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Amitriptyline Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Amitriptyline Hydrochloride | 10 mg/1 | 856783 | View |
| Amitriptyline Hydrochloride | 100 mg/1 | 856783 | View |
| Amitriptyline Hydrochloride | 150 mg/1 | 856783 | View |
| Amitriptyline Hydrochloride | 25 mg/1 | 856783 | View |
| Amitriptyline Hydrochloride | 50 mg/1 | 856783 | View |
| Amitriptyline Hydrochloride | 75 mg/1 | 856783 | View |
Forms, 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 |
|---|---|---|---|---|---|---|---|
| 214548-001 | AMITRIPTYLINE HYDROCHLORIDE | TABLET | AMITRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 214548-002 | AMITRIPTYLINE HYDROCHLORIDE | TABLET | AMITRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 214548-003 | AMITRIPTYLINE HYDROCHLORIDE | TABLET | AMITRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 214548-004 | AMITRIPTYLINE HYDROCHLORIDE | TABLET | AMITRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 214548-005 | AMITRIPTYLINE HYDROCHLORIDE | TABLET | AMITRIPTYLINE HYDROCHLORIDE | Prescription | AB | ||
| 214548-006 | AMITRIPTYLINE HYDROCHLORIDE | TABLET | AMITRIPTYLINE 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 | 14 | Labeling | Approved | June 24, 2025 | Standard |
| Supplement | 2 | Labeling | Approved | June 24, 2025 | Standard |
| Original application | 1 | Approved | May 19, 2021 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260408). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingSuicidality 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 amitriptyline hydrochloride tablets 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. amitriptyline hydrochloride tablets are 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 AND USAGE: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Oral Dosage Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Initial Dosage for Adults For outpatients, 75 mg of amitriptyline hydrochloride a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline hydrochloride at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day. Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages. Maintenance The usual maintenance dosage of amitriptyline hydrochloride is 50 to 100 mg per day. In some patients, 40 mg per day is sufficient. For maintenance therapy, the total daily dosage may be given in a single dose, preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse. Usage in Pediatric Patients In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age. Plasma Levels Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Because of increased intestinal transit time and decreased hepatic metabolism in elderly patients, plasma levels are generally higher for a given oral dose of amitriptyline hydrochloride than in younger patients. Elderly patients should be monitored carefully and quantitative serum levels obtained as clinically appropriate. Adjustments in dosage should be made according to the patient's clinical response and not on the basis of plasma levels. 2 2 Hollister, L.E.; Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2,530-2,533.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS: Amitriptyline hydrochloride tablets are contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardial infarction.
Warnings and Cautions
openFDA Drug LabelingClinical 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 4,400 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 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated Increases Compared to Placebo <18 14 additional cases 18-24 5 additional cases Decreases Compared to Placebo 25-64 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 changing the therape …
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 1 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 Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered. Cardiovascular Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. CNS and Neuromuscular Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns. Anticholinergic Paralytic ileus, hyperpyrexia; urinary retention, dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth. Allergic Skin rash; urticaria; photosensitization; edema of face and tongue. Hematologic Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia. Gastrointestinal Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue. Endocrine Testicular swelling and gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido; impotence; elevation and lowering of blood sugar levels. Other Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration. Withdrawal Symptoms After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance. These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants. Causal Relationship Unknown Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians: Body as a Whole Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor). Digestive Hepatic failure, ageusia. Post marketing Adverse Events A syndrome resembling neuroleptic malignant syndrome (NMS) has been very rarely reported after starting or increasing the dose of amitriptyline hydrochloride, with and without concomitant medications known to cause NMS. Symptoms have included muscle rigidity, fever, mental status changes, diaphoresis, tachycardia, and tremor. Very rare cases of serotonin syndrome (SS) have been reported with amitriptyline hydrochloride in combination with other drugs that have a recognized association with SS. To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.
Cardiovascular Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation.
CNS and Neuromuscular Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involu …
Drug Interactions
openFDA Drug LabelingDrug Interactions Topiramate Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels. 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 coadministration 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 coadministered with another drug known to be an inhibitor of P450 2D6. Monoamine oxidase inhibitors – see CONTRAINDICATIONS section. Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see WARNINGS section. When amitriptyline hydrochloride is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required. Hyperpyrexia has been reported when amitriptyline hydrochloride is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather. Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic type drugs. Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and ci …
Description
