Duloxetine Capsule, Delayed Release
Product Images NDC 82009-173

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Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 82009-173). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Quallent Pharmaceuticals Health 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

20mg (Duloxetine 20mg)

20mg (Duloxetine 20mg)
This text provides details about a medication in the form of capsules containing enteric-coated pellets of Duloxetine Hydrochloride. It includes information such as the dosage instructions, storage conditions, manufacturer details, and the associated pharmaceutical company. The medication is prescribed for use and comes with a Medication Guide to be dispensed by the pharmacist. The text mentions important warnings such as keeping the medication out of reach of children and not using it if the inner seal is missing or broken.*
FDA Label Image

30mg (Duloxetine 30mg)

30mg (Duloxetine 30mg)
This is a product label for Duloxetine Delayed-Release Capsules containing 30 mg of Duloxetine Hydrochloride. Each capsule contains enteric-coated pellets. The usual dosage information is provided in the accompanying literature. The medication should be dispensed in a tightly closed container and kept out of reach of children. The storage instructions indicate a temperature range of between 25°C to 30°C (59°F to 86°F). The manufacturer is Ajanta Pharma Limited in India, and the product is manufactured for Quallent Pharmaceuticals Health LLC in Grand Cayman, Cayman Islands. The label includes relevant codes such as NDC 82009-171-10 and manufacturer codes.*
FDA Label Image

40mg (Duloxetine 40mg)

40mg (Duloxetine 40mg)
This text provides details for a medication named Duloxetine. Each capsule contains 44.9 mg of Duloxetine Hydrochloride USP, equivalent to 40 mg of Duloxetine. The usual dosage instructions are included with the medication. The capsules are enteric-coated pellets and should be dispensed in a tightly closed container. It is advised to keep the medication out of the reach of children. The manufacturer is Ajanta Pharma Limited in India, and the product is manufactured for Quallent Pharmaceuticals Health LLC in Grand Cayman, Cayman Islands. The storage conditions include keeping the medication at 25°C (77°F) with permissible excursions to 15° to 30°C (59° to 86°F). Additionally, the text mentions a pending USP Assay & Organic Impurities test and a warning not to use the medication if the inner seal is missing or broken.*
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60mg (Duloxetine 60mg)

60mg (Duloxetine 60mg)
This evaluation did not provide a clear description.*
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Figure1 (Duloxetine Fig1)

Figure1 (Duloxetine Fig1)
This text provides data on the number of patients experiencing relapse under different treatments (Placebo and DULOXETINE) over a certain period measured in days from randomization. The graph indicates a comparison of relapse rates between the two treatments over time.*
FDA Label Image

Figure10 (Duloxetine Fig10)

Figure10 (Duloxetine Fig10)
This is a description of a clinical trial involving the medication Duloxetine at doses of 60mg or 120mg once daily. The text also references a comparison to a placebo group. The chart depicts the percent improvement in pain from baseline for different time points.*
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Figure2 (Duloxetine Fig2)

Figure2 (Duloxetine Fig2)
This text presents a graph showing the proportion of patients with relapse over time for two different treatments: Placebo and Duloxetine. The x-axis represents the time from randomization to relapse in days and the y-axis shows the percentage of patients experiencing a relapse. The graph indicates how the relapse rates change over time for the two treatments.*
FDA Label Image

Figure3 (Duloxetine Fig3)

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Figure4 (Duloxetine Fig4)

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Figure5 (Duloxetine Fig5)

Figure5 (Duloxetine Fig5)
This text provides a comparison of the percentage of patients who improved with different treatments - Duloxetine 60mg twice daily, Duloxetine 60mg once daily, and a placebo. It also includes a measurement of the percent improvement in pain from the baseline.*
FDA Label Image

Figure6 (Duloxetine Fig6)

FDA Label Image

Figure7 (Duloxetine Fig7)

Figure7 (Duloxetine Fig7)
This is a chart showing the percentage of patients improved after taking Duloxetine 60 mg once daily compared to a placebo. The percentage of improvement in pain from baseline reaches around 80-90% for the patients in the study.*
FDA Label Image

Figure8 (Duloxetine Fig8)

Figure8 (Duloxetine Fig8)
This text mentions the use of Duloxetine in doses of 60/120 mg once daily for pain management. The information includes data on the percentage of improvement in pain compared to the baseline.*
FDA Label Image

Figure9 (Duloxetine Fig9)

Figure9 (Duloxetine Fig9)
This is information related to a clinical trial or study evaluating the pain improvement in patients taking Duloxetine 60 mg once daily compared to a placebo. The text shows figures indicating the percentage of improvement in pain from baseline using the BOCF method. This data may be used to assess the efficacy of Duloxetine in pain management.*
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Structure (Duloxetine Structure)

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Logo (Quallent)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.