Buspirone hydrochloride
Tablet · Oral
Uses
Buspirone hydrochloride tablets 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 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 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: Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 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. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 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 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 for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
Dosage 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 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 C ONTRAINDICATIONS and 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 C ONTRAINDICATIONS, WARNINGS and DRUG INTERACTIONS ).
Contraindications
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 DRUG INTERACTIONS ).
Warnings
The administration of buspirone hydrochloride tablets 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 tablets not be used concomitantly with an MAOI.
Precautions
General Interference with Cognitive and Motor Performance Studies indicate that buspirone hydrochloride tablets are 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 tablets 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 with buspirone hydrochloride tablets, it is advisable to withdraw patients gradually, especially patients who have been using a CNS-depressant drug chronically, from their prior treatment. Rebound or withdrawal symptoms may occur over varying time periods, depending in part on the type of drug, and its effective half-life of elimination. The syndrome of withdrawal from sedative/hypnotic/anxiolytic drugs can appear as any combination of irritability, anxiety, agitation, insomnia, tremor, abdominal cramps, muscle cramps, vomiting, sweating, flu-like symptoms without fever, and occasionally, even as seizures. Possible Concerns Related to Buspirone's Binding to Dopamine Receptors Because buspirone can bind to central dopamine receptors, a question has been raised about its potential to cause acute and chronic changes in dopamine-mediated neurological function (e.g., dystonia, pseudo-parkinsonism, akathisia, and tardive dyskinesia). Clinical experience in controlled trials has failed to identify any significant neuroleptic-like activity; however, a syndrome of restlessness, appearing shortly after initiation of treatment, has been reported in some small fraction of buspirone-treated patients. The syndrome may be explained in several ways. For example, buspirone may increase central noradrenergic activity; alternatively, the effect may be attributable to dopaminergic effects (i.e., represent akathisia). See ADVERSE REACTIONS: Postmarketing Experience .
Side effects
(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.
Overdosage
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 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.
Description
Buspirone hydrochloride tablets, USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 421.96. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The empirical 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 contains 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, 7.5 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 tablets are scored such that they may be bisected or trisected. Thus, a single 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). The 30 mg tablets are scored such that they may be bisected or trisected. Thus, a single 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, USP contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. chemical-structure
How supplied
Buspirone Hydrochloride Tablets, USP 5 mg are available as white to slightly off-white, oval, uncoated tablets, debossed with “349” on one side and a score on the other side. NDC 11788-057-01 Bottles of 100 NDC 11788-057-05 Bottles of 500 Buspirone Hydrochloride Tablets, USP 7.5 mg are available as white to slightly off-white, oval, uncoated tablets, debossed with “350” on one side and a score on the other side. NDC 11788-058-01 Bottles of 100 Buspirone Hydrochloride Tablets, USP 10 mg are available as white to slightly off-white, oval, uncoated tablets, debossed with “351” on one side and a score on the other side. NDC 11788-059-01 Bottles of 100 NDC 11788-059-05 Bottles of 500 Buspirone Hydrochloride Tablets, USP 15 mg are available as white to slightly off-white, rectangular, uncoated tablets, debossed with “3” and “52” with a score in between on one side and two scores on the other side. These tablets are scored to provide 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). NDC 11788-060-60 Bottles of 60 NDC 11788-060-01 Bottles of 100 NDC 11788-060-03 Bottles of 180 NDC 11788-060-05 Bottles of 500 Buspirone Hydrochloride Tablets, USP 30 mg are available as white to slightly off-white, rectangular, uncoated tablets, debossed with “3” and “53” with a score in between on one side and two scores on the other side. These tablets are scored to provide 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). NDC 11788-061-60 Bottles of 60 NDC 11788-061-05 Bottles of 500 Store at 20° to 25° C (68° to 77° 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 MEDICATIONS OUT OF THE REACH OF CHILDREN.