openFDA Drug LabelingDESCRIPTION Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, crystalline powder or small crystals which is freely soluble in water, in alcohol, in chloroform, in methanol and insoluble in ether. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5 H -dibenzo[a,d] cycloheptene-Δ 5 , γ-propylamine hydrochloride. It has the following structural formula: Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include ascorbic acid, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose. The 10 mg also includes D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide and xanthan gum 25 mg – D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 50 mg - D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, talc, titanium dioxide, and xanthan gum; 75 mg- FD&C blue #2 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum; 100 mg – D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum ; 150 mg - FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, D&C yellow #10 aluminum lake, lecithin (soya), talc, titanium dioxide, and xanthan gum. Meets USP Dissolution Test 2. amitriptyline HCl chemical structure
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, convulsions, and CNS depression, including coma. Changes in the electrocardiogram particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. In addition, a rightward axis shift in the terminal QRS complex together with a prolonged QT interval and sinus tachycardia are specific and sensitive indicators of first generation tricyclic overdose. The absence of these findings is not exclusionary. Prolonged PR interval, ST-T wave changes, ventricular tachycardia and fibrillation may also occur. Other signs of overdose may include: impaired myocardial contractility, confusion, disturbed concentration, transient visual hallucinations, dilated pupils, disorders of ocular motility, agitation, hyperactive reflexes, polyradiculoneuropathy, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS. 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 the 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 mm Hg 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 …
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Amitriptyline hydrochloride tablets, USP: 100 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I5” on one side and plain on other side, and supplied as: NDC: 71335-0040-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0040-2 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0040-3 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0040-4 180 TABLET, FILM COATED in a BOTTLE NDC: 71335-0040-5 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-0040-6 120 TABLET, FILM COATED in a BOTTLE NDC: 71335-0040-7 18 TABLET, FILM COATED in a BOTTLE NDC: 71335-0040-8 8 TABLET, FILM COATED in a BOTTLE 75 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I4” on one side and plain on other side, and supplied as: NDC: 71335-0173-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0173-2 100 TABLET, FILM COATED in a BOTTLE NDC: 71335-0173-3 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-0173-4 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0173-5 90 TABLET, FILM COATED in a BOTTLE 25 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I2” on one side and plain on other side, and supplied as: NDC: 71335-0306-0 120 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-1 20 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-2 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-3 100 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-4 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-5 50 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-6 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-7 45 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-8 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-0306-9 56 TABLET, FILM COATED in a BOTTLE 50 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I3” on one side and plain on other side, and supplied as: NDC: 71335-0366-1 100 TABLET, FILM COATED in a BOTTLE NDC: 71335-0366-2 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0366-3 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0366-4 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0366-5 20 TABLET, FILM COATED in a BOTTLE NDC: 71335-0366-6 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-0366-7 56 TABLET, FILM COATED in a BOTTLE NDC: 71335-0366-8 180 TABLET, FILM COATED in a BOTTLE 10 mg: Brown coloured, round, biconvex, film coated tablet debossed with “I1” on one side and plain on other side, and supplied as: NDC: 71335-0395-0 100 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-2 15 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-3 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-4 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-5 28 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-6 120 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-7 50 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-8 180 TABLET, FILM COATED in a BOTTLE NDC: 71335-0395-9 6 TABLET, FILM COATED in a BOTTLE 150 mg: Brown coloured, capsule shaped, biconvex, film coated tablet debossed with “I6” on one side and plain on other side, and supplied as: NDC: 71335-0566-1 30 TABLET, FILM COATED in a BOTTLE NDC: 71335-0566-2 120 TABLET, FILM COATED in a BOTTLE NDC: 71335-0566-3 60 TABLET, FILM COATED in a BOTTLE NDC: 71335-0566-4 90 TABLET, FILM COATED in a BOTTLE NDC: 71335-0566-5 18 TABLET, FILM COATED in a BOTTLE Store at 20o to 25oC (68o to 77oF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: AMITRIPTYLINE 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 III | July 12, 2017 | Sandoz Incorporated | Cross Contamination With Other Product: Imipramine | Terminated |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-3564-2 | 50090-3564 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-3564-2) | August 30, 2018 |
| 50090-4005-0 | 50090-4005 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-4005-0) | December 27, 2018 |
| 50090-4005-1 | 50090-4005 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4005-1) | December 26, 2017 |
| 50090-4005-4 | 50090-4005 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-4005-4) | February 12, 2019 |
| 50090-4005-8 | 50090-4005 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4005-8) | December 26, 2017 |
| 50090-6179-0 | 50090-6179 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6179-0) | October 20, 2022 |
| 50090-6179-1 | 50090-6179 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6179-1) | October 20, 2022 |
| 50090-6179-6 | 50090-6179 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6179-6) | October 20, 2022 |
| 50090-6179-7 | 50090-6179 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6179-7) | December 21, 2023 |
| 50090-6313-0 | 50090-6313 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6313-0) | January 6, 2023 |
| 50090-6313-1 | 50090-6313 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6313-1) | January 6, 2023 |
| 50090-6313-4 | 50090-6313 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6313-4) | January 6, 2023 |
| 50090-6313-8 | 50090-6313 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6313-8) | January 6, 2023 |
| 50090-6315-0 | 50090-6315 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6315-0) | January 6, 2023 |
| 50090-6315-1 | 50090-6315 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6315-1) | January 6, 2023 |
