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Buspirone Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Buspirone Hydrochloride | 10 mg/1 | 866094 | View |
| Buspirone Hydrochloride | 12.5 mg/1 | 866094 | View |
| Buspirone Hydrochloride | 15 mg/1 | 866094 | View |
| Buspirone Hydrochloride | 2.5 mg/1 | 866094 | View |
| Buspirone Hydrochloride | 30 mg/1 | 866094 | View |
| Buspirone Hydrochloride | 5 mg/1 | 866094 | View |
| Buspirone Hydrochloride | 7.5 mg/1 | 866094 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 210907-001 | BUSPIRONE HYDROCHLORIDE | TABLET | BUSPIRONE HYDROCHLORIDE | Prescription | AB | ||
| 210907-002 | BUSPIRONE HYDROCHLORIDE | TABLET | BUSPIRONE HYDROCHLORIDE | Prescription | AB | ||
| 210907-003 | BUSPIRONE HYDROCHLORIDE | TABLET | BUSPIRONE HYDROCHLORIDE | Prescription | AB | RS | |
| 210907-004 | BUSPIRONE HYDROCHLORIDE | TABLET | BUSPIRONE 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 |
|---|---|---|---|---|---|
| Original application | 1 | Approved | November 14, 2019 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260615). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets, USP in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 mg to 30 mg per day were commonly employed. The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY ). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food. When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS: Drug Interactions section should be followed. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with buspirone hydrochloride tablets. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets before starting an MAOI antidepressant (see CONTRAINDICATIONS and PRECAUTIONS : Drug Interactions ). Use of Buspirone Hydrochloride Tablets with (Reversible) MAOIs, Such as Linezolid or Methylene Blue Do not start buspirone hydrochloride tablets in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see CONTRAINDICATIONS and PRECAUTIONS : Drug Interactions ). In some cases, a patient already receiving therapy with buspirone hydrochloride tablets may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, buspirone hydrochloride tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with buspirone hydrochloride tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS ). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg per kg with buspirone hydrochloride tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see CONTRAINDICATIONS , WARNINGS and PRECAUTIONS : Drug Interactions ).
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride. The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated. Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see WARNINGS , DOSAGE AND ADMINISTRATION and PRECAUTIONS : Drug Interactions )
Warnings and Cautions
openFDA Drug LabelingWarnings and Precautions The administration of buspirone hydrochloride to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride not be used concomitantly with an MAOI. Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs, SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for emergence of serotonin syndrome. The concomitant use of buspirone with MAOIs intended to treat depression is contraindicated. Buspirone should also not be started in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. There have been no reports involving the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a reversible MAOI such as linezolid or intravenous methylene blue in a patient taking buspirone. Buspirone should be discontinued before initiating treatment with the reversible MAOI (see CONTRAINDICATIONS, DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS). If concomitant use of buspirone with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended. Treatment with buspirone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Because buspirone hydrochloride has no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment. PRECAUTIONS General Interference with Cognitive and Motor Performance Studies indicate that buspirone hydrochloride is less sedating than other anxiolytics and that it does not produce significant functional impairment. However, its CNS effects in any individual patient may not be predictable. Therefore, patients should be cautioned about operating an automobile or using complex machinery until they are reasonably certain that buspirone treatment does not affect them adversely. While formal studies of the interaction of buspirone hydrochloride with alcohol indicate that buspirone does not increase alcohol-induced impairment in motor and mental performance, it is prudent to avoid concomitant use of alcohol and buspirone. Potential for Withdrawal Reactions in Sedative/Hypnotic/Anxiolytic Drug-Dependent Patients Because buspirone hydrochloride do not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs. Therefore, before starting therapy wit …
Warnings
openFDA Drug LabelingWARNINGS The administration of buspirone hydrochloride tablets, USP to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride, USP has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride tablets, USP not be used concomitantly with an MAOI. Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for emergence of serotonin syndrome. The concomitant use of buspirone with MAOIs intended to treat depression is contraindicated. Buspirone should also not be started in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. There have been no reports involving the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a reversible MAOI such as linezolid or intravenous methylene blue in a patient taking buspirone. Buspirone should be discontinued before initiating treatment with the reversible MAOI [see CONTRAINDICATIONS , DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS ]. If concomitant use of buspirone with a 5-hydroxytryptmine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. The concomitant use of buspirone with serotonin precursors (such as tryptophan) is not recommended. Treatment with buspirone and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Because buspirone hydrochloride tablets, USP have no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS (SEE ALSO PRECAUTIONS ) Commonly Observed The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement. Associated with Discontinuation of Treatment One guide to the relative clinical importance of adverse events associated with buspirone hydrochloride tablets are provided by the frequency with which they caused drug discontinuation during clinical testing. Approximately 10% of the 2200 anxious patients who participated in the buspirone hydrochloride tablets premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. The more common events causing discontinuation included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue. In addition, 3.4% of patients had multiple complaints, none of which could be characterized as primary. Incidence in Controlled Clinical Trials The table that follows enumerates adverse events that occurred at a frequency of 1% or more among buspirone hydrochloride patients who participated in 4 week, controlled trials comparing buspirone hydrochloride tablets with placebo. The frequencies were obtained from pooled data for 17 trials. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. Comparison of the cited figures, however, does provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied. TREATMENT-EMERGENT ADVERSE EXPERIENCE INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Events reported by at least 1% of buspirone hydrochloride tablets patients are included. - Incidence less than 1 %. (Percent of Patients Reporting) Adverse Experience Buspirone Hydrochloride Tablets (n=477) Placebo (n=464) Cardiovascular Tachycardia/Palpitations 1 1 CNS Dizziness 12 3 Drowsiness 10 9 Nervousness 5 1 Insomnia 3 3 Lightheadedness 3 - Decreased Concentration 2 2 Excitement 2 - Anger/Hostility 2 - Confusion 2 - Depression 2 2 EENT Blurred Vision 2 - Gastrointestinal Nausea 8 5 Dry Mouth 3 4 Abdominal/Gastric Distress 2 2 Diarrhea 2 - Constipation 1 2 Vomiting 1 2 Musculoskeletal Musculoskeletal Aches/Pains 1 - Neurological Numbness 2 - Paresthesia 1 - Incoordination 1 - Tremor 1 - Skin Skin Rash 1 - Miscellaneous Headache 6 3 Fatigue 4 4 Weakness 2 - Sweating/Clamminess 1 - Other Events Observed During the Entire Premarketing Evaluation of Buspirone Hydrochloride Tablets During its premarketing assessment, buspirone hydrochloride tablets were evaluated in over 3500 subjects. This section reports event frequencies for adverse events occurring in approximately 3000 subjects from this group who took multiple doses of buspirone hydrochloride tablets in the dose range for which buspirone hydrochloride tablets are being recommended (i.e., the modal daily dose of buspirone hydrochloride tablets fell between 10 mg and 30 mg for 70% of the patients studied) and for whom safety data were systematically collected. The conditions and duration of exposure to buspirone hydrochloride tablets varied greatly, involving well-controlled studies as well as experience in open and uncontrolled clinical settings. As part of the total experience gained in clinical studies, various adverse events were rep …
Drug Interactions
openFDA Drug LabelingDrug Interactions: Psychotropic Agents: MAO inhibitors: The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated. Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see WARNINGS , DOSAGE AND ADMINISTRATION and CONCOMITANT DRUG ) Amitriptyline: After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C max , AUC, and C min ) of amitriptyline or its metabolite nortriptyline were observed. Diazepam : After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C max , AUC, and C min ) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache, and nausea) were observed. Haloperidol : In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear. Nefazodone: [see Inhibitors and Inducers of Cytochrome P450 3A4 (CYP3A4) ]. Trazodone: There is one report suggesting that the concomitant use of Desyrel ®# (trazodone hydrochloride) and buspirone may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients. In a similar study attempting to replicate this finding, no interactive effect on hepatic transaminases was identified. Triazolam/Flurazepam : Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine. Other Psychotropics: Because the effects of concomitant administration of buspirone with most other psychotropic drugs have not been studied, the concomitant use of buspirone with other CNS-active drugs should be approached with caution. Inhibitors and Inducers of Cytochrome P450 3A4 (CYP3A4) : Buspirone has been shown in vitro to be metabolized by CYP3A4. This finding is consistent with the in vivo interactions observed between buspirone and the following: Diltiazem and Verapamil: In a study of nine healthy volunteers, coadministration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma buspirone concentrations (verapamil increased AUC and C max of buspirone 3.4-fold while diltiazem increased AUC and C max 5.5-fold and 4-fold, respectively.) Adverse events attributable to buspirone may be more likely during concomitant administration with either diltiazem or verapamil. Subsequent dose adjustment may be necessary and should be based on clinical assessment. Erythromycin: In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with erythromycin (1.5 g/day for 4 days) increased plasma buspirone concentrations (5-fold increase in C max and 6-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment. Grapefruit Juice: In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with grapefruit juice (200 mL double-strength t.i.d. for 2 days) increased plasma buspirone concentrations (4.3-fold increase in C max ; 9.2-fold increase in AUC). Patients receiving buspirone should be advised to avoid drinking such large amo …
Use in Specific Populations
openFDA Drug LabelingSpecial Populations Age and Gender Effects After single or multiple doses in adults, no significant differences in buspirone pharmacokinetics (AUC and C max ) were observed between elderly and younger subjects or between men and women. Hepatic Impairment After multiple-dose administration of buspirone to patients with hepatic impairment, steady-state AUC of buspirone increased 13 fold compared with healthy subjects (see PRECAUTIONS ). Renal Impairment After multiple-dose administration of buspirone to renally impaired (Cl cr = 10 to 70 mL/min/1.73 m 2 ) patients, steady-state AUC of buspirone increased 4 fold compared with healthy (Cl cr ≥ 80 mL/min/1.73 m 2 ) subjects (see PRECAUTIONS ). Race Effects The effects of race on the pharmacokinetics of buspirone have not been studied.
Description
openFDA Drug LabelingDESCRIPTION Buspirone hydrochloride tablets, USP is an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride is a white crystalline powder, very soluble in water, freely soluble in methanol and in methylene chloride; sparingly soluble in ethanol and in acetonitrile; very slightly soluble in ethyl acetate, practically insoluble in hexane with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21 H 31 N 5 O 2 • HCl is represented by the following structural formula: Buspirone hydrochloride is supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg, or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The 30 mg tablet also contains ferric oxide. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Signs and Symptoms In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome. No deaths have been reported following overdosage with buspirone hydrochloride tablets, USP alone. Rare cases of intentional overdosage with a fatal outcome were invariably associated with ingestion of multiple drugs and/or alcohol, and a causal relationship to buspirone could not be determined. Toxicology studies of buspirone yielded the following LD 50 values: mice, 655 mg/kg; rats, 196 mg/kg; dogs, 586 mg/kg; and monkeys, 356 mg/kg. These dosages are 160 to 550 times the recommended human daily dose. Recommended Overdose Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage. Respiration, pulse, and blood pressure should be monitored as in all cases of drug overdosage. No specific antidote is known to buspirone, and dialyzability of buspirone has not been determined.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Buspirone Hydrochloride Tablets, USP, are supplied as follows: Buspirone Hydrochloride Tablets, USP 5 mg: White to off white, round flat faced beveled edge tablet, debossed with "244" on one side and "U" on either side of the break line. Bottle of 30: NDC 76420-807-30 (repackaged from NDC 29300-244-XX) Bottle of 60: NDC 76420-807-60 (repackaged from NDC 29300-244-XX) Bottle of 90: NDC 76420-807-90 (repackaged from NDC 29300-244-XX) Bottle of 100: NDC 76420-807-01 (relabeled from NDC 29300-244-01) Bottle of 500: NDC 76420-807-05 (relabeled from NDC 29300-244-05) Buspirone Hydrochloride Tablets, USP 10 mg: White to off white, round flat faced beveled edge tablet, debossed with "245" on one side and "U" on either side of the break line. Bottle of 30: NDC 76420-808-30 (repackaged from NDC 29300-245-XX) Bottle of 60: NDC 76420-808-60 (repackaged from NDC 29300-245-XX) Bottle of 90: NDC 76420-808-90 (repackaged from NDC 29300-245-XX) Bottle of 100: NDC 76420-808-01 (relabeled from NDC 29300-245-01) Bottle of 500: NDC 76420-808-05 (relabeled from NDC 29300-245-05) Buspirone Hydrochloride Tablets, USP 15 mg: White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with "U" and "246" on one side of the trisect segments and plain on other side of the trisect segment. Bottle of 30: NDC 76420-809-30 (repackaged from NDC 29300-246-XX) Bottle of 60: NDC 76420-809-60 (relabeled from NDC 