Quetiapine Fumarate Tablet, Film Coated, Extended Release
Product Images NDC 65862-877

9 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Quetiapine Fumarate (NDC 65862-877). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1 Kaplan-meier Curves Of Time To Schizophrenic Relapse (study 3) (Quetiapine Fig1)

Figure 1 Kaplan-meier Curves Of Time To Schizophrenic Relapse (study 3) (Quetiapine Fig1)
A Kaplan-Meier survival curve chart showing the proportion of patients with schizophrenic relapse over time (months). It compares two groups: PLA (Placebo) with a dashed line and QTP ER (Quetiapine Extended Release) with a solid line. The vertical axis represents the proportion of patients with relapse in percentage, and the horizontal axis represents time in months, spanning from 0 to 7 months. The chart visually demonstrates relapse rates during the study period.*
FDA Label Image

Figure 3 (Quetiapine Fig2)

Figure 3 (Quetiapine Fig2)
Kaplan-Meier curves showing the time to recurrence of a mood event in Study 9. The graph plots the proportion of patients with relapse (%) on the vertical axis against time in weeks on the horizontal axis, comparing Quetiapine fumarate plus Li/Val treatment versus placebo plus Li/Val treatment.*
FDA Label Image

Figure 3 (Quetiapine Fig3)

Figure 3 (Quetiapine Fig3)
A Kaplan-Meier plot illustrating the time to recurrence of a mood event in Study 10 for Quetiapine (QTP) plus Li/Val versus placebo (PLA) plus Li/Val. The x-axis represents time in weeks up to 100, and the y-axis shows the proportion of patients with relapse as a percentage. Two curves compare relapse proportions over time between treatment groups.*
FDA Label Image

Package Label-principal Display Panel (50 mg (60 Tablet Bottle))

Package Label-principal Display Panel (50 mg (60 Tablet Bottle))
Label for Quetiapine Extended-Release Tablets USP, 50 mg film-coated extended-release tablets. The label states each tablet contains 58 mg quetiapine fumarate equivalent to 50 mg quetiapine. It is distributed by Aurobindo Pharma USA, Inc. and made in India. The package contains 60 tablets. Usage instructions emphasize swallowing whole and once daily dosage.*
FDA Label Image

Package Label-principal Display Panel (150 mg (60 Tablet Bottle))

Package Label-principal Display Panel (150 mg (60 Tablet Bottle))
Label for Quetiapine Extended-Release Tablets USP 150 mg, film-coated extended-release oral tablets by Aurobindo Pharma Limited. The label includes the NDC 65862-874-60, instructions to swallow whole, usual dosage as once daily, storage information, and distribution by Aurobindo Pharma USA, Inc. Package contains 60 tablets.*
FDA Label Image

Package Label-principal Display Panel (200 mg (60 Tablet Bottle))

Package Label-principal Display Panel (200 mg (60 Tablet Bottle))
Label for Quetiapine Extended-Release Tablets USP 200 mg, oral film-coated extended-release tablets. The label indicates a 60-tablet package and is distributed by Aurobindo Pharma USA, Inc. It includes instructions for dosage, storage temperature, and warnings, as well as the NDC number 65862-875-60. The label highlights the dose as '200 mg Once Daily' and notes the product is made in India.*
FDA Label Image

Package Label-principal Display Panel (300 mg (60 Tablet Bottle))

Package Label-principal Display Panel (300 mg (60 Tablet Bottle))
Quetiapine Extended-Release Tablets USP 300 mg film-coated extended-release tablets, packaged in a container of 60 tablets. The label indicates the dosage form is oral, with directions to swallow whole and not to split, crush, or chew. The product is distributed by Aurobindo Pharma USA, Inc., made in India, with NDC 65862-876-60.*
FDA Label Image

Package Label-principal Display Panel (400 mg (60 Tablet Bottle))

Package Label-principal Display Panel (400 mg (60 Tablet Bottle))
Quetiapine Extended-Release Tablets USP 400 mg film-coated extended-release tablets, packaged as 60 tablets. Distributed by Aurobindo Pharma USA, Inc., made in India. The label includes usage instructions such as swallowing whole and storage conditions, with a National Drug Code (NDC) 65862-877-60.*
FDA Label Image

Chemical Structure (Quetiapine Str)

Chemical Structure (Quetiapine Str)
Chemical structure of quetiapine fumarate, showing the molecular arrangement of quetiapine and fumarate ions in the compound.*

* 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.