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Nortriptyline Hydrochloride
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Tricyclic Antidepressant [EPC] | EPC | All 29 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 073556-001 | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE | NORTRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 073556-002 | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE | NORTRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 073556-003 | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE | NORTRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 073556-004 | NORTRIPTYLINE HYDROCHLORIDE | CAPSULE | NORTRIPTYLINE HYDROCHLORIDE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 55 | Labeling | Approved | February 21, 2020 | Standard |
| Supplement | 52 | Labeling | Approved | July 15, 2015 | Standard |
| Supplement | 50 | Labeling | Approved | July 15, 2015 | Standard |
| Supplement | 34 | Labeling | Approved | February 20, 2008 | — |
| Supplement | 32 | Labeling | Approved | July 3, 2007 | — |
| Supplement | 29 | Labeling | Approved | April 12, 2007 | — |
| Supplement | 24 | Labeling | Approved | November 1, 2006 | — |
| Supplement | 22 | Labeling | Approved | July 26, 2005 | — |
| Supplement | 16 | Labeling | Approved | January 4, 2002 | — |
| Supplement | 15 | Manufacturing (CMC) | Approved | April 25, 2001 | — |
| Supplement | 13 | Manufacturing (CMC) | Approved | August 26, 1998 | — |
| Supplement | 12 | Manufacturing (CMC) | Approved | August 26, 1998 | — |
| Supplement | 11 | Labeling | Approved | February 7, 1997 | — |
| Supplement | 10 | Labeling | Approved | December 5, 1995 | — |
| Supplement | 8 | Manufacturing (CMC) | Approved | July 11, 1995 | — |
| Supplement | 9 | Manufacturing (CMC) | Approved | May 25, 1995 | — |
| Supplement | 7 | Manufacturing (CMC) | Approved | May 25, 1995 | — |
| Supplement | 6 | Manufacturing (CMC) | Approved | February 16, 1995 | — |
| Supplement | 5 | Manufacturing (CMC) | Approved | February 16, 1995 | — |
| Supplement | 4 | Labeling | Approved | August 31, 1993 | — |
| Original application | 1 | Approved | March 30, 1992 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260701). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBOXED WARNING SECTION 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 nortriptyline hydrochloride 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. Nortriptyline hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients ; and PRECAUTIONS, Pediatric Use ).
Indications and Usage
openFDA Drug LabelingINDICATIONS & USAGE SECTION Nortriptyline hydrochloride, USP is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
Dosage and Administration
openFDA Drug LabelingDOSAGE 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 ng/mL to 150 ng/mL. Doses above 150 mg/day are not recommended. Elderly and Adolescent Patients – 30 mg/day to 50 mg/day, in divided doses, or the total daily dosage may be given once a day. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with nortriptyline hydrochloride. Conversely, at least 14 days should be allowed after stopping nortriptyline hydrochloride before starting an MAOI intended to treat psychiatric disorders ( see CONTRAINDICATIONS ). Use of Nortriptyline Hydrochloride With Other MAOIs, Such as Linezolid or Methylene Blue Do not start nortriptyline hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered ( see CONTRAINDICATIONS ). In some cases, a patient already receiving nortriptyline hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, nortriptyline hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with nortriptyline hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue ( see WARNINGS ). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with nortriptyline hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use ( see WARNINGS ).
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS SECTION 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 W ARNINGS 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.
Warnings
openFDA Drug LabelingWARNINGS 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 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1 . Table Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated Increases Compared to Placebo <18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case ≥65 6 fewer cases No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changin …
Adverse Reactions
openFDA Drug LabelingADVERSE 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 and tongue), drug fever, cross-sensitivity with other tricyclic drugs. Hematologic - Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia. Gastrointestinal - Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, blacktongue. Endocrine - Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion. Other - Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia. Withdrawal Symptoms - Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise. Postmarketing Experience The following adverse drug reaction has been reported during post-approval use of nortriptyline hydrochloride. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency. Cardiac Disorders – Brugada syndrome Eye Disorders – angle-closure glaucoma To report SUSPECTED ADVERSE EVENTS, contact Dr. Reddy's Laboratories at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
