Ziprasidone Hydrochloride

Recent Major Changes Dosage and Administration ( 2.5 ) 1/2025 Contraindications ( 4 ) 1/2025 Warnings and Precautions ( 5.4 , 5.15 ) 1/2025

1 INDICATIONS & USAGE Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [ see Warnings and Precautions ( 5.3 ) ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [ see Warnings and Precautions ( 5.3 ) ] Schizophrenia • Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [ see Clinical Studies ( 14.1 ) ]. Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) • Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [ see Clinical Studies ( 14.2 ) ]. • Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [ see Clinical Studies ( 14.2 ) ]. Ziprasidone hydrochloride is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride to prolong the QT interval and may consider the use of other drugs first ( 1 ) Ziprasidone capsules are indicated for the: • treatment of schizophrenia in adults. ( 1 ) • acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. ( 1 ) • maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. ( 1 )

2 DOSAGE AND ADMINISTRATION Administer capsules orally with food. Do not open, crush, or chew. ( 2.1 ) Schizophrenia: Initiate at 20 mg twice daily. Daily dosage may be adjusted up to 80 mg twice daily. Dose adjustments should occur at intervals of not less than 2 days. Safety and efficacy has been demonstrated in doses up to 100 mg twice daily. The lowest effective dose should be used. ( 2.2 ) Acute treatment of manic/mixed episodes of bipolar I disorder: Initiate at 40 mg twice daily. Increase to 60 mg or 80 mg twice daily on day 2 of treatment. Subsequent dose adjustments should be based on tolerability and efficacy within the range of 40 to 80 mg twice daily. ( 2.3 ) Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate: Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 to 80 mg twice daily. ( 2.3 ) 2.1 Administration Information for Ziprasidone Capsules Administer ziprasidone capsules orally with food. Swallow capsules whole, do not open, crush, or chew the capsules. 2.2 Schizophrenia Dose Selection Ziprasidone capsules should be administered at an initial daily dose of 20 mg twice daily with food. In some patients, daily dosage may subsequently be adjusted on the basis of individual clinical status up to 80 mg twice daily. Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state is achieved within 1 to 3 days. In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment. Efficacy in schizophrenia was demonstrated in a dose range of 20 mg to 100 mg twice daily in short-term, placebo-controlled clinical trials. There were trends toward dose response within the range of 20 mg to 80 mg twice daily, but results were not consistent. An increase to a dose greater than 80 mg twice daily is not generally recommended. The safety of doses above 100 mg twice daily has not been systematically evaluated in clinical trials [ see Clinical Studies (14.1) ]. Maintenance Treatment While there is no body of evidence available to answer the question of how long a patient treated with ziprasidone should remain on it, a maintenance study in patients who had been symptomatically stable and then randomized to continue ziprasidone or switch to placebo demonstrated a delay in time to relapse for patients receiving ziprasidone capsules [ see Clinical Studies (14.1) ]. No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should be periodically reassessed to determine the need for maintenance treatment. 2.3 Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Acute Treatment of Manic or Mixed Episodes In adults oral ziprasidone should be administered at an initial daily dose of 40 mg twice daily with food. The dose may then be increased to 60 mg or 80 mg twice daily on the second day of treatment and subsequently adjusted on the basis of tolerance and efficacy within the range 40 mg to 80 mg twice daily. In the flexible-dose clinical trials, the mean daily dose administered was approximately 120 mg [see Clinical Studies ( 14.2 )]. Maintenance Treatment (as an adjunct to lithium or valproate) Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 mg to 80 mg twice daily with food. Patients should be periodically reassessed to determine the need for maintenance treatment [see Clinical Studies ( 14.2 )]. 2.5 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days must elapse between discontinuation of an MAOI (intended to treat psychiatric disorders) and initiation of therapy with ziprasidone capsules. In addition, at least 3 days should be allowed after stopping ziprasidone capsules before starting an MAOI intended to treat psychiatric dis …

