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Doxepin Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Doxepin Hydrochloride | 10 mg/1 | 1000048 | View |
| Doxepin Hydrochloride | 100 mg/1 | 1000048 | View |
| Doxepin Hydrochloride | 150 mg/1 | 1000048 | View |
| Doxepin Hydrochloride | 25 mg/1 | 1000048 | View |
| Doxepin Hydrochloride | 50 mg/1 | 1000048 | View |
| Doxepin Hydrochloride | 75 mg/1 | 1000048 | 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 |
|---|---|---|---|---|---|---|---|
| 070791-001 | DOXEPIN HYDROCHLORIDE | CAPSULE | DOXEPIN HYDROCHLORIDE | Prescription | AB | ||
| 070791-002 | DOXEPIN HYDROCHLORIDE | CAPSULE | DOXEPIN HYDROCHLORIDE | Prescription | AB | ||
| 070791-003 | DOXEPIN HYDROCHLORIDE | CAPSULE | DOXEPIN HYDROCHLORIDE | Prescription | AB | RS | |
| 070791-004 | DOXEPIN HYDROCHLORIDE | CAPSULE | DOXEPIN HYDROCHLORIDE | Prescription | AB | ||
| 070791-005 | DOXEPIN HYDROCHLORIDE | CAPSULE | DOXEPIN HYDROCHLORIDE | Prescription | AB | RS |
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 | 40 | Labeling | Approved | July 16, 2026 | Standard |
| Supplement | 28 | Labeling | Approved | May 29, 2015 | Standard |
| Supplement | 27 | Labeling | Approved | July 17, 2014 | Standard |
| Supplement | 19 | Labeling | Approved | April 17, 2008 | — |
| Supplement | 18 | Labeling | Approved | July 11, 2007 | — |
| Supplement | 17 | Labeling | Approved | November 14, 2005 | — |
| Supplement | 16 | Labeling | Approved | July 8, 2005 | — |
| Supplement | 15 | Labeling | Approved | July 8, 2005 | — |
| Supplement | 12 | Labeling | Approved | October 25, 2000 | — |
| Supplement | 11 | Manufacturing (CMC) | Approved | February 25, 1998 | — |
| Supplement | 10 | Manufacturing (CMC) | Approved | February 5, 1998 | — |
| Supplement | 9 | Labeling | Approved | July 5, 1995 | — |
| Supplement | 8 | Manufacturing (CMC) | Approved | November 19, 1993 | — |
| Supplement | 7 | Labeling | Approved | June 30, 1993 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | July 11, 1989 | — |
| Supplement | 5 | Labeling | Approved | June 22, 1989 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | October 28, 1986 | — |
| Original application | 1 | Approved | May 13, 1986 | — |
Review documents
- 0 · Supplement · September 5, 2014
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260723). 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 doxepin hydrochloride capsules 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. Doxepin hydrochloride capsule is not approved for use in pediatric patients. ( See Warnings: Clinical Worsening and Suicide Risk , Precautions: Information for Patients , and Precautions: Pediatric Use )
Recent Major Changes
openFDA Drug LabelingRECENT MAJOR CHANGES Dosage and Administration (2.4, 2.5, 2.6, 2.7, 2.8) 7/2025 Warnings and Precautions (5.2, 5.5) 7/2025
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Clinical experience has shown that doxepin hydrochloride capsules are safe and well tolerated even in the elderly patient. Owing to lack of clinical experience in the pediatric population, doxepin hydrochloride capsules are not recommended for use in children under 12 years of age.
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION • Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 ) • Recommended starting oral dosage is 25 mg three times daily or 75 mg once daily. ( 2.2 ) • Recommended target total dosage range is between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). ( 2.2 ) • Maximum recommended dosage is 100 mg three times daily. ( 2.2 ) • Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules. ( 2.3 ) • See the Full Prescribing Information for dosage modifications intended to reduce the risk of anticholinergic effects, for strong CYP2D6 inhibitors, and in known CYP2D6 and CYP2C19 poor metabolizers. ( 2.4 , 2.5 , 2.6 ). • When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued. ( 2.7 ) 2.1 Screen for Bipolar Disorder Prior to Starting doxepin hydrochloride capsules Prior to initiating treatment with doxepin hydrochloride capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.5) ]. 2.2 Recommended Dosage The recommended starting oral dosage for doxepin hydrochloride capsules are 25 mg three times daily or 75 mg once daily. The recommended target total oral dosage range for doxepin hydrochloride capsules are between 75 mg/day and 150 mg/day (may be given once daily or in divided doses). The maximum recommended oral dosage for doxepin hydrochloride capsules are 100 mg three times daily. 2.3 Switching Patients to or from a Monoamine Oxidase Inhibitor Wait at least 14 days after discontinuation of a monoamine oxidase inhibitor (MAOI) before initiating therapy with doxepin hydrochloride capsules [see Contraindications (4 ), Warnings and Precautions ( 5.2) , and Drug Interactions (7) ]. Wait at least 14 days after discontinuation of doxepin hydrochloride capsules before initiating therapy with an MAOI [see Contraindications ( 4.4) , Warnings and Precautions ( 5.2 ), and Drug Interactions (7) ]. 2.4 Dosage Modifications Intended to Reduce the Risk of Anticholinergic Effects If anticholinergic effects (e.g., dry mouth, blurred vision, constipation) develop, reduce the doxepin hydrochloride capsules dosage [see Adverse Reactions ( 6.1 )]. 2.5 Dosage Modifications for Strong CYP2D6 Inhibitors Reduce the doxepin hydrochloride capsules dosage based on doxepin plasma concentrations when used concomitantly with strong CYP2D6 inhibitors [see Drug Interactions (7) ]. 2.6 Dosage Modifications in Known CYP2D6 and CYP2C19 Poor Metabolizers Reduce the doxepin hydrochloride capsules dosage based on doxepin plasma concentrations in patients who are known CYP2D6 and CYP2C19 poor metabolizers [see Use in Specific Populations ( 8.7 )]. 2.7 Discontinuation of Doxepin Hydrochloride Capsules Treatment When discontinuing doxepin hydrochloride capsules, gradually reduce the dosage until discontinued [see Adverse Reactions (6) ].