| 50090-6315-2 | 50090-6315 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6315-2) | January 6, 2023 |
| 50090-6315-5 | 50090-6315 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6315-5) | January 6, 2023 |
| 50090-6418-2 | 50090-6418 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6418-2) | March 31, 2023 |
| 50090-6925-0 | 50090-6925 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6925-0) | December 14, 2023 |
| 50090-6925-1 | 50090-6925 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-6925-1) | December 14, 2023 |
| 50090-6925-4 | 50090-6925 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-6925-4) | December 14, 2023 |
| 50090-6925-8 | 50090-6925 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6925-8) | December 14, 2023 |
| 50090-6927-0 | 50090-6927 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6927-0) | December 14, 2023 |
| 50090-7183-0 | 50090-7183 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7183-0) | June 18, 2024 |
| 50090-7183-1 | 50090-7183 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7183-1) | June 18, 2024 |
| 50090-7183-2 | 50090-7183 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-7183-2) | June 18, 2024 |
| 50090-7183-5 | 50090-7183 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7183-5) | June 18, 2024 |
| 50090-7513-0 | 50090-7513 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7513-0) | February 24, 2025 |
| 16729-171-01 | 16729-171 | Accord Healthcare Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (16729-171-01) | December 18, 2014 |
| 16729-171-17 | 16729-171 | Accord Healthcare Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (16729-171-17) | December 5, 2014 |
| 16729-176-01 | 16729-176 | Accord Healthcare Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (16729-176-01) | December 26, 2014 |
| 72888-067-00 | 72888-067 | Advagen Pharma Ltd | 1000 TABLET, FILM COATED in 1 BOTTLE (72888-067-00) | May 1, 2023 |
| 72888-067-01 | 72888-067 | Advagen Pharma Ltd | 100 TABLET, FILM COATED in 1 BOTTLE (72888-067-01) | May 1, 2023 |
| 72888-068-00 | 72888-068 | Advagen Pharma Ltd | 1000 TABLET, FILM COATED in 1 BOTTLE (72888-068-00) | May 1, 2023 |
| 72888-068-01 | 72888-068 | Advagen Pharma Ltd | 100 TABLET, FILM COATED in 1 BOTTLE (72888-068-01) | May 1, 2023 |
| 72888-069-00 | 72888-069 | Advagen Pharma Ltd | 1000 TABLET, FILM COATED in 1 BOTTLE (72888-069-00) | May 1, 2023 |
| 72888-069-01 | 72888-069 | Advagen Pharma Ltd | 100 TABLET, FILM COATED in 1 BOTTLE (72888-069-01) | May 1, 2023 |
| 72888-070-01 | 72888-070 | Advagen Pharma Ltd | 100 TABLET, FILM COATED in 1 BOTTLE (72888-070-01) | May 1, 2023 |
| 72888-071-01 | 72888-071 | Advagen Pharma Ltd | 100 TABLET, FILM COATED in 1 BOTTLE (72888-071-01) | May 1, 2023 |
| 72888-071-03 | 72888-071 | Advagen Pharma Ltd | 300 TABLET, FILM COATED in 1 BOTTLE (72888-071-03) | May 1, 2023 |
| 72888-072-01 | 72888-072 | Advagen Pharma Ltd | 100 TABLET, FILM COATED in 1 BOTTLE (72888-072-01) | May 1, 2023 |
| 80425-0285-1 | 80425-0285 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0285-1) | March 22, 2023 |
| 80425-0285-2 | 80425-0285 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0285-2) | March 22, 2023 |
| 80425-0285-3 | 80425-0285 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0285-3) | March 22, 2023 |
| 80425-0287-1 | 80425-0287 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0287-1) | March 22, 2023 |
| 80425-0287-2 | 80425-0287 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0287-2) | March 22, 2023 |
| 80425-0287-3 | 80425-0287 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0287-3) | March 22, 2023 |
| 80425-0362-1 | 80425-0362 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0362-1) | October 20, 2023 |
| 80425-0386-1 | 80425-0386 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0386-1) | May 21, 2024 |
| 80425-0386-2 | 80425-0386 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0386-2) | May 21, 2024 |
| 80425-0386-3 | 80425-0386 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0386-3) | May 21, 2024 |
| 60687-433-01 | 60687-433 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-433-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-433-11) | August 15, 2019 |
| 60687-444-01 | 60687-444 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-444-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-444-11) | August 12, 2019 |
| 71610-695-30 | 71610-695 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (71610-695-30) | March 20, 2023 |
| 71610-695-53 | 71610-695 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-695-53) | March 20, 2023 |
| 71610-695-60 | 71610-695 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-695-60) | March 20, 2023 |
| 71610-703-30 | 71610-703 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-30) | April 26, 2023 |
| 71610-703-53 | 71610-703 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-53) | April 27, 2023 |
| 71610-703-60 | 71610-703 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-703-60) | April 26, 2023 |
| 71610-710-30 | 71610-710 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-30) | June 29, 2023 |
| 71610-710-53 | 71610-710 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-53) | June 29, 2023 |
| 71610-710-60 | 71610-710 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-60) | May 31, 2023 |
| 71610-710-80 | 71610-710 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-80) | June 29, 2023 |
| 71610-711-29 | 71610-711 | Aphena Pharma Solutions - Tennessee, LLC | 29 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-711-29) | September 15, 2023 |
| 71610-711-30 | 71610-711 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-711-30) | May 31, 2023 |
| 71610-711-60 | 71610-711 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-711-60) | June 29, 2023 |
| 71610-750-30 | 71610-750 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-750-30) | November 13, 2023 |
| 71610-750-53 | 71610-750 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-750-53) | November 13, 2023 |
| 71610-750-60 | 71610-750 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-750-60) | November 13, 2023 |
| 71610-750-80 | 71610-750 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-750-80) | November 13, 2023 |
| 71610-751-30 | 71610-751 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-30) | November 13, 2023 |
| 71610-751-53 | 71610-751 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-53) | November 13, 2023 |
| 71610-751-60 | 71610-751 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-60) | November 13, 2023 |
| 71610-751-80 | 71610-751 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-751-80) | November 13, 2023 |
| 71610-752-30 | 71610-752 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-30) | November 13, 2023 |
| 71610-752-53 | 71610-752 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-53) | November 13, 2023 |
| 71610-752-60 | 71610-752 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-60) | November 13, 2023 |