3 DOSAGE FORMS AND STRENGTHS Ziprasidone capsules, USP 20 mg (ziprasidone), are light pink to brown granular powder filled in size “4” hard gelatin capsules having Lavender opaque cap and Flesh opaque body, imprinted “RDY” on cap and “256” on body with black ink. Ziprasidone capsules, USP 40 mg (ziprasidone), are light pink to brown granular powder filled in size “4” hard gelatin capsules having Lavender opaque cap and LT Turquoise blue opaque body, imprinted “RDY” on cap and “257” on body with black ink. Ziprasidone capsules, USP 60 mg (ziprasidone), are light pink to brown granular powder filled in size “3” hard gelatin capsules having Flesh opaque cap and Flesh opaque body, imprinted “RDY” on cap and “258” on body with black ink. Ziprasidone capsules, USP 80 mg (ziprasidone), are light pink to brown granular powder filled in size “2” hard gelatin capsules having LT Turquoise blue opaque cap and Flesh opaque body, imprinted “RDY” on cap and “259” on body with black ink. Capsules: 20 mg, 40 mg, 60 mg, and 80 mg (3)

4 CONTRAINDICATIONS Do not use in patients with a known history of QT prolongation ( 4.1 ) Do not use in patients with recent acute myocardial infarction ( 4.1 ) Do not use in patients with uncompensated heart failure ( 4.1 ) Do not use in combination with other drugs that have demonstrated QT prolongation ( 4.1 ) Do not use in patients with known hypersensitivity to ziprasidone ( 4.2 ) Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs. ( 4.3 ) 4.1 QT Prolongation Because of ziprasidone’s dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs, ziprasidone is contraindicated: in patients with a known history of QT prolongation (including congenital long QT syndrome) in patients with recent acute myocardial infarction in patients with uncompensated heart failure Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with: dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus. other drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in the full prescribing information as a contraindication or a boxed or bolded warning [see Warnings and Precautions (5.3) ] . 4.2 Hypersensitivity Ziprasidone is contraindicated in individuals with a known hypersensitivity to the product. 4.3 Monoamine Oxidase Inhibitors (MAOIs) Ziprasidone is contraindicated in patients taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.4 ), Drug Interaction ( 7.3 )].

6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions ( 5.2 )] QT Prolongation and Risk of Sudden Death [see Contraindications ( 4.2 ), Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Contraindications ( 4.3 ), Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.1 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.5 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.6 )] Tardive Dyskinesia [see Warnings and Precautions ( 5.7 )] Metabolic Changes [see Warnings and Precautions ( 5.8 )] Rash [see Warnings and Precautions ( 5.9 )] Orthostatic Hypotension [see Warnings and Precautions ( 5.10 )] Falls [see Warnings and Precautions ( 5.11 )] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions ( 5.12 )] Seizures [see Warnings and Precautions ( 5.13 )] Dysphagia [see Warnings and Precautions ( 5.14 )] Hyperprolactinemia [see Warnings and Precautions ( 5.15 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.16 )] Priapism [see Warnings and Precautions ( 5.17 )] Body Temperature Regulation [see Warnings and Precautions ( 5.18 )] Suicide [see Warnings and Precautions ( 5.19 )] Commonly observed adverse reactions (incidence ≥5% and at least twice the incidence for placebo) were : Schizophrenia : Somnolence, respiratory tract infection. ( 6.1 ) Manic and Mixed Episodes Associated with Bipolar Disorder: Somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical trials in adults for oral ziprasidone included approximately 5,700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Of these 5,700, over 4,800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1,831 patient-years. These patients include: (1) 4,331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1,698 patient-years of exposure as of February 5, 2000; and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure. An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone. The conditions and duration of treatment with ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure. Adverse reactions during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone The following findings are based on the short-term placebo …