Drug Interactions
openFDA Drug LabelingDrug Interactions Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a "stimulating" effect in some depressed patients. Close supervision and careful adjustment of the dosage are required when nortriptyline hydrochloride is used with other anticholinergic drugs and sympathomimetic drugs. Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant. The patient should be informed that the response to alcohol may be exaggerated. A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day). Drugs Metabolized by P450 2D6 The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA). In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the co-administration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary). Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6. Monoamine Oxidase Inhibitors (MAOIs) ( See CONTRAINDICATIONS , WARNINGS , and DOSAGE AND ADMINISTRATION . ) Serotonergic Drugs ( See CONTRAINDICATIONS , WARNINGS , and DOSAGE AND ADMINISTRATION . )
Description
openFDA Drug LabelingDESCRIPTION Nortriptyline hydrochloride, USP is 1-propanamine, 3-(10,11-dihydro-5 H -dibenzo[ a,d ]cyclohepten-5-ylidene)- N -methyl-, hydrochloride. The structural formula is as follows: C 19 H 21 N•HCl M.W. 299.8 Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, dimethicone, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6. nortriptyline hydrochloride structural formula
Overdosage
openFDA Drug LabelingOVERDOSAGE Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible. Manifestations Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, shock, congestive heart failure, pulmonary edema, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include: confusion, restlessness, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the acute symptoms listed under ADVERSE REACTIONS . There have been reports of patients recovering from nortriptyline overdoses of up to 525 mg. Management General - Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient. Gastrointestinal Decontamination - All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. EMESIS IS CONTRAINDICATED. Cardiovascular - A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH >7.60 or a pCO 2 <20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide). In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning. CNS - In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center. Psychiatric Follow-up - Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate. Pediatric Management - The principles of management …
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Nortriptyline hydrochloride capsules USP, equivalent to 10 mg, 25 mg, 50 mg or 75 mg base, are available as follows: Nortriptyline hydrochloride capsules USP, 10 mg: #3 capsules with a white body and an orange cap, imprinted "TEVA" on the cap and "10mg"-"0810" on the body, in bottles of 100, and 500. Nortriptyline hydrochloride capsules USP, 25 mg: #4 capsules with a white body and an orange cap, imprinted "TEVA"-"TEVA" on the cap and "25mg"-"0811" on the body, in bottles of 100, and 500. Nortriptyline hydrochloride capsules USP, 50 mg: #1 capsules with a white body and a white cap, imprinted "TEVA" on the cap and "50mg"-"0812" on the body, in bottles of 100, and 500. Nortriptyline hydrochloride capsules USP, 75 mg: #1 capsules with an orange body and an orange cap, imprinted "TEVA" on the cap and "75mg"-"0813" on the body, in bottles of 100, and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense contents in a tight container as defined in the USP, with a child-resistant closure (as required). TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. V 11/2012 MEDICATION GUIDE Nortriptyline Hydrochloride Capsules USP Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Rx only Read the Medication Guide that comes with your or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about: all risks and benefits of treatment with antidepressant medicines all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2.Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying attempts to commit suicide new or worse depression new or worse anxiety feeling very agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulsesan extreme increase in activity and talking (mania) other unusual changes in behavior or mood Who should not take nortriptyline hydrochloride? Do not take nortriptyline hydrochloride if you: take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid. ° Do not take an MAOI within 2 weeks of stopping nortriptyline hydrochloride unless directed to do so by your physician. ° Do not start nortriptyline hydrochloride if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. W …