| 71610-752-80 | 71610-752 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-752-80) | November 13, 2023 |
| 76420-693-01 | 76420-693 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-693-01) | March 2, 2024 |
| 76420-693-30 | 76420-693 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-693-30) | March 2, 2024 |
| 76420-693-60 | 76420-693 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-693-60) | March 2, 2024 |
| 76420-693-90 | 76420-693 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-693-90) | March 2, 2024 |
| 76420-694-01 | 76420-694 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-694-01) | March 2, 2024 |
| 76420-694-30 | 76420-694 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-694-30) | March 2, 2024 |
| 76420-694-60 | 76420-694 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-694-60) | March 2, 2024 |
| 76420-694-90 | 76420-694 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-694-90) | March 2, 2024 |
| 76420-695-01 | 76420-695 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-695-01) | March 2, 2024 |
| 76420-695-30 | 76420-695 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-695-30) | March 2, 2024 |
| 76420-695-60 | 76420-695 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-695-60) | March 2, 2024 |
| 76420-695-90 | 76420-695 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-695-90) | March 2, 2024 |
| 76420-696-01 | 76420-696 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-696-01) | March 2, 2024 |
| 76420-696-30 | 76420-696 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-696-30) | March 2, 2024 |
| 76420-696-60 | 76420-696 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-696-60) | March 2, 2024 |
| 76420-696-90 | 76420-696 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-696-90) | March 2, 2024 |
| 76420-697-01 | 76420-697 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-697-01) | March 2, 2024 |
| 76420-697-30 | 76420-697 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-697-30) | March 2, 2024 |
| 76420-697-60 | 76420-697 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-697-60) | March 2, 2024 |
| 76420-697-90 | 76420-697 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-697-90) | March 2, 2024 |
| 76420-698-01 | 76420-698 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-698-01) | March 2, 2024 |
| 76420-698-30 | 76420-698 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-698-30) | March 2, 2024 |
| 76420-698-60 | 76420-698 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-698-60) | March 2, 2024 |
| 76420-698-90 | 76420-698 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-698-90) | March 2, 2024 |
| 59651-818-01 | 59651-818 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-818-01) | March 20, 2026 |
| 59651-818-99 | 59651-818 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-818-99) | March 20, 2026 |
| 59651-819-01 | 59651-819 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-819-01) | March 20, 2026 |
| 59651-819-99 | 59651-819 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (59651-819-99) | March 20, 2026 |
| 59651-820-01 | 59651-820 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-820-01) | March 20, 2026 |
| 59651-821-01 | 59651-821 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-821-01) | March 20, 2026 |
| 59651-821-60 | 59651-821 | Aurobindo Pharma Limited | 60 TABLET, FILM COATED in 1 BOTTLE (59651-821-60) | March 20, 2026 |
| 59651-822-01 | 59651-822 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (59651-822-01) | March 20, 2026 |
| 50268-037-15 | 50268-037 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-037-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-037-11) | June 6, 2023 |
| 50268-038-15 | 50268-038 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-038-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-038-11) | June 6, 2023 |
| 50268-039-15 | 50268-039 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-039-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-039-11) | June 6, 2023 |
| 50268-040-15 | 50268-040 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-040-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-040-11) | June 6, 2023 |
| 50268-041-15 | 50268-041 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-041-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-041-11) | February 28, 2023 |
| 71335-0395-0 | 71335-0395 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0395-0) | December 5, 2014 |
| 71335-0395-1 | 71335-0395 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0395-1) | December 5, 2014 |
| 71335-0395-2 | 71335-0395 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0395-2) | December 5, 2014 |
| 71335-0395-3 | 71335-0395 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0395-3) | December 5, 2014 |
| 71335-0395-4 | 71335-0395 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0395-4) | December 5, 2014 |
| 71335-0395-5 | 71335-0395 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-0395-5) | December 5, 2014 |
| 71335-0395-6 | 71335-0395 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0395-6) | December 5, 2014 |
| 71335-0395-7 | 71335-0395 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-0395-7) | December 5, 2014 |
| 71335-0395-8 | 71335-0395 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-0395-8) | December 5, 2014 |
| 71335-0395-9 | 71335-0395 | Bryant Ranch Prepack | 6 TABLET, FILM COATED in 1 BOTTLE (71335-0395-9) | December 5, 2014 |
| 71335-0566-1 | 71335-0566 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0566-1) | September 21, 2015 |
| 71335-0566-2 | 71335-0566 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0566-2) | September 21, 2015 |
| 71335-0566-3 | 71335-0566 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0566-3) | September 21, 2015 |
| 71335-0566-4 | 71335-0566 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0566-4) | September 21, 2015 |
| 71335-0566-5 | 71335-0566 | Bryant Ranch Prepack | 18 TABLET, FILM COATED in 1 BOTTLE (71335-0566-5) | September 21, 2015 |
| 71335-1254-0 | 71335-1254 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-0) | December 28, 2021 |
| 71335-1254-1 | 71335-1254 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1254-1) | December 28, 2021 |
| 71335-1254-2 | 71335-1254 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1254-2) | July 19, 2019 |
| 71335-1254-3 | 71335-1254 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1254-3) | December 28, 2021 |
| 71335-1254-4 | 71335-1254 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1254-4) | July 24, 2019 |
| 71335-1254-5 | 71335-1254 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1254-5) | December 28, 2021 |
| 71335-1254-6 | 71335-1254 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1254-6) | June 27, 2019 |
| 71335-1254-7 | 71335-1254 | Bryant Ranch Prepack | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1254-7) | December 28, 2021 |