Label text from the FDA structured product label by AiPing Pharmaceutical, Inc. (revised Jul 29, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Buspirone Hydrochloride in 257 products
- Buspirone in 3 products
Buspirone hydrochloride NDC products (260)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7682 | Buspirone Hydrochloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7864 | Buspirone Hydrochloride 10 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7785 | Buspirone Hydrochloride 10 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-8018 | Buspirone Hydrochloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7742 | Buspirone Hydrochloride 30 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7652 | Buspirone Hydrochloride 30 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7293 | Buspirone Hydrochloride 15 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7161 | Buspirone Hydrochloride 15 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-4862 | Buspirone Hydrochloride 30 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5614 | Buspirone Hydrochloride 7.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-7075 | Buspirone Hydrochloride 7.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6971 | Buspirone Hydrochloride 15 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6719 | Buspirone Hydrochloride 10 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6649 | Buspirone Hydrochloride 10 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6188 | Buspirone Hydrochloride 15 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5886 | Buspirone Hydrochloride 15 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5797 | Buspirone Hydrochloride 5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5347 | Buspirone Hydrochloride 10 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 16729-200 | Buspirone Hydrochloride 5 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-201 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-202 | Buspirone Hydrochloride 10 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-203 | Buspirone Hydrochloride 15 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-289 | Buspirone Hydrochloride 30 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 80425-0505 | Buspirone Hydrochloride 5 mg/1 Tablet | Advanced Rx of Tennessee, LLC | ANDA |
| 80425-0303 | Buspirone Hydrochloride 15 mg/1 Tablet | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0334 | Buspirone Hydrochloride 5 mg/1 Tablet | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 80425-0387 | Buspirone Hydrochloride 15 mg/1 Tablet | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 11788-060 | Buspirone Hydrochloride 15 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-061 | Buspirone Hydrochloride 30 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-059 | Buspirone Hydrochloride 10 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-058 | Buspirone Hydrochloride 7.5 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-057 | Buspirone Hydrochloride 5 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 60687-801 | Buspirone Hydrochloride 7.5 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-812 | Buspirone Hydrochloride 10 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-823 | Buspirone Hydrochloride 15 mg/1 Tablet | American Health Packaging | ANDA |
| 71610-208 | Buspirone Hydrochloride 10 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-165 | Buspirone Hydrochloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-183 | Buspirone Hydrochloride 15 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-206 | Buspirone Hydrochloride 15 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-975 | Buspirone Hydrochloride 15 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-974 | Buspirone Hydrochloride 10 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-962 | Buspirone Hydrochloride 10 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-959 | Buspirone Hydrochloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-953 | Buspirone Hydrochloride 10 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-943 | Buspirone Hydrochloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-826 | Buspirone Hydrochloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-640 | Buspirone Hydrochloride 15 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-608 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-604 | Buspirone Hydrochloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-596 | Buspirone Hydrochloride 10 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-404 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-291 | Buspirone Hydrochloride 15 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-203 | Buspirone Hydrochloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-266 | Buspirone Hydrochloride 5 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-257 | Buspirone Hydrochloride 10 mg/1 Tablet | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 24689-781 | Buspirone Hydrochloride 5 mg/1 Tablet | APNAR PHARMA LP | ANDA |
| 24689-785 | Buspirone Hydrochloride 7.5 mg/1 Tablet | APNAR PHARMA LP | ANDA |
| 24689-907 | Buspirone Hydrochloride 10 mg/1 Tablet | APNAR PHARMA LP | ANDA |
| 24689-921 | Buspirone Hydrochloride 15 mg/1 Tablet | APNAR PHARMA LP | ANDA |
| 24689-933 | Buspirone Hydrochloride 30 mg/1 Tablet | APNAR PHARMA LP | ANDA |