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NORTRIPTYLINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | February 10, 2021 | Taro Pharmaceuticals U.S.A., Inc. | CGMP deviations. | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0537-0 | 50090-0537 | A-S Medication Solutions | 60 CAPSULE in 1 BOTTLE (50090-0537-0) | June 29, 2016 |
| 50090-0537-1 | 50090-0537 | A-S Medication Solutions | 30 CAPSULE in 1 BOTTLE (50090-0537-1) | June 29, 2016 |
| 50090-1322-0 | 50090-1322 | A-S Medication Solutions | 90 CAPSULE in 1 BOTTLE (50090-1322-0) | November 28, 2014 |
| 50090-7174-0 | 50090-7174 | A-S Medication Solutions | 60 CAPSULE in 1 BOTTLE (50090-7174-0) | May 23, 2024 |
| 50090-7174-1 | 50090-7174 | A-S Medication Solutions | 30 CAPSULE in 1 BOTTLE (50090-7174-1) | May 23, 2024 |
| 50090-7191-0 | 50090-7191 | A-S Medication Solutions | 30 CAPSULE in 1 BOTTLE (50090-7191-0) | July 8, 2024 |
| 50090-7191-3 | 50090-7191 | A-S Medication Solutions | 90 CAPSULE in 1 BOTTLE (50090-7191-3) | July 8, 2024 |
| 80425-0401-1 | 80425-0401 | Advanced Rx Pharmacy of Tennessee, LLC | 30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-1) | June 7, 2024 |
| 80425-0401-2 | 80425-0401 | Advanced Rx Pharmacy of Tennessee, LLC | 60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-2) | June 7, 2024 |
| 80425-0401-3 | 80425-0401 | Advanced Rx Pharmacy of Tennessee, LLC | 90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0401-3) | June 7, 2024 |
| 80425-0534-1 | 80425-0534 | Advanced Rx of Tennessee, LLC | 30 CAPSULE in 1 BOTTLE, PLASTIC (80425-0534-1) | June 3, 2025 |
| 80425-0534-2 | 80425-0534 | Advanced Rx of Tennessee, LLC | 60 CAPSULE in 1 BOTTLE, PLASTIC (80425-0534-2) | June 3, 2025 |
| 80425-0534-3 | 80425-0534 | Advanced Rx of Tennessee, LLC | 90 CAPSULE in 1 BOTTLE, PLASTIC (80425-0534-3) | June 3, 2025 |
| 60687-900-01 | 60687-900 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-900-01) / 1 CAPSULE in 1 BLISTER PACK (60687-900-11) | December 1, 2025 |
| 60687-911-01 | 60687-911 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-911-01) / 1 CAPSULE in 1 BLISTER PACK (60687-911-11) | December 1, 2025 |
| 71610-785-30 | 71610-785 | Aphena Pharma Solutions - Tennessee, LLC | 30 CAPSULE in 1 BOTTLE (71610-785-30) | January 26, 2024 |
| 71610-785-60 | 71610-785 | Aphena Pharma Solutions - Tennessee, LLC | 90 CAPSULE in 1 BOTTLE (71610-785-60) | January 26, 2024 |
| 76420-910-01 | 76420-910 | Asclemed USA, Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-01) | January 28, 2025 |
| 76420-910-05 | 76420-910 | Asclemed USA, Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-05) | January 28, 2025 |
| 76420-910-30 | 76420-910 | Asclemed USA, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-30) | January 28, 2025 |
| 76420-910-60 | 76420-910 | Asclemed USA, Inc. | 60 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-60) | January 28, 2025 |
| 76420-910-90 | 76420-910 | Asclemed USA, Inc. | 90 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-90) | January 28, 2025 |
| 76420-911-01 | 76420-911 | Asclemed USA, Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (76420-911-01) | January 28, 2025 |
| 76420-911-05 | 76420-911 | Asclemed USA, Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (76420-911-05) | January 28, 2025 |
| 76420-911-30 | 76420-911 | Asclemed USA, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (76420-911-30) | January 28, 2025 |
| 76420-911-60 | 76420-911 | Asclemed USA, Inc. | 60 CAPSULE in 1 BOTTLE, PLASTIC (76420-911-60) | January 28, 2025 |
| 76420-911-90 | 76420-911 | Asclemed USA, Inc. | 90 CAPSULE in 1 BOTTLE, PLASTIC (76420-911-90) | January 28, 2025 |
| 76420-912-01 | 76420-912 | Asclemed USA, Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-01) | January 28, 2025 |
| 76420-912-05 | 76420-912 | Asclemed USA, Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-05) | January 28, 2025 |
| 76420-912-30 | 76420-912 | Asclemed USA, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-30) | January 28, 2025 |
| 76420-912-60 | 76420-912 | Asclemed USA, Inc. | 60 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-60) | January 28, 2025 |
| 76420-912-90 | 76420-912 | Asclemed USA, Inc. | 90 CAPSULE in 1 BOTTLE, PLASTIC (76420-912-90) | January 28, 2025 |
| 76420-913-01 | 76420-913 | Asclemed USA, Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-01) | January 28, 2025 |
| 76420-913-30 | 76420-913 | Asclemed USA, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-30) | January 28, 2025 |
| 76420-913-60 | 76420-913 | Asclemed USA, Inc. | 60 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-60) | January 28, 2025 |
| 76420-913-90 | 76420-913 | Asclemed USA, Inc. | 90 CAPSULE in 1 BOTTLE, PLASTIC (76420-913-90) | January 28, 2025 |
| 63629-3204-1 | 63629-3204 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (63629-3204-1) | August 16, 2006 |
| 63629-3204-2 | 63629-3204 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (63629-3204-2) | October 13, 2008 |
| 63629-3204-3 | 63629-3204 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (63629-3204-3) | November 18, 2013 |
| 63629-3204-4 | 63629-3204 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (63629-3204-4) | December 22, 2021 |