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Capsules: The 10 mg capsule is a hard-shell, gelatin capsule with a buff opaque cap and buff opaque body imprinted with ‘ap’ logo on cap and ‘DXP10’ on body in black ink containing white to off-white colored powder. The 25 mg capsule is a hard-shell, gelatin capsule with a ivory opaque cap and white opaque body imprinted with ‘ap’ logo on cap and ‘DXP25’ on body in black ink containing white to off-white colored powder. The 50 mg capsule is a hard-shell, gelatin capsule with a ivory opaque cap and ivory opaque body imprinted with ‘ap’ logo on cap and ‘DXP50’ on body in black ink containing white to off-white colored powder. The 75 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and light green opaque body imprinted with ‘ap’ logo on cap and ‘DXP75’ on body in black ink containing white to off-white colored powder. The 100 mg capsule is a hard-shell, gelatin capsule with a light green opaque cap and white opaque body imprinted with ‘ap’ logo on cap and ‘DXP100’ on body in black ink containing white to off-white colored powder. Active ingredients in the capsules include: 10 mg, 25, mg, 50 mg, 75 mg, and 100 mg of doxepin. Capsules: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Doxepin hydrochloride capsules are contraindicated in patients: • With hypersensitivity to doxepin (hypersensitivity reactions have included tongue edema and urticaria). The possibility of cross sensitivity with other dibenzoxepines should be kept in mind. • With glaucoma [see Warnings and Precautions (5.3) ]. • With current or past urinary retention [see Adverse Reactions (6.1) ]. • Taking MAOIs, or within 14 days of stopping MAOIs (including the MAOIs linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7) ]. • Hypersensitivity to doxepin ( 4 ) • Glaucoma ( 4 ) • Current or past urinary retention ( 4 ) • Taking MAOIs, or within 14 days of stopping MAOIs ( 4 )
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 nine 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 1,000 patients treated) are provided in Table 1. Table 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality Per 1,000 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 changing …
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 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 1,000 patients treated) are provided in Table 1. Table 1 Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 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 chan …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Angle-Closure Glaucoma [see Warnings and Precautions (5.3)] Sedation and Driving Risks [see Warnings and Precautions (5.4)] Activation of Mania or Hypomania [see Warnings and Precautions (5.5)] Risk of Seizures [see Warnings and Precautions (5.6)] Psychosis [see Warnings and Precautions (5.7)] To report SUSPECTED ADVERSE REACTIONS, contact First Nation Group, LLC at 1-855-221-5332 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Most common adverse reactions (incidence ≥ 5%) are somnolence, dry mouth, dizziness, constipation and fatigue. To report SUSPECTED ADVERSE REACTIONS, contact First Nation Group, LLC at 1-855-221-5332 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions (≥ 2% of doxepin hydrochloride -treated patients) in 1,635 doxepin hydrochloride -treated patients with MDD in clinical trials included somnolence (17%), dry mouth (15%), dizziness (6%), constipation (5%), fatigue (5%), blurred vision (3%), tachycardia (3%), hypotension (3%), insomnia (2%), tremor (2%), nausea (2%), hyperhidrosis (2%), and increased weight (2%). Other Adverse Reactions Observed in Clinical Trials Other adverse reactions that occurred at an incidence of < 2% in patients treated with doxepin hydrochloride in clinical trials were: . Ear and Labyrinth Disorders : Tinnitus. Gastrointestinal Disorders : Diarrhea, dyspepsia, vomiting. General Disorders and Administration Site Conditions : Asthenia, edema, chills. Metabolism and Nutrition Disorders : Decreased appetite. Nervous System Disorders : Ataxia, paresthesia, headache, extrapyramidal disorder. Psychiatric Disorders : Agitation, confusional state, libido decreased. Pulmonary Disorders : Asthma exacerbation. Renal and Urinary Disorders : Urinary retention. Reproductive System and Breast Disorders : Breast enlargement. Skin & Subcutaneous Tissue Disorders : Rash, pruritus. Vascular Disorders : Flushing. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of doxepin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders : Agranulocytosis, leukopenia, thrombocytopenia, eosinophilia, purpura. Cardiac Disorders : Conduction disorder, arrhythmia. Endocrine Disorders : Inappropriate antidiuretic hormone secretion. Eye Disorders : Angle-closure glaucoma, mydriasis. Gastrointestinal Disorders : Aphthous stomatitis, abdominal pain upper. General Disorders and Administration Site Conditions : Facial edema, hyperpyrexia. Hepatobiliary Disorders : Jaundice. Investigations : Blood glucose increased. Nervous System Disorders : Hypoesthesia, dysgeusia, convulsion, tardive dyskinesia, serotonin syndrome. Psychiatric Disorders : Hallucination, disorientation. Reproductive System and Breast Disorders : Testicular swelling, gynecomastia, galactorrhea. Skin and Subcutaneous Tissue Disorders : Photosensitivity reaction, tongue edema, alopecia, urticaria. Vascular Disorders : Hypertension. Withdrawal syndrome occurred after stopping doxepin hydrochloride [see Drug Abuse and Dependence (9.3)]. The following adverse reaction has been reported with use with other tricyclic antidepressants: decreased blood glucose.
Drug Interactions
openFDA Drug LabelingDrug Interactions: 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., citalopram, escitalopram, 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. Doxepin is primarily metabolized by CYP2D6 (with CYP1A2 & CYP3A4 as minor pathways). Inhibitors or substrates of CYP2D6 (i.e., quinidine, selective serotonin reuptake inhibitors [SSRIs]) may increase the plasma concentration of Doxepin when administered concomitantly. The extent of interaction depends on the variability of effect on CYP2D6. The clinical significance of this interaction with Doxepin has not been systematically evaluated. MAO Inhibitors: Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Therefore, MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with Doxepin. The exact length of time may vary and is dependent upon the particular MAO inhibitor being used, the length of time it has been administered, and the dosage involved. Cimetidine: Cimetidine has been reported to produce clinically significant fluctuations in steady-state serum concentrations of various tricyclic antidepressants. Serious anticholinergic symptoms (i.e., severe dry mouth, urinary retention and blurred vision) have been associated with elevations in the serum levels of tricyclic antidepressant when cimetidine therapy is initiated. Additionally, higher than expected tricyclic antidepressant levels have been observed when they are begun in patients already taking cimetidine. In patients who have been reported to be well controlled on tricyclic antidepressants receiving concurrent cimetidine therapy, discontinuation of cimetid …
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS • Pregnancy: Neonates exposed to TCAs, including doxepin hydrochloride capsules, late in the third trimester have developed poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, irritability). Monitor neonates who were exposed to doxepin hydrochloride capsules in the third trimester of pregnancy for poor neonatal adaptation syndrome. (8.1) • Lactation: Breastfeeding not recommended. (8.2) • Geriatric Use: May cause confusion and oversedation. (8.5) • CYP2C19 and CYP2D6 Poor Metabolizers: Increased risk of doxepin hydrochloride capsules -associated adverse reactions. (8.7) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including doxepin hydrochloride capsules, during pregnancy. Health care providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants. Risk Summary Available data from published epidemiological studies and postmarketing reports have not established an increased risk for major birth defects or miscarriage with doxepin hydrochloride capsules use (see Data) . There are risks (see Clinical Considerations): • To the mother associated with untreated depression in pregnancy. • Poor neonate adaptation from exposure to tricyclic antidepressants (TCAs), including doxepin hydrochloride capsules, during the third trimester of pregnancy. Animal reproduction toxicity of doxepin has not been fully characterized. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryofetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of MDD than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of MDD who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated MDD when considering discontinuation of doxepin hydrochloride capsules drugs during pregnancy and the postpartum period. Fetal/Neonatal Adverse Reactions Neonates previously exposed to TCAs, including doxepin hydrochloride capsules, late in the third trimester during pregnancy have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome. Monitor neonates who were exposed to doxepin hydrochloride capsules in the third trimester of pregnancy for poor neonatal adaptation syndrome. Data Human Data: Published epidemiological studies of pregnant women exposed to TCAs, including doxepin hydrochloride capsules, have not established an association with major birth defects, miscarriage, or adverse maternal outcomes. Methodological limitations of these observational studies include small sample size and lack of adequate controls. 8.2 Lactation Risk Summary Data from published literature report the presence of doxepin and nordoxepin in human milk. There are reports of ex …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action The mechanism of action of the doxepin hydrochloride capsules in the treatment of MDD in adult patients is not well understood.