29300-246-16) Bottle of 90: NDC 76420-809-90 (repackaged from NDC 29300-246-XX) Bottle of 100: NDC 76420-809-01 (relabeled from NDC 29300-246-01) Bottle of 180: NDC 76420-809-18 (relabeled from NDC 29300-246-18) Bottle of 500: NDC 76420-809-05 (relabeled from NDC 29300-246-05) Bottle of 30: NDC 76420-724-30 (repackaged from NDC 29300-477-XX) Bottle of 60: NDC 76420-724-60 (relabeled from NDC 29300-477-16) Bottle of 90: NDC 76420-724-90 (repackaged from NDC 29300-477-XX) Bottle of 100: NDC 76420-724-01 (relabeled from NDC 29300-477-01) Bottle of 120: NDC 76420-724-12 (repackaged from NDC 29300-477-XX) Bottle of 180: NDC 76420-724-18 (relabeled from NDC 29300-477-18) Bottle of 500: NDC 76420-724-05 (relabeled from NDC 29300-477-05) Buspirone Hydrochloride Tablets, USP 30 mg: White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with "U" and "247" on one side of the trisect segments and plain on other side of the trisect segment. Bottle of 30: NDC 76420-811-30 (repackaged from NDC 29300-247-XX) Bottle of 60: NDC 76420-811-60 (relabeled from NDC 29300-247-16) Bottle of 90: NDC 76420-811-90 (repackaged from NDC 29300-247-XX) Bottle of 100: NDC 76420-811-01 (relabeled from NDC 29300-247-01) Bottle of 500: NDC 76420-811-05 (relabeled from NDC 29300-247-05) Bottle of 30: NDC 76420-725-30 (repackaged from NDC 29300-478-XX) Bottle of 60: NDC 76420-725-60 (relabeled from NDC 29300-478-16) Bottle of 90: NDC 76420-725-90 (repackaged from NDC 29300-478-XX) Bottle of 100: NDC 76420-725-01 (relabeled from NDC 29300-478-01) Bottle of 500: NDC 76420-725-05 (relabeled from NDC 29300-478-05) Store at 20 0 to 25 0 C (68 0 to 77 0 F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all drugs out of reach of children. Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: BUSPIRONE 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 | May 13, 2026 | Unichem Pharmaceuticals USA Inc. | Subpotent drug | Ongoing |
| Class III | November 29, 2023 | NCS Healthcare of Kentucky Inc | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | Terminated |
| Class III | November 29, 2023 | NCS Healthcare of Kentucky Inc | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots | Terminated |
| Class II | May 3, 2023 | Northwind Pharmaceuticals LLC | CGMP Deviations | Ongoing |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | March 8, 2023 | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated |
| Class II | June 9, 2021 | Oxford Pharmaceuticals, LLC | Presence of Foreign Tablets/Capsules | Completed |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-4862-0 | 50090-4862 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-4862-0) | January 22, 2020 |
| 50090-4862-1 | 50090-4862 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-4862-1) | January 2, 2024 |
| 50090-5347-0 | 50090-5347 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5347-0) | November 9, 2020 |
| 50090-5347-1 | 50090-5347 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5347-1) | November 9, 2020 |
| 50090-5347-3 | 50090-5347 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-5347-3) | November 9, 2020 |
| 50090-5347-4 | 50090-5347 | A-S Medication Solutions | 45 TABLET in 1 BOTTLE (50090-5347-4) | November 9, 2020 |
| 50090-5347-5 | 50090-5347 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5347-5) | November 9, 2020 |
| 50090-5614-0 | 50090-5614 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5614-0) | August 18, 2021 |
| 50090-5797-1 | 50090-5797 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5797-1) | October 13, 2021 |
| 50090-5797-2 | 50090-5797 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5797-2) | December 6, 2024 |
| 50090-5886-0 | 50090-5886 | A-S Medication Solutions | 500 TABLET in 1 BOTTLE (50090-5886-0) | December 28, 2021 |
| 50090-5886-1 | 50090-5886 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5886-1) | December 28, 2021 |
| 50090-5886-3 | 50090-5886 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5886-3) | December 28, 2021 |
| 50090-6188-0 | 50090-6188 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-6188-0) | October 27, 2022 |
| 50090-6188-1 | 50090-6188 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6188-1) | October 27, 2022 |
| 50090-6188-3 | 50090-6188 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6188-3) | October 27, 2022 |
| 50090-6649-0 | 50090-6649 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6649-0) | August 30, 2023 |
| 50090-6649-1 | 50090-6649 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6649-1) | August 30, 2023 |
| 50090-6649-3 | 50090-6649 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-6649-3) | August 30, 2023 |
| 50090-6649-4 | 50090-6649 | A-S Medication Solutions | 45 TABLET in 1 BOTTLE (50090-6649-4) | August 30, 2023 |
| 50090-6649-5 | 50090-6649 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6649-5) | August 30, 2023 |
| 50090-6719-0 | 50090-6719 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6719-0) | October 5, 2023 |
| 50090-6971-1 | 50090-6971 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6971-1) | December 21, 2023 |
| 50090-6971-3 | 50090-6971 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6971-3) | December 21, 2023 |
| 50090-7075-0 | 50090-7075 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7075-0) | January 25, 2024 |
| 50090-7075-1 | 50090-7075 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7075-1) | November 25, 2024 |
| 50090-7161-1 | 50090-7161 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7161-1) | May 6, 2024 |
| 50090-7161-3 | 50090-7161 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7161-3) | May 6, 2024 |
| 50090-7293-0 | 50090-7293 | A-S Medication Solutions | 180 TABLET in 1 BOTTLE (50090-7293-0) | October 8, 2024 |
| 50090-7293-1 | 50090-7293 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7293-1) | October 8, 2024 |
| 50090-7293-3 | 50090-7293 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7293-3) | October 8, 2024 |
| 50090-7652-0 | 50090-7652 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7652-0) | September 9, 2025 |
| 50090-7652-1 | 50090-7652 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7652-1) | September 9, 2025 |
| 50090-7682-1 | 50090-7682 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7682-1) | October 9, 2025 |
| 50090-7682-2 | 50090-7682 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7682-2) | October 9, 2025 |
| 50090-7742-0 | 50090-7742 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7742-0) | October 29, 2025 |
| 50090-7742-1 | 50090-7742 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7742-1) | October 29, 2025 |
| 50090-7785-0 | 50090-7785 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7785-0) | November 21, 2025 |
| 50090-7864-0 | 50090-7864 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7864-0) | January 26, 2026 |
| 50090-8018-1 | 50090-8018 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-8018-1) | July 20, 2026 |
| 50090-8018-2 | 50090-8018 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-8018-2) | July 20, 2026 |
| 24689-781-01 | 24689-781 | APNAR PHARMA LP | 100 TABLET in 1 BOTTLE (24689-781-01) | June 17, 2024 |
| 24689-781-05 | 24689-781 | APNAR PHARMA LP | 500 TABLET in 1 BOTTLE (24689-781-05) | June 17, 2024 |
| 24689-785-01 | 24689-785 | APNAR PHARMA LP | 100 TABLET in 1 BOTTLE (24689-785-01) | June 17, 2024 |
| 24689-907-01 | 24689-907 | APNAR PHARMA LP | 100 TABLET in 1 BOTTLE (24689-907-01) | June 17, 2024 |
| 24689-907-05 | 24689-907 | APNAR PHARMA LP | 500 TABLET in 1 BOTTLE (24689-907-05) | June 17, 2024 |
| 24689-921-01 | 24689-921 | APNAR PHARMA LP | 100 TABLET in 1 BOTTLE (24689-921-01) | June 17, 2024 |
| 24689-921-05 | 24689-921 | APNAR PHARMA LP | 500 TABLET in 1 BOTTLE (24689-921-05) | June 17, 2024 |
| 24689-921-06 | 24689-921 | APNAR PHARMA LP | 60 TABLET in 1 BOTTLE (24689-921-06) | June 17, 2024 |