| 63629-3204-5 | 63629-3204 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (63629-3204-5) | May 10, 2011 |
| 63629-3204-6 | 63629-3204 | Bryant Ranch Prepack | 15 CAPSULE in 1 BOTTLE (63629-3204-6) | June 13, 2014 |
| 63629-4276-1 | 63629-4276 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (63629-4276-1) | August 1, 2011 |
| 63629-4276-2 | 63629-4276 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (63629-4276-2) | August 1, 2011 |
| 63629-4276-3 | 63629-4276 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (63629-4276-3) | June 7, 2010 |
| 63629-4276-4 | 63629-4276 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (63629-4276-4) | June 7, 2010 |
| 63629-4276-5 | 63629-4276 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (63629-4276-5) | June 7, 2010 |
| 71335-0065-1 | 71335-0065 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-0065-1) | July 27, 2018 |
| 71335-0065-2 | 71335-0065 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-0065-2) | December 27, 2021 |
| 71335-0065-3 | 71335-0065 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-0065-3) | December 27, 2021 |
| 71335-0065-4 | 71335-0065 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-0065-4) | December 27, 2021 |
| 71335-0083-2 | 71335-0083 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-0083-2) | July 28, 2015 |
| 71335-0083-4 | 71335-0083 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-0083-4) | July 28, 2015 |
| 71335-0083-5 | 71335-0083 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-0083-5) | July 28, 2015 |
| 71335-0083-6 | 71335-0083 | Bryant Ranch Prepack | 50 CAPSULE in 1 BOTTLE (71335-0083-6) | July 28, 2015 |
| 71335-0083-7 | 71335-0083 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (71335-0083-7) | July 28, 2015 |
| 71335-0083-8 | 71335-0083 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-0083-8) | July 28, 2015 |
| 71335-0083-9 | 71335-0083 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-0083-9) | July 28, 2015 |
| 71335-0155-1 | 71335-0155 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-0155-1) | February 3, 2012 |
| 71335-0155-2 | 71335-0155 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-0155-2) | February 3, 2012 |
| 71335-0155-3 | 71335-0155 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-0155-3) | February 3, 2012 |
| 71335-0155-4 | 71335-0155 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-0155-4) | February 3, 2012 |
| 71335-0155-5 | 71335-0155 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-0155-5) | February 3, 2012 |
| 71335-0426-1 | 71335-0426 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-0426-1) | April 29, 2015 |
| 71335-0426-2 | 71335-0426 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-0426-2) | April 29, 2015 |
| 71335-0426-3 | 71335-0426 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-0426-3) | April 29, 2015 |
| 71335-0426-4 | 71335-0426 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (71335-0426-4) | April 29, 2015 |
| 71335-0426-5 | 71335-0426 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-0426-5) | April 29, 2015 |
| 71335-0426-6 | 71335-0426 | Bryant Ranch Prepack | 15 CAPSULE in 1 BOTTLE (71335-0426-6) | April 29, 2015 |
| 71335-1552-1 | 71335-1552 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-1552-1) | March 31, 2020 |
| 71335-1552-2 | 71335-1552 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-1552-2) | March 31, 2020 |
| 71335-1552-3 | 71335-1552 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-1552-3) | March 31, 2020 |
| 71335-1552-4 | 71335-1552 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-1552-4) | March 31, 2020 |
| 71335-2350-2 | 71335-2350 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-2) | February 21, 2024 |
| 71335-2350-4 | 71335-2350 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-4) | February 21, 2024 |
| 71335-2350-5 | 71335-2350 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-5) | February 21, 2024 |
| 71335-2350-6 | 71335-2350 | Bryant Ranch Prepack | 50 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-6) | February 21, 2024 |
| 71335-2350-7 | 71335-2350 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-7) | February 21, 2024 |
| 71335-2350-8 | 71335-2350 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-8) | February 21, 2024 |
| 71335-2350-9 | 71335-2350 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE, PLASTIC (71335-2350-9) | February 21, 2024 |
| 71335-2351-1 | 71335-2351 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-1) | February 21, 2024 |
| 71335-2351-2 | 71335-2351 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-2) | February 21, 2024 |
| 71335-2351-3 | 71335-2351 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-3) | February 21, 2024 |
| 71335-2351-4 | 71335-2351 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-4) | February 21, 2024 |
| 71335-2351-5 | 71335-2351 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2351-5) | February 21, 2024 |
| 71335-2459-1 | 71335-2459 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2459-1) | August 22, 2024 |
| 71335-2459-2 | 71335-2459 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2459-2) | August 22, 2024 |
