Duloxetine Capsule, Delayed Release
Product Images NDC 71610-957

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 71610-957). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, 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

Label (71610 0957 74)

Label for Duloxetine DR USP delayed-release capsules, 20 mg strength. The label shows packaging for 500 capsules, including storage instructions, manufacturer (Lupin Pharmaceuticals, Inc., Naples, FL), and packager (Aphena Pharma Solutions, Cookeville, TN). The NDC number 71610-957-74 and barcode are visible, along with warnings to keep out of reach of children and to dispense in a light-resistant container.*

FDA Label Image

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

Chemical structure of Duloxetine hydrochloride showing a naphthalene moiety connected via an oxygen to a chiral carbon bonded to a thiophene ring and a methylated amine group with hydrochloride.*

FDA Label Image

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

A Kaplan-Meier estimator method chart showing the proportion of patients with relapse over time in days from randomization. The chart compares two treatments: Duloxetine and Placebo, with Duloxetine showing a lower proportion of relapse over approximately 200 days.*

FDA Label Image

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

A Kaplan-Meier estimator method chart showing the proportion of patients with relapse over time from randomization to relapse in days. The graph compares two treatments: Duloxetine (solid line) and Placebo (dashed line), illustrating a lower proportion of relapse in the Duloxetine group throughout the duration, up to approximately 250 days.*

FDA Label Image

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

A line graph depicting the percentage of patients improved versus percent improvement in pain from baseline. The graph compares Duloxetine 60 mg twice daily (BID), Duloxetine 60 mg once daily (QD), Duloxetine 20 mg QD, and placebo, showing their respective trends in patient pain improvement.*

FDA Label Image

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

A line graph showing percentage of patients improved on the vertical axis versus percent improvement in pain from baseline on the horizontal axis. The graph compares three groups: Duloxetine 60 mg BID, Duloxetine 60 mg QD, and placebo, illustrating their respective response rates across different levels of pain improvement.*

FDA Label Image

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

A line graph showing percentage of patients improved versus percent improvement in pain from baseline. It compares Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, and placebo groups, illustrating differences in patient-reported pain improvement under these treatments.*

FDA Label Image

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

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline. It compares Duloxetine at 120 mg twice daily, Duloxetine 60 mg once daily from two sources, and placebo. The graph plots patient improvement across increasing pain improvement thresholds from 0 to 100 percent.*

FDA Label Image

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

A line graph 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 (0 to 100%), and the y-axis shows the percentage of patients improved (0 to 100%). Two lines compare Duloxetine 60mg once daily versus placebo, with Duloxetine showing higher percentages of pain improvement across all levels.*

FDA Label Image

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

A line graph comparing percent improvement in pain from baseline between Duloxetine 60/120 mg once daily and placebo. The graph plots the percentage of patients improved against various percent improvement thresholds, showing higher efficacy for Duloxetine over placebo across the range.*

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

A line graph comparing the percentage of patients improved between placebo and duloxetine 60 mg once daily. The x-axis represents percent improvement in pain from baseline (BOCF) in increments from >0 to 100, and the y-axis shows the percentage of patients improved, ranging from 0 to 100%. Two trend lines indicate that duloxetine generally results in higher patient improvement percentages across measured thresholds compared to placebo.*

FDA Label Image

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

A line graph comparing percentage of patients improved against percent improvement in pain from baseline (BOCF). It shows two data series: Placebo and Duloxetine 60/120 mg once daily, with Duloxetine consistently showing higher patient improvement percentages across the range.*

FDA Label Image

Image (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 935 1)

The image shows a blister card containing delayed-release capsules of Duloxetine 20 mg. The capsules are arranged in two rows of five, with alternating black and gray colors. No additional text or branding is visible on the blister card.*

FDA Label Image

Image (7ad45dfa A630 4e5f 85c0 25dc9e8bfbb7 942 1)

Duloxetine 20 mg delayed release capsules are shown blister-packed in a silver foil tray with a card backing. The capsules have two halves, one white and the other yellow, arranged in two rows of five. The labeler is Aphena Pharma Solutions - Tennessee, LLC. The product is for oral use.*

FDA Label Image

Aphena (Aphena)

* 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.