| 24689-933-06 | 24689-933 | APNAR PHARMA LP | 60 TABLET in 1 BOTTLE (24689-933-06) | June 17, 2024 |
| 16729-200-01 | 16729-200 | Accord Healthcare Inc. | 100 TABLET in 1 BOTTLE (16729-200-01) | December 15, 2016 |
| 16729-200-16 | 16729-200 | Accord Healthcare Inc. | 500 TABLET in 1 BOTTLE (16729-200-16) | December 15, 2016 |
| 16729-201-01 | 16729-201 | Accord Healthcare Inc. | 100 TABLET in 1 BOTTLE (16729-201-01) | November 14, 2016 |
| 16729-202-01 | 16729-202 | Accord Healthcare Inc. | 100 TABLET in 1 BOTTLE (16729-202-01) | December 15, 2016 |
| 16729-202-16 | 16729-202 | Accord Healthcare Inc. | 500 TABLET in 1 BOTTLE (16729-202-16) | December 15, 2016 |
| 16729-203-01 | 16729-203 | Accord Healthcare Inc. | 100 TABLET in 1 BOTTLE (16729-203-01) | December 15, 2016 |
| 16729-203-12 | 16729-203 | Accord Healthcare Inc. | 60 TABLET in 1 BOTTLE (16729-203-12) | December 15, 2016 |
| 16729-289-12 | 16729-289 | Accord Healthcare Inc. | 60 TABLET in 1 BOTTLE (16729-289-12) | December 15, 2016 |
| 80425-0303-1 | 80425-0303 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0303-1) | April 6, 2023 |
| 80425-0303-2 | 80425-0303 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0303-2) | April 6, 2023 |
| 80425-0303-3 | 80425-0303 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0303-3) | April 6, 2023 |
| 80425-0334-1 | 80425-0334 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0334-1) | May 19, 2023 |
| 80425-0334-2 | 80425-0334 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0334-2) | May 19, 2023 |
| 80425-0334-3 | 80425-0334 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0334-3) | May 19, 2023 |
| 80425-0387-1 | 80425-0387 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (80425-0387-1) | May 22, 2024 |
| 80425-0387-2 | 80425-0387 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (80425-0387-2) | May 22, 2024 |
| 80425-0387-3 | 80425-0387 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (80425-0387-3) | May 22, 2024 |
| 80425-0505-1 | 80425-0505 | Advanced Rx of Tennessee, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (80425-0505-1) | March 20, 2025 |
| 80425-0505-2 | 80425-0505 | Advanced Rx of Tennessee, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (80425-0505-2) | March 20, 2025 |
| 80425-0505-3 | 80425-0505 | Advanced Rx of Tennessee, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (80425-0505-3) | March 20, 2025 |
| 11788-057-01 | 11788-057 | AiPing Pharmaceutical, Inc. | 100 TABLET in 1 BOTTLE (11788-057-01) | September 26, 2025 |
| 11788-057-05 | 11788-057 | AiPing Pharmaceutical, Inc. | 500 TABLET in 1 BOTTLE (11788-057-05) | September 26, 2025 |
| 11788-058-01 | 11788-058 | AiPing Pharmaceutical, Inc. | 100 TABLET in 1 BOTTLE (11788-058-01) | September 26, 2025 |
| 11788-059-01 | 11788-059 | AiPing Pharmaceutical, Inc. | 100 TABLET in 1 BOTTLE (11788-059-01) | September 26, 2025 |
| 11788-059-05 | 11788-059 | AiPing Pharmaceutical, Inc. | 500 TABLET in 1 BOTTLE (11788-059-05) | September 26, 2025 |
| 11788-060-01 | 11788-060 | AiPing Pharmaceutical, Inc. | 100 TABLET in 1 BOTTLE (11788-060-01) | September 26, 2025 |
| 11788-060-03 | 11788-060 | AiPing Pharmaceutical, Inc. | 180 TABLET in 1 BOTTLE (11788-060-03) | August 1, 2026 |
| 11788-060-05 | 11788-060 | AiPing Pharmaceutical, Inc. | 500 TABLET in 1 BOTTLE (11788-060-05) | September 26, 2025 |
| 11788-060-60 | 11788-060 | AiPing Pharmaceutical, Inc. | 60 TABLET in 1 BOTTLE (11788-060-60) | August 1, 2026 |
| 11788-061-05 | 11788-061 | AiPing Pharmaceutical, Inc. | 500 TABLET in 1 BOTTLE (11788-061-05) | September 26, 2025 |
| 11788-061-60 | 11788-061 | AiPing Pharmaceutical, Inc. | 60 TABLET in 1 BOTTLE (11788-061-60) | September 26, 2025 |
| 60687-801-21 | 60687-801 | American Health Packaging | 30 BLISTER PACK in 1 CARTON (60687-801-21) / 1 TABLET in 1 BLISTER PACK (60687-801-11) | February 21, 2024 |
| 60687-812-01 | 60687-812 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-812-01) / 1 TABLET in 1 BLISTER PACK (60687-812-11) | March 7, 2024 |
| 60687-823-01 | 60687-823 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-823-01) / 1 TABLET in 1 BLISTER PACK (60687-823-11) | February 28, 2024 |
| 71610-165-53 | 71610-165 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-165-53) | September 28, 2018 |
| 71610-165-60 | 71610-165 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-165-60) | September 28, 2018 |
| 71610-165-80 | 71610-165 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-165-80) | September 28, 2018 |
| 71610-183-60 | 71610-183 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-183-60) | October 31, 2018 |
| 71610-203-53 | 71610-203 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-203-53) | December 3, 2018 |
| 71610-203-60 | 71610-203 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-203-60) | December 3, 2018 |
| 71610-203-80 | 71610-203 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-203-80) | December 3, 2018 |
| 71610-206-30 | 71610-206 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-206-30) | December 13, 2018 |
| 71610-208-53 | 71610-208 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-208-53) | December 13, 2018 |
| 71610-208-60 | 71610-208 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-208-60) | December 13, 2018 |
| 71610-208-80 | 71610-208 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-208-80) | December 13, 2018 |
| 71610-257-53 | 71610-257 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-257-53) | March 29, 2019 |
| 71610-257-60 | 71610-257 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-257-60) | March 29, 2019 |
| 71610-257-80 | 71610-257 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-257-80) | March 29, 2019 |
| 71610-257-92 | 71610-257 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-257-92) | April 14, 2026 |
| 71610-266-53 | 71610-266 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-266-53) | April 25, 2019 |
| 71610-266-60 | 71610-266 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-266-60) | April 25, 2019 |
| 71610-266-80 | 71610-266 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-266-80) | April 25, 2019 |
| 71610-291-60 | 71610-291 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-291-60) | June 5, 2019 |
| 71610-404-60 | 71610-404 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-404-60) | March 9, 2020 |
| 71610-596-53 | 71610-596 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-596-53) | September 9, 2021 |
| 71610-596-60 | 71610-596 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-596-60) | September 9, 2021 |
| 71610-596-70 | 71610-596 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-596-70) | September 9, 2021 |
| 71610-596-80 | 71610-596 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-596-80) | September 9, 2021 |
| 71610-596-92 | 71610-596 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-596-92) | September 9, 2021 |
| 71610-604-53 | 71610-604 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-604-53) | October 19, 2021 |
| 71610-604-60 | 71610-604 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-604-60) | October 19, 2021 |
| 71610-604-80 | 71610-604 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-604-80) | October 19, 2021 |
| 71610-604-92 | 71610-604 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-604-92) | October 19, 2021 |
| 71610-608-60 | 71610-608 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-608-60) | October 26, 2021 |
| 71610-640-30 | 71610-640 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-640-30) | March 16, 2022 |
| 71610-640-60 | 71610-640 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-640-60) | March 16, 2022 |
| 71610-640-80 | 71610-640 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-640-80) | March 16, 2022 |
| 71610-640-92 | 71610-640 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-640-92) | March 16, 2022 |