7 DRUG INTERACTIONS Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using ziprasidone in combination with other drugs have been evaluated as described below. All interactions studies have been conducted with oral ziprasidone. Based upon the pharmacodynamic and pharmacokinetic profile of ziprasidone, possible interactions could be anticipated: Ziprasidone should not be used in combination with other drugs that have demonstrated QT prolongation. ( 4.1 , 7.3 ) The absorption of ziprasidone is increased up to two-fold in the presence of food. ( 7.10 ) The full prescribing information contains additional drug interactions. ( 7 ). 7.1 Metabolic Pathway Approximately two-thirds of ziprasidone is metabolized via a combination of chemical reduction by glutathione and enzymatic reduction by aldehyde oxidase. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Less than one-third of ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation. 7.2 In Vitro Studies An in vitro enzyme inhibition study utilizing human liver microsomes showed that ziprasidone had little inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, and thus would not likely interfere with the metabolism of drugs primarily metabolized by these enzymes. There is little potential for drug interactions with ziprasidone due to displacement [see Clinical Pharmacology (12.3) ] . 7.3 Pharmacodynamic Interactions Ziprasidone should not be used with any drug that prolongs the QT interval [see Contraindications ( 4.1 )]. Given the primary CNS effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting drugs. Because of its potential for inducing hypotension, ziprasidone may enhance the effects of certain antihypertensive agents. Ziprasidone may antagonize the effects of levodopa and dopamine agonists. Risk of serotonin syndrome with concomitant therapy with other serotonergic drugs such as SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort [see Contraindications ( 4.3 ), Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.2 )]. 7.4 Pharmacokinetic Interactions Carbamazepine Carbamazepine is an inducer of CYP3A4; administration of 200 mg twice daily for 21 days resulted in a decrease of approximately 35% in the AUC of ziprasidone. This effect may be greater when higher doses of carbamazepine are administered. Ketoconazole Ketoconazole, a potent inhibitor of CYP3A4, at a dose of 400 mg QD for 5 days, increased the AUC and C max of ziprasidone by about 35 to 40%. Other inhibitors of CYP3A4 would be expected to have similar effects. Cimetidine Cimetidine at a dose of 800 mg QD for 2 days did not affect ziprasidone pharmacokinetics. Antacid The co-administration of 30 mL of Maalox ® with ziprasidone did not affect the pharmacokinetics of ziprasidone. 7.5 Lithium Ziprasidone at a dose of 40 mg twice daily administered concomitantly with lithium at a dose of 450 mg twice daily for 7 days did not affect the steady-state level or renal clearance of lithium. Ziprasidone dosed adjunctively to lithium in a maintenance trial of bipolar patients did not affect mean therapeutic lithium levels. 7.6 Oral Contraceptives In vivo studies have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components. Ziprasidone at a dose of 20 mg twice daily did not affect the pharmacokinetics of concomitantly administered oral contraceptives, ethinyl estradiol (0.03 mg) and levonorgestrel (0.15 mg). 7.7 Dextromethorphan Consistent with in vitro results, a study in normal healthy volunteers showed that ziprasidone did not alter the metabolism of dextromethorphan, a CYP2D6 model substrate, to its major metabolite, dextrorphan. There was no statistically significant change in the urinary dextrometh …

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. ( 8.1 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including ziprasidone capsules, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs, including ziprasidone capsules, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations) . Overall available data from published epidemiologic studies of pregnant women exposed to ziprasidone have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including ziprasidone capsules, during pregnancy (see Clinical Considerations) . In animal studies, ziprasidone administration to pregnant rats and rabbits during organogenesis caused developmental toxicity at doses similar to recommended human doses, and was teratogenic in rabbits at 3 times the maximum recommended human dose (MRHD). Rats exposed to ziprasidone during gestation and lactation exhibited increased perinatal pup mortality and delayed neurobehavioral and functional development of offspring at doses less than or similar to human therapeutic doses (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors. Fetal/neonatal adverse reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including ziprasidone capsules, during the third trimester of pregnancy. These symptoms have varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Data Human Data Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. Animal Data When ziprasidone was administered to pregnant rabbits during the period of organogenesis, an increased incidence of fetal structural abnormalities (ventricular septal defects and other cardiovascular malformations, and kidney alterations) was observed at a dose of 30 mg/kg/day (3 times the MRHD of 200 mg/day based on mg/m 2 body surface area). There was no evidence to suggest that these developmental effects were secondary to mate …

12.1 Mechanism of Action The mechanism of action of ziprasidone, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.

11 DESCRIPTION Ziprasidone is an atypical antipsychotic available as ziprasidone capsules, USP for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 g/mol (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro- 2H -indol-2-one. The molecular formula of C 21 H 21 ClN 4 OS (free base of ziprasidone) represents the following structural formula: Ziprasidone capsules, USP contain a monohydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride is 5-[2-[4-(1,2-­benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro- 2H -indol-2-one, monohydrochloride. The molecular formula is C 21 H 21 ClN 4 OS · HCl and its molecular weight is 449.40 g/mol. Ziprasidone hydrochloride is an off white to beige brown powder. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (of ziprasidone free base), 40 mg (of ziprasidone free base), 60 mg (of ziprasidone free base), and 80 mg (of ziprasidone free base) capsules. Ziprasidone capsules contain ziprasidone hydrochloride, colloidal silicon dioxide, crospovidone, magnesium stearate and sodium starch glycolate. Each capsule shell contains the following inactive ingredients: gelatin and titanium dioxide. The 20 mg, 40 mg and 80 mg capsule shells also contain the following inactive ingredients: D&C Red #28, FD&C Blue #1, FD&C Yellow #6. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, potassium hydroxide, propylene glycol and shellac. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone. chemical-structure.jpg

10 OVERDOSAGE 10.1 Human Experience In premarketing trials involving more than 5,400 patients and/or normal subjects, accidental or intentional overdosage of oral ziprasidone was documented in 10 patients. All of these patients survived without sequelae. In the patient taking the largest confirmed amount, 3,240 mg, the only symptoms reported were minimal sedation, slurring of speech, and transitory hypertension (200/95). Adverse reactions reported with ziprasidone overdose included extrapyramidal symptoms, somnolence, tremor, and anxiety. [see Adverse Reactions (6.2) ] 10.2 Management of Overdosage In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Intravenous access should be established, and gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizure, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects that might be additive to those of ziprasidone. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids. If sympathomimetic agents are used for vascular support, epinephrine and dopamine should not be used, since beta stimulation combined with α 1 antagonism associated with ziprasidone may worsen hypotension. Similarly, it is reasonable to expect that the alpha-adrenergic-blocking properties of bretylium might be additive to those of ziprasidone, resulting in problematic hypotension. In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. There is no specific antidote to ziprasidone, and it is not dialyzable. The possibility of multiple drug involvement should be considered. Close medical supervision and monitoring should continue until the patient recovers.

16 HOW SUPPLIED/STORAGE AND HANDLING Ziprasidone capsules, USP 20 mg are blue/white, size 4, hard gelatin capsules imprinted in black ink with “CL62” on cap and “20 mg” on the body containing pale pink coloured powder and are available as follows: Bottles of 60 capsules NDC 33342-144-09 Bottles of 300 capsules NDC 33342-144-51 Unit dose blister pack of 100 NDC 33342-144-12 (10×10) capsules Ziprasidone capsules, USP 40 mg are blue/ blue, size 2, hard gelatin capsules imprinted in black ink with “CL63” on cap and “40 mg” on the body containing pale pink coloured powder and are available as follows: Bottles of 60 capsules NDC 33342-145-09 Bottles of 300 capsules NDC 33342-145-51 Unit dose blister pack of 100 NDC 33342-145-12 (10×10) capsules Ziprasidone capsules, USP 60 mg are white/ white, size 1, hard gelatin capsules imprinted in black ink with “CL64” on cap and “60 mg” on the body containing pale pink coloured powder and are available as follows: Bottles of 60 capsules NDC 33342-146-09 Bottles of 300 capsules NDC 33342-146-51 Unit dose blister pack of 100 NDC 33342-146-12 (10×10) capsules Ziprasidone capsules, USP 80 mg are blue/ white, size 0, hard gelatin capsules imprinted in black ink with “CL65” on cap and “80 mg” on the body containing pale pink coloured powder and are available as follows: Bottles of 60 capsules NDC 33342-147-09 Bottles of 300 capsules NDC 33342-147-51 Unit dose blister pack of 100 NDC 33342-147-12 (10×10) capsules Store ziprasidone capsules, USP at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers, and store at controlled room temperature.