Description
openFDA Drug LabelingDoxepin hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NO•HCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in alcohol and methylene chloride. CHEMISTRY Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz [ b , e ]oxepin-11(6 H )ylidene- N,N -dimethyl-, hydrochloride. It may be represented by the following structural formula: Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg Doxepin capsule for oral administration contains Doxepin hydrochloride equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of Doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Potassium Hydroxide and Black Iron Oxide. FDA approved dissolution specifications differ from the USP. Doxepine
CHEMISTRY Doxepin hydrochloride is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz [ b , e ]oxepin-11(6 H )ylidene- N,N -dimethyl-, hydrochloride. It may be represented by the following structural formula: Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg Doxepin capsule for oral administration contains Doxepin hydrochloride equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of Doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. The empty gelatin capsule shells contain D&C Yellow No. 10, gelatin and titanium dioxide. In addition, the 10 mg, 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3. The imprinting ink contains Shellac, Dehydrated Alcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Strong Ammonia Solution, Potassium Hydroxide and Black Iron Oxide. FDA approved dissolution specifications differ from the USP. Doxepine
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. Other signs of overdose may include: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia, or any of the symptoms listed under ADVERSE REACTIONS . Deaths have been reported involving overdoses of doxepin. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500. General Recommendations: 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 strongly advised. If signs of toxicity occur at any time during this period, extended monitoring is recommended. 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 pCO2 <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 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 …
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Doxepin Hydrochloride Capsules, USP are available containing doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg or 100 mg of doxepin. The 10 mg capsule is light yellow to yellow opaque cap /light yellow to yellow opaque body, hard gelatin capsule, imprinted with on cap and "424" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-424-11 bottles of 100 capsules, with child-resistant closure NDC 70756-424-51 Bottles of 500 capsules. This package is not child resistant. The 25 mg capsule is light yellow to yellow opaque cap/white to off white opaque body, hard gelatin capsule, imprinted with on cap and "425" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-425-11 bottles of 100 capsules, with child-resistant closure NDC 70756-425-51 bottles of 500 capsules. This package is not child resistant. The 50 mg capsule is light yellow to yellow opaque cap and light yellow to yellow opaque body, hard gelatin capsule, imprinted with on cap and "426"" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-426-11 bottles of 100 capsules, with child-resistant closure NDC 70756-426-51 bottles of 500 capsules. This package is not child resistant. The 75 mg capsule is light green to green opaque cap and light green to green opaque body, hard gelatin capsule, imprinted with on cap and "427" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-427-11 bottles of 100 capsules, with child-resistant closure NDC 70756-427-51 bottles of 500 capsules, This package is not child resistant. The 100 mg capsule is light green to green opaque cap and white to off white opaque body, hard gelatin capsule, imprinted with on cap and "428" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-428-11 bottles of 100 capsules, with child-resistant closure NDC 70756-428-51 bottles of 500 capsules, This package is not child resistant. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Image Image Image Image Image
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: DOXEPIN 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 | August 13, 2025 | Alembic Pharmaceuticals Limited | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. | Ongoing |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-5286-0 | 50090-5286 | A-S Medication Solutions | 100 CAPSULE in 1 BOTTLE (50090-5286-0) | October 22, 2020 |
| 50090-5286-1 | 50090-5286 | A-S Medication Solutions | 30 CAPSULE in 1 BOTTLE (50090-5286-1) | October 22, 2020 |
| 50090-7184-1 | 50090-7184 | A-S Medication Solutions | 30 CAPSULE in 1 BOTTLE (50090-7184-1) | June 18, 2024 |
| 50090-7819-1 | 50090-7819 | A-S Medication Solutions | 30 CAPSULE in 1 BOTTLE (50090-7819-1) | December 11, 2025 |
| 50090-8009-0 | 50090-8009 | A-S Medication Solutions | 90 CAPSULE in 1 BOTTLE (50090-8009-0) | July 7, 2026 |
| 80425-0316-1 | 80425-0316 | Advanced Rx Pharmacy of Tennessee, LLC | 30 CAPSULE in 1 BOTTLE (80425-0316-1) | April 10, 2023 |
| 80425-0316-2 | 80425-0316 | Advanced Rx Pharmacy of Tennessee, LLC | 60 CAPSULE in 1 BOTTLE (80425-0316-2) | April 10, 2023 |
| 80425-0316-3 | 80425-0316 | Advanced Rx Pharmacy of Tennessee, LLC | 90 CAPSULE in 1 BOTTLE (80425-0316-3) | April 10, 2023 |
| 80425-0411-1 | 80425-0411 | Advanced Rx of Tennessee, LLC | 30 CAPSULE in 1 BOTTLE (80425-0411-1) | July 10, 2024 |
| 80425-0411-2 | 80425-0411 | Advanced Rx of Tennessee, LLC | 60 CAPSULE in 1 BOTTLE (80425-0411-2) | July 10, 2024 |
| 80425-0411-3 | 80425-0411 | Advanced Rx of Tennessee, LLC | 90 CAPSULE in 1 BOTTLE (80425-0411-3) | July 10, 2024 |
| 27241-167-01 | 27241-167 | Ajanta Pharma USA Inc. | 100 CAPSULE in 1 BOTTLE (27241-167-01) | December 20, 2019 |
| 27241-167-10 | 27241-167 | Ajanta Pharma USA Inc. | 1000 CAPSULE in 1 BOTTLE (27241-167-10) | February 20, 2020 |
| 27241-168-01 | 27241-168 | Ajanta Pharma USA Inc. | 100 CAPSULE in 1 BOTTLE (27241-168-01) | December 20, 2019 |
| 27241-168-10 | 27241-168 | Ajanta Pharma USA Inc. | 1000 CAPSULE in 1 BOTTLE (27241-168-10) | February 20, 2020 |
| 27241-169-01 | 27241-169 | Ajanta Pharma USA Inc. | 100 CAPSULE in 1 BOTTLE (27241-169-01) | December 20, 2019 |
| 27241-169-10 | 27241-169 | Ajanta Pharma USA Inc. | 1000 CAPSULE in 1 BOTTLE (27241-169-10) | February 20, 2020 |
| 27241-170-01 | 27241-170 | Ajanta Pharma USA Inc. | 100 CAPSULE in 1 BOTTLE (27241-170-01) | December 20, 2019 |
| 27241-170-10 | 27241-170 | Ajanta Pharma USA Inc. | 1000 CAPSULE in 1 BOTTLE (27241-170-10) | February 20, 2020 |
| 27241-171-01 | 27241-171 | Ajanta Pharma USA Inc. | 100 CAPSULE in 1 BOTTLE (27241-171-01) | December 20, 2019 |
| 27241-171-10 | 27241-171 | Ajanta Pharma USA Inc. | 1000 CAPSULE in 1 BOTTLE (27241-171-10) | February 20, 2020 |
| 62332-637-31 | 62332-637 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-637-31) | April 23, 2021 |
| 62332-637-91 | 62332-637 | Alembic Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE (62332-637-91) | April 23, 2021 |
| 62332-638-31 | 62332-638 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-638-31) | April 23, 2021 |
| 62332-638-91 | 62332-638 | Alembic Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE (62332-638-91) | April 23, 2021 |
| 62332-639-31 | 62332-639 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-639-31) | April 23, 2021 |
| 62332-639-91 | 62332-639 | Alembic Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE (62332-639-91) | April 23, 2021 |
| 62332-640-31 | 62332-640 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-640-31) | April 23, 2021 |
| 62332-640-91 | 62332-640 | Alembic Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE (62332-640-91) | April 23, 2021 |