| 71610-826-30 | 71610-826 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-826-30) | May 2, 2024 |
| 71610-826-53 | 71610-826 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-826-53) | May 2, 2024 |
| 71610-826-60 | 71610-826 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-826-60) | May 2, 2024 |
| 71610-826-80 | 71610-826 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-826-80) | August 18, 2025 |
| 71610-943-53 | 71610-943 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-943-53) | September 2, 2025 |
| 71610-943-60 | 71610-943 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-943-60) | September 2, 2025 |
| 71610-943-80 | 71610-943 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-943-80) | September 2, 2025 |
| 71610-943-92 | 71610-943 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-943-92) | September 3, 2025 |
| 71610-953-53 | 71610-953 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-953-53) | October 10, 2025 |
| 71610-953-60 | 71610-953 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-953-60) | October 10, 2025 |
| 71610-953-70 | 71610-953 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-953-70) | October 10, 2025 |
| 71610-953-80 | 71610-953 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-953-80) | October 10, 2025 |
| 71610-953-92 | 71610-953 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-953-92) | October 10, 2025 |
| 71610-959-30 | 71610-959 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-959-30) | October 28, 2025 |
| 71610-959-53 | 71610-959 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-959-53) | October 28, 2025 |
| 71610-959-60 | 71610-959 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-959-60) | October 28, 2025 |
| 71610-959-80 | 71610-959 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-959-80) | October 28, 2025 |
| 71610-959-92 | 71610-959 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-959-92) | December 9, 2025 |
| 71610-962-53 | 71610-962 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-962-53) | November 5, 2025 |
| 71610-962-60 | 71610-962 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-962-60) | October 31, 2025 |
| 71610-962-70 | 71610-962 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-962-70) | January 8, 2026 |
| 71610-962-80 | 71610-962 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-962-80) | November 5, 2025 |
| 71610-962-92 | 71610-962 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-962-92) | January 8, 2026 |
| 71610-974-30 | 71610-974 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-974-30) | December 9, 2025 |
| 71610-974-53 | 71610-974 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-974-53) | December 9, 2025 |
| 71610-974-60 | 71610-974 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-974-60) | December 9, 2025 |
| 71610-974-70 | 71610-974 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-974-70) | March 26, 2026 |
| 71610-974-80 | 71610-974 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-974-80) | December 9, 2025 |
| 71610-974-92 | 71610-974 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE (71610-974-92) | December 9, 2025 |
| 71610-975-60 | 71610-975 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-975-60) | December 12, 2025 |
| 76420-724-01 | 76420-724 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-724-01) | May 6, 2024 |
| 76420-724-05 | 76420-724 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-724-05) | May 6, 2024 |
| 76420-724-12 | 76420-724 | Asclemed USA, Inc. | 120 TABLET in 1 BOTTLE, PLASTIC (76420-724-12) | May 4, 2026 |
| 76420-724-18 | 76420-724 | Asclemed USA, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (76420-724-18) | May 6, 2024 |
| 76420-724-30 | 76420-724 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-724-30) | May 6, 2024 |
| 76420-724-60 | 76420-724 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-724-60) | May 6, 2024 |
| 76420-724-90 | 76420-724 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-724-90) | May 6, 2024 |
| 76420-725-01 | 76420-725 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-725-01) | May 6, 2024 |
| 76420-725-05 | 76420-725 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-725-05) | May 6, 2024 |
| 76420-725-30 | 76420-725 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-725-30) | May 6, 2024 |
| 76420-725-60 | 76420-725 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-725-60) | May 6, 2024 |
| 76420-725-90 | 76420-725 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-725-90) | May 6, 2024 |
| 76420-807-01 | 76420-807 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-807-01) | May 6, 2024 |
| 76420-807-05 | 76420-807 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-807-05) | May 6, 2024 |
| 76420-807-30 | 76420-807 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-807-30) | May 6, 2024 |
| 76420-807-60 | 76420-807 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-807-60) | May 6, 2024 |
| 76420-807-90 | 76420-807 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-807-90) | May 6, 2024 |
| 76420-808-01 | 76420-808 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-808-01) | May 6, 2024 |
| 76420-808-05 | 76420-808 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-808-05) | May 6, 2024 |
| 76420-808-30 | 76420-808 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-808-30) | May 6, 2024 |
| 76420-808-60 | 76420-808 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-808-60) | May 6, 2024 |
| 76420-808-90 | 76420-808 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-808-90) | May 6, 2024 |
| 76420-809-01 | 76420-809 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-809-01) | May 6, 2024 |
| 76420-809-05 | 76420-809 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-809-05) | May 6, 2024 |
| 76420-809-18 | 76420-809 | Asclemed USA, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (76420-809-18) | May 6, 2024 |
| 76420-809-30 | 76420-809 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-809-30) | May 6, 2024 |
| 76420-809-60 | 76420-809 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-809-60) | May 6, 2024 |
| 76420-809-90 | 76420-809 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-809-90) | May 6, 2024 |
| 76420-811-01 | 76420-811 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-811-01) | May 6, 2024 |
| 76420-811-05 | 76420-811 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-811-05) | May 6, 2024 |
| 76420-811-30 | 76420-811 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-811-30) | May 6, 2024 |
| 76420-811-60 | 76420-811 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-811-60) | May 6, 2024 |
| 76420-811-90 | 76420-811 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-811-90) | May 6, 2024 |
| 59651-389-01 | 59651-389 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-389-01) | February 21, 2020 |
| 59651-389-05 | 59651-389 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (59651-389-05) | February 21, 2020 |
| 59651-389-10 | 59651-389 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-389-10) / 10 TABLET in 1 BLISTER PACK | February 21, 2020 |
| 59651-389-30 | 59651-389 | Aurobindo Pharma Limited | 30 TABLET in 1 BOTTLE (59651-389-30) | February 21, 2020 |
| 59651-389-60 | 59651-389 | Aurobindo Pharma Limited | 60 TABLET in 1 BOTTLE (59651-389-60) | February 21, 2020 |
| 59651-390-01 | 59651-390 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-390-01) | February 21, 2020 |
| 59651-390-05 | 59651-390 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (59651-390-05) | February 21, 2020 |
| 59651-391-01 | 59651-391 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-391-01) | February 21, 2020 |
| 59651-391-05 | 59651-391 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (59651-391-05) | February 21, 2020 |
| 59651-391-10 | 59651-391 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-391-10) / 10 TABLET in 1 BLISTER PACK | February 21, 2020 |
