Quetiapine
Product Images NDC 42291-696

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Quetiapine (NDC 42291-696). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

FDA Label Image

1000 (695 10)

Quetiapine Tablets, USP 25 mg carton label by AvKARE. The package contains 1000 tablets for prescription use only. Label includes the NDC number 42291-695-10, dosing instructions, storage information, safety warnings, and a barcode.*

FDA Label Image

1000 (696 10)

Quetiapine Tablets USP by AvKARE, 50 mg strength, packaged in a container with 1000 tablets. The label includes storage instructions and a warning to keep the medication out of reach of children. It displays the NDC number 42291-696-10 and a barcode.*

FDA Label Image

1000 (697 10)

Quetiapine Tablets, USP 100 mg label from AvKARE. The label indicates the product contains 1000 tablets, marked Rx Only. It includes storage instructions, dosing guidance, and a barcode on the right side, with the NDC number 42291-697-10 in red.*

FDA Label Image

500 (698 50)

Quetiapine Tablets, USP 200 mg tablet strength label from AvKARE. The label displays the AvKARE logo, NDC number 42291-698-50, and indicates a package count of 500 tablets. It includes storage instructions, dispensing information for pharmacists, and a barcode.*

FDA Label Image

500 (699 50)

Label for Quetiapine Tablets, USP 300 mg by AvKARE. The label indicates a quantity of 500 tablets with prescription use only (Rx Only). Storage instructions and handling cautions are included along with the NDC code 42291-699-50 and manufacturer details.*

FDA Label Image

500 (700 50)

A rectangular label for Quetiapine Tablets USP from AvKARE, showing a strength of 400 mg and a total of 500 tablets in the package. The label includes usage instructions, storage information, warnings about light sensitivity and child safety, and a barcode on the right side. The label is white with red and black text and a curved black and red border on the left.*

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10 (Table 10)

A data table titled 'Table 10: Adverse Reaction Incidence in 3-Week Placebo-Controlled Clinical Trials for the Treatment of Bipolar Mania (Adjunct Therapy)' comparing the percentage incidence of various adverse reactions between Quetiapine (n=196) and Placebo (n=203). The table lists many preferred terms such as somnolence, dry mouth, headache, asthenia, and others with their corresponding incidence percentages for each group.*

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11 (Table 11)

A data table titled 'Adverse Reaction Incidence in 8-Week Placebo-Controlled Clinical Trials for the Treatment of Bipolar Depression' comparing the incidence percentages of various adverse reactions between Quetiapine (n=698) and placebo (n=347). The table lists multiple preferred terms such as somnolence, dry mouth, dizziness, constipation, and others alongside their corresponding incidence percentages for both groups.*

FDA Label Image

12 (Table 12)

A table summarizing adverse reactions associated with extrapyramidal symptoms (EPS) from a short-term, placebo-controlled, multiple fixed-dose Phase III schizophrenia trial of Quetiapine over 6 weeks. It lists preferred terms of reactions and the number and percentage of occurrences across Quetiapine doses (75 mg/day to 750 mg/day) and placebo groups.*

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13 (Table 13)

A data table titled 'Adverse Reaction Incidence in a 6-Week Placebo-Controlled Clinical Trial for the Treatment of Schizophrenia in Adolescent Patients.' It lists adverse reaction incidences by preferred term for Quetiapine at 400 mg and 800 mg doses compared to placebo, showing percentages of patients experiencing each adverse event. Includes footnotes clarifying combined terms for somnolence and tachycardia.*

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14 (Table 14)

Data table showing adverse reactions in a 3-week placebo-controlled clinical trial for Quetiapine at 400 mg and 600 mg doses compared to placebo in children and adolescents with bipolar mania. The table lists each adverse reaction with the percentage incidence across the three groups.*

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14 (Table 15)

A table presenting the adverse reactions associated with extrapyramidal symptoms during a placebo-controlled trial in adolescent patients with schizophrenia over six weeks. It compares the frequency (number and percentage) of events like dystonic event, parkinsonism, akathisia, dyskinetic event, and other extrapyramidal events among groups receiving Quetiapine 400 mg/day, Quetiapine 800 mg/day, all Quetiapine doses combined, and placebo.*

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16 (Table 16)

A table listing adverse reactions associated with extrapyramidal symptoms in a placebo-controlled trial of Quetiapine in children and adolescent patients with bipolar I mania. It compares incidences for Quetiapine 400 mg/day, 600 mg/day, all Quetiapine doses combined, and placebo groups, detailing conditions such as Parkinsonism, akathisia, and other extrapyramidal events.*

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8 (Table 8)

A data table titled 'Incidence of Shifts in Thyroid Hormone Levels and TSH in Short-Term Placebo-Controlled Clinical Trials,' showing the percentages and counts of shifts in total T4, free T4, total T3, free T3, and TSH comparing Quetiapine and placebo groups. Footnotes explain criteria for shifts and inclusion of quetiapine extended-release data.*

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9 (Table 9)

A data table titled 'Adverse Reaction Incidence in 3- to 12-Week Placebo-Controlled Clinical Trials for the Treatment of Schizophrenia and Bipolar Mania (Monotherapy).' It compares the incidence percentages of various adverse reactions between Quetiapine (n=719) and Placebo (n=404). Reactions listed include headache, agitation, somnolence, dizziness, dry mouth, constipation, and others, with higher percentages generally observed in the Quetiapine group.*

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Quetiapine Fumarate Structural Formula (Image 1)

Chemical structure diagram showing the molecular structure of Quetiapine, including its characteristic ring systems and associated chemical components.*

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Figure 1 (Image 2)

A Kaplan-Meier plot displaying the proportion of patients with relapse over time (in weeks). The graph compares relapse rates between two groups: one treated with Quetiapine (QTP) plus Li/Val (lithium/valproate) shown with a dashed line, and the other with placebo (PLA) plus Li/Val shown with a solid line. The vertical axis represents the percentage of patients with relapse, and the horizontal axis represents time in weeks, up to 100 weeks.*

FDA Label Image

Figure 2 (Image 3)

A line graph showing the proportion of patients with relapse (%) over time in weeks. Two lines represent groups labeled 'QTP + LI/VAL' (dashed line) and 'PLA + LI/VAL' (solid line), with the latter showing a higher relapse proportion over time compared to the former.*

* 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.