Duloxetine Capsule, Delayed Release
Product Images NDC 80425-0389

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 80425-0389). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Of 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.

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Structure (69d6387b 794f 415d 8013 23cca0a6984f 01)

Chemical structure of duloxetine hydrochloride, displaying a naphthalene ring connected to a thiophene ring and an amine group with hydrochloride salt.*

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Figure 1 (69d6387b 794f 415d 8013 23cca0a6984f 02)

A Kaplan-Meier survival curve graph showing the proportion of patients with relapse over time in days from randomization, comparing two treatments: placebo (dashed line) and duloxetine (solid line). The graph illustrates relapse rates up to approximately 200 days for each treatment group.*

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Figure 2 (69d6387b 794f 415d 8013 23cca0a6984f 03)

A Kaplan-Meier estimator graph showing the proportion of patients with relapse over time from randomization to relapse (days) for Duloxetine compared to placebo. The graph includes two treatment groups: Duloxetine (solid line) and placebo (dashed line), with relapse proportion on the y-axis and time in days on the x-axis.*

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Figure 1 (69d6387b 794f 415d 8013 23cca0a6984f 04)

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline. The graph compares four groups: Duloxetine 60 mg twice daily (BID), Duloxetine 60 mg once daily (QD), Duloxetine 20 mg once daily (QD), and placebo, illustrating higher improvement percentages for the Duloxetine groups compared to placebo.*

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Figure 2 (69d6387b 794f 415d 8013 23cca0a6984f 05)

A line graph depicting the percentage of patients improved versus percent improvement in pain from baseline. The graph compares three groups: Duloxetine 60 mg BID, Duloxetine 60 mg QD, and placebo, showing how patient improvement varies with pain reduction percentages.*

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Fig 5 (69d6387b 794f 415d 8013 23cca0a6984f 06)

A line graph illustrating the percentage of patients improved versus percent improvement in pain from baseline, comparing Duloxetine 60 mg taken twice daily, once daily, and placebo. The graph shows higher percentages of patient improvement with Duloxetine compared to placebo at various pain improvement levels.*

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Fig 6 (69d6387b 794f 415d 8013 23cca0a6984f 07)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine at doses of 120 mg twice daily, 60 mg once daily (two datasets with different line styles), and placebo. The vertical axis shows patient improvement percentage, and the horizontal axis shows percent pain improvement intervals from greater than 0 to 100.*

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Fig 7 (69d6387b 794f 415d 8013 23cca0a6984f 08)

A line graph depicting the percentage of pediatric patients aged 13 to 17 years with Juvenile Fibromyalgia Syndrome achieving various levels of pain relief at week 12, comparing Duloxetine 60 mg once daily with placebo. The x-axis shows percent improvement in pain from baseline, and the y-axis shows the percentage of patients improved. Two lines represent Duloxetine and placebo responses across pain relief percentages.*

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Figure 8 (69d6387b 794f 415d 8013 23cca0a6984f 09)

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

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Figure 9 (69d6387b 794f 415d 8013 23cca0a6984f 10)

A line graph comparing the percentage of patients improved in pain from baseline for Duloxetine 60 mg once daily versus placebo. The x-axis represents percent improvement in pain from baseline, and the y-axis shows the percentage of patients improved. The graph demonstrates higher patient improvement percentages for Duloxetine 60 mg compared to placebo across various levels of pain improvement.*

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Figure 10 (69d6387b 794f 415d 8013 23cca0a6984f 11)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BOCF) for Duloxetine 60/120 mg once daily and placebo. The x-axis represents percent improvement in pain, and the y-axis represents the percentage of patients improved. Data points are plotted for each treatment showing Duloxetine generally higher than placebo across the range.*

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Duloxetine 60mg #30 (Duloxetine HCl Dr 60mg 80425 0389 01)

Label for Duloxetine HCL delayed-release capsules, 60 mg strength, in a package of 30 capsules. The label indicates the product is marketed by Advanced Rx of Tennessee, LLC and manufactured by Lupin Pharmaceuticals, Inc. Storage instructions specify keeping the capsules at 20°-25°C (68°-77°F). The label includes NDC numbers and an expiration date of 9/30/2025.*

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Duloxetine 60mg #60 (Duloxetine HCl Dr 60mg 80425 0389 02)

Duloxetine HCL DR 60 mg delayed release capsules packaging label from Advanced Rx of Tennessee, LLC, Nashville, TN. The label states comparison to CYMBALTA and lists NDC codes 80425-0389-02 and source NDC 68180-0296-03. The quantity is 60 capsules, with an expiration date of 9/30/2025. Label includes storage instructions at 20-25°C and a barcode.*

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Duloxetine 60mg # 90 (Duloxetine HCl Dr 60mg 80425 0389 03)

Duloxetine HCL DR 60 mg capsule label from Advanced Rx of Tennessee, LLC, comparing product to Cymbalta. Shows NDC 80425-0389-03, lot number and expiry 9/30/2025, with storage instructions at 20°C to 25°C (68°F to 77°F). Includes barcodes and caution about Federal law restricting transfer.*

* 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.