| 59651-391-30 | 59651-391 | Aurobindo Pharma Limited | 30 TABLET in 1 BOTTLE (59651-391-30) | February 21, 2020 |
| 59651-391-60 | 59651-391 | Aurobindo Pharma Limited | 60 TABLET in 1 BOTTLE (59651-391-60) | February 21, 2020 |
| 59651-392-01 | 59651-392 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-392-01) | February 21, 2020 |
| 59651-392-05 | 59651-392 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (59651-392-05) | February 21, 2020 |
| 59651-392-10 | 59651-392 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-392-10) / 10 TABLET in 1 BLISTER PACK | February 21, 2020 |
| 59651-392-18 | 59651-392 | Aurobindo Pharma Limited | 180 TABLET in 1 BOTTLE (59651-392-18) | February 21, 2020 |
| 59651-392-30 | 59651-392 | Aurobindo Pharma Limited | 30 TABLET in 1 BOTTLE (59651-392-30) | February 21, 2020 |
| 59651-392-60 | 59651-392 | Aurobindo Pharma Limited | 60 TABLET in 1 BOTTLE (59651-392-60) | February 21, 2020 |
| 59651-393-01 | 59651-393 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-393-01) | February 21, 2020 |
| 59651-393-05 | 59651-393 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (59651-393-05) | February 21, 2020 |
| 59651-393-10 | 59651-393 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-393-10) / 10 TABLET in 1 BLISTER PACK | February 21, 2020 |
| 59651-393-30 | 59651-393 | Aurobindo Pharma Limited | 30 TABLET in 1 BOTTLE (59651-393-30) | February 21, 2020 |
| 59651-393-60 | 59651-393 | Aurobindo Pharma Limited | 60 TABLET in 1 BOTTLE (59651-393-60) | February 21, 2020 |
| 50268-135-15 | 50268-135 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-135-15) / 1 TABLET in 1 BLISTER PACK (50268-135-11) | October 21, 2020 |
| 83209-303-15 | 83209-303 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 15 TABLET in 1 BLISTER PACK (83209-303-15) | November 13, 2025 |
| 83209-303-20 | 83209-303 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 20 TABLET in 1 BLISTER PACK (83209-303-20) | November 13, 2025 |
| 83209-303-30 | 83209-303 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 30 TABLET in 1 BLISTER PACK (83209-303-30) | November 13, 2025 |
| 83209-303-60 | 83209-303 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 60 TABLET in 1 BLISTER PACK (83209-303-60) | November 13, 2025 |
| 83209-554-15 | 83209-554 | Boswell Pharmacy Services d/b/a BPS Wholesale | 15 TABLET in 1 BLISTER PACK (83209-554-15) | May 15, 2024 |
| 83209-554-21 | 83209-554 | Boswell Pharmacy Services d/b/a BPS Wholesale | 21 TABLET in 1 BLISTER PACK (83209-554-21) | May 15, 2024 |
| 83209-554-30 | 83209-554 | Boswell Pharmacy Services d/b/a BPS Wholesale | 30 TABLET in 1 BLISTER PACK (83209-554-30) | May 15, 2024 |
| 83209-554-60 | 83209-554 | Boswell Pharmacy Services d/b/a BPS Wholesale | 60 TABLET in 1 BLISTER PACK (83209-554-60) | May 15, 2024 |
| 63629-2408-1 | 63629-2408 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-2408-1) | February 24, 2021 |
| 63629-2409-1 | 63629-2409 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-2409-1) | February 24, 2021 |
| 63629-2410-1 | 63629-2410 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-2410-1) | February 24, 2021 |
| 63629-2411-1 | 63629-2411 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-2411-1) | February 24, 2021 |
| 63629-2412-1 | 63629-2412 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-2412-1) | February 24, 2021 |
| 63629-2413-1 | 63629-2413 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-2413-1) | February 24, 2021 |
| 63629-2414-1 | 63629-2414 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-2414-1) | February 24, 2021 |
| 63629-2415-1 | 63629-2415 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-2415-1) | February 24, 2021 |
| 71335-0007-1 | 71335-0007 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0007-1) | May 14, 2026 |
| 71335-0007-2 | 71335-0007 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0007-2) | May 14, 2026 |
| 71335-0007-3 | 71335-0007 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0007-3) | May 14, 2026 |
| 71335-0007-4 | 71335-0007 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-0007-4) | May 14, 2026 |
| 71335-0007-5 | 71335-0007 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-0007-5) | May 14, 2026 |
| 71335-0007-6 | 71335-0007 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-0007-6) | May 14, 2026 |
| 71335-0007-7 | 71335-0007 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-0007-7) | May 14, 2026 |
| 71335-0007-8 | 71335-0007 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0007-8) | May 14, 2026 |
| 71335-0222-1 | 71335-0222 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0222-1) | December 27, 2021 |
| 71335-0222-2 | 71335-0222 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0222-2) | April 11, 2019 |
| 71335-0222-3 | 71335-0222 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0222-3) | December 27, 2021 |
| 71335-0222-4 | 71335-0222 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-0222-4) | December 27, 2021 |
| 71335-0222-5 | 71335-0222 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-0222-5) | December 27, 2021 |
| 71335-0222-6 | 71335-0222 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-0222-6) | December 27, 2021 |
| 71335-0253-1 | 71335-0253 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0253-1) | July 9, 2024 |
| 71335-0253-2 | 71335-0253 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-0253-2) | July 9, 2024 |
| 71335-0253-3 | 71335-0253 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0253-3) | July 9, 2024 |
| 71335-0253-4 | 71335-0253 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0253-4) | March 5, 2018 |
| 71335-0253-5 | 71335-0253 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-0253-5) | July 9, 2024 |
| 71335-0253-6 | 71335-0253 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-0253-6) | July 9, 2024 |
| 71335-1105-1 | 71335-1105 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1105-1) | August 7, 2006 |
| 71335-1105-2 | 71335-1105 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1105-2) | August 7, 2006 |
| 71335-1105-3 | 71335-1105 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1105-3) | August 7, 2006 |
| 71335-1105-4 | 71335-1105 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-1105-4) | August 7, 2006 |
| 71335-1105-5 | 71335-1105 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1105-5) | August 7, 2006 |
| 71335-1105-6 | 71335-1105 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1105-6) | August 7, 2006 |
| 71335-1144-1 | 71335-1144 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1144-1) | July 9, 2024 |
| 71335-1144-2 | 71335-1144 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1144-2) | July 9, 2024 |
| 71335-1144-3 | 71335-1144 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1144-3) | July 9, 2024 |
| 71335-1144-4 | 71335-1144 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-1144-4) | July 9, 2024 |
| 71335-1144-5 | 71335-1144 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1144-5) | July 9, 2024 |
| 71335-1144-6 | 71335-1144 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1144-6) | July 9, 2024 |
| 71335-1605-1 | 71335-1605 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1605-1) | May 20, 2024 |
| 71335-1605-2 | 71335-1605 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1605-2) | May 20, 2024 |
| 71335-1605-3 | 71335-1605 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1605-3) | May 29, 2020 |
| 71335-1605-4 | 71335-1605 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1605-4) | May 27, 2020 |
| 71335-1605-5 | 71335-1605 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1605-5) | May 20, 2024 |
| 71335-1605-6 | 71335-1605 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1605-6) | May 20, 2024 |
| 71335-1605-7 | 71335-1605 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1605-7) | May 20, 2024 |