| 62332-645-31 | 62332-645 | Alembic Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (62332-645-31) | April 23, 2021 |
| 62332-645-91 | 62332-645 | Alembic Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE (62332-645-91) | April 23, 2021 |
| 46708-637-31 | 46708-637 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-637-31) | April 23, 2021 |
| 46708-637-91 | 46708-637 | Alembic Pharmaceuticals Limited | 1000 CAPSULE in 1 BOTTLE (46708-637-91) | April 23, 2021 |
| 46708-638-31 | 46708-638 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-638-31) | April 23, 2021 |
| 46708-638-91 | 46708-638 | Alembic Pharmaceuticals Limited | 1000 CAPSULE in 1 BOTTLE (46708-638-91) | April 23, 2021 |
| 46708-639-31 | 46708-639 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-639-31) | April 23, 2021 |
| 46708-639-91 | 46708-639 | Alembic Pharmaceuticals Limited | 1000 CAPSULE in 1 BOTTLE (46708-639-91) | April 23, 2021 |
| 46708-640-31 | 46708-640 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-640-31) | April 23, 2021 |
| 46708-640-91 | 46708-640 | Alembic Pharmaceuticals Limited | 1000 CAPSULE in 1 BOTTLE (46708-640-91) | April 23, 2021 |
| 46708-645-31 | 46708-645 | Alembic Pharmaceuticals Limited | 100 CAPSULE in 1 BOTTLE (46708-645-31) | April 23, 2021 |
| 46708-645-91 | 46708-645 | Alembic Pharmaceuticals Limited | 1000 CAPSULE in 1 BOTTLE (46708-645-91) | April 23, 2021 |
| 69238-1166-1 | 69238-1166 | Amneal Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE (69238-1166-1) | June 28, 2017 |
| 69238-1166-3 | 69238-1166 | Amneal Pharmaceuticals LLC | 30 CAPSULE in 1 BOTTLE (69238-1166-3) | June 28, 2017 |
| 69238-1166-9 | 69238-1166 | Amneal Pharmaceuticals LLC | 90 CAPSULE in 1 BOTTLE (69238-1166-9) | June 28, 2017 |
| 69238-1170-1 | 69238-1170 | Amneal Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE (69238-1170-1) | June 28, 2017 |
| 69238-1170-3 | 69238-1170 | Amneal Pharmaceuticals LLC | 30 CAPSULE in 1 BOTTLE (69238-1170-3) | June 28, 2017 |
| 69238-1170-9 | 69238-1170 | Amneal Pharmaceuticals LLC | 90 CAPSULE in 1 BOTTLE (69238-1170-9) | June 28, 2017 |
| 69238-1171-1 | 69238-1171 | Amneal Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE (69238-1171-1) | June 28, 2017 |
| 69238-1171-3 | 69238-1171 | Amneal Pharmaceuticals LLC | 30 CAPSULE in 1 BOTTLE (69238-1171-3) | June 28, 2017 |
| 69238-1171-9 | 69238-1171 | Amneal Pharmaceuticals LLC | 90 CAPSULE in 1 BOTTLE (69238-1171-9) | June 28, 2017 |
| 69238-1172-1 | 69238-1172 | Amneal Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE (69238-1172-1) | June 28, 2017 |
| 69238-1172-3 | 69238-1172 | Amneal Pharmaceuticals LLC | 30 CAPSULE in 1 BOTTLE (69238-1172-3) | June 28, 2017 |
| 69238-1172-9 | 69238-1172 | Amneal Pharmaceuticals LLC | 90 CAPSULE in 1 BOTTLE (69238-1172-9) | June 28, 2017 |
| 69238-1173-1 | 69238-1173 | Amneal Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE (69238-1173-1) | June 28, 2017 |
| 69238-1173-3 | 69238-1173 | Amneal Pharmaceuticals LLC | 30 CAPSULE in 1 BOTTLE (69238-1173-3) | June 28, 2017 |
| 69238-1173-9 | 69238-1173 | Amneal Pharmaceuticals LLC | 90 CAPSULE in 1 BOTTLE (69238-1173-9) | June 28, 2017 |
| 43353-329-09 | 43353-329 | Aphena Pharma Solutions - Tennessee, LLC | 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-329-09) | May 21, 2017 |
| 43353-331-09 | 43353-331 | Aphena Pharma Solutions - Tennessee, LLC | 9000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-09) | May 21, 2017 |
| 43353-331-16 | 43353-331 | Aphena Pharma Solutions - Tennessee, LLC | 6000 CAPSULE in 1 BOTTLE, PLASTIC (43353-331-16) | May 25, 2017 |
| 55801-527-01 | 55801-527 | Appco Pharma LLC | 100 CAPSULE in 1 BOTTLE (55801-527-01) | June 1, 2021 |
| 55801-527-02 | 55801-527 | Appco Pharma LLC | 500 CAPSULE in 1 BOTTLE (55801-527-02) | June 1, 2021 |
| 55801-528-01 | 55801-528 | Appco Pharma LLC | 100 CAPSULE in 1 BOTTLE (55801-528-01) | June 1, 2021 |
| 55801-528-02 | 55801-528 | Appco Pharma LLC | 500 CAPSULE in 1 BOTTLE (55801-528-02) | June 1, 2021 |
| 55801-529-01 | 55801-529 | Appco Pharma LLC | 100 CAPSULE in 1 BOTTLE (55801-529-01) | June 1, 2021 |
| 55801-529-02 | 55801-529 | Appco Pharma LLC | 500 CAPSULE in 1 BOTTLE (55801-529-02) | June 1, 2021 |
| 55801-530-01 | 55801-530 | Appco Pharma LLC | 100 CAPSULE in 1 BOTTLE (55801-530-01) | June 1, 2021 |
| 55801-530-02 | 55801-530 | Appco Pharma LLC | 500 CAPSULE in 1 BOTTLE (55801-530-02) | June 1, 2021 |
| 55801-531-01 | 55801-531 | Appco Pharma LLC | 100 CAPSULE in 1 BOTTLE (55801-531-01) | June 1, 2021 |
| 55801-531-02 | 55801-531 | Appco Pharma LLC | 500 CAPSULE in 1 BOTTLE (55801-531-02) | June 1, 2021 |
| 59651-173-01 | 59651-173 | Aurobindo Pharma Limited | 100 CAPSULE in 1 BOTTLE (59651-173-01) | March 27, 2019 |
| 59651-174-01 | 59651-174 | Aurobindo Pharma Limited | 100 CAPSULE in 1 BOTTLE (59651-174-01) | March 27, 2019 |
| 59651-175-01 | 59651-175 | Aurobindo Pharma Limited | 100 CAPSULE in 1 BOTTLE (59651-175-01) | March 27, 2019 |
| 59651-176-01 | 59651-176 | Aurobindo Pharma Limited | 100 CAPSULE in 1 BOTTLE (59651-176-01) | March 27, 2019 |
| 59651-177-01 | 59651-177 | Aurobindo Pharma Limited | 100 CAPSULE in 1 BOTTLE (59651-177-01) | March 27, 2019 |
| 83209-424-30 | 83209-424 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 30 CAPSULE in 1 BLISTER PACK (83209-424-30) | September 4, 2024 |
| 83209-638-30 | 83209-638 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 30 CAPSULE in 1 BLISTER PACK (83209-638-30) | September 4, 2024 |
| 63629-5033-1 | 63629-5033 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (63629-5033-1) | June 12, 2013 |
| 63629-5033-2 | 63629-5033 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (63629-5033-2) | June 2, 2016 |
| 63629-5033-3 | 63629-5033 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (63629-5033-3) | October 8, 2024 |
| 63629-5033-4 | 63629-5033 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (63629-5033-4) | October 8, 2024 |
| 63629-5033-5 | 63629-5033 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (63629-5033-5) | October 8, 2024 |
| 71335-0072-1 | 71335-0072 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-0072-1) | January 22, 2020 |
| 71335-0072-2 | 71335-0072 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-0072-2) | January 28, 2025 |
| 71335-0072-3 | 71335-0072 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-0072-3) | January 28, 2025 |
| 71335-0072-4 | 71335-0072 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-0072-4) | January 28, 2025 |
| 71335-0072-5 | 71335-0072 | Bryant Ranch Prepack | 180 CAPSULE in 1 BOTTLE (71335-0072-5) | January 28, 2025 |
| 71335-1941-1 | 71335-1941 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-1941-1) | December 29, 2021 |
| 71335-1941-2 | 71335-1941 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-1941-2) | December 29, 2021 |
| 71335-1941-3 | 71335-1941 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-1941-3) | December 29, 2021 |
| 71335-1941-4 | 71335-1941 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-1941-4) | December 29, 2021 |
| 71335-1941-5 | 71335-1941 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-1941-5) | August 31, 2021 |
| 71335-2092-1 | 71335-2092 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2092-1) | May 17, 2022 |
| 71335-2092-2 | 71335-2092 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2092-2) | May 17, 2022 |
| 71335-2092-3 | 71335-2092 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-2092-3) | May 17, 2022 |
| 71335-2092-4 | 71335-2092 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2092-4) | May 17, 2022 |
| 71335-2092-5 | 71335-2092 | Bryant Ranch Prepack | 180 CAPSULE in 1 BOTTLE (71335-2092-5) | May 17, 2022 |
