Duloxetine Capsule, Delayed Release
Product Images NDC 70518-4440

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 70518-4440). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Structure (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 01)

Chemical structure of duloxetine hydrochloride, showing fused aromatic rings including a naphthalene moiety and a thiophene ring, with functional groups including an oxygen atom and a methylated amine group associated with hydrochloride.*

FDA Label Image

Figure 1 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 02)

A Kaplan-Meier estimator method plot showing the proportion of patients with relapse over time in days from randomization. The graph compares two treatment groups: placebo and duloxetine, with relapse proportions depicted on the y-axis and time on the x-axis. The duloxetine group shows a lower proportion of relapse compared to placebo over approximately 200 days.*

FDA Label Image

Figure 2 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 03)

Kaplan-Meier estimator graph showing the proportion of patients with relapse over time (days) from randomization for Duloxetine versus placebo treatment. The graph displays two lines: a solid line for Duloxetine and a dashed line for placebo, illustrating relapse rates among patients over approximately 250 days.*

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Figure 1 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 04)

A line chart depicting the percentage of patients improved versus percent improvement in pain from baseline. It compares four groups: Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, Duloxetine 20 mg once daily, and placebo, showing patient response rates across varying levels of pain improvement.*

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Figure 2 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 05)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline for three groups: Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, and placebo. The x-axis shows percent improvement in pain from 0 to 100, and the y-axis shows percentage of patients improved from 0 to 100.*

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Fig 5 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 06)

A line chart comparing the percentage of patients improved against the percent improvement in pain from baseline. It includes three lines representing Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, and a placebo, showing how patient improvement varies with increasing pain relief percentages.*

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Fig 6 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 07)

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline. The graph compares four groups: Duloxetine 120 mg twice daily, Duloxetine 60 mg once daily, Duloxetine 60 mg once daily (repeated label), and Placebo, over a range of pain improvement percentages from >0 to 100. The y-axis represents the percentage of patients improved, and the x-axis shows percent pain improvement thresholds.*

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Fig 7 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 08)

A line chart showing the percentage of pediatric patients aged 13 to 17 years with juvenile fibromyalgia syndrome achieving various levels of pain relief at week 12. The x-axis represents percent improvement in pain from baseline, while the y-axis shows the percentage of patients improved. Two lines compare patients treated with Duloxetine 60 mg once daily versus placebo, indicating higher pain relief percentages in the Duloxetine group across improvement levels.*

FDA Label Image

Figure 8 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 09)

A line graph comparing the percentage of patients improved in pain from baseline between placebo and Duloxetine 60/120 mg once daily. The x-axis represents percent improvement in pain from baseline (BOCF), ranging from 0 to 100%. The y-axis shows the percentage of patients improved, ranging from 0 to 100%. Duloxetine shows higher patient improvement percentages compared to placebo across all levels of pain improvement.*

FDA Label Image

Figure 9 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 10)

A line chart comparing percentage of patients improved versus percent improvement in pain from baseline (BOCF). Two lines show data for placebo and Duloxetine 60 mg once daily, with percentage improvement in pain on the horizontal axis and percentage of patients improved on the vertical axis. Duloxetine shows higher improvement percentages compared to placebo across most pain improvement levels.*

FDA Label Image

Figure 10 (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 11)

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline (BOCF). It compares placebo and duloxetine 60/120 mg once daily, with duloxetine showing consistently higher percentages of improved patients across increasing pain improvement thresholds.*

FDA Label Image

Remedy_label (Remedy Label)

Label for Duloxetine delayed-release capsules, 20 mg strength, containing 30 capsules. The label indicates the capsules are green and are repackaged by RemedyRepack Inc., Indiana, PA. Manufacturer is Lupin Pharma, Baltimore, MD. Storage instructions and safety warnings are also present.*

* 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.