
fatigue461 reports
hypersensitivity443 reports
rheumatoid arthritis393 reports
hepatic enzyme increased386 reports
immunodeficiency368 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

Dosage & Administration

DOSAGE AND ADMINISTRATION Nortriptyline hydrochloride is not recommended for children. Nortriptyline hydrochloride is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission. If a patient develops minor side effects, the dosage should be reduced. The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur. Usual Adult Dose 25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day…

Warnings

WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age …

Contraindications

CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting nortriptyline hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION). Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. Myocardial Infarction Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.

Adverse Reactions

ADVERSE REACTIONS Note - Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered. Cardiovascular - Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric - Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia, panic, nightmares; hypomania; exacerbation of psychosis. Neurologic - Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus. Anticholinergic - Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic - Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face…

Frequently Asked Questions

What is Nortriptyline Hydrochloride used for?

Nortriptyline Hydrochloride contains Nortriptyline Hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Nortriptyline Hydrochloride a controlled substance?

Nortriptyline Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Nortriptyline Hydrochloride?

The generic name for Nortriptyline Hydrochloride is Nortriptyline Hydrochloride. There are 4 other brand versions of Nortriptyline Hydrochloride.

What is the NDC code for Nortriptyline Hydrochloride 50 mg/1?

The NDC (National Drug Code) for Nortriptyline Hydrochloride 50 mg/1 is 67046-1530, listed by Coupler LLC.

Product NDC

67046-1530

Package NDC

67046-1530-3

Other Nortriptyline Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)