Quetiapine Tablet, Film Coated, Extended Release
Product Images NDC 69948-003

8 FDA label images from Alignscience Pharma 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 (NDC 69948-003). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alignscience Pharma 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

Chemical Structure (Ea718ade 4560 42bb 9068 1fe72a30c5ba Chemical Structure)

Chemical Structure (Ea718ade 4560 42bb 9068 1fe72a30c5ba Chemical Structure)
Chemical structure diagram depicting the active ingredient Quetiapine in its extended-release form, as identified from the product data provided. The diagram shows the molecular arrangement of atoms and bonds characteristic of Quetiapine.*
FDA Label Image

Figure 1 Kaplan-meier Curves Of Time To Schizophrenic Relapse Study 3.jpg (Ea718ade 4560 42bb 9068 1fe72a30c5ba Figure 1)

Figure 1 Kaplan-meier Curves Of Time To Schizophrenic Relapse Study 3.jpg (Ea718ade 4560 42bb 9068 1fe72a30c5ba Figure 1)
A line graph showing the proportion of patients with relapse (%) over time (months) for two groups: PLA and QTP XR. The y-axis represents the percentage of patients with relapse, ranging from 0 to 100%, and the x-axis represents time in months from 0 to 7. The PLA group shows a rising proportion of relapse over time, while the QTP XR group has a notably lower relapse proportion throughout the time period.*
FDA Label Image

Figure 2 Kaplan-maier Curves Of Time To Recurrence Of A Mood Event.jpg (Ea718ade 4560 42bb 9068 1fe72a30c5ba Figure 2)

Figure 2 Kaplan-maier Curves Of Time To Recurrence Of A Mood Event.jpg (Ea718ade 4560 42bb 9068 1fe72a30c5ba Figure 2)
This is a Kaplan-Meier survival curve graph showing the proportion of patients with relapse over time in weeks. It compares relapse rates between two groups: QTP+LI/VAL (Quetiapine plus Lithium/Valproate) and PLA+LI/VAL (Placebo plus Lithium/Valproate). The y-axis represents the proportion of patients with relapse in percentage, and the x-axis represents time in weeks up to 100 weeks.*
FDA Label Image

Figure 3 Kaplan-meier Curves Of Time To Recurrence Of A Mood Event (study 19).jpg (Ea718ade 4560 42bb 9068 1fe72a30c5ba Figure 3)

Figure 3 Kaplan-meier Curves Of Time To Recurrence Of A Mood Event (study 19).jpg (Ea718ade 4560 42bb 9068 1fe72a30c5ba Figure 3)
A line graph showing the proportion of patients with relapse (%) over time (weeks). Two groups are compared: one treated with Quetiapine Extended-Release plus LiVAL and the other with placebo plus LiVAL. The graph depicts patient relapse trends over a period of 100 weeks, with the Quetiapine group showing a lower relapse proportion compared to placebo.*
FDA Label Image

Quetiapine Fumarate 150 mg 60 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 150mg60s)

Quetiapine Fumarate 150 mg 60 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 150mg60s)
Label for Quetiapine Extended-Release Tablets, USP 150 mg, oral extended-release film-coated tablets. The label includes dosage instructions 'Once Daily' and indicates a package count of 60 tablets. Manufactured for AlignScience Pharma Inc., China, and produced by Haimen Pharma Inc. Storage and warning information is also provided along with a barcode.*
FDA Label Image

Quetiapine Fumarate 150 mg 500 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 150mg500s)

Quetiapine Fumarate 150 mg 500 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 150mg500s)
Label for Quetiapine Extended-Release Tablets, USP 150 mg, oral film-coated tablets. The label includes dosing instructions indicating once daily use and contains 500 tablets per container. The product is manufactured by Haimen Pharma Inc. and labeled for AlignScience Pharma Inc., with storage and handling instructions provided.*
FDA Label Image

Quetiapine Fumarate 200 mg 60 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 200mg60s)

Quetiapine Fumarate 200 mg 60 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 200mg60s)
Label for Quetiapine Extended-Release Tablets USP 200 mg, oral extended-release film-coated tablets. The label includes the NDC 69948-003-03 and indicates a package count of 60 tablets. It is manufactured for AlignScience Pharma Inc. and produced by Haimen Pharma Inc. Directions note swallowing whole without crushing or chewing.*
FDA Label Image

Quetiapine Fumarate 200 mg 500 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 200mg500s)

Quetiapine Fumarate 200 mg 500 Count Label (Ea718ade 4560 42bb 9068 1fe72a30c5ba 200mg500s)
Label for Quetiapine Extended-Release Tablets, USP 200 mg by AlignScience Pharma Inc. The label shows the product name, strength, dosage form as extended-release tablets, and quantity of 500 tablets. It includes storage instructions, a pharmacist note, usage warning, and manufacturer details in China. The NDC is 69948-003-11.*

* 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.