| 76420-809 | Buspirone Hydrochloride 15 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-808 | Buspirone Hydrochloride 10 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-807 | Buspirone Hydrochloride 5 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-725 | Buspirone Hydrochloride 30 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-724 | Buspirone Hydrochloride 15 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 76420-811 | Buspirone Hydrochloride 30 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 59651-393 | Buspirone Hydrochloride 30 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-392 | Buspirone Hydrochloride 15 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-391 | Buspirone Hydrochloride 10 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-389 | Buspirone Hydrochloride 5 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-390 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 50268-135 | Buspirone Hydrochloride 15 mg/1 Tablet | AvPAK | ANDA |
| 83209-554 | Buspirone Hydrochloride 10 mg/1 Tablet | Boswell Pharmacy Services d/b/a BPS Wholesale | ANDA |
| 83209-303 | Buspirone Hydrochloride 15 mg/1 Tablet | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | ANDA |
| 71335-1749 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2408 | Buspirone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1673 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1608 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1605 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1144 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1105 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0253 | Buspirone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0222 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0007 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2199 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2415 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2414 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2413 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2412 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2411 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2410 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-2409 | Buspirone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1927 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2458 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1926 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1925 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1924 | Buspirone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-9673 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2820 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2768 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2576 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2510 | Buspirone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1752 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2237 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2193 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2081 | Buspirone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2073 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2060 | Buspirone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1938 | Buspirone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1930 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1924 | Buspirone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 55154-0285 | Buspirone Hydrochloride 5 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-5494 | Buspirone Hydrochloride 5 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-5397 | Buspirone Hydrochloride 10 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-4312 | Buspirone Hydrochloride 5 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-4305 | Buspirone Hydrochloride 10 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-3364 | Buspirone Hydrochloride 15 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 55154-0286 | Buspirone Hydrochloride 10 mg/1 Tablet | Cardinal Health 107, LLC | ANDA |
| 67046-0645 | Buspirone Hydrochloride 5 mg/1 Tablet | Coupler LLC | ANDA |
| 67046-1352 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Coupler LLC | ANDA |
| 72189-175 | Buspirone Hydrochloride 10 mg/1 Tablet | DIRECT RX | ANDA |
| 72189-200 | Buspirone Hydrochloride 10 mg/1 Tablet | DIRECT RX | ANDA |
| 61919-166 | Buspirone Hydrochloride 5 mg/1 Tablet | Direct_Rx | ANDA |
| 42806-662 | Buspirone Hydrochloride 5 mg/1 Tablet | EPIC PHARMA, LLC | ANDA |
| 42806-833 | Buspirone 15 mg/1 Capsule | EPIC PHARMA, LLC | ANDA |
| 42806-832 | Buspirone 10 mg/1 Capsule | EPIC PHARMA, LLC | ANDA |
| 42806-831 | Buspirone 7.5 mg/1 Capsule | EPIC PHARMA, LLC | ANDA |
| 42806-664 | Buspirone Hydrochloride 15 mg/1 Tablet | EPIC PHARMA, LLC | ANDA |
| 42806-665 | Buspirone Hydrochloride 30 mg/1 Tablet | EPIC PHARMA, LLC | ANDA |
| 42806-082 | Buspirone Hydrochloride 5 mg/1 Tablet | Epic Pharma, LLC | ANDA |
| 42806-083 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Epic Pharma, LLC | ANDA |
| 42806-084 | Buspirone Hydrochloride 10 mg/1 Tablet | Epic Pharma, LLC | ANDA |
| 42806-085 | Buspirone Hydrochloride 15 mg/1 Tablet | Epic Pharma, LLC | ANDA |
| 42806-663 | Buspirone Hydrochloride 10 mg/1 Tablet | EPIC PHARMA, LLC | ANDA |
| 42806-086 | Buspirone Hydrochloride 30 mg/1 Tablet | Epic Pharma, LLC | ANDA |
| 51407-415 | Buspirone Hydrochloride 10 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-416 | Buspirone Hydrochloride 15 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-414 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-417 | Buspirone Hydrochloride 30 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 51407-413 | Buspirone Hydrochloride 5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 23155-097 | Buspirone Hydrochloride 30 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-025 | Buspirone Hydrochloride 15 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-024 | Buspirone Hydrochloride 10 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 23155-023 | Buspirone Hydrochloride 5 mg/1 Tablet | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA |
| 71085-093 | Buspirone Hydrochloride 2.5 mg/1 Tablet | IPG Pharmaceuticals, Inc | ANDA |
| 71085-094 | Buspirone Hydrochloride 12.5 mg/1 Tablet | IPG Pharmaceuticals, Inc | ANDA |
| 0904-7122 | Buspirone Hydrochloride 5 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-7121 | Buspirone Hydrochloride 10 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 0904-6899 | Buspirone Hydrochloride 15 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 51079-994 | Buspirone Hydrochloride 30 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-960 | Buspirone Hydrochloride 15 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-985 | Buspirone Hydrochloride 5 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 51079-986 | Buspirone Hydrochloride 10 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 0378-1150 | Buspirone Hydrochloride 10 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1140 | Buspirone Hydrochloride 5 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1165 | Buspirone Hydrochloride 15 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-1175 | Buspirone Hydrochloride 30 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 0615-7689 | Buspirone Hydrochloride 15 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7714 | Buspirone Hydrochloride 5 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7718 | Buspirone Hydrochloride 10 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8434 | Buspirone Hydrochloride 7.5 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-8527 | Buspirone Hydrochloride 30 mg/1 Tablet | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 51655-796 | Buspirone Hydrochloride 10 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-097 | Buspirone Hydrochloride 10 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-015 | Buspirone Hydrochloride 15 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 51655-511 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Northwind Health Company, LLC | ANDA |
| 68071-3336 | Buspirone Hydrochloride 10 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3881 | Buspirone Hydrochloride 10 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3834 | Buspirone Hydrochloride 15 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3989 | Buspirone Hydrochloride 10 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-2995 | Buspirone Hydrochloride 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2987 | Buspirone Hydrochloride 15 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA |
| 69584-091 | Buspirone Hydrochloride 5 mg/1 Tablet | Oxford Pharmaceuticals, LLC | ANDA |
| 69584-092 | Buspirone Hydrochloride 10 mg/1 Tablet | Oxford Pharmaceuticals, LLC | ANDA |
| 69584-093 | Buspirone Hydrochloride 15 mg/1 Tablet | Oxford Pharmaceuticals, LLC | ANDA |
| 69584-094 | Buspirone Hydrochloride 30 mg/1 Tablet | Oxford Pharmaceuticals, LLC | ANDA |
| 43063-785 | Buspirone Hydrochloride 10 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-141 | Buspirone Hydrochloride 15 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-142 | Buspirone Hydrochloride 30 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-181 | Buspirone Hydrochloride 10 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-332 | Buspirone Hydrochloride 15 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-140 | Buspirone Hydrochloride 10 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-139 | Buspirone Hydrochloride 5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8086 | Buspirone Hydrochloride 10 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8681 | Buspirone Hydrochloride 15 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7968 | Buspirone Hydrochloride 15 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7952 | Buspirone Hydrochloride 5 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 82804-963 | Buspirone Hydrochloride 15 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-039 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-062 | Buspirone Hydrochloride 5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-104 | Buspirone Hydrochloride 10 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-961 | Buspirone Hydrochloride 5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-962 | Buspirone Hydrochloride 10 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-799 | Buspirone Hydrochloride 5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-493 | Buspirone Hydrochloride 5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 71205-280 | Buspirone Hydrochloride 15 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-402 | Buspirone Hydrochloride 15 mg/1 Tablet | Proficient Rx LP | ANDA |
| 82804-964 | Buspirone Hydrochloride 30 mg/1 Tablet | Proficient Rx LP | ANDA |
| 63187-904 | Buspirone Hydrochloride 10 mg/1 Tablet | Proficient Rx LP | ANDA |
| 77771-234 | Buspirone Hydrochloride 5 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 77771-235 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 77771-236 | Buspirone Hydrochloride 10 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 77771-237 | Buspirone Hydrochloride 15 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 77771-238 | Buspirone Hydrochloride 30 mg/1 Tablet | Radha Pharmaceuticals, Inc. | ANDA |
| 67296-2276 | Buspirone Hydrochloride 10 mg/1 Tablet | Redpharm Drug | ANDA |