| 71335-2188-1 | 71335-2188 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2188-1) | November 15, 2022 |
| 71335-2188-2 | 71335-2188 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2188-2) | November 15, 2022 |
| 71335-2188-3 | 71335-2188 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-2188-3) | November 15, 2022 |
| 71335-2188-4 | 71335-2188 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-2188-4) | November 15, 2022 |
| 71335-2188-5 | 71335-2188 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2188-5) | November 15, 2022 |
| 71335-2408-1 | 71335-2408 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2408-1) | September 18, 2024 |
| 71335-2408-2 | 71335-2408 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2408-2) | September 18, 2024 |
| 71335-2408-3 | 71335-2408 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2408-3) | September 18, 2024 |
| 71335-2408-4 | 71335-2408 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-2408-4) | September 18, 2024 |
| 71335-2418-1 | 71335-2418 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2418-1) | November 12, 2024 |
| 71335-2418-2 | 71335-2418 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2418-2) | November 12, 2024 |
| 71335-2418-3 | 71335-2418 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-2418-3) | November 12, 2024 |
| 71335-2418-4 | 71335-2418 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-2418-4) | November 12, 2024 |
| 71335-2418-5 | 71335-2418 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2418-5) | November 12, 2024 |
| 71335-2452-1 | 71335-2452 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-1) | August 20, 2024 |
| 71335-2452-2 | 71335-2452 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-2) | August 20, 2024 |
| 71335-2452-3 | 71335-2452 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-3) | August 20, 2024 |
| 71335-2452-4 | 71335-2452 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-4) | August 20, 2024 |
| 71335-2452-5 | 71335-2452 | Bryant Ranch Prepack | 180 CAPSULE in 1 BOTTLE, PLASTIC (71335-2452-5) | August 20, 2024 |
| 71335-2472-1 | 71335-2472 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2472-1) | November 13, 2024 |
| 71335-2472-2 | 71335-2472 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2472-2) | November 13, 2024 |
| 71335-2472-3 | 71335-2472 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2472-3) | November 13, 2024 |
| 71335-2472-4 | 71335-2472 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-2472-4) | November 13, 2024 |
| 71335-2557-1 | 71335-2557 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2557-1) | January 23, 2025 |
| 71335-2557-2 | 71335-2557 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2557-2) | January 23, 2025 |
| 71335-2557-3 | 71335-2557 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-2557-3) | January 23, 2025 |
| 71335-2557-4 | 71335-2557 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-2557-4) | January 23, 2025 |
| 71335-2557-5 | 71335-2557 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2557-5) | January 23, 2025 |
| 71335-2647-1 | 71335-2647 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2647-1) | June 3, 2025 |
| 71335-2647-2 | 71335-2647 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2647-2) | June 3, 2025 |
| 71335-2647-3 | 71335-2647 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-2647-3) | June 3, 2025 |
| 71335-2647-4 | 71335-2647 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2647-4) | June 3, 2025 |
| 71335-2647-5 | 71335-2647 | Bryant Ranch Prepack | 180 CAPSULE in 1 BOTTLE (71335-2647-5) | June 3, 2025 |
| 71335-2804-1 | 71335-2804 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-1) | October 13, 2025 |
| 71335-2804-2 | 71335-2804 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-2) | October 13, 2025 |
| 71335-2804-3 | 71335-2804 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-3) | October 13, 2025 |
| 71335-2804-4 | 71335-2804 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-4) | October 13, 2025 |
| 71335-2817-1 | 71335-2817 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-2817-1) | October 16, 2025 |
| 71335-2817-2 | 71335-2817 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-2817-2) | October 16, 2025 |
| 71335-2817-3 | 71335-2817 | Bryant Ranch Prepack | 28 CAPSULE in 1 BOTTLE (71335-2817-3) | October 16, 2025 |
| 71335-2817-4 | 71335-2817 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-2817-4) | October 16, 2025 |
| 71335-2817-5 | 71335-2817 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-2817-5) | October 16, 2025 |
| 71335-9732-1 | 71335-9732 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-9732-1) | June 30, 2023 |
| 71335-9732-2 | 71335-9732 | Bryant Ranch Prepack | 30 CAPSULE in 1 BOTTLE (71335-9732-2) | June 30, 2023 |
| 71335-9732-3 | 71335-9732 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-9732-3) | June 30, 2023 |
| 71335-9732-4 | 71335-9732 | Bryant Ranch Prepack | 120 CAPSULE in 1 BOTTLE (71335-9732-4) | June 30, 2023 |
| 72162-2227-1 | 72162-2227 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (72162-2227-1) | January 26, 2024 |
| 72162-2228-1 | 72162-2228 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (72162-2228-1) | January 26, 2024 |
| 62135-560-90 | 62135-560 | Chartwell RX, LLC | 90 CAPSULE in 1 BOTTLE (62135-560-90) | November 22, 2022 |
| 62135-561-90 | 62135-561 | Chartwell RX, LLC | 90 CAPSULE in 1 BOTTLE (62135-561-90) | November 22, 2022 |
| 62135-562-90 | 62135-562 | Chartwell RX, LLC | 90 CAPSULE in 1 BOTTLE (62135-562-90) | November 22, 2022 |
| 62135-563-90 | 62135-563 | Chartwell RX, LLC | 90 CAPSULE in 1 BOTTLE (62135-563-90) | November 22, 2022 |
| 62135-564-90 | 62135-564 | Chartwell RX, LLC | 90 CAPSULE in 1 BOTTLE (62135-564-90) | November 22, 2022 |
| 10267-5059-4 | 10267-5059 | Contract Pharmacal Corp. | 1000 CAPSULE in 1 BOTTLE (10267-5059-4) | January 24, 2021 |
| 10267-5059-9 | 10267-5059 | Contract Pharmacal Corp. | 90 CAPSULE in 1 BOTTLE (10267-5059-9) | January 24, 2021 |
| 10267-5060-4 | 10267-5060 | Contract Pharmacal Corp. | 1000 CAPSULE in 1 BOTTLE (10267-5060-4) | January 24, 2021 |
| 10267-5060-9 | 10267-5060 | Contract Pharmacal Corp. | 90 CAPSULE in 1 BOTTLE (10267-5060-9) | January 24, 2021 |
| 10267-5061-4 | 10267-5061 | Contract Pharmacal Corp. | 1000 CAPSULE in 1 BOTTLE (10267-5061-4) | January 24, 2021 |
| 10267-5061-9 | 10267-5061 | Contract Pharmacal Corp. | 90 CAPSULE in 1 BOTTLE (10267-5061-9) | January 24, 2021 |
| 10267-5062-4 | 10267-5062 | Contract Pharmacal Corp. | 1000 CAPSULE in 1 BOTTLE (10267-5062-4) | January 24, 2021 |
| 10267-5062-9 | 10267-5062 | Contract Pharmacal Corp. | 90 CAPSULE in 1 BOTTLE (10267-5062-9) | January 24, 2021 |
| 10267-5063-4 | 10267-5063 | Contract Pharmacal Corp. | 1000 CAPSULE in 1 BOTTLE (10267-5063-4) | January 24, 2021 |
| 10267-5063-9 | 10267-5063 | Contract Pharmacal Corp. | 90 CAPSULE in 1 BOTTLE (10267-5063-9) | January 24, 2021 |
| 67046-0393-3 | 67046-0393 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-0393-3) | June 5, 2026 |
| 67046-0394-3 | 67046-0394 | Coupler LLC | 30 CAPSULE in 1 BLISTER PACK (67046-0394-3) | June 16, 2026 |
| 42806-529-01 | 42806-529 | Epic Pharma, LLC | 100 CAPSULE in 1 BOTTLE (42806-529-01) | June 6, 2017 |
| 42806-529-10 | 42806-529 | Epic Pharma, LLC | 1000 CAPSULE in 1 BOTTLE (42806-529-10) | June 6, 2017 |
| 42806-530-01 | 42806-530 | Epic Pharma, LLC | 100 CAPSULE in 1 BOTTLE (42806-530-01) | June 6, 2017 |
| 42806-530-10 | 42806-530 | Epic Pharma, LLC | 1000 CAPSULE in 1 BOTTLE (42806-530-10) | June 6, 2017 |
| 42806-531-01 | 42806-531 | Epic Pharma, LLC | 100 CAPSULE in 1 BOTTLE (42806-531-01) | March 3, 2022 |
| 42806-531-10 | 42806-531 | Epic Pharma, LLC | 1000 CAPSULE in 1 BOTTLE (42806-531-10) | March 3, 2022 |
| 42806-532-01 | 42806-532 | Epic Pharma, LLC | 100 CAPSULE in 1 BOTTLE (42806-532-01) | March 3, 2022 |