| 71335-2459-3 | 71335-2459 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2459-3) | August 22, 2024 |
| 71335-2459-4 | 71335-2459 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE, PLASTIC (71335-2459-4) | August 22, 2024 |
| 71335-2772-1 | 71335-2772 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-1) | October 13, 2025 |
| 71335-2772-2 | 71335-2772 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-2) | October 13, 2025 |
| 71335-2772-3 | 71335-2772 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-3) | October 13, 2025 |
| 71335-2772-4 | 71335-2772 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-4) | October 13, 2025 |
| 71335-2772-5 | 71335-2772 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-5) | October 13, 2025 |
| 71335-2772-6 | 71335-2772 | Bryant Ranch Prepack | 15 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-6) | October 13, 2025 |
| 67046-1411-3 | 67046-1411 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-1411-3) | January 25, 2025 |
| 67046-1500-3 | 67046-1500 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-1500-3) | January 28, 2025 |
| 67046-1530-3 | 67046-1530 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-1530-3) | March 10, 2025 |
| 67046-1661-3 | 67046-1661 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-1661-3) | March 3, 2026 |
| 61919-353-30 | 61919-353 | DIRECT RX | 30 CAPSULE in 1 BOTTLE (61919-353-30) | September 15, 2021 |
| 61919-353-60 | 61919-353 | DIRECT RX | 60 CAPSULE in 1 BOTTLE (61919-353-60) | September 15, 2021 |
| 61919-353-90 | 61919-353 | DIRECT RX | 90 CAPSULE in 1 BOTTLE (61919-353-90) | September 15, 2021 |
| 61919-171-30 | 61919-171 | Direct Rx | 30 CAPSULE in 1 BOTTLE (61919-171-30) | January 1, 2015 |
| 61919-171-60 | 61919-171 | Direct Rx | 60 BOTTLE in 1 BOTTLE (61919-171-60) / 30 CAPSULE in 1 BOTTLE (61919-171-30) | August 6, 2025 |
| 61919-435-30 | 61919-435 | Direct Rx | 30 CAPSULE in 1 BOTTLE (61919-435-30) | January 1, 2015 |
| 61919-435-60 | 61919-435 | Direct Rx | 60 CAPSULE in 1 BOTTLE (61919-435-60) | January 1, 2015 |
| 61919-435-90 | 61919-435 | Direct Rx | 90 CAPSULE in 1 BOTTLE (61919-435-90) | January 1, 2015 |
| 75907-069-01 | 75907-069 | Dr. Reddy's Laboratories Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (75907-069-01) | November 17, 2023 |
| 75907-069-05 | 75907-069 | Dr. Reddy's Laboratories Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (75907-069-05) | November 17, 2023 |
| 75907-070-01 | 75907-070 | Dr. Reddy's Laboratories Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-01) | November 17, 2023 |
| 75907-070-05 | 75907-070 | Dr. Reddy's Laboratories Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-05) | November 17, 2023 |
| 75907-071-01 | 75907-071 | Dr. Reddy's Laboratories Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-01) | November 17, 2023 |
| 75907-071-05 | 75907-071 | Dr. Reddy's Laboratories Inc. | 500 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-05) | November 17, 2023 |
| 75907-072-01 | 75907-072 | Dr. Reddy's Laboratories Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (75907-072-01) | November 17, 2023 |
| 51862-016-10 | 51862-016 | Mayne Pharma Inc. | 1000 CAPSULE in 1 BOTTLE, PLASTIC (51862-016-10) | June 1, 2016 |
| 51655-507-52 | 51655-507 | Northwind Health Company, LLC | 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-507-52) | January 13, 2021 |
| 82868-023-60 | 82868-023 | Northwind Health Company, LLC | 60 CAPSULE in 1 BOTTLE, PLASTIC (82868-023-60) | October 31, 2023 |
| 68071-3211-1 | 68071-3211 | NuCare Pharmaceuticals, Inc. | 120 CAPSULE in 1 BOTTLE (68071-3211-1) | June 8, 2017 |
| 68071-3211-2 | 68071-3211 | NuCare Pharmaceuticals, Inc. | 20 CAPSULE in 1 BOTTLE (68071-3211-2) | June 8, 2017 |
| 68071-3211-3 | 68071-3211 | NuCare Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE (68071-3211-3) | June 8, 2017 |
| 68071-3211-5 | 68071-3211 | NuCare Pharmaceuticals, Inc. | 45 CAPSULE in 1 BOTTLE (68071-3211-5) | June 8, 2017 |
| 68071-3211-6 | 68071-3211 | NuCare Pharmaceuticals, Inc. | 60 CAPSULE in 1 BOTTLE (68071-3211-6) | June 8, 2017 |
| 68071-3211-9 | 68071-3211 | NuCare Pharmaceuticals, Inc. | 90 CAPSULE in 1 BOTTLE (68071-3211-9) | June 8, 2017 |
| 43063-722-30 | 43063-722 | PD-Rx Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-722-30) | October 27, 2016 |
| 72789-425-30 | 72789-425 | PD-Rx Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-425-30) | August 7, 2024 |
| 68788-8721-1 | 68788-8721 | Preferred Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-1) | August 9, 2024 |
| 68788-8721-3 | 68788-8721 | Preferred Pharmaceuticals Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-3) | August 9, 2024 |
| 68788-8721-6 | 68788-8721 | Preferred Pharmaceuticals Inc. | 60 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-6) | August 9, 2024 |
| 68788-8721-9 | 68788-8721 | Preferred Pharmaceuticals Inc. | 90 CAPSULE in 1 BOTTLE, PLASTIC (68788-8721-9) | August 9, 2024 |
| 68788-8900-3 | 68788-8900 | Preferred Pharmaceuticals Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8900-3) | July 10, 2025 |
