Duloxetine Capsule, Delayed Release
Product Images NDC 76420-623

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 76420-623). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Asclemed 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

20mg (Duloxetine 20mg)

Four separate packaging labels for Duloxetine DR Capsules 20 mg, manufactured by Enovachem Pharmaceuticals and marketed by Ajanta Pharma USA Inc. Each label shows different quantities: 30, 60, 90, and 100 capsules. Labels include NDC numbers, barcodes, QR codes, and storage instructions to keep at 20-25°C. Capsules are described as having a white body color with a blue cap.*

FDA Label Image

30mg (Duloxetine 30mg)

Four product labels for Duloxetine DR Capsules 30 mg, each showing packaging by Enovachem Pharmaceuticals, marketed by Ajanta Pharma USA Inc. Each label includes the NDC code, quantity (30, 60, 90, and 100 capsules), a blue capsule description, barcodes, and storage instructions. Labels also repeat the drug status as prescription only and contain caution statements about dispensing and storage.*

FDA Label Image

40mg (Duloxetine 40mg)

Packaging labels for Duloxetine DR Capsules 40 mg from Enovachem Pharmaceuticals, showing multiple quantities (30, 60, 90, 100) with respective NDC numbers. Labels include information on the labeler Ajanta Pharma USA Inc., lot number placeholders, storage conditions, drug status RX, barcodes, QR codes, and cautionary statements.*

FDA Label Image

60mg (Duloxetine 60mg)

Label images for Duloxetine DR Capsules 60 mg from Enovachem Pharmaceuticals show multiple package sizes: 30, 60, 90, and 100 capsules. The label states the product is marketed by Ajanta Pharma USA Inc. The capsules are described as having a white body and blue cap. Each label includes NDC numbers, lot and batch placeholders, storage instructions, and cautions about prescription dispensing.*

FDA Label Image

Figure1 (Duloxetine Fig1)

A Kaplan-Meier survival plot depicting the proportion of patients with relapse over time in days following randomization. Two treatment groups are compared: Duloxetine and Placebo. The graph tracks relapse rates up to approximately 200 days, showing the relapse proportion on the vertical axis and time on the horizontal axis.*

FDA Label Image

Figure10 (Duloxetine Fig10)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline. It shows two groups: Placebo and Duloxetine 60/120 mg once daily. The x-axis represents percent improvement in pain from baseline, and the y-axis represents percentage of patients improved. Duloxetine demonstrates higher patient improvement across increasing pain improvement percentages compared to placebo.*

FDA Label Image

Figure2 (Duloxetine Fig2)

A line graph showing the proportion of patients with relapse over time (days) from randomization, comparing treatment with Duloxetine versus placebo. The x-axis represents time in days up to 300, and the y-axis shows the proportion of patients with relapse from 0 to 1. Two lines depict relapse rates: a dashed line for placebo and a solid line for Duloxetine, with placebo showing a higher relapse proportion over time.*

FDA Label Image

Figure3 (Duloxetine Fig3)

A line graph showing percentage of patients improved versus percent improvement in pain from baseline. It compares Duloxetine 60 mg BID, Duloxetine 60 mg QD, Duloxetine 20 mg QD, and placebo, with plotted lines indicating patient response at various thresholds of pain improvement.*

FDA Label Image

Figure4 (Duloxetine Fig4)

A line graph comparing the percentage of patients improved against percent improvement in pain from baseline. It includes three lines representing Duloxetine 60 mg BID, Duloxetine 60 mg QD, and placebo. The vertical axis shows the percentage of patients improved, and the horizontal axis shows the percent improvement in pain from baseline, ranging from greater than 0 to 100 percent.*

FDA Label Image

Figure5 (Duloxetine Fig5)

Line graph showing the percentage of patients improved on the y-axis versus percent improvement in pain from baseline on the x-axis. The graph compares three groups: Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, and placebo, with separate trend lines indicating patient response rates for each group.*

FDA Label Image

Figure6 (Duloxetine Fig6)

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine doses of 20 mg, 60 mg, and 120 mg taken once daily compared to placebo. The graph illustrates higher patient improvement percentages across various pain improvement thresholds for all Duloxetine doses relative to placebo.*

FDA Label Image

Figure7 (Duloxetine Fig7)

A line graph comparing percentage of patients improved versus percent improvement in pain from baseline, showing data for Duloxetine 60 mg once daily and placebo groups. The x-axis represents percent improvement in pain from baseline, ranging from >0 to 100, and the y-axis represents the percentage of patients improved, from 0 to 100. Two lines indicate results for Duloxetine and placebo over the improvement range.*

FDA Label Image

Figure8 (Duloxetine Fig8)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine 60/120 mg once daily and placebo. The graph shows higher patient improvement percentages with Duloxetine across various pain improvement thresholds.*

FDA Label Image

Figure9 (Duloxetine Fig9)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BOCF) for Duloxetine 60 mg once daily and placebo. The x-axis represents percent improvement in pain, ranging from >0 to 100%, and the y-axis represents the percentage of patients improved, ranging from 0 to 100%. Duloxetine shows a higher percentage of patients improved across most improvement levels compared to placebo.*

FDA Label Image

Structure (Duloxetine Structure)

Chemical structure of duloxetine hydrochloride depicted with molecular rings including a thiophene and naphthalene group, along with a hydrochloride moiety.*

* 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.