Quetiapine Fumarate Tablet
Product Images NDC 0054-0221

13 FDA label images from Hikma Pharmaceuticals Usa Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Quetiapine Fumarate (NDC 0054-0221). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Chem.jpg (Chem)

Chem.jpg (Chem)
Chemical structure of quetiapine fumarate, showing the molecular arrangement of the quetiapine moiety and associated fumarate counterion.*
FDA Label Image

Fig1.jpg (Fig1)

Fig1.jpg (Fig1)
A Kaplan-Meier survival curve chart showing the proportion of patients with relapse (%) on the y-axis over time in weeks on the x-axis, up to 100 weeks. The chart compares two groups: one receiving Quetiapine Fumarate plus LI/VAL (dashed line) and the other receiving placebo plus LI/VAL (solid line), with the placebo group showing a higher proportion of relapse over time.*
FDA Label Image

Fig2.jpg (Fig2)

Fig2.jpg (Fig2)
A Kaplan-Meier plot showing the proportion of patients with relapse (%) over time (weeks) for two groups: QTP+LI/VAL (dashed line) and PLA+LI/VAL (solid line). The graph displays a lower proportion of relapse in the QTP+LI/VAL group compared to the PLA+LI/VAL group throughout the approximately 100-week period.*
FDA Label Image

Fpl-bl-25mg-100tab-04.jpg (Image 01)

Fpl-bl-25mg-100tab-04.jpg (Image 01)
Label for Quetiapine Fumarate Tablets, USP 25 mg, showing a bottle pack with 100 tablets. It includes dosage strength and a pharmacist dispensing instruction. Distributed by Hikma Pharmaceuticals USA Inc. The label also contains storage instructions and a warning to keep out of reach of children.*
FDA Label Image

Fpl-bl-50-mg-100tab-04.jpg (Image 02)

Fpl-bl-50-mg-100tab-04.jpg (Image 02)
Quetiapine Tablets USP 50 mg oral tablet label from Hikma Pharmaceuticals USA Inc. The label includes a barcode, states the package contains 100 tablets, and provides storage instructions and a warning to keep out of reach of children. It also notes the pharmacist should dispense with an attached medication guide.*
FDA Label Image

Fpl-bl-100mg-100tab-04.jpg (Image 03)

Fpl-bl-100mg-100tab-04.jpg (Image 03)
Label for Quetiapine Tablets, USP 100 mg by Hikma Pharmaceuticals USA Inc. The label indicates a bottle containing 100 tablets. It includes the NDC number 0054-0221-25, directions to dispense with a medication guide, and storage instructions at controlled room temperature. Warnings advise to keep out of reach of children.*
FDA Label Image

Fpl-bl-200mg-100tab-03.jpg (Image 04)

Fpl-bl-200mg-100tab-03.jpg (Image 04)
Label for Quetiapine Tablets, USP 200 mg, containing 100 tablets. Distributed by Hikma Pharmaceuticals USA Inc. The label states each tablet contains quetiapine fumarate equivalent to 200 mg quetiapine base, with storage instructions and a reminder for pharmacists to dispense with the Medication Guide. Includes an NDC barcode and the prescription-only designation.*
FDA Label Image

Fpl-bl-300mg-60tab-03.jpg (Image 05)

Fpl-bl-300mg-60tab-03.jpg (Image 05)
Label for Quetiapine Tablets, USP 300 mg, oral tablets in a 60-tablet bottle, distributed by Hikma Pharmaceuticals USA Inc. The label includes the NDC 0054-0223-21, storage instructions at 20° to 25°C, and advises dispensing with an attached Medication Guide. It features a prominent orange box highlighting the 300 mg strength.*
FDA Label Image

Fpl-bl-400mg-100tab-05.jpg (Image 06)

Fpl-bl-400mg-100tab-05.jpg (Image 06)
Label for Quetiapine Tablets USP 400 mg, distributed by Hikma Pharmaceuticals USA Inc. The label indicates a package containing 100 tablets. It includes the NDC number 0054-0230-25, pharmacist dispensing instructions, a warning to keep out of reach of children, and storage conditions. The label features the Hikma logo and barcode.*
FDA Label Image

Image 07

Image 07
Packaging label for Quetiapine Tablets USP 25 mg by Hikma Pharmaceuticals USA Inc. The label indicates unit-dose packaging with 2x5x10 tablets. It includes standard storage instructions, dosage note to see the package insert, and warnings to keep out of reach of children. Barcodes and distribution information for Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ are also visible.*
FDA Label Image

Image 08

Image 08
Label for Quetiapine Tablets, USP 50 mg by Hikma Pharmaceuticals USA Inc. The packaging is for unit-dose tablets with a 2x5x10 count. The label includes storage instructions, dosage warnings, and pharmacist dispensing information. The design features a green block highlighting the 50 mg strength and the Hikma logo in orange.*
FDA Label Image

Image 09

Image 09
Packaging label for Quetiapine Fumarate Tablets USP 100 mg by Hikma Pharmaceuticals USA Inc. The label indicates it is a 2x5x10 unit-dose tablet package. The design features a white background with a prominent blue panel displaying the strength 100 mg. Additional text includes storage instructions, dosage reference, warning to keep out of reach of children, and dispensing guidance.*
FDA Label Image

Image 10

Image 10
Packaging label for Quetiapine Tablets, USP 300 mg, oral tablets in a unit-dose package. The label shows the product name prominently with strength in an orange block. The labeler is Hikma Pharmaceuticals USA Inc., and the packaging includes dosage, pharmacist instructions, and storage information. The package contains 2 trays of 5x10 unit-dose tablets.*

* 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.