| 63187-396-30 | 63187-396 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (63187-396-30) | October 3, 2016 |
| 63187-396-60 | 63187-396 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (63187-396-60) | October 3, 2016 |
| 63187-396-90 | 63187-396 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (63187-396-90) | October 3, 2016 |
| 63187-715-30 | 63187-715 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (63187-715-30) | June 1, 2016 |
| 63187-715-60 | 63187-715 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (63187-715-60) | June 1, 2016 |
| 63187-715-90 | 63187-715 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (63187-715-90) | June 1, 2016 |
| 63187-759-30 | 63187-759 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (63187-759-30) | October 3, 2016 |
| 63187-759-60 | 63187-759 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (63187-759-60) | October 3, 2016 |
| 63187-759-90 | 63187-759 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (63187-759-90) | October 3, 2016 |
| 63187-798-30 | 63187-798 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (63187-798-30) | January 1, 2017 |
| 63187-798-60 | 63187-798 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (63187-798-60) | January 1, 2017 |
| 63187-798-90 | 63187-798 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (63187-798-90) | January 1, 2017 |
| 63187-809-00 | 63187-809 | Proficient Rx LP | 100 CAPSULE in 1 BOTTLE (63187-809-00) | February 1, 2017 |
| 63187-809-30 | 63187-809 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (63187-809-30) | February 1, 2017 |
| 63187-809-60 | 63187-809 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (63187-809-60) | February 1, 2017 |
| 63187-809-90 | 63187-809 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (63187-809-90) | February 1, 2017 |
| 71205-254-30 | 71205-254 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (71205-254-30) | April 1, 2019 |
| 71205-254-60 | 71205-254 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (71205-254-60) | April 1, 2019 |
| 71205-254-90 | 71205-254 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (71205-254-90) | April 1, 2019 |
| 71205-770-30 | 71205-770 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (71205-770-30) | March 10, 2023 |
| 71205-770-60 | 71205-770 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (71205-770-60) | March 10, 2023 |
| 71205-770-90 | 71205-770 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (71205-770-90) | March 10, 2023 |
| 82804-139-30 | 82804-139 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE, PLASTIC (82804-139-30) | September 6, 2024 |
| 82804-302-90 | 82804-302 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE, PLASTIC (82804-302-90) | July 9, 2026 |
| 70518-3920-1 | 70518-3920 | REMEDYREPACK INC. | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-3920-1) | May 18, 2025 |
| 70518-4017-0 | 70518-4017 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4017-0) | February 9, 2024 |
| 70518-4086-0 | 70518-4086 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4086-0) | May 25, 2024 |
| 70518-4086-1 | 70518-4086 | REMEDYREPACK INC. | 50 POUCH in 1 BOX (70518-4086-1) / 1 CAPSULE in 1 POUCH (70518-4086-2) | April 24, 2026 |
| 70518-4122-0 | 70518-4122 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4122-0) | June 28, 2024 |
| 70518-4122-1 | 70518-4122 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4122-1) | March 3, 2025 |
| 70518-4281-0 | 70518-4281 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4281-0) | February 8, 2025 |
| 60760-908-60 | 60760-908 | ST. MARY'S MEDICAL PARK PHARMACY | 60 CAPSULE in 1 BOTTLE, PLASTIC (60760-908-60) | August 28, 2024 |
| 60760-909-30 | 60760-909 | St. Mary's Medical Park Pharmacy | 30 CAPSULE in 1 BOTTLE, PLASTIC (60760-909-30) | August 14, 2025 |
| 51672-4001-1 | 51672-4001 | Sun Pharmaceutical Industries, Inc. | 100 CAPSULE in 1 BOTTLE (51672-4001-1) | May 8, 2000 |
| 51672-4001-2 | 51672-4001 | Sun Pharmaceutical Industries, Inc. | 500 CAPSULE in 1 BOTTLE (51672-4001-2) | May 8, 2000 |
| 51672-4001-5 | 51672-4001 | Sun Pharmaceutical Industries, Inc. | 90 CAPSULE in 1 BOTTLE (51672-4001-5) | May 8, 2000 |
| 51672-4001-6 | 51672-4001 | Sun Pharmaceutical Industries, Inc. | 30 CAPSULE in 1 BOTTLE (51672-4001-6) | May 8, 2000 |
| 51672-4002-1 | 51672-4002 | Sun Pharmaceutical Industries, Inc. | 100 CAPSULE in 1 BOTTLE (51672-4002-1) | May 8, 2000 |
| 51672-4002-2 | 51672-4002 | Sun Pharmaceutical Industries, Inc. | 500 CAPSULE in 1 BOTTLE (51672-4002-2) | May 8, 2000 |
| 51672-4002-4 | 51672-4002 | Sun Pharmaceutical Industries, Inc. | 60 CAPSULE in 1 BOTTLE (51672-4002-4) | May 8, 2000 |
| 51672-4002-5 | 51672-4002 | Sun Pharmaceutical Industries, Inc. | 90 CAPSULE in 1 BOTTLE (51672-4002-5) | May 8, 2000 |
| 51672-4002-6 | 51672-4002 | Sun Pharmaceutical Industries, Inc. | 30 CAPSULE in 1 BOTTLE (51672-4002-6) | May 8, 2000 |
| 51672-4003-1 | 51672-4003 | Sun Pharmaceutical Industries, Inc. | 100 CAPSULE in 1 BOTTLE (51672-4003-1) | May 8, 2000 |
