Quetiapine Fumarate Tablet, Extended Release
Product Images NDC 50742-638

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Quetiapine Fumarate (NDC 50742-638). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ingenus Pharmaceuticals, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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A data table titled 'Fasting Glucose-Proportion of Patients Shifting to ≥ 126 mg/dL in Short-Term (≤12 weeks) Placebo-Controlled Studies' showing patient proportions shifting from normal or borderline fasting glucose levels to high levels during treatment with quetiapine versus placebo. The table compares the number and percentage of patients experiencing glucose shifts across treatment arms.*

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A data table showing the percentage of patients with blood glucose levels shifting to 126 mg/dL or higher during MDD adjunct therapy trials. It compares quetiapine fumarate extended-release tablets at 150 mg and 300 mg doses against placebo, including patient counts and percentages for each group.*

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A data table presenting the percentage of adult patients with shifts in total cholesterol, triglycerides, LDL-cholesterol, and HDL-cholesterol from baseline to clinically significant levels by indication. The table compares treatment arms of quetiapine fumarate extended-release tablets and placebo across indications including schizophrenia, bipolar depression, bipolar mania, and major depressive disorder adjunct therapy with sample sizes and patient percentage data.*

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A data table titled 'Percentage of Patients with Shifts in Total Cholesterol, Triglycerides, LDL-Cholesterol, and HDL-Cholesterol from Baseline to Clinically Significant Levels in MDD Adjunctive Therapy Trials By Dose' showing laboratory analytes (cholesterol, triglycerides, LDL, HDL) with thresholds, treatment arms (Quetiapine fumarate extended-release tablets 150 mg, 300 mg, and placebo), number of patients (N), and the percentage of patients with shifts to clinically significant levels after 6 weeks of treatment.*

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A data table titled 'Percentage of Children and Adolescents with Shifts in Total Cholesterol, Triglycerides, LDL-Cholesterol and HDL-Cholesterol from Baseline to Clinically Significant Levels by Indication.' It presents laboratory analytes including Total Cholesterol, Triglycerides, LDL-Cholesterol, and HDL-Cholesterol against two indications: Schizophrenia and Bipolar Mania. For each, it compares results between treatment arms of quetiapine fumarate tablets and placebo, listing sample sizes (N) and number and percentage of patients with clinically significant changes. Footnotes indicate ages and treatment durations for each indication.*

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A data table titled 'Percentage of Patients with Weight Gain ≥7% of Body Weight (Adults) by Indication' showing comparison between Quetiapine fumarate extended-release tablets and placebo across four indications: Schizophrenia, Bipolar Mania, Bipolar Depression, and Major Depressive Disorder (Adjunctive Therapy). It includes patient counts (N) and number (percentage) of patients experiencing significant weight gain.*

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A data table titled 'Percentage of Patients with Weight Gain ≥7% of Body Weight in MDD Adjunctive Therapy Trials by Dose (Adults).' It presents weight gain data for quetiapine fumarate extended-release tablets at 150 mg and 300 mg doses compared to placebo, including patient counts and percentages experiencing weight gain.*

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A data table titled 'Percentage of Patients with Weight Gain ≥7% of Body Weight (Children and Adolescents)' presenting weight gain percentages linked to quetiapine fumarate tablets versus placebo in schizophrenia and bipolar mania treatments. Columns include Vital sign, Indication, Treatment Arm, sample size (N), and Patients n (%). The table shows weight gain occurrence for 111 schizophrenia patients on quetiapine (21%), 44 on placebo (7%), 157 bipolar mania patients on quetiapine (12%), and 68 on placebo (0%).*

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A data table titled 'Incidence of Shifts in Thyroid Hormone Levels and TSH in Short-term Placebo-controlled Clinical Trials' comparing Quetiapine and placebo groups. Columns display percentages and occurrences of shifts in Total T4, Free T4, Total T3, Free T3, and TSH levels among subjects treated with quetiapine fumarate extended-release tablets versus placebo.*

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A table titled 'Adverse Reactions Associated with Extrapyramidal Symptoms in a Placebo-Controlled Clinical Trial for Bipolar Mania' comparing the incidence of dystonic event, parkinsonism, akathisia, and other extrapyramidal events between quetiapine fumarate extended-release tablets (N=151) and placebo (N=160). The table lists the number and percentage of patients experiencing each event.*

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A data table presenting adverse reactions linked to extrapyramidal symptoms in a placebo-controlled clinical trial of quetiapine fumarate extended-release tablets for bipolar depression. It compares the number and percentage of events for dystonic event, parkinsonism, akathisia, and other extrapyramidal events between 137 patients on quetiapine fumarate and 140 patients on placebo.*

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A data table titled 'Adverse Reactions Associated with EPS in MDD Trials by Dose, Adjunctive Therapy Clinical Trials (6 weeks duration)' displaying adverse event counts and percentages for quetiapine fumarate extended-release tablets at 150 mg/day and 300 mg/day, all doses combined, and placebo groups. Events include dystonic events, parkinsonism, akathisia, dyskinetic events, and other extrapyramidal events.*

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A data table titled 'Adverse Reactions in a 6-Week Placebo-Controlled Clinical Trial for the Treatment of Schizophrenia in Adolescent Patients.' It presents adverse reaction rates for Quetiapine fumarate tablets at 400 mg and 800 mg doses compared to placebo, listing terms such as somnolence, dizziness, dry mouth, tachycardia, irritability, and others with associated percentages for each group.*

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Data table showing adverse reactions in a 3-week placebo-controlled clinical trial for treatment of bipolar mania in children and adolescents. The table lists preferred terms and percentages of patients experiencing reactions in groups receiving quetiapine fumarate tablets 400 mg, 600 mg, and placebo. Reactions include somnolence, dizziness, nausea, fatigue, increased appetite, tachycardia, dry mouth, vomiting, and others.*

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A table titled 'Adverse Reactions Associated with Extrapyramidal Symptoms in the Placebo-Controlled Trial in Adolescent Patients with Schizophrenia (6-week duration)' displaying the number and percentage of various extrapyramidal events in groups receiving quetiapine fumarate tablets at 400 mg/day, 800 mg/day, all doses combined, and placebo.*

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A data table titled 'Adverse Reactions Associated with Extrapyramidal Symptoms in a Placebo-Controlled Trial in Children and Adolescent Patients with Bipolar I Mania (3-week duration)'. It presents the incidence of extrapyramidal symptom-related adverse reactions for Quetiapine fumarate extended release tablets at doses of 400 mg/day and 600 mg/day, combined total for all doses, and placebo, listing preferred terms such as Parkinsonism, Akathisia, and Other Extrapyramidal Event with corresponding number and percentage of occurrences in each group.*

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Chemical structure of quetiapine fumarate showing the molecular arrangement including the quetiapine base and fumarate ions. The structure highlights the bicyclic system with sulfur and nitrogen atoms, and the fumarate counter-ion.*

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A data table titled 'The Effect of Other Drugs on the Pharmacokinetics of Quetiapine' showing various coadministered drugs with their dose schedules alongside quetiapine dose schedules. The table details pharmacokinetic effects such as changes in oral clearance, plasma concentration, and steady state pharmacokinetics for drugs including Phenytoin, Divalproex, Thioridazine, Cimetidine, Ketoconazole, Fluoxetine, Imipramine, Haloperidol, and Risperidone.*

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Table 26 titled 'Schizophrenia Short-Term Trials' displays study data comparing quetiapine fumarate extended-release tablets and immediate-release tablets at various doses to placebo. It summarizes mean baseline scores, least-squares mean change from baseline, and placebo-subtracted differences for the PANSS Total efficacy endpoint across two studies, including adolescent subjects.*

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A Kaplan-Meier curve chart showing the time to schizophrenic relapse over 7 months. The chart compares the proportion of patients with relapse between two groups: placebo (PLA) and quetiapine extended-release (QTP XR). The x-axis represents time in months, and the y-axis shows the percentage of patients with relapse. The placebo group shows a higher relapse rate over time compared to the quetiapine extended-release group. A note below the chart states that results are from an interim analysis.*

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A data table titled 'Table 27: Mania Trials' summarizing primary efficacy results with quetiapine fumarate tablets in various studies. It lists study numbers, treatment groups, mean baseline scores, least-squares mean change from baseline, and placebo-subtracted differences with confidence intervals across multiple trials involving adults, children, and adolescents. Comparators include placebo, haloperidol, lithium, and mood stabilizers.*

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A data table titled 'Depressive Episodes Associated with Bipolar Disorder' presenting study results for Quetiapine fumarate extended-release and immediate-release tablets at dosages of 300 mg/day and 600 mg/day compared to placebo. It includes mean baseline scores, least-squares mean change from baseline, and placebo-subtracted differences with confidence intervals for multiple studies.*

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A Kaplan-Meier curve chart showing the time to recurrence of a mood event over a period of 100 weeks. The graph plots the proportion of patients with relapse (%) on the vertical axis against time in weeks on the horizontal axis. Two curves are shown: one for QTP+ LI/VAL (quetiapine fumarate plus LI/VAL) and one for PLA+ LI/VAL (placebo plus LI/VAL), illustrating comparative relapse rates over time.*

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A Kaplan-Meier survival curve illustrating the time to recurrence of a mood event in a study. The x-axis represents time in weeks up to 100, and the y-axis shows the proportion of patients with relapse in percentage. Two curves compare QTP+LIV/VAL versus PLA+LIV/VAL groups, showing different relapse rates over time.*

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A data table titled 'Major Depressive Disorder, Adjunctive Therapy to Antidepressants' showing efficacy measures for quetiapine fumarate extended-release tablets at doses of 150 mg/day and 300 mg/day compared to placebo. It presents mean baseline scores, least-squares mean change from baseline, and placebo-subtracted difference with confidence intervals for two studies, including sample standard deviations and statistical notes.*

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Quetiapine Fumarate Extended-Release Tablets 50 mg by Ingenus Pharmaceuticals, LLC. The label includes dosing instructions (once daily), storage conditions, warnings, and manufacturer information. The package contains 60 tablets. The NDC code is 50742-635-60, with barcode and lot and expiration details visible.*

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Label for Quetiapine Fumarate Extended-Release Tablets 150 mg by Ingenus Pharmaceuticals, LLC. The oral tablet package contains 60 tablets with a daily dosage recommendation. It includes storage instructions and warnings about keeping the medication out of children's reach. The label features the NDC 50742-636-60 and batch information including lot number and expiration date.*

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Quetiapine Fumarate Extended-Release Tablets 200 mg, oral dosage form, labeled for once daily use. The label shows the product name, strength, directions to swallow whole without splitting or crushing, and storage instructions. It is manufactured for Ingenus Pharmaceuticals, LLC and contains 60 tablets per container.*

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Label for Quetiapine Fumarate Extended-Release Tablets 300 mg by Ingenus Pharmaceuticals, LLC. The oral tablet label states "Once Daily" dosage with a 60 tablets count. It notes each tablet contains 345 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine and includes storage instructions and warnings. UPC and lot/expiration details are also visible.*

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Quetiapine Fumarate Extended-Release Tablets 400 mg oral tablets packaging label from Ingenus Pharmaceuticals, LLC. The label states the dosage form as extended-release and indicates a quantity of 60 tablets per package. Additional label details include storage instructions, a warning to swallow whole, and prescription-only status.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.