| 71335-1254-8 | 71335-1254 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1254-8) | December 28, 2021 |
| 71335-1254-9 | 71335-1254 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1254-9) | December 28, 2021 |
| 71335-1256-1 | 71335-1256 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1256-1) | February 9, 2022 |
| 71335-1256-2 | 71335-1256 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1256-2) | February 9, 2022 |
| 71335-1256-3 | 71335-1256 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1256-3) | February 9, 2022 |
| 71335-1256-4 | 71335-1256 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1256-4) | February 9, 2022 |
| 71335-1256-5 | 71335-1256 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1256-5) | February 9, 2022 |
| 71335-1256-6 | 71335-1256 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1256-6) | February 9, 2022 |
| 71335-1256-7 | 71335-1256 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1256-7) | February 9, 2022 |
| 71335-1256-8 | 71335-1256 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1256-8) | February 9, 2022 |
| 71335-9633-0 | 71335-9633 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9633-0) | February 6, 2023 |
| 71335-9633-1 | 71335-9633 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9633-1) | February 6, 2023 |
| 71335-9633-2 | 71335-9633 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9633-2) | February 6, 2023 |
| 71335-9633-3 | 71335-9633 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9633-3) | February 6, 2023 |
| 71335-9633-4 | 71335-9633 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9633-4) | February 6, 2023 |
| 71335-9633-5 | 71335-9633 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-9633-5) | February 6, 2023 |
| 71335-9633-6 | 71335-9633 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9633-6) | February 6, 2023 |
| 71335-9633-7 | 71335-9633 | Bryant Ranch Prepack | 45 TABLET, FILM COATED in 1 BOTTLE (71335-9633-7) | February 6, 2023 |
| 71335-9633-8 | 71335-9633 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9633-8) | February 6, 2023 |
| 71335-9633-9 | 71335-9633 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-9633-9) | February 6, 2023 |
| 71335-9635-1 | 71335-9635 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9635-1) | February 6, 2023 |
| 71335-9635-2 | 71335-9635 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9635-2) | February 6, 2023 |
| 71335-9635-3 | 71335-9635 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9635-3) | February 6, 2023 |
| 71335-9635-4 | 71335-9635 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9635-4) | February 6, 2023 |
| 71335-9635-5 | 71335-9635 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9635-5) | February 6, 2023 |
| 71335-9635-6 | 71335-9635 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9635-6) | February 6, 2023 |
| 71335-9635-7 | 71335-9635 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-9635-7) | February 6, 2023 |
| 71335-9635-8 | 71335-9635 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9635-8) | February 6, 2023 |
| 71335-9637-0 | 71335-9637 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9637-0) | February 6, 2023 |
| 71335-9637-1 | 71335-9637 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9637-1) | February 6, 2023 |
| 71335-9637-2 | 71335-9637 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-9637-2) | February 6, 2023 |
| 71335-9637-3 | 71335-9637 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9637-3) | February 6, 2023 |
| 71335-9637-4 | 71335-9637 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9637-4) | February 6, 2023 |
| 71335-9637-5 | 71335-9637 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9637-5) | February 6, 2023 |
| 71335-9637-6 | 71335-9637 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9637-6) | February 6, 2023 |
| 71335-9637-7 | 71335-9637 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-9637-7) | February 6, 2023 |
| 71335-9637-8 | 71335-9637 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9637-8) | February 6, 2023 |
| 71335-9637-9 | 71335-9637 | Bryant Ranch Prepack | 6 TABLET, FILM COATED in 1 BOTTLE (71335-9637-9) | February 6, 2023 |
| 71335-9668-1 | 71335-9668 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9668-1) | March 27, 2023 |
| 71335-9668-2 | 71335-9668 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9668-2) | March 27, 2023 |
| 71335-9668-3 | 71335-9668 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9668-3) | March 27, 2023 |
| 71335-9668-4 | 71335-9668 | Bryant Ranch Prepack | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9668-4) | March 27, 2023 |
| 71335-9668-5 | 71335-9668 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9668-5) | March 27, 2023 |
| 71335-9668-6 | 71335-9668 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9668-6) | March 27, 2023 |
| 71335-9668-7 | 71335-9668 | Bryant Ranch Prepack | 18 TABLET, FILM COATED in 1 BOTTLE (71335-9668-7) | March 27, 2023 |
| 71335-9668-8 | 71335-9668 | Bryant Ranch Prepack | 8 TABLET, FILM COATED in 1 BOTTLE (71335-9668-8) | March 27, 2023 |
| 71335-9685-1 | 71335-9685 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9685-1) | April 11, 2023 |
| 71335-9685-2 | 71335-9685 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9685-2) | April 11, 2023 |
| 71335-9685-3 | 71335-9685 | Bryant Ranch Prepack | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9685-3) | April 11, 2023 |
| 71335-9685-4 | 71335-9685 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9685-4) | April 11, 2023 |
| 71335-9685-5 | 71335-9685 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9685-5) | April 11, 2023 |
| 71335-9710-1 | 71335-9710 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9710-1) | April 10, 2026 |
| 71335-9710-2 | 71335-9710 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9710-2) | April 10, 2026 |
| 71335-9710-3 | 71335-9710 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9710-3) | June 6, 2023 |
| 71335-9710-4 | 71335-9710 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9710-4) | April 10, 2026 |
| 71335-9710-5 | 71335-9710 | Bryant Ranch Prepack | 18 TABLET, FILM COATED in 1 BOTTLE (71335-9710-5) | April 10, 2026 |
| 67046-0689-3 | 67046-0689 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0689-3) | August 21, 2026 |
| 67046-0764-3 | 67046-0764 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0764-3) | April 24, 2026 |
| 67046-1625-3 | 67046-1625 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1625-3) | December 16, 2025 |
| 67046-1669-3 | 67046-1669 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1669-3) | April 22, 2026 |
| 67046-1671-3 | 67046-1671 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1671-3) | April 27, 2026 |
| 67046-1694-3 | 67046-1694 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1694-3) | August 21, 2026 |
| 51407-793-01 | 51407-793 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-793-01) | September 1, 2023 |