| 71335-1608-1 | 71335-1608 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1608-1) | February 10, 2022 |
| 71335-1608-2 | 71335-1608 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1608-2) | February 10, 2022 |
| 71335-1608-3 | 71335-1608 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1608-3) | February 10, 2022 |
| 71335-1608-4 | 71335-1608 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1608-4) | February 10, 2022 |
| 71335-1608-5 | 71335-1608 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1608-5) | February 10, 2022 |
| 71335-1608-6 | 71335-1608 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-1608-6) | February 10, 2022 |
| 71335-1608-7 | 71335-1608 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1608-7) | February 10, 2022 |
| 71335-1673-1 | 71335-1673 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1673-1) | July 28, 2020 |
| 71335-1673-2 | 71335-1673 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1673-2) | October 13, 2020 |
| 71335-1673-3 | 71335-1673 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1673-3) | October 26, 2021 |
| 71335-1673-4 | 71335-1673 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-1673-4) | April 4, 2024 |
| 71335-1673-5 | 71335-1673 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1673-5) | July 24, 2020 |
| 71335-1673-6 | 71335-1673 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1673-6) | December 22, 2020 |
| 71335-1673-7 | 71335-1673 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1673-7) | December 22, 2020 |
| 71335-1749-1 | 71335-1749 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1749-1) | August 10, 2021 |
| 71335-1749-2 | 71335-1749 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1749-2) | June 4, 2021 |
| 71335-1749-3 | 71335-1749 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1749-3) | April 12, 2021 |
| 71335-1749-4 | 71335-1749 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1749-4) | January 19, 2022 |
| 71335-1749-5 | 71335-1749 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1749-5) | January 31, 2022 |
| 71335-1749-6 | 71335-1749 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-1749-6) | January 21, 2021 |
| 71335-1749-7 | 71335-1749 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1749-7) | December 10, 2021 |
| 71335-1752-1 | 71335-1752 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1752-1) | April 22, 2021 |
| 71335-1752-2 | 71335-1752 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1752-2) | December 31, 2020 |
| 71335-1752-3 | 71335-1752 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1752-3) | February 4, 2021 |
| 71335-1752-4 | 71335-1752 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1752-4) | April 12, 2021 |
| 71335-1752-5 | 71335-1752 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1752-5) | December 10, 2021 |
| 71335-1752-6 | 71335-1752 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1752-6) | May 3, 2022 |
| 71335-1752-7 | 71335-1752 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1752-7) | March 1, 2022 |
| 71335-1924-1 | 71335-1924 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE, PLASTIC (71335-1924-1) | August 12, 2021 |
| 71335-1924-2 | 71335-1924 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE, PLASTIC (71335-1924-2) | October 19, 2022 |
| 71335-1924-3 | 71335-1924 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE, PLASTIC (71335-1924-3) | December 13, 2021 |
| 71335-1924-4 | 71335-1924 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE, PLASTIC (71335-1924-4) | November 29, 2021 |
| 71335-1924-5 | 71335-1924 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE, PLASTIC (71335-1924-5) | April 5, 2024 |
| 71335-1924-6 | 71335-1924 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE, PLASTIC (71335-1924-6) | April 5, 2024 |
| 71335-1930-1 | 71335-1930 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1930-1) | August 19, 2021 |
| 71335-1930-2 | 71335-1930 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1930-2) | August 19, 2021 |
| 71335-1930-3 | 71335-1930 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-1930-3) | August 19, 2021 |
| 71335-1930-4 | 71335-1930 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1930-4) | August 19, 2021 |
| 71335-1930-5 | 71335-1930 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1930-5) | August 19, 2021 |
| 71335-1938-1 | 71335-1938 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1938-1) | October 27, 2021 |
| 71335-1938-2 | 71335-1938 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-1938-2) | April 8, 2024 |
| 71335-1938-3 | 71335-1938 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1938-3) | June 3, 2022 |
| 71335-1938-4 | 71335-1938 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1938-4) | September 26, 2022 |
| 71335-1938-5 | 71335-1938 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1938-5) | April 8, 2024 |
| 71335-1938-6 | 71335-1938 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1938-6) | April 8, 2024 |
| 71335-2060-1 | 71335-2060 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE, PLASTIC (71335-2060-1) | March 23, 2022 |
| 71335-2060-2 | 71335-2060 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE, PLASTIC (71335-2060-2) | April 3, 2024 |
| 71335-2060-3 | 71335-2060 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE, PLASTIC (71335-2060-3) | March 7, 2022 |
| 71335-2060-4 | 71335-2060 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE, PLASTIC (71335-2060-4) | February 1, 2023 |
| 71335-2060-5 | 71335-2060 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE, PLASTIC (71335-2060-5) | February 2, 2023 |
| 71335-2060-6 | 71335-2060 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE, PLASTIC (71335-2060-6) | April 3, 2024 |
| 71335-2060-7 | 71335-2060 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE, PLASTIC (71335-2060-7) | April 3, 2024 |
| 71335-2073-1 | 71335-2073 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2073-1) | April 25, 2022 |
| 71335-2073-2 | 71335-2073 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2073-2) | April 25, 2022 |
| 71335-2073-3 | 71335-2073 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2073-3) | April 25, 2022 |
| 71335-2073-4 | 71335-2073 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2073-4) | April 25, 2022 |
| 71335-2073-5 | 71335-2073 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2073-5) | April 25, 2022 |
| 71335-2073-6 | 71335-2073 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-2073-6) | April 25, 2022 |
| 71335-2073-7 | 71335-2073 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2073-7) | April 25, 2022 |
| 71335-2081-1 | 71335-2081 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2081-1) | May 2, 2022 |
| 71335-2081-2 | 71335-2081 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2081-2) | May 2, 2022 |
| 71335-2081-3 | 71335-2081 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2081-3) | May 2, 2022 |
| 71335-2081-4 | 71335-2081 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-2081-4) | May 2, 2022 |
| 71335-2081-5 | 71335-2081 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2081-5) | May 2, 2022 |
| 71335-2081-6 | 71335-2081 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2081-6) | May 2, 2022 |
| 71335-2193-1 | 71335-2193 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2193-1) | December 1, 2022 |
| 71335-2193-2 | 71335-2193 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2193-2) | December 1, 2022 |
| 71335-2193-3 | 71335-2193 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-2193-3) | December 1, 2022 |
| 71335-2193-4 | 71335-2193 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-2193-4) | December 1, 2022 |
| 71335-2193-5 | 71335-2193 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2193-5) | December 1, 2022 |