| 70518-4068 | Buspirone Hydrochloride 30 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4443 | Buspirone Hydrochloride 10 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-0380 | Buspirone Hydrochloride 15 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-0682 | Buspirone Hydrochloride 5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2031 | Buspirone Hydrochloride 10 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2660 | Buspirone Hydrochloride 15 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2987 | Buspirone Hydrochloride 15 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3279 | Buspirone Hydrochloride 10 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3686 | Buspirone Hydrochloride 5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-3906 | Buspirone Hydrochloride 7.5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4052 | Buspirone Hydrochloride 15 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4317 | Buspirone Hydrochloride 7.5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-4586 | Buspirone Hydrochloride 5 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 64980-654 | Buspirone Hydrochloride 30 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 64980-653 | Buspirone Hydrochloride 15 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 64980-652 | Buspirone Hydrochloride 10 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 64980-651 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 64980-650 | Buspirone Hydrochloride 5 mg/1 Tablet | Rising Pharma Holdings, Inc. | ANDA |
| 48433-013 | Buspirone Hydrochloride 15 mg/1 Tablet | Safecor Health, LLC | ANDA |
| 48433-011 | Buspirone Hydrochloride 5 mg/1 Tablet | Safecor Health, LLC | ANDA |
| 48433-012 | Buspirone Hydrochloride 10 mg/1 Tablet | Safecor Health, LLC | ANDA |
| 48433-014 | Buspirone Hydrochloride 30 mg/1 Tablet | Safecor Health, LLC | ANDA |
| 42543-741 | Buspirone Hydrochloride 5 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 42543-742 | Buspirone Hydrochloride 10 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 42543-743 | Buspirone Hydrochloride 15 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 42543-744 | Buspirone Hydrochloride 30 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 42543-787 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 64380-787 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-744 | Buspirone Hydrochloride 30 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-743 | Buspirone Hydrochloride 15 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-742 | Buspirone Hydrochloride 10 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-741 | Buspirone Hydrochloride 5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 0093-0054 | Buspirone Hydrochloride 10 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-0053 | Buspirone Hydrochloride 5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-1003 | Buspirone Hydrochloride 15 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-5200 | Buspirone Hydrochloride 30 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 29300-244 | Buspirone Hydrochloride 5 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-245 | Buspirone Hydrochloride 10 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-246 | Buspirone Hydrochloride 15 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-247 | Buspirone Hydrochloride 30 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-478 | Buspirone Hydrochloride 30 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-477 | Buspirone Hydrochloride 15 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 87441-020 | Buspirone Hydrochloride 5 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA |
| 87441-019 | Buspirone Hydrochloride 15 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA |
| 87441-018 | Buspirone Hydrochloride 10 mg/1 Tablet | Unit Dose Solutions, Inc. | ANDA |
| 65841-781 | Buspirone Hydrochloride 5 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 65841-782 | Buspirone Hydrochloride 10 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 65841-783 | Buspirone Hydrochloride 15 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 65841-784 | Buspirone Hydrochloride 30 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 65841-842 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 68382-180 | Buspirone Hydrochloride 5 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-181 | Buspirone Hydrochloride 10 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-182 | Buspirone Hydrochloride 15 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-183 | Buspirone Hydrochloride 30 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-623 | Buspirone Hydrochloride 7.5 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
Buspirone hydrochloride recalls
- D-0511-2026 May 13, 2026 · Class III · Ongoing
Subpotent drug - D-0113-2024 Nov 29, 2023 · Class III · Terminated
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots - D-0114-2024 Nov 29, 2023 · Class III · Terminated
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots - D-0549-2023 May 3, 2023 · Class II · Ongoing
CGMP Deviations - D-0375-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0376-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0377-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0378-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0379-2023 Mar 8, 2023 · Class II · Terminated
CGMP Deviations: recalling drug products following an FDA inspection. - D-0602-2021 Jun 9, 2021 · Class II · Completed
Presence of Foreign Tablets/Capsules
Frequently asked questions
What is Buspirone hydrochloride used for?
Buspirone hydrochloride tablets 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 has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly…
What are the side effects of Buspirone hydrochloride?
(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. See the full label for the complete list.
Who makes Buspirone hydrochloride?
Buspirone hydrochloride is listed by 46 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., Advanced Rx of Tennessee, LLC, Advanced Rx Pharmacy of Tennessee, LLC.
Has Buspirone hydrochloride been recalled?
The FDA enforcement database lists 10 recalls for Buspirone hydrochloride, most recently D-0511-2026 (class iii): Subpotent drug