| 51672-4003-2 | 51672-4003 | Sun Pharmaceutical Industries, Inc. | 500 CAPSULE in 1 BOTTLE (51672-4003-2) | May 8, 2000 |
| 51672-4003-5 | 51672-4003 | Sun Pharmaceutical Industries, Inc. | 90 CAPSULE in 1 BOTTLE (51672-4003-5) | May 8, 2000 |
| 51672-4003-6 | 51672-4003 | Sun Pharmaceutical Industries, Inc. | 30 CAPSULE in 1 BOTTLE (51672-4003-6) | May 8, 2000 |
| 51672-4004-1 | 51672-4004 | Sun Pharmaceutical Industries, Inc. | 100 CAPSULE in 1 BOTTLE (51672-4004-1) | May 8, 2000 |
| 51672-4004-2 | 51672-4004 | Sun Pharmaceutical Industries, Inc. | 500 CAPSULE in 1 BOTTLE (51672-4004-2) | May 8, 2000 |
| 51672-4004-5 | 51672-4004 | Sun Pharmaceutical Industries, Inc. | 90 CAPSULE in 1 BOTTLE (51672-4004-5) | May 8, 2000 |
| 51672-4004-6 | 51672-4004 | Sun Pharmaceutical Industries, Inc. | 30 CAPSULE in 1 BOTTLE (51672-4004-6) | May 8, 2000 |
| 0093-0810-01 | 0093-0810 | Teva Pharmaceuticals USA, Inc. | 100 CAPSULE in 1 BOTTLE (0093-0810-01) | April 5, 1995 |
| 0093-0810-05 | 0093-0810 | Teva Pharmaceuticals USA, Inc. | 500 CAPSULE in 1 BOTTLE (0093-0810-05) | April 5, 1995 |
| 0093-0811-01 | 0093-0811 | Teva Pharmaceuticals USA, Inc. | 100 CAPSULE in 1 BOTTLE (0093-0811-01) | April 6, 1995 |
| 0093-0811-05 | 0093-0811 | Teva Pharmaceuticals USA, Inc. | 500 CAPSULE in 1 BOTTLE (0093-0811-05) | April 6, 1995 |
| 0093-0812-01 | 0093-0812 | Teva Pharmaceuticals USA, Inc. | 100 CAPSULE in 1 BOTTLE (0093-0812-01) | April 5, 1995 |
| 0093-0812-05 | 0093-0812 | Teva Pharmaceuticals USA, Inc. | 500 CAPSULE in 1 BOTTLE (0093-0812-05) | April 6, 1995 |
| 0093-0813-01 | 0093-0813 | Teva Pharmaceuticals USA, Inc. | 100 CAPSULE in 1 BOTTLE (0093-0813-01) | April 5, 1995 |
| 70771-1612-1 | 70771-1612 | Zydus Lifesciences Limited | 100 CAPSULE in 1 BOTTLE (70771-1612-1) | February 10, 2022 |
| 70771-1612-3 | 70771-1612 | Zydus Lifesciences Limited | 30 CAPSULE in 1 BOTTLE (70771-1612-3) | February 10, 2022 |
| 70771-1612-5 | 70771-1612 | Zydus Lifesciences Limited | 500 CAPSULE in 1 BOTTLE (70771-1612-5) | February 10, 2022 |
| 70771-1613-1 | 70771-1613 | Zydus Lifesciences Limited | 100 CAPSULE in 1 BOTTLE (70771-1613-1) | February 10, 2022 |
| 70771-1613-3 | 70771-1613 | Zydus Lifesciences Limited | 30 CAPSULE in 1 BOTTLE (70771-1613-3) | February 10, 2022 |
| 70771-1613-5 | 70771-1613 | Zydus Lifesciences Limited | 500 CAPSULE in 1 BOTTLE (70771-1613-5) | February 10, 2022 |
| 70771-1614-1 | 70771-1614 | Zydus Lifesciences Limited | 100 CAPSULE in 1 BOTTLE (70771-1614-1) | February 10, 2022 |
| 70771-1614-3 | 70771-1614 | Zydus Lifesciences Limited | 30 CAPSULE in 1 BOTTLE (70771-1614-3) | February 10, 2022 |
| 70771-1614-5 | 70771-1614 | Zydus Lifesciences Limited | 500 CAPSULE in 1 BOTTLE (70771-1614-5) | February 10, 2022 |
| 70771-1615-1 | 70771-1615 | Zydus Lifesciences Limited | 100 CAPSULE in 1 BOTTLE (70771-1615-1) | February 10, 2022 |
| 70771-1615-3 | 70771-1615 | Zydus Lifesciences Limited | 30 CAPSULE in 1 BOTTLE (70771-1615-3) | February 10, 2022 |
| 70771-1615-5 | 70771-1615 | Zydus Lifesciences Limited | 500 CAPSULE in 1 BOTTLE (70771-1615-5) | February 10, 2022 |
| 70710-1153-1 | 70710-1153 | Zydus Pharmaceuticals (USA) Inc. | 100 CAPSULE in 1 BOTTLE (70710-1153-1) | February 10, 2022 |
| 70710-1153-3 | 70710-1153 | Zydus Pharmaceuticals (USA) Inc. | 30 CAPSULE in 1 BOTTLE (70710-1153-3) | February 10, 2022 |
| 70710-1153-5 | 70710-1153 | Zydus Pharmaceuticals (USA) Inc. | 500 CAPSULE in 1 BOTTLE (70710-1153-5) | February 10, 2022 |
| 70710-1154-1 | 70710-1154 | Zydus Pharmaceuticals (USA) Inc. | 100 CAPSULE in 1 BOTTLE (70710-1154-1) | February 10, 2022 |
| 70710-1154-3 | 70710-1154 | Zydus Pharmaceuticals (USA) Inc. | 30 CAPSULE in 1 BOTTLE (70710-1154-3) | February 10, 2022 |
| 70710-1154-5 | 70710-1154 | Zydus Pharmaceuticals (USA) Inc. | 500 CAPSULE in 1 BOTTLE (70710-1154-5) | February 10, 2022 |
| 70710-1155-1 | 70710-1155 | Zydus Pharmaceuticals (USA) Inc. | 100 CAPSULE in 1 BOTTLE (70710-1155-1) | February 10, 2022 |
| 70710-1155-3 | 70710-1155 | Zydus Pharmaceuticals (USA) Inc. | 30 CAPSULE in 1 BOTTLE (70710-1155-3) | February 10, 2022 |
| 70710-1155-5 | 70710-1155 | Zydus Pharmaceuticals (USA) Inc. | 500 CAPSULE in 1 BOTTLE (70710-1155-5) | February 10, 2022 |
| 70710-1156-1 | 70710-1156 | Zydus Pharmaceuticals (USA) Inc. | 100 CAPSULE in 1 BOTTLE (70710-1156-1) | February 10, 2022 |
| 70710-1156-3 | 70710-1156 | Zydus Pharmaceuticals (USA) Inc. | 30 CAPSULE in 1 BOTTLE (70710-1156-3) | February 10, 2022 |
| 70710-1156-5 | 70710-1156 | Zydus Pharmaceuticals (USA) Inc. | 500 CAPSULE in 1 BOTTLE (70710-1156-5) | February 10, 2022 |
| 50090-0537 | 50090-0537 | A-S Medication Solutions | — | May 8, 2000 |
| 50090-1322 | 50090-1322 | A-S Medication Solutions | — | April 5, 1995 |
| 50090-7174 | 50090-7174 | A-S Medication Solutions | — | April 5, 1995 |
| 50090-7191 | 50090-7191 | A-S Medication Solutions | — | November 17, 2023 |
| 80425-0401 | 80425-0401 | Advanced Rx Pharmacy of Tennessee, LLC | — | June 7, 2024 |
| 80425-0534 | 80425-0534 | Advanced Rx of Tennessee, LLC | — | June 3, 2025 |
| 60687-900 | 60687-900 | American Health Packaging | — | December 1, 2025 |
