Quetiapine Fumarate Tablet, Film Coated
Product Images NDC 65862-492

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

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Quetiapine Fumarate (NDC 65862-492). 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

Figure1 (Quetiapine Fig1)

Figure1 (Quetiapine Fig1)
A Kaplan-Meier curve graph showing the proportion of patients with relapse over time (weeks). The graph compares two groups: QTP+LI/VAL (solid line) and PLA+LI/VAL (dashed line), illustrating relapse rates up to 100 weeks in a clinical study.*
FDA Label Image

Package Label-principal Display Panel (150 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (150 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Quetiapine Tablets, USP 150 mg film-coated tablets by Aurobindo Pharma Limited. The label indicates prescription-only status and contains 100 tablets in unit-dose packaging (10 x 10). Additional text includes dosing and storage instructions and distributor information for Aurobindo Pharma USA, Inc.*
FDA Label Image

Package Label-principal Display Panel (200 mg (100 Tablets Bottle))

Package Label-principal Display Panel (200 mg (100 Tablets Bottle))
Label for Quetiapine Tablets USP 200 mg film-coated tablets by Aurobindo Pharma Limited. The label states the product contains 230.244 mg of quetiapine fumarate USP equivalent to 200 mg quetiapine per tablet. Package size is 100 tablets. Distributed by Aurobindo Pharma USA, Inc., made in India. Includes storage instructions and warnings.*
FDA Label Image

Package Label-principal Display Panel (200 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (200 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Quetiapine Tablets, USP 200 mg film-coated tablets. The label indicates a unit-dose package containing 100 tablets (10 x 10). It is labeled for prescription use only, with dispensing instructions for pharmacists. The labeler is Aurobindo Pharma Limited, and the distributor address is Aurobindo Pharma USA, Inc., East Windsor, NJ. Storage and warning information are also provided on the label.*
FDA Label Image

Package Label-principal Display Panel (300 mg (100 Tablets Bottle))

Package Label-principal Display Panel (300 mg (100 Tablets Bottle))
Label for Quetiapine Tablets, USP 300 mg film-coated tablets, supplied as 100 tablets. The label indicates the tablet contains 345.366 mg of quetiapine fumarate USP equivalent to 300 mg quetiapine. It shows the distributor as Aurobindo Pharma USA, Inc., with a listed address in East Windsor, NJ, and states the product is made in India by Aurobindo Pharma Limited. Storage instructions and a warning to keep out of reach of children are included.*
FDA Label Image

Package Label-principal Display Panel (300 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (300 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Quetiapine Tablets, USP 300 mg film-coated tablets by Aurobindo Pharma Limited. The package contains 100 unit-dose tablets (10 x 10). The label includes storage instructions, dosage guidance to consult package insert, and warnings to keep out of reach of children. Distributed by Aurobindo Pharma USA, Inc., made in India.*
FDA Label Image

Package Label-principal Display Panel (400 mg (100 Tablets Bottle))

Package Label-principal Display Panel (400 mg (100 Tablets Bottle))
Label for Quetiapine Tablets, USP 400 mg film-coated tablets, containing 100 tablets. Distributed by Aurobindo Pharma USA, Inc., made in India. Label includes storage instructions, a warning to keep out of reach of children, and a note to dispense with medication guide separately.*
FDA Label Image

Package Label-principal Display Panel (400 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (400 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Quetiapine Tablets, USP 400 mg film-coated tablets by Aurobindo Pharma Limited. The carton contains 100 unit-dose tablets (10 x 10). The label includes storage instructions, a warning to keep out of reach of children, and advises pharmacists to dispense with a medication guide provided separately. The product is distributed by Aurobindo Pharma USA, Inc.*
FDA Label Image

Figure2 (Quetiapine Fig2)

Figure2 (Quetiapine Fig2)
A Kaplan-Meier curve showing the time to recurrence of a mood event in patients over a period of 100 weeks. The y-axis represents the proportion of patients with relapse (%) and the x-axis shows time in weeks. Two curves are compared: QTP+L/VAL (quetiapine fumarate plus lithium/valproate) and PLA+L/VAL (placebo plus lithium/valproate). The placebo group shows a higher relapse rate over time compared to the QTP group.*
FDA Label Image

Package Label-principal Display Panel (25 mg (100 Tablets Bottle))

Package Label-principal Display Panel (25 mg (100 Tablets Bottle))
Label for Quetiapine Tablets USP, 25 mg film-coated tablets. The label states each tablet contains 28.780 mg quetiapine fumarate USP equal to 25 mg quetiapine. It is marked Rx only, distributed by Aurobindo Pharma USA, Inc., with labeler Aurobindo Pharma Limited. The package contains 100 tablets with storage instructions and a barcode on the right side.*
FDA Label Image

Package Label-principal Display Panel (25 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (25 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Quetiapine Tablets, USP 25 mg film-coated tablets by Aurobindo Pharma Limited. The label indicates a unit-dose package containing 100 tablets (10 x 10). Includes provider dispensing instructions and storage warnings. The product is distributed by Aurobindo Pharma USA, Inc.*
FDA Label Image

Package Label-principal Display Panel (50 mg (100 Tablets Bottle))

Package Label-principal Display Panel (50 mg (100 Tablets Bottle))
Label for Quetiapine Tablets, USP 50 mg film-coated tablets by Aurobindo Pharma Limited. The label shows a 100 tablet count, with storage instructions, dosage references, and a barcode on the right. Distributed by Aurobindo Pharma USA, Inc. Made in India.*
FDA Label Image

Package Label-principal Display Panel (50 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (50 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Quetiapine Tablets, USP 50 mg film-coated tablets by Aurobindo Pharma. The label shows the product as 100 unit-dose tablets in a 10 x 10 count container. It includes storage information, dosage instructions, warnings, and barcode. The label notes it's Rx only, and distributed by Aurobindo Pharma USA, made in India.*
FDA Label Image

Package Label-principal Display Panel (100 mg (100 Tablets Bottle))

Package Label-principal Display Panel (100 mg (100 Tablets Bottle))
Quetiapine Tablets USP 100 mg film-coated tablet label for 100-count packaging by Aurobindo Pharma Limited. The label includes dosing information, storage instructions, a warning to keep out of reach of children, distributor details (Aurobindo Pharma USA, Inc.), and barcode. Made in India.*
FDA Label Image

Package Label-principal Display Panel (100 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (100 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Quetiapine Tablets, USP 100 mg by Aurobindo Pharma Limited. The label indicates the medication is film-coated, provided in a package of 100 unit-dose tablets (10 x 10). Directions advise dispensing with a medication guide. Storage and warning information are included, along with distributor details, barcodes, and the NDC number 65862-491-10.*
FDA Label Image

Package Label-principal Display Panel (150 mg (100 Tablets Bottle))

Package Label-principal Display Panel (150 mg (100 Tablets Bottle))
Label for Quetiapine Tablets, USP 150 mg film-coated tablets, packaged in a container of 100 tablets. The label states each tablet contains 172.683 mg quetiapine fumarate equivalent to 150 mg quetiapine. Distributed by Aurobindo Pharma USA, Inc., made in India. Includes storage instructions and a warning to keep out of children’s reach. NDC 65862-492-01 is visible.*
FDA Label Image

Chemical Structure (Quetiapine Str)

Chemical Structure (Quetiapine Str)
Chemical structure of Quetiapine Fumarate, showing the molecular arrangement of quetiapine units paired with fumarate ions.*

* 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.