Duloxetine Capsule, Delayed Release
Product Images NDC 25000-610

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 25000-610). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Marksans Pharma Limited, 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

Duloxetine (Dulo)

Chemical structure of Duloxetine Hydrochloride, showing the molecular arrangement including a naphthalene ring, a thiophene ring, and an amine group with a hydrochloride moiety.*

FDA Label Image

Dulo-20mg-60s (Duloxetine 20mg 60s Label)

The label for Duloxetine Delayed-Release Capsules, USP 20 mg from Marksans Pharma Limited shows the product name, strength, and form clearly. It includes a graphic of a green capsule marked with 'RBY808' and '20 mg,' and a count of 60 capsules. The label specifies storage instructions, dispensing guidelines, and manufacturer information for Time-Cap Labs, Inc. and Marksans Pharma Ltd.*

FDA Label Image

Dulo-30mg-30s (Duloxetine 30mg 30s Label)

Duloxetine 30 mg delayed-release capsules, USP by Marksans Pharma Limited. The label shows a blue and white capsule marked with '30 mg' and the package contains 30 capsules. It includes dosage information and storage instructions, warns not to use if the inner seal is broken, and lists the manufacturer details.*

FDA Label Image

Dulo-30mg-90s (Duloxetine 30mg 90s Label)

Label for Duloxetine Delayed-Release Capsules, USP 30 mg by Marksans Pharma Limited. The label shows a blue and white capsule marked with 'RDY609' and '30mg'. It contains 90 capsules and includes storage instructions, manufacturer details, barcode, and a caution advising not to use if the inner seal is missing or broken.*

FDA Label Image

Dulo-60mg-30s (Duloxetine 60mg 30s Label)

Duloxetine 60 mg delayed-release capsules, USP, oral use, packaged in a container of 30 capsules. The label highlights the strength, dosage form, and indicates the product is manufactured by Marksans Pharma Ltd. and distributed by Time-Cap Labs, Inc. It includes storage instructions, a warning to not use if the inner seal is broken, and a reminder for pharmacists to dispense the medication guide separately to patients.*

FDA Label Image

Dulo-60mg-90s (Duloxetine 60mg 90s Label)

Label for Duloxetine Delayed-Release Capsules, USP 60 mg by Marksans Pharma Limited. The label shows a blue and yellow capsule image, package count of 90 capsules, and states the active ingredient amount equivalent to 60 mg duloxetine. It includes storage instructions, a barcode, and manufacturing information for Marksans Pharma Ltd and Time-Cap Labs, Inc.*

FDA Label Image

Fig1 (Fig1)

A Kaplan-Meier curve comparing the proportion of patients with relapse over time (days) from randomization between Duloxetine and placebo treatments. The x-axis shows time from randomization to relapse in days, and the y-axis shows the proportion of patients with relapse, ranging from 0 to 1. The graph illustrates lower relapse proportion for Duloxetine compared to placