Quetiapine Fumarate Tablet, Extended Release
Product Images NDC 16729-096

8 FDA label images from Accord Healthcare Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Quetiapine Fumarate (NDC 16729-096). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare Inc., 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

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 150mg 60 Label)

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 150mg 60 Label)
Label for Quetiapine extended-release tablets USP 150 mg by Accord Healthcare Inc. The label indicates tablets are for oral use, dispensed as 60 count per package, to be taken once daily. It includes storage instructions, a warning about keeping out of reach of children, and mentions the medication guide availability. The label also shows two barcodes and manufacturing information.*
FDA Label Image

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 200mg 60 Label)

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 200mg 60 Label)
Label for Quetiapine Extended-release Tablets USP 200 mg, oral dosage form by Accord Healthcare Inc. The package contains 60 tablets. The label includes dosage instructions of once daily, storage conditions, and a warning to keep out of reach of children. It also states that each tablet contains 230 mg Quetiapine Fumarate equivalent to 200 mg Quetiapine.*
FDA Label Image

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 300mg 60 Label)

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 300mg 60 Label)
Label for Quetiapine Extended-release Tablets USP 300 mg by Accord Healthcare Inc. The oral tablet is for once daily use, with the package containing 60 tablets. The label includes storage instructions, usage warnings, and manufacturer information. It displays the NDC code 16729-096-12 and dosage strength prominently.*
FDA Label Image

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 400mg 60 Label)

Quetiapine Fumarate Tablet, Extended Release 400 mg 60 Tablets Bottle (Quetiapine 400mg 60 Label)
Label for Quetiapine Extended-release Tablets USP 400 mg, oral dosage form, manufactured by Intas Pharmaceuticals Limited and labeled by Accord Healthcare Inc. The label includes directions for use once daily, storage instructions, a warning to keep out of reach of children, package size of 60 tablets, and a barcode. NDC 16729-097-12 is visible.*
FDA Label Image

Figure 1 Kaplan-meier Curves Of Time To Schizophrenic Relapse Study 3.jpg (Quetiapine Figure 1)

Figure 1 Kaplan-meier Curves Of Time To Schizophrenic Relapse Study 3.jpg (Quetiapine Figure 1)
A line chart showing the proportion of patients with relapse (%) over time in months, comparing two groups labeled PLA (placebo) and QTP XR (quetiapine fumarate extended release). The PLA group is represented by a dashed line increasing steadily up to nearly 100% by 7 months, while the QTP XR group is represented by a solid line showing a slower increase, reaching around 50% at 7 months.*
FDA Label Image

Figure 2 Kaplan-maier Curves Of Time To Recurrence Of A Mood Event.jpg (Quetiapine Figure 2)

Figure 2 Kaplan-maier Curves Of Time To Recurrence Of A Mood Event.jpg (Quetiapine Figure 2)
A Kaplan-Meier curve chart showing the proportion of patients with relapse (%) over time (weeks) for two groups. One group labeled QTP+ LI/VAL (dashed line) and the other PLA+ LI/VAL (solid line), illustrating different relapse rates over a 100-week period.*
FDA Label Image

Figure 3 Kaplan-meier Curves Of Time To Recurrence Of A Mood Event (study 19).jpg (Quetiapine Figure 3)

Figure 3 Kaplan-meier Curves Of Time To Recurrence Of A Mood Event (study 19).jpg (Quetiapine Figure 3)
A line graph depicting the proportion of patients with relapse (%) over time (weeks up to 100). Two groups are compared: QTP+LIVAL (dashed line) and PLA+LIVAL (solid line), showing relapse rates increasing over time with PLA+LIVAL having a higher relapse proportion throughout the period.*
FDA Label Image

Structural Formula (Quetiapine Structure)

Structural Formula (Quetiapine Structure)
Chemical structure of quetiapine fumarate, showing the molecular arrangement of the active ingredient quetiapine combined with fumarate ions, as depicted in a structural formula diagram.*

* 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.