| 71335-2193-6 | 71335-2193 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2193-6) | December 1, 2022 |
| 71335-2237-1 | 71335-2237 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2237-1) | April 3, 2024 |
| 71335-2237-2 | 71335-2237 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2237-2) | August 29, 2023 |
| 71335-2237-3 | 71335-2237 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-2237-3) | April 3, 2024 |
| 71335-2237-4 | 71335-2237 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-2237-4) | April 3, 2024 |
| 71335-2237-5 | 71335-2237 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2237-5) | April 3, 2024 |
| 71335-2237-6 | 71335-2237 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2237-6) | April 3, 2024 |
| 71335-2458-1 | 71335-2458 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE, PLASTIC (71335-2458-1) | August 20, 2024 |
| 71335-2458-2 | 71335-2458 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE, PLASTIC (71335-2458-2) | August 20, 2024 |
| 71335-2458-3 | 71335-2458 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE, PLASTIC (71335-2458-3) | August 20, 2024 |
| 71335-2458-4 | 71335-2458 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE, PLASTIC (71335-2458-4) | August 20, 2024 |
| 71335-2458-5 | 71335-2458 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE, PLASTIC (71335-2458-5) | August 20, 2024 |
| 71335-2458-6 | 71335-2458 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE, PLASTIC (71335-2458-6) | August 20, 2024 |
| 71335-2458-7 | 71335-2458 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE, PLASTIC (71335-2458-7) | August 20, 2024 |
| 71335-2510-1 | 71335-2510 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2510-1) | October 21, 2024 |
| 71335-2510-2 | 71335-2510 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2510-2) | October 21, 2024 |
| 71335-2510-3 | 71335-2510 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-2510-3) | October 21, 2024 |
| 71335-2510-4 | 71335-2510 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2510-4) | October 21, 2024 |
| 71335-2510-5 | 71335-2510 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2510-5) | October 21, 2024 |
| 71335-2510-6 | 71335-2510 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-2510-6) | October 21, 2024 |
| 71335-2510-7 | 71335-2510 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2510-7) | October 21, 2024 |
| 71335-2576-1 | 71335-2576 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2576-1) | February 5, 2025 |
| 71335-2576-2 | 71335-2576 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2576-2) | February 5, 2025 |
| 71335-2576-3 | 71335-2576 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2576-3) | February 5, 2025 |
| 71335-2576-4 | 71335-2576 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2576-4) | February 5, 2025 |
| 71335-2576-5 | 71335-2576 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2576-5) | February 5, 2025 |
| 71335-2576-6 | 71335-2576 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-2576-6) | February 5, 2025 |
| 71335-2576-7 | 71335-2576 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2576-7) | February 5, 2025 |
| 71335-2768-1 | 71335-2768 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2768-1) | October 3, 2025 |
| 71335-2768-2 | 71335-2768 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2768-2) | October 3, 2025 |
| 71335-2768-3 | 71335-2768 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-2768-3) | October 3, 2025 |
| 71335-2768-4 | 71335-2768 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2768-4) | October 3, 2025 |
| 71335-2768-5 | 71335-2768 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2768-5) | October 3, 2025 |
| 71335-2768-6 | 71335-2768 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-2768-6) | October 3, 2025 |
| 71335-2768-7 | 71335-2768 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2768-7) | October 3, 2025 |
| 71335-2820-1 | 71335-2820 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2820-1) | November 10, 2025 |
| 71335-9673-1 | 71335-9673 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-9673-1) | September 26, 2023 |
| 71335-9673-2 | 71335-9673 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-9673-2) | July 13, 2023 |
| 71335-9673-3 | 71335-9673 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-9673-3) | March 20, 2023 |
| 71335-9673-4 | 71335-9673 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-9673-4) | April 3, 2024 |
| 71335-9673-5 | 71335-9673 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-9673-5) | April 3, 2024 |
| 71335-9673-6 | 71335-9673 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-9673-6) | April 3, 2024 |
| 71335-9673-7 | 71335-9673 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-9673-7) | April 3, 2024 |
| 71335-9673-8 | 71335-9673 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-9673-8) | April 3, 2024 |
| 72162-1924-1 | 72162-1924 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1924-1) | January 31, 2024 |
| 72162-1924-5 | 72162-1924 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1924-5) | January 31, 2024 |
| 72162-1925-1 | 72162-1925 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1925-1) | July 27, 2020 |
| 72162-1925-5 | 72162-1925 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1925-5) | July 27, 2020 |
| 72162-1926-1 | 72162-1926 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1926-1) | July 27, 2020 |
| 72162-1926-5 | 72162-1926 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1926-5) | July 27, 2020 |
| 72162-1927-5 | 72162-1927 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1927-5) | May 1, 2020 |
| 72162-1927-6 | 72162-1927 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (72162-1927-6) | May 1, 2020 |
| 72162-2199-1 | 72162-2199 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2199-1) | December 15, 2023 |
| 55154-0285-0 | 55154-0285 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-0285-0) / 1 TABLET in 1 BLISTER PACK | September 2, 2026 |
| 55154-0286-0 | 55154-0286 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-0286-0) / 1 TABLET in 1 BLISTER PACK | September 2, 2026 |
| 55154-3364-0 | 55154-3364 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-3364-0) / 1 TABLET in 1 BLISTER PACK | May 3, 2014 |
| 55154-4305-0 | 55154-4305 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-4305-0) / 1 TABLET in 1 BLISTER PACK | June 29, 2012 |
| 55154-4312-0 | 55154-4312 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-4312-0) / 1 TABLET in 1 BLISTER PACK | June 29, 2012 |
| 55154-5397-0 | 55154-5397 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-5397-0) / 1 TABLET in 1 BLISTER PACK | March 31, 2010 |
| 55154-5494-0 | 55154-5494 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-5494-0) / 1 TABLET in 1 BLISTER PACK | March 31, 2010 |
| 67046-0645-3 | 67046-0645 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-0645-3) | May 4, 2026 |
| 67046-1352-3 | 67046-1352 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1352-3) | June 10, 2026 |
| 72189-175-30 | 72189-175 | DIRECT RX | 30 TABLET in 1 BOTTLE (72189-175-30) | February 9, 2021 |
| 72189-175-82 | 72189-175 | DIRECT RX | 180 TABLET in 1 BOTTLE (72189-175-82) | February 9, 2021 |
| 72189-175-90 | 72189-175 | DIRECT RX | 90 TABLET in 1 BOTTLE (72189-175-90) | February 9, 2021 |
| 72189-200-82 | 72189-200 | DIRECT RX | 180 TABLET in 1 BOTTLE (72189-200-82) | April 12, 2021 |
| 61919-166-60 | 61919-166 | Direct_Rx | 60 TABLET in 1 BOTTLE (61919-166-60) | July 26, 2019 |
| 42806-662-01 | 42806-662 | EPIC PHARMA, LLC | 100 TABLET in 1 BOTTLE (42806-662-01) | June 19, 2020 |
| 42806-662-05 | 42806-662 | EPIC PHARMA, LLC | 500 TABLET in 1 BOTTLE (42806-662-05) | June 19, 2020 |
| 42806-663-01 | 42806-663 | EPIC PHARMA, LLC | 100 TABLET in 1 BOTTLE (42806-663-01) | June 19, 2020 |
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 · 12 sections on this page.