| 42806-532-10 | 42806-532 | Epic Pharma, LLC | 1000 CAPSULE in 1 BOTTLE (42806-532-10) | March 3, 2022 |
| 42806-533-01 | 42806-533 | Epic Pharma, LLC | 100 CAPSULE in 1 BOTTLE (42806-533-01) | June 6, 2017 |
| 42806-533-10 | 42806-533 | Epic Pharma, LLC | 1000 CAPSULE in 1 BOTTLE (42806-533-10) | June 6, 2017 |
| 81469-415-01 | 81469-415 | First Nation Group, LLC | 100 CAPSULE in 1 BOTTLE (81469-415-01) | January 11, 2023 |
| 81469-415-05 | 81469-415 | First Nation Group, LLC | 500 CAPSULE in 1 BOTTLE (81469-415-05) | January 11, 2023 |
| 81469-416-01 | 81469-416 | First Nation Group, LLC | 100 CAPSULE in 1 BOTTLE (81469-416-01) | January 11, 2023 |
| 81469-416-05 | 81469-416 | First Nation Group, LLC | 500 CAPSULE in 1 BOTTLE (81469-416-05) | January 11, 2023 |
| 81469-417-01 | 81469-417 | First Nation Group, LLC | 100 CAPSULE in 1 BOTTLE (81469-417-01) | January 11, 2023 |
| 81469-417-05 | 81469-417 | First Nation Group, LLC | 500 CAPSULE in 1 BOTTLE (81469-417-05) | January 11, 2023 |
| 81469-418-01 | 81469-418 | First Nation Group, LLC | 100 CAPSULE in 1 BOTTLE (81469-418-01) | January 11, 2023 |
| 81469-418-05 | 81469-418 | First Nation Group, LLC | 500 CAPSULE in 1 BOTTLE (81469-418-05) | January 11, 2023 |
| 81469-419-01 | 81469-419 | First Nation Group, LLC | 100 CAPSULE in 1 BOTTLE (81469-419-01) | January 11, 2023 |
| 81469-419-05 | 81469-419 | First Nation Group, LLC | 500 CAPSULE in 1 BOTTLE (81469-419-05) | January 11, 2023 |
| 71921-162-01 | 71921-162 | Florida Pharmaceutical Products, LLC | 100 CAPSULE in 1 BOTTLE (71921-162-01) | May 1, 2021 |
| 71921-163-01 | 71921-163 | Florida Pharmaceutical Products, LLC | 100 CAPSULE in 1 BOTTLE (71921-163-01) | May 1, 2021 |
| 71921-164-01 | 71921-164 | Florida Pharmaceutical Products, LLC | 100 CAPSULE in 1 BOTTLE (71921-164-01) | May 1, 2021 |
| 71921-165-01 | 71921-165 | Florida Pharmaceutical Products, LLC | 100 CAPSULE in 1 BOTTLE (71921-165-01) | May 1, 2021 |
| 71921-166-01 | 71921-166 | Florida Pharmaceutical Products, LLC | 100 CAPSULE in 1 BOTTLE (71921-166-01) | May 1, 2021 |
| 23155-794-01 | 23155-794 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (23155-794-01) | December 30, 2021 |
| 23155-795-01 | 23155-795 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (23155-795-01) | December 30, 2021 |
| 23155-796-01 | 23155-796 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (23155-796-01) | December 30, 2021 |
| 23155-797-01 | 23155-797 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (23155-797-01) | December 30, 2021 |
| 23155-798-01 | 23155-798 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE (23155-798-01) | December 30, 2021 |
| 69315-158-01 | 69315-158 | Leading Pharma, LLC | 100 CAPSULE in 1 PACKAGE (69315-158-01) | April 15, 2021 |
| 69315-158-10 | 69315-158 | Leading Pharma, LLC | 1000 CAPSULE in 1 PACKAGE (69315-158-10) | April 15, 2021 |
| 69315-159-01 | 69315-159 | Leading Pharma, LLC | 100 CAPSULE in 1 PACKAGE (69315-159-01) | April 15, 2021 |
| 69315-159-10 | 69315-159 | Leading Pharma, LLC | 1000 CAPSULE in 1 PACKAGE (69315-159-10) | April 15, 2021 |
| 69315-160-01 | 69315-160 | Leading Pharma, LLC | 100 CAPSULE in 1 PACKAGE (69315-160-01) | April 15, 2021 |
| 69315-160-10 | 69315-160 | Leading Pharma, LLC | 1000 CAPSULE in 1 PACKAGE (69315-160-10) | April 15, 2021 |
| 69315-161-01 | 69315-161 | Leading Pharma, LLC | 100 CAPSULE in 1 PACKAGE (69315-161-01) | April 15, 2021 |
| 69315-161-10 | 69315-161 | Leading Pharma, LLC | 1000 CAPSULE in 1 PACKAGE (69315-161-10) | April 15, 2021 |
| 69315-162-01 | 69315-162 | Leading Pharma, LLC | 100 CAPSULE in 1 PACKAGE (69315-162-01) | April 15, 2021 |
| 69315-162-10 | 69315-162 | Leading Pharma, LLC | 1000 CAPSULE in 1 PACKAGE (69315-162-10) | April 15, 2021 |
| 69315-163-01 | 69315-163 | Leading Pharma, LLC | 100 CAPSULE in 1 PACKAGE (69315-163-01) | April 15, 2021 |
| 69315-163-05 | 69315-163 | Leading Pharma, LLC | 500 CAPSULE in 1 PACKAGE (69315-163-05) | April 15, 2021 |
| 69315-163-50 | 69315-163 | Leading Pharma, LLC | 50 CAPSULE in 1 PACKAGE (69315-163-50) | April 15, 2021 |
| 70756-424-11 | 70756-424 | Lifestar Pharma LLC | 100 CAPSULE in 1 BOTTLE (70756-424-11) | February 10, 2022 |
| 70756-424-51 | 70756-424 | Lifestar Pharma LLC | 500 CAPSULE in 1 BOTTLE (70756-424-51) | February 10, 2022 |
| 70756-425-11 | 70756-425 | Lifestar Pharma LLC | 100 CAPSULE in 1 BOTTLE (70756-425-11) | February 10, 2022 |
| 70756-425-51 | 70756-425 | Lifestar Pharma LLC | 500 CAPSULE in 1 BOTTLE (70756-425-51) | February 10, 2022 |
| 70756-426-11 | 70756-426 | Lifestar Pharma LLC | 100 CAPSULE in 1 BOTTLE (70756-426-11) | February 10, 2022 |
| 70756-426-51 | 70756-426 | Lifestar Pharma LLC | 500 CAPSULE in 1 BOTTLE (70756-426-51) | February 10, 2022 |
| 70756-427-11 | 70756-427 | Lifestar Pharma LLC | 100 CAPSULE in 1 BOTTLE (70756-427-11) | February 10, 2022 |
| 70756-427-51 | 70756-427 | Lifestar Pharma LLC | 500 CAPSULE in 1 BOTTLE (70756-427-51) | February 10, 2022 |
| 70756-428-11 | 70756-428 | Lifestar Pharma LLC | 100 CAPSULE in 1 BOTTLE (70756-428-11) | February 10, 2022 |
| 70756-428-51 | 70756-428 | Lifestar Pharma LLC | 500 CAPSULE in 1 BOTTLE (70756-428-51) | February 10, 2022 |
| 0904-7052-61 | 0904-7052 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7052-61) / 1 CAPSULE in 1 BLISTER PACK | June 28, 2017 |
| 0904-7053-61 | 0904-7053 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7053-61) / 1 CAPSULE in 1 BLISTER PACK | June 28, 2017 |
| 0904-7054-61 | 0904-7054 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7054-61) / 1 CAPSULE in 1 BLISTER PACK | June 28, 2017 |
| 0904-7055-61 | 0904-7055 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7055-61) / 1 CAPSULE in 1 BLISTER PACK | June 28, 2017 |
| 51079-436-20 | 51079-436 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 CARTON (51079-436-20) / 1 CAPSULE in 1 BLISTER PACK (51079-436-01) | June 12, 1998 |
| 51079-437-20 | 51079-437 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 CARTON (51079-437-20) / 1 CAPSULE in 1 BLISTER PACK (51079-437-01) | May 8, 1998 |
| 51079-438-20 | 51079-438 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 CARTON (51079-438-20) / 1 CAPSULE in 1 BLISTER PACK (51079-438-01) | May 28, 1998 |
| 51079-651-20 | 51079-651 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 CARTON (51079-651-20) / 1 CAPSULE in 1 BLISTER PACK (51079-651-01) | June 2, 1998 |
| 0378-1049-01 | 0378-1049 | Mylan Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-01) | May 13, 1986 |
| 0378-1049-10 | 0378-1049 | Mylan Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-1049-10) | May 13, 1986 |
| 0378-3125-01 | 0378-3125 | Mylan Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-01) | May 13, 1986 |
| 0378-3125-10 | 0378-3125 | Mylan Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-3125-10) | May 13, 1986 |
| 0378-4250-01 | 0378-4250 | Mylan Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4250-01) | May 13, 1986 |
| 0378-4250-10 | 0378-4250 | Mylan Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-4250-10) | May 13, 1986 |
| 0378-5375-01 | 0378-5375 | Mylan Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-01) | May 13, 1986 |
| 0378-5375-10 | 0378-5375 | Mylan Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-10) | May 13, 1986 |
| 0378-6410-01 | 0378-6410 | Mylan Pharmaceuticals Inc. | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-01) | May 13, 1986 |
| 0378-6410-10 | 0378-6410 | Mylan Pharmaceuticals Inc. | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-6410-10) | May 13, 1986 |
| 72603-390-01 | 72603-390 | NorthStar RxLLC | 100 CAPSULE in 1 BOTTLE (72603-390-01) | May 1, 2025 |
| 72603-391-01 | 72603-391 | NorthStar RxLLC | 100 CAPSULE in 1 BOTTLE (72603-391-01) | May 1, 2025 |