| 60687-911 | 60687-911 | American Health Packaging | — | December 1, 2025 |
| 71610-785 | 71610-785 | Aphena Pharma Solutions - Tennessee, LLC | — | April 6, 1995 |
| 76420-910 | 76420-910 | Asclemed USA, Inc. | — | November 17, 2023 |
| 76420-911 | 76420-911 | Asclemed USA, Inc. | — | November 17, 2023 |
| 76420-912 | 76420-912 | Asclemed USA, Inc. | — | November 17, 2023 |
| 76420-913 | 76420-913 | Asclemed USA, Inc. | — | November 17, 2023 |
| 63629-3204 | 63629-3204 | Bryant Ranch Prepack | — | April 5, 1995 |
| 63629-4276 | 63629-4276 | Bryant Ranch Prepack | — | April 5, 1995 |
| 71335-0065 | 71335-0065 | Bryant Ranch Prepack | — | April 5, 1995 |
| 71335-0083 | 71335-0083 | Bryant Ranch Prepack | — | May 8, 2000 |
| 71335-0155 | 71335-0155 | Bryant Ranch Prepack | — | May 8, 2000 |
| 71335-0426 | 71335-0426 | Bryant Ranch Prepack | — | May 8, 2000 |
| 71335-1552 | 71335-1552 | Bryant Ranch Prepack | — | May 8, 2000 |
| 71335-2350 | 71335-2350 | Bryant Ranch Prepack | — | November 17, 2023 |
| 71335-2351 | 71335-2351 | Bryant Ranch Prepack | — | November 17, 2023 |
| 71335-2459 | 71335-2459 | Bryant Ranch Prepack | — | November 17, 2023 |
| 71335-2772 | 71335-2772 | Bryant Ranch Prepack | — | November 17, 2023 |
| 67046-1411 | 67046-1411 | Coupler LLC | — | January 25, 2025 |
| 67046-1500 | 67046-1500 | Coupler LLC | — | January 28, 2025 |
| 67046-1530 | 67046-1530 | Coupler LLC | — | March 10, 2025 |
| 67046-1661 | 67046-1661 | Coupler LLC | — | March 3, 2026 |
| 61919-353 | 61919-353 | DIRECT RX | — | September 15, 2021 |
| 61919-171 | 61919-171 | Direct Rx | — | January 1, 2015 |
| 61919-435 | 61919-435 | Direct Rx | — | January 1, 2015 |
| 75907-069 | 75907-069 | Dr. Reddy's Laboratories Inc. | — | November 17, 2023 |
| 75907-070 | 75907-070 | Dr. Reddy's Laboratories Inc. | — | November 17, 2023 |
| 75907-071 | 75907-071 | Dr. Reddy's Laboratories Inc. | — | November 17, 2023 |
| 75907-072 | 75907-072 | Dr. Reddy's Laboratories Inc. | — | November 17, 2023 |
| 51862-016 | 51862-016 | Mayne Pharma Inc. | — | June 1, 2016 |
| 51655-507 | 51655-507 | Northwind Health Company, LLC | — | January 13, 2021 |
| 82868-023 | 82868-023 | Northwind Health Company, LLC | — | October 31, 2023 |
| 68071-3211 | 68071-3211 | NuCare Pharmaceuticals, Inc. | — | May 8, 2000 |
| 43063-722 | 43063-722 | PD-Rx Pharmaceuticals, Inc. | — | June 1, 2016 |
| 72789-425 | 72789-425 | PD-Rx Pharmaceuticals, Inc. | — | November 17, 2023 |
| 68788-8721 | 68788-8721 | Preferred Pharmaceuticals Inc. | — | August 9, 2024 |
| 68788-8900 | 68788-8900 | Preferred Pharmaceuticals Inc. | — | July 10, 2025 |
| 63187-396 | 63187-396 | Proficient Rx LP | — | May 8, 2000 |
| 63187-715 | 63187-715 | Proficient Rx LP | — | May 8, 2000 |
| 63187-759 | 63187-759 | Proficient Rx LP | — | April 5, 1995 |
| 63187-798 | 63187-798 | Proficient Rx LP | — | May 8, 2000 |
| 63187-809 | 63187-809 | Proficient Rx LP | — | April 5, 1995 |
| 71205-254 | 71205-254 | Proficient Rx LP | — | April 6, 1995 |
| 71205-770 | 71205-770 | Proficient Rx LP | — | April 5, 1995 |
| 82804-139 | 82804-139 | Proficient Rx LP | — | November 17, 2023 |
| 82804-302 | 82804-302 | Proficient Rx LP | — | November 17, 2023 |
| 70518-3920 | 70518-3920 | REMEDYREPACK INC. | — | November 21, 2023 |
| 70518-4017 | 70518-4017 | REMEDYREPACK INC. | — | February 9, 2024 |
| 70518-4086 | 70518-4086 | REMEDYREPACK INC. | — | May 25, 2024 |
| 70518-4122 | 70518-4122 | REMEDYREPACK INC. | — | June 28, 2024 |
| 70518-4281 | 70518-4281 | REMEDYREPACK INC. | — | February 8, 2025 |
| 60760-908 | 60760-908 | ST. MARY'S MEDICAL PARK PHARMACY | — | November 17, 2023 |
| 60760-909 | 60760-909 | St. Mary's Medical Park Pharmacy | — | August 14, 2025 |
| 51672-4001 | 51672-4001 | Sun Pharmaceutical Industries, Inc. | — | May 8, 2000 |
| 51672-4002 | 51672-4002 | Sun Pharmaceutical Industries, Inc. | — | May 8, 2000 |
| 51672-4003 | 51672-4003 | Sun Pharmaceutical Industries, Inc. | — | May 8, 2000 |
| 51672-4004 | 51672-4004 | Sun Pharmaceutical Industries, Inc. | — | May 8, 2000 |
| 0093-0810 | 0093-0810 | Teva Pharmaceuticals USA, Inc. | — | April 5, 1995 |
| 0093-0811 | 0093-0811 | Teva Pharmaceuticals USA, Inc. | — | April 6, 1995 |
| 0093-0812 | 0093-0812 | Teva Pharmaceuticals USA, Inc. | — | April 5, 1995 |
| 0093-0813 | 0093-0813 | Teva Pharmaceuticals USA, Inc. | — | April 5, 1995 |
| 70771-1612 | 70771-1612 | Zydus Lifesciences Limited | — | February 10, 2022 |
| 70771-1613 | 70771-1613 | Zydus Lifesciences Limited | — | February 10, 2022 |
| 70771-1614 | 70771-1614 | Zydus Lifesciences Limited | — | February 10, 2022 |
| 70771-1615 | 70771-1615 | Zydus Lifesciences Limited | — | February 10, 2022 |
| 70710-1153 | 70710-1153 | Zydus Pharmaceuticals (USA) Inc. | — | February 10, 2022 |
| 70710-1154 | 70710-1154 | Zydus Pharmaceuticals (USA) Inc. | — | February 10, 2022 |
| 70710-1155 | 70710-1155 | Zydus Pharmaceuticals (USA) Inc. | — | February 10, 2022 |
| 70710-1156 | 70710-1156 | Zydus Pharmaceuticals (USA) Inc. | — | February 10, 2022 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.