| 51407-793-10 | 51407-793 | Golden State Medical Supply, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-793-10) | September 1, 2023 |
| 51407-794-01 | 51407-794 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-794-01) | September 1, 2023 |
| 51407-794-10 | 51407-794 | Golden State Medical Supply, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-794-10) | September 1, 2023 |
| 51407-795-01 | 51407-795 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-795-01) | September 1, 2023 |
| 51407-795-10 | 51407-795 | Golden State Medical Supply, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-795-10) | September 1, 2023 |
| 51407-796-01 | 51407-796 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-796-01) | September 1, 2023 |
| 51407-797-01 | 51407-797 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-797-01) | September 1, 2023 |
| 51407-798-01 | 51407-798 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-798-01) | September 1, 2023 |
| 70756-201-11 | 70756-201 | Lifestar Pharma LLC | 100 TABLET, FILM COATED in 1 BOTTLE (70756-201-11) | February 23, 2021 |
| 70756-201-12 | 70756-201 | Lifestar Pharma LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (70756-201-12) | February 23, 2021 |
| 70756-202-11 | 70756-202 | Lifestar Pharma LLC | 100 TABLET, FILM COATED in 1 BOTTLE (70756-202-11) | February 23, 2021 |
| 70756-202-12 | 70756-202 | Lifestar Pharma LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (70756-202-12) | February 23, 2021 |
| 70756-203-11 | 70756-203 | Lifestar Pharma LLC | 100 TABLET, FILM COATED in 1 BOTTLE (70756-203-11) | February 23, 2021 |
| 70756-203-12 | 70756-203 | Lifestar Pharma LLC | 1000 TABLET, FILM COATED in 1 BOTTLE (70756-203-12) | February 23, 2021 |
| 70756-204-11 | 70756-204 | Lifestar Pharma LLC | 100 TABLET, FILM COATED in 1 BOTTLE (70756-204-11) | February 23, 2021 |
| 70756-205-11 | 70756-205 | Lifestar Pharma LLC | 100 TABLET, FILM COATED in 1 BOTTLE (70756-205-11) | February 23, 2021 |
| 70756-206-11 | 70756-206 | Lifestar Pharma LLC | 100 TABLET, FILM COATED in 1 BOTTLE (70756-206-11) | February 23, 2021 |
| 16714-257-01 | 16714-257 | Northstar Rx LLC. | 100 TABLET, FILM COATED in 1 BOTTLE (16714-257-01) | August 25, 2021 |
| 16714-257-02 | 16714-257 | Northstar Rx LLC. | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-257-02) | August 25, 2021 |
| 16714-258-01 | 16714-258 | Northstar Rx LLC. | 100 TABLET, FILM COATED in 1 BOTTLE (16714-258-01) | August 25, 2021 |
| 16714-258-02 | 16714-258 | Northstar Rx LLC. | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-258-02) | August 25, 2021 |
| 16714-259-01 | 16714-259 | Northstar Rx LLC. | 100 TABLET, FILM COATED in 1 BOTTLE (16714-259-01) | August 25, 2021 |
| 16714-259-02 | 16714-259 | Northstar Rx LLC. | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-259-02) | August 25, 2021 |
| 16714-260-01 | 16714-260 | Northstar Rx LLC. | 100 TABLET, FILM COATED in 1 BOTTLE (16714-260-01) | August 25, 2021 |
| 16714-261-01 | 16714-261 | Northstar Rx LLC. | 100 TABLET, FILM COATED in 1 BOTTLE (16714-261-01) | August 25, 2021 |
| 16714-262-01 | 16714-262 | Northstar Rx LLC. | 100 TABLET, FILM COATED in 1 BOTTLE (16714-262-01) | August 25, 2021 |
| 51655-084-26 | 51655-084 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-26) | March 6, 2023 |
| 51655-084-52 | 51655-084 | Northwind Health Company, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-52) | March 6, 2023 |
| 51655-334-26 | 51655-334 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-334-26) | March 24, 2023 |
| 51655-632-26 | 51655-632 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-632-26) | June 2, 2022 |
| 51655-969-26 | 51655-969 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-969-26) | February 28, 2023 |
| 51655-969-52 | 51655-969 | Northwind Health Company, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-969-52) | February 28, 2023 |
| 82868-075-30 | 82868-075 | Northwind Health Company, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-075-30) | June 11, 2025 |
| 82868-075-90 | 82868-075 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-075-90) | March 26, 2025 |
| 82868-086-90 | 82868-086 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-086-90) | August 21, 2025 |
| 82868-093-30 | 82868-093 | Northwind Health Company, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-093-30) | July 7, 2026 |
| 82868-093-90 | 82868-093 | Northwind Health Company, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-093-90) | November 26, 2025 |
| 68071-3913-3 | 68071-3913 | NuCare Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3913-3) | November 10, 2025 |
| 68071-4092-2 | 68071-4092 | NuCare Pharmaceuticals,Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-4092-2) | September 12, 2017 |
| 68071-4092-3 | 68071-4092 | NuCare Pharmaceuticals,Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4092-3) | September 12, 2017 |
| 68071-4092-6 | 68071-4092 | NuCare Pharmaceuticals,Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68071-4092-6) | September 12, 2017 |
| 68071-4092-9 | 68071-4092 | NuCare Pharmaceuticals,Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68071-4092-9) | September 12, 2017 |
| 68071-4104-1 | 68071-4104 | NuCare Pharmaceuticals,Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68071-4104-1) | September 29, 2017 |
| 43063-822-30 | 43063-822 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-822-30) | January 8, 2018 |
| 43063-836-30 | 43063-836 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-836-30) | February 14, 2018 |
| 72789-305-30 | 72789-305 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-305-30) | March 2, 2022 |
| 68788-8218-3 | 68788-8218 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8218-3) | September 8, 2022 |
| 68788-8218-6 | 68788-8218 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8218-6) | September 8, 2022 |
| 68788-8218-9 | 68788-8218 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8218-9) | September 8, 2022 |
| 68788-8339-1 | 68788-8339 | Preferred Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8339-1) | February 2, 2023 |
| 68788-8339-3 | 68788-8339 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8339-3) | February 2, 2023 |
| 68788-8339-6 | 68788-8339 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8339-6) | February 2, 2023 |
| 68788-8339-8 | 68788-8339 | Preferred Pharmaceuticals Inc. | 28 TABLET, FILM COATED in 1 BOTTLE (68788-8339-8) | February 2, 2023 |
| 68788-8339-9 | 68788-8339 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8339-9) | February 2, 2023 |
| 68788-8346-1 | 68788-8346 | Preferred Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8346-1) | February 6, 2023 |
| 68788-8346-3 | 68788-8346 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8346-3) | February 6, 2023 |
| 68788-8346-6 | 68788-8346 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8346-6) | February 6, 2023 |
| 68788-8346-8 | 68788-8346 | Preferred Pharmaceuticals Inc. | 28 TABLET, FILM COATED in 1 BOTTLE (68788-8346-8) | February 6, 2023 |
| 68788-8346-9 | 68788-8346 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8346-9) | February 6, 2023 |
| 68788-8363-3 | 68788-8363 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8363-3) | February 1, 2023 |
| 68788-8363-6 | 68788-8363 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8363-6) | February 1, 2023 |
| 68788-8363-8 | 68788-8363 | Preferred Pharmaceuticals Inc. | 28 TABLET, FILM COATED in 1 BOTTLE (68788-8363-8) | February 1, 2023 |
| 68788-8363-9 | 68788-8363 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8363-9) | February 1, 2023 |
| 68788-8380-3 | 68788-8380 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8380-3) | March 7, 2023 |
| 68788-8380-6 | 68788-8380 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8380-6) | March 7, 2023 |
| 68788-8380-8 | 68788-8380 | Preferred Pharmaceuticals Inc. | 28 TABLET, FILM COATED in 1 BOTTLE (68788-8380-8) | March 7, 2023 |
| 68788-8380-9 | 68788-8380 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8380-9) | March 7, 2023 |
| 63187-637-30 | 63187-637 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (63187-637-30) | December 1, 2018 |
| 63187-637-60 | 63187-637 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (63187-637-60) | December 1, 2018 |
| 63187-637-90 | 63187-637 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (63187-637-90) | December 1, 2018 |
| 71205-823-30 | 71205-823 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (71205-823-30) | August 1, 2023 |
| 71205-823-60 | 71205-823 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (71205-823-60) | August 1, 2023 |
| 71205-823-90 | 71205-823 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (71205-823-90) | August 1, 2023 |
| 82804-048-30 | 82804-048 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (82804-048-30) | December 21, 2023 |
| 82804-048-60 | 82804-048 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (82804-048-60) | December 21, 2023 |
| 82804-048-90 | 82804-048 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (82804-048-90) | December 21, 2023 |
| 82804-092-30 | 82804-092 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (82804-092-30) | March 29, 2024 |
| 82804-100-30 | 82804-100 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (82804-100-30) | May 1, 2024 |
| 70518-3621-0 | 70518-3621 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3621-0) | January 25, 2023 |
| 70518-3621-1 | 70518-3621 | REMEDYREPACK INC. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3621-1) | January 28, 2023 |
| 70518-3621-2 | 70518-3621 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3621-2) | May 5, 2023 |
| 70518-3641-2 | 70518-3641 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3641-2) | August 13, 2025 |
| 70518-3979-0 | 70518-3979 | REMEDYREPACK INC. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3979-0) | January 10, 2024 |
| 0781-1486-01 | 0781-1486 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1486-01) | November 21, 1977 |
| 0781-1486-10 | 0781-1486 | Sandoz Inc | 1000 TABLET, FILM COATED in 1 BOTTLE (0781-1486-10) | November 21, 1977 |
| 0781-1487-01 | 0781-1487 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1487-01) | November 21, 1977 |
| 0781-1487-10 | 0781-1487 | Sandoz Inc | 1000 TABLET, FILM COATED in 1 BOTTLE (0781-1487-10) | November 21, 1977 |
| 0781-1488-01 | 0781-1488 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1488-01) | November 29, 1977 |
| 0781-1488-10 | 0781-1488 | Sandoz Inc | 1000 TABLET, FILM COATED in 1 BOTTLE (0781-1488-10) | November 29, 1977 |
| 0781-1489-01 | 0781-1489 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1489-01) | November 29, 1977 |
| 0781-1490-01 | 0781-1490 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1490-01) | November 21, 1977 |
| 0781-1491-01 | 0781-1491 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1491-01) | November 21, 1977 |
| 60760-556-15 | 60760-556 | St. Mary's Medical Park Pharmacy | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-556-15) | July 13, 2022 |
| 60760-556-90 | 60760-556 | St. Mary's Medical Park Pharmacy | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-556-90) | May 13, 2025 |
| 60760-907-90 | 60760-907 | St. Mary's Medical Park Pharmacy | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-907-90) | June 12, 2024 |
| 57664-687-18 | 57664-687 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-18) | July 14, 1987 |
| 57664-687-88 | 57664-687 | Sun Pharmaceutical Industries, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-687-88) | July 14, 1987 |
| 57664-688-18 | 57664-688 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-688-18) | July 14, 1987 |
| 57664-688-88 | 57664-688 | Sun Pharmaceutical Industries, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-688-88) | July 14, 1987 |
| 57664-689-18 | 57664-689 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-689-18) | July 14, 1987 |
| 57664-689-88 | 57664-689 | Sun Pharmaceutical Industries, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-689-88) | July 14, 1987 |
| 57664-690-88 | 57664-690 | Sun Pharmaceutical Industries, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-690-88) | July 14, 1987 |
| 57664-691-88 | 57664-691 | Sun Pharmaceutical Industries, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-691-88) | July 14, 1987 |
| 57664-692-88 | 57664-692 | Sun Pharmaceutical Industries, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-692-88) | July 14, 1987 |
| 29300-419-01 | 29300-419 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (29300-419-01) | May 26, 2021 |
| 29300-419-05 | 29300-419 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (29300-419-05) | May 26, 2021 |
| 29300-419-10 | 29300-419 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (29300-419-10) | November 16, 2021 |
| 29300-420-01 | 29300-420 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (29300-420-01) | May 26, 2021 |
| 29300-420-05 | 29300-420 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (29300-420-05) | May 26, 2021 |
| 29300-420-10 | 29300-420 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (29300-420-10) | November 16, 2021 |
| 29300-421-01 | 29300-421 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (29300-421-01) | May 26, 2021 |
| 29300-421-05 | 29300-421 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (29300-421-05) | May 26, 2021 |
| 29300-421-10 | 29300-421 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (29300-421-10) | November 16, 2021 |
| 29300-422-01 | 29300-422 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (29300-422-01) | May 26, 2021 |
| 29300-422-05 | 29300-422 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (29300-422-05) | May 26, 2021 |
| 29300-423-01 | 29300-423 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (29300-423-01) | May 26, 2021 |
| 29300-423-05 | 29300-423 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (29300-423-05) | May 26, 2021 |
| 29300-424-01 | 29300-424 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (29300-424-01) | May 26, 2021 |
| 29300-424-05 | 29300-424 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (29300-424-05) | May 26, 2021 |
| 70771-1173-0 | 70771-1173 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1173-0) | December 26, 2017 |
| 70771-1173-1 | 70771-1173 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1173-1) | December 26, 2017 |
| 70771-1174-0 | 70771-1174 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1174-0) | December 26, 2017 |
| 70771-1174-1 | 70771-1174 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1174-1) | December 26, 2017 |
| 70771-1175-0 | 70771-1175 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1175-0) | December 26, 2017 |
| 70771-1175-1 | 70771-1175 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1175-1) | December 26, 2017 |
| 70771-1176-0 | 70771-1176 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1176-0) | December 26, 2017 |
| 70771-1176-1 | 70771-1176 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1176-1) | December 26, 2017 |
| 70771-1177-0 | 70771-1177 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1177-0) | December 26, 2017 |
| 70771-1177-1 | 70771-1177 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1177-1) | December 26, 2017 |
| 70771-1178-0 | 70771-1178 | Zydus Lifesciences Limited | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1178-0) | December 26, 2017 |
| 70771-1178-1 | 70771-1178 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1178-1) | December 26, 2017 |
| 70710-1225-0 | 70710-1225 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1225-0) | December 26, 2017 |
| 70710-1225-1 | 70710-1225 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1225-1) | December 26, 2017 |
| 70710-1226-0 | 70710-1226 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1226-0) | December 26, 2017 |
| 70710-1226-1 | 70710-1226 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1226-1) | December 26, 2017 |
| 70710-1227-0 | 70710-1227 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1227-0) | December 26, 2017 |
| 70710-1227-1 | 70710-1227 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1227-1) | December 26, 2017 |
| 70710-1228-0 | 70710-1228 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1228-0) | December 26, 2017 |
| 70710-1228-1 | 70710-1228 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1228-1) | December 26, 2017 |
| 70710-1229-0 | 70710-1229 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1229-0) | December 26, 2017 |
| 70710-1229-1 | 70710-1229 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1229-1) | December 26, 2017 |
| 70710-1230-0 | 70710-1230 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1230-0) | December 26, 2017 |
| 70710-1230-1 | 70710-1230 | Zydus Pharmaceuticals USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1230-1) | December 26, 2017 |
| 50090-3564 | 50090-3564 | A-S Medication Solutions | — | December 5, 2014 |
| 50090-4005 | 50090-4005 | A-S Medication Solutions | — | December 26, 2017 |
| 50090-6179 | 50090-6179 | A-S Medication Solutions | — | May 26, 2021 |
| 50090-6313 | 50090-6313 | A-S Medication Solutions | — | May 26, 2021 |
| 50090-6315 | 50090-6315 | A-S Medication Solutions | — | May 26, 2021 |
| 50090-6418 | 50090-6418 | A-S Medication Solutions | — | May 26, 2021 |
| 50090-6925 | 50090-6925 | A-S Medication Solutions | — | August 25, 2021 |
| 50090-6927 | 50090-6927 | A-S Medication Solutions | — | August 25, 2021 |
| 50090-7183 | 50090-7183 | A-S Medication Solutions | — | August 25, 2021 |
| 50090-7513 | 50090-7513 | A-S Medication Solutions | — | May 26, 2021 |
| 16729-171 | 16729-171 | Accord Healthcare Inc. | — | December 5, 2014 |
| 16729-175 | 16729-175 | Accord Healthcare Inc. | — | December 5, 2014 |
| 16729-176 | 16729-176 | Accord Healthcare Inc. | — | December 26, 2014 |
| 72888-067 | 72888-067 | Advagen Pharma Ltd | — | May 1, 2023 |
| 72888-068 | 72888-068 | Advagen Pharma Ltd | — | May 1, 2023 |
| 72888-069 | 72888-069 | Advagen Pharma Ltd | — | May 1, 2023 |
| 72888-070 | 72888-070 | Advagen Pharma Ltd | — | May 1, 2023 |
| 72888-071 | 72888-071 | Advagen Pharma Ltd | — | May 1, 2023 |
| 72888-072 | 72888-072 | Advagen Pharma Ltd | — | May 1, 2023 |
| 80425-0285 | 80425-0285 | Advanced Rx Pharmacy of Tennessee, LLC | — | March 22, 2023 |
| 80425-0287 | 80425-0287 | Advanced Rx Pharmacy of Tennessee, LLC | — | March 22, 2023 |
| 80425-0362 | 80425-0362 | Advanced Rx of Tennessee, LLC | — | October 20, 2023 |
| 80425-0386 | 80425-0386 | Advanced Rx of Tennessee, LLC | — | May 21, 2024 |
| 60687-433 | 60687-433 | American Health Packaging | — | August 15, 2019 |
| 60687-444 | 60687-444 | American Health Packaging | — | August 12, 2019 |
| 71610-695 | 71610-695 | Aphena Pharma Solutions - Tennessee, LLC | — | May 26, 2021 |
| 71610-703 | 71610-703 | Aphena Pharma Solutions - Tennessee, LLC | — | July 14, 1987 |
| 71610-710 | 71610-710 | Aphena Pharma Solutions - Tennessee, LLC | — | July 14, 1987 |
| 71610-711 | 71610-711 | Aphena Pharma Solutions - Tennessee, LLC | — | July 14, 1987 |
| 71610-750 | 71610-750 | Aphena Pharma Solutions - Tennessee, LLC | — | July 14, 1987 |
| 71610-751 | 71610-751 | Aphena Pharma Solutions - Tennessee, LLC | — | July 14, 1987 |
| 71610-752 | 71610-752 | Aphena Pharma Solutions - Tennessee, LLC | — | July 14, 1987 |
| 76420-693 | 76420-693 | Asclemed USA, Inc. | — | May 26, 2021 |
| 76420-694 | 76420-694 | Asclemed USA, Inc. | — | May 26, 2021 |
| 76420-695 | 76420-695 | Asclemed USA, Inc. | — | May 26, 2021 |
| 76420-696 | 76420-696 | Asclemed USA, Inc. | — | May 26, 2021 |
| 76420-697 | 76420-697 | Asclemed USA, Inc. | — | May 26, 2021 |
| 76420-698 | 76420-698 | Asclemed USA, Inc. | — | May 26, 2021 |
| 59651-818 | 59651-818 | Aurobindo Pharma Limited | — | March 20, 2026 |
| 59651-819 | 59651-819 | Aurobindo Pharma Limited | — | March 20, 2026 |
| 59651-820 | 59651-820 | Aurobindo Pharma Limited | — | March 20, 2026 |
| 59651-821 | 59651-821 | Aurobindo Pharma Limited | — | March 20, 2026 |
| 59651-822 | 59651-822 | Aurobindo Pharma Limited | — | March 20, 2026 |
| 50268-037 | 50268-037 | AvPAK | — | June 6, 2023 |
| 50268-038 | 50268-038 | AvPAK | — | June 6, 2023 |
| 50268-039 | 50268-039 | AvPAK | — | June 6, 2023 |
| 50268-040 | 50268-040 | AvPAK | — | June 6, 2023 |
| 50268-041 | 50268-041 | AvPAK | — | February 28, 2023 |
| 71335-0395 | 71335-0395 | Bryant Ranch Prepack | — | December 5, 2014 |
| 71335-0566 | 71335-0566 | Bryant Ranch Prepack | — | December 26, 2014 |
| 71335-1254 | 71335-1254 | Bryant Ranch Prepack | — | July 14, 1987 |
| 71335-1256 | 71335-1256 | Bryant Ranch Prepack | — | July 14, 1987 |
| 71335-9633 | 71335-9633 | Bryant Ranch Prepack | — | May 26, 2021 |
| 71335-9635 | 71335-9635 | Bryant Ranch Prepack | — | May 26, 2021 |
| 71335-9637 | 71335-9637 | Bryant Ranch Prepack | — | May 26, 2021 |
| 71335-9668 | 71335-9668 | Bryant Ranch Prepack | — | May 26, 2021 |
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.