| 72603-392-01 | 72603-392 | NorthStar RxLLC | 100 CAPSULE in 1 BOTTLE (72603-392-01) | May 1, 2025 |
| 72603-393-01 | 72603-393 | NorthStar RxLLC | 100 CAPSULE in 1 BOTTLE (72603-393-01) | May 1, 2025 |
| 72603-394-01 | 72603-394 | NorthStar RxLLC | 100 CAPSULE in 1 BOTTLE (72603-394-01) | May 1, 2025 |
| 72205-088-91 | 72205-088 | Novadoz Pharmaceuticals LLC | 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-91) | June 27, 2022 |
| 72205-088-99 | 72205-088 | Novadoz Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-088-99) | June 27, 2022 |
| 72205-089-91 | 72205-089 | Novadoz Pharmaceuticals LLC | 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-089-91) | June 27, 2022 |
| 72205-089-99 | 72205-089 | Novadoz Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-089-99) | June 27, 2022 |
| 72205-090-91 | 72205-090 | Novadoz Pharmaceuticals LLC | 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-090-91) | June 27, 2022 |
| 72205-090-99 | 72205-090 | Novadoz Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-090-99) | June 27, 2022 |
| 72205-091-91 | 72205-091 | Novadoz Pharmaceuticals LLC | 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-091-91) | June 27, 2022 |
| 72205-091-99 | 72205-091 | Novadoz Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-091-99) | June 27, 2022 |
| 72205-092-91 | 72205-092 | Novadoz Pharmaceuticals LLC | 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-092-91) | June 27, 2022 |
| 72205-092-99 | 72205-092 | Novadoz Pharmaceuticals LLC | 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-092-99) | June 27, 2022 |
| 68071-5179-9 | 68071-5179 | NuCare Pharmaceuticals,Inc. | 90 CAPSULE in 1 BOTTLE (68071-5179-9) | February 18, 2020 |
| 55289-370-30 | 55289-370 | PD-Rx Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-30) | August 2, 2007 |
| 55289-370-90 | 55289-370 | PD-Rx Pharmaceuticals, Inc. | 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-370-90) | March 16, 2020 |
| 72789-072-30 | 72789-072 | PD-Rx Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-072-30) | April 1, 2020 |
| 72789-220-30 | 72789-220 | PD-Rx Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-30) | December 22, 2021 |
| 72789-220-90 | 72789-220 | PD-Rx Pharmaceuticals, Inc. | 90 CAPSULE in 1 BOTTLE, PLASTIC (72789-220-90) | September 6, 2024 |
| 72789-334-30 | 72789-334 | PD-Rx Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-334-30) | July 28, 2023 |
| 72789-542-30 | 72789-542 | PD-Rx Pharmaceuticals, Inc. | 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-542-30) | December 18, 2025 |
| 24658-793-01 | 24658-793 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 100 CAPSULE in 1 BOTTLE (24658-793-01) | March 14, 2023 |
| 24658-793-10 | 24658-793 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 1000 CAPSULE in 1 BOTTLE (24658-793-10) | March 14, 2023 |
| 24658-794-01 | 24658-794 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 100 CAPSULE in 1 BOTTLE (24658-794-01) | March 14, 2023 |
| 24658-794-10 | 24658-794 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 1000 CAPSULE in 1 BOTTLE (24658-794-10) | March 14, 2023 |
| 24658-795-01 | 24658-795 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 100 CAPSULE in 1 BOTTLE (24658-795-01) | March 14, 2023 |
| 24658-795-10 | 24658-795 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 1000 CAPSULE in 1 BOTTLE (24658-795-10) | March 14, 2023 |
| 24658-796-01 | 24658-796 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 100 CAPSULE in 1 BOTTLE (24658-796-01) | March 14, 2023 |
| 24658-796-10 | 24658-796 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 1000 CAPSULE in 1 BOTTLE (24658-796-10) | March 14, 2023 |
| 24658-797-01 | 24658-797 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 100 CAPSULE in 1 BOTTLE (24658-797-01) | March 14, 2023 |
| 24658-797-05 | 24658-797 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 500 CAPSULE in 1 BOTTLE (24658-797-05) | March 14, 2023 |
| 24658-797-10 | 24658-797 | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 1000 CAPSULE in 1 BOTTLE (24658-797-10) | March 14, 2023 |
| 71205-534-30 | 71205-534 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (71205-534-30) | February 16, 2021 |
| 71205-534-60 | 71205-534 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (71205-534-60) | February 16, 2021 |
| 71205-534-90 | 71205-534 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (71205-534-90) | February 16, 2021 |
| 71205-610-30 | 71205-610 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (71205-610-30) | October 8, 2021 |
| 71205-610-60 | 71205-610 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (71205-610-60) | October 8, 2021 |
| 71205-610-90 | 71205-610 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (71205-610-90) | October 8, 2021 |
| 71205-695-30 | 71205-695 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (71205-695-30) | September 12, 2022 |
| 71205-695-60 | 71205-695 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (71205-695-60) | September 12, 2022 |
| 71205-695-90 | 71205-695 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (71205-695-90) | September 12, 2022 |
| 82804-011-30 | 82804-011 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (82804-011-30) | September 21, 2023 |
| 82804-011-60 | 82804-011 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (82804-011-60) | September 21, 2023 |
| 82804-011-90 | 82804-011 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (82804-011-90) | September 21, 2023 |
| 82804-305-30 | 82804-305 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE, PLASTIC (82804-305-30) | July 21, 2026 |
| 70518-3594-1 | 70518-3594 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-3594-1) | February 7, 2025 |
| 70518-3767-0 | 70518-3767 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-3767-0) | June 16, 2023 |
| 70518-4179-0 | 70518-4179 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4179-0) | September 23, 2024 |
| 70518-4222-0 | 70518-4222 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4222-0) | October 26, 2024 |
| 70518-4231-0 | 70518-4231 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4231-0) | November 13, 2024 |
| 70518-4238-0 | 70518-4238 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4238-0) | December 13, 2024 |
| 70518-4252-0 | 70518-4252 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4252-0) | January 10, 2025 |
| 70518-4282-0 | 70518-4282 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4282-0) | February 10, 2025 |
| 70518-4733-0 | 70518-4733 | REMEDYREPACK INC. | 30 CAPSULE in 1 BLISTER PACK (70518-4733-0) | August 24, 2026 |
| 67296-2165-2 | 67296-2165 | Redpharm Drug | 20 CAPSULE in 1 BOTTLE (67296-2165-2) | June 28, 2017 |
| 64980-594-01 | 64980-594 | Rising Pharma Holdings, Inc. | 100 CAPSULE in 1 BOTTLE (64980-594-01) | December 25, 2023 |
| 64980-595-01 | 64980-595 | Rising Pharma Holdings, Inc. | 100 CAPSULE in 1 BOTTLE (64980-595-01) | December 25, 2023 |
| 64980-596-01 | 64980-596 | Rising Pharma Holdings, Inc. | 100 CAPSULE in 1 BOTTLE (64980-596-01) | December 25, 2023 |
| 64980-597-01 | 64980-597 | Rising Pharma Holdings, Inc. | 100 CAPSULE in 1 BOTTLE (64980-597-01) | December 25, 2023 |
| 64980-598-01 | 64980-598 | Rising Pharma Holdings, Inc. | 100 CAPSULE in 1 BOTTLE (64980-598-01) | December 25, 2023 |
| 48433-035-20 | 48433-035 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-035-20) / 1 CAPSULE in 1 BLISTER PACK (48433-035-01) | February 23, 2026 |
| 48433-036-20 | 48433-036 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-036-20) / 1 CAPSULE in 1 BLISTER PACK (48433-036-01) | February 23, 2026 |
| 48433-037-20 | 48433-037 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-037-20) / 1 CAPSULE in 1 BLISTER PACK (48433-037-01) | February 23, 2026 |
| 48433-038-20 | 48433-038 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-038-20) / 1 CAPSULE in 1 BLISTER PACK (48433-038-01) | February 23, 2026 |
| 72189-161-30 | 72189-161 | direct rx | 30 CAPSULE in 1 BOTTLE (72189-161-30) | December 1, 2020 |
| 50090-5286 | 50090-5286 | A-S Medication Solutions | — | July 1, 2020 |
| 50090-7184 | 50090-7184 | A-S Medication Solutions | — | April 23, 2021 |
| 50090-7819 | 50090-7819 | A-S Medication Solutions | — | June 27, 2022 |
| 50090-8009 | 50090-8009 | A-S Medication Solutions | — | June 28, 2017 |
| 80425-0316 | 80425-0316 | Advanced Rx Pharmacy of Tennessee, LLC | — | April 10, 2023 |
| 80425-0411 | 80425-0411 | Advanced Rx of Tennessee, LLC | — | July 10, 2024 |
| 27241-167 | 27241-167 | Ajanta Pharma USA Inc. | — | December 20, 2019 |
| 27241-168 | 27241-168 | Ajanta Pharma USA Inc. | — | December 20, 2019 |
| 27241-169 | 27241-169 | Ajanta Pharma USA Inc. | — | December 20, 2019 |
| 27241-170 | 27241-170 | Ajanta Pharma USA Inc. | — | December 20, 2019 |
| 27241-171 | 27241-171 | Ajanta Pharma USA Inc. | — | December 20, 2019 |
| 62332-637 | 62332-637 | Alembic Pharmaceuticals Inc. | — | April 23, 2021 |
| 62332-638 | 62332-638 | Alembic Pharmaceuticals Inc. | — | April 23, 2021 |
| 62332-639 | 62332-639 | Alembic Pharmaceuticals Inc. | — | April 23, 2021 |
| 62332-640 | 62332-640 | Alembic Pharmaceuticals Inc. | — | April 23, 2021 |
| 62332-645 | 62332-645 | Alembic Pharmaceuticals Inc. | — | April 23, 2021 |
| 46708-637 | 46708-637 | Alembic Pharmaceuticals Limited | — | April 23, 2021 |
| 46708-638 | 46708-638 | Alembic Pharmaceuticals Limited | — | April 23, 2021 |
| 46708-639 | 46708-639 | Alembic Pharmaceuticals Limited | — | April 23, 2021 |
| 46708-640 | 46708-640 | Alembic Pharmaceuticals Limited | — | April 23, 2021 |
| 46708-645 | 46708-645 | Alembic Pharmaceuticals Limited | — | April 23, 2021 |
| 69238-1166 | 69238-1166 | Amneal Pharmaceuticals LLC | — | June 28, 2017 |
| 69238-1170 | 69238-1170 | Amneal Pharmaceuticals LLC | — | June 28, 2017 |
| 69238-1171 | 69238-1171 | Amneal Pharmaceuticals LLC | — | June 28, 2016 |
| 69238-1172 | 69238-1172 | Amneal Pharmaceuticals LLC | — | June 28, 2017 |
| 69238-1173 | 69238-1173 | Amneal Pharmaceuticals LLC | — | June 28, 2017 |
| 43353-329 | 43353-329 | Aphena Pharma Solutions - Tennessee, LLC | — | May 13, 1986 |
| 43353-331 | 43353-331 | Aphena Pharma Solutions - Tennessee, LLC | — | May 13, 1986 |
| 55801-527 | 55801-527 | Appco Pharma LLC | — | June 1, 2021 |
| 55801-528 | 55801-528 | Appco Pharma LLC | — | June 1, 2021 |
| 55801-529 | 55801-529 | Appco Pharma LLC | — | June 1, 2021 |
| 55801-530 | 55801-530 | Appco Pharma LLC | — | June 1, 2021 |
| 55801-531 | 55801-531 | Appco Pharma LLC | — | June 1, 2021 |
| 59651-173 | 59651-173 | Aurobindo Pharma Limited | — | March 27, 2019 |
| 59651-174 | 59651-174 | Aurobindo Pharma Limited | — | March 27, 2019 |
| 59651-175 | 59651-175 | Aurobindo Pharma Limited | — | March 27, 2019 |
| 59651-176 | 59651-176 | Aurobindo Pharma Limited | — | March 27, 2019 |
| 59651-177 | 59651-177 | Aurobindo Pharma Limited | — | March 27, 2019 |
| 83209-424 | 83209-424 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | — | September 4, 2024 |
| 83209-638 | 83209-638 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | — | September 4, 2024 |
| 63629-5033 | 63629-5033 | Bryant Ranch Prepack | — | May 13, 1986 |
| 71335-0072 | 71335-0072 | Bryant Ranch Prepack | — | June 28, 2017 |
| 71335-1941 | 71335-1941 | Bryant Ranch Prepack | — | May 1, 2021 |
| 71335-2092 | 71335-2092 | Bryant Ranch Prepack | — | December 20, 2019 |
| 71335-2188 | 71335-2188 | Bryant Ranch Prepack | — | December 20, 2019 |
| 71335-2408 | 71335-2408 | Bryant Ranch Prepack | — | May 1, 2021 |
| 71335-2418 | 71335-2418 | Bryant Ranch Prepack | — | June 27, 2022 |
| 71335-2452 | 71335-2452 | Bryant Ranch Prepack | — | June 27, 2022 |
| 71335-2472 | 71335-2472 | Bryant Ranch Prepack | — | April 23, 2021 |
| 71335-2557 | 71335-2557 | Bryant Ranch Prepack | — | April 23, 2021 |
| 71335-2647 | 71335-2647 | Bryant Ranch Prepack | — | April 23, 2021 |
| 71335-2804 | 71335-2804 | Bryant Ranch Prepack | — | June 27, 2022 |
| 71335-2817 | 71335-2817 | Bryant Ranch Prepack | — | February 10, 2022 |
| 71335-9732 | 71335-9732 | Bryant Ranch Prepack | — | December 20, 2019 |
| 72162-2227 | 72162-2227 | Bryant Ranch Prepack | — | May 1, 2021 |
| 72162-2228 | 72162-2228 | Bryant Ranch Prepack | — | May 1, 2021 |
| 62135-560 | 62135-560 | Chartwell RX, LLC | — | September 4, 2020 |
| 62135-561 | 62135-561 | Chartwell RX, LLC | — | September 4, 2020 |
| 62135-562 | 62135-562 | Chartwell RX, LLC | — | September 4, 2020 |
| 62135-563 | 62135-563 | Chartwell RX, LLC | — | September 4, 2020 |
| 62135-564 | 62135-564 | Chartwell RX, LLC | — | September 4, 2020 |
| 10267-5059 | 10267-5059 | Contract Pharmacal Corp. | — | January 24, 2021 |
| 10267-5060 | 10267-5060 | Contract Pharmacal Corp. | — | January 24, 2021 |
| 10267-5061 | 10267-5061 | Contract Pharmacal Corp. | — | January 24, 2021 |
| 10267-5062 | 10267-5062 | Contract Pharmacal Corp. | — | January 24, 2021 |
| 10267-5063 | 10267-5063 | Contract Pharmacal Corp. | — | January 24, 2021 |
| 67046-0393 | 67046-0393 | Coupler LLC | — | June 5, 2026 |
| 67046-0394 | 67046-0394 | Coupler LLC | — | June 16, 2026 |
| 42806-529 | 42806-529 | Epic Pharma, LLC | — | June 6, 2017 |
| 42806-530 | 42806-530 | Epic Pharma, LLC | — | June 6, 2017 |
| 42806-531 | 42806-531 | Epic Pharma, LLC | — | March 3, 2022 |
| 42806-532 | 42806-532 | Epic Pharma, LLC | — | March 3, 2022 |
| 42806-533 | 42806-533 | Epic Pharma, LLC | — | June 6, 2017 |
| 81469-415 | 81469-415 | First Nation Group, LLC | — | January 11, 2023 |
| 81469-416 | 81469-416 | First Nation Group, LLC | — | January 11, 2023 |
| 81469-417 | 81469-417 | First Nation Group, LLC | — | January 11, 2023 |
| 81469-418 | 81469-418 | First Nation Group, LLC | — | January 11, 2023 |
| 81469-419 | 81469-419 | First Nation Group, LLC | — | January 11, 2023 |
| 71921-162 | 71921-162 | Florida Pharmaceutical Products, LLC | — | May 1, 2021 |
| 71921-163 | 71921-163 | Florida Pharmaceutical Products, LLC | — | May 1, 2021 |
| 71921-164 | 71921-164 | Florida Pharmaceutical Products, LLC | — | May 1, 2021 |
| 71921-165 | 71921-165 | Florida Pharmaceutical Products, LLC | — | May 1, 2021 |
| 71921-166 | 71921-166 | Florida Pharmaceutical Products, LLC | — | May 1, 2021 |
| 23155-794 | 23155-794 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | December 30, 2021 |
| 23155-795 | 23155-795 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | December 30, 2021 |
| 23155-796 | 23155-796 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | December 30, 2021 |
| 23155-797 | 23155-797 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | December 30, 2021 |
| 23155-798 | 23155-798 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | December 30, 2021 |
| 69315-158 | 69315-158 | Leading Pharma, LLC | — | April 15, 2021 |
| 69315-159 | 69315-159 | Leading Pharma, LLC | — | April 15, 2021 |
| 69315-160 | 69315-160 | Leading Pharma, LLC | — | April 15, 2021 |
| 69315-161 | 69315-161 | Leading Pharma, LLC | — | April 15, 2021 |
| 69315-162 | 69315-162 | Leading Pharma, LLC | — | April 15, 2021 |
| 69315-163 | 69315-163 | Leading Pharma, LLC | — | April 15, 2021 |
| 70756-424 | 70756-424 | Lifestar Pharma LLC | — | February 10, 2022 |
| 70756-425 | 70756-425 | Lifestar Pharma LLC | — | February 10, 2022 |
| 70756-426 | 70756-426 | Lifestar Pharma LLC | — | February 10, 2022 |
| 70756-427 | 70756-427 | Lifestar Pharma LLC | — | February 10, 2022 |
| 70756-428 | 70756-428 | Lifestar Pharma LLC | — | February 10, 2022 |
| 0904-7052 | 0904-7052 | Major Pharmaceuticals | — | June 28, 2017 |
| 0904-7053 | 0904-7053 | Major Pharmaceuticals | — | June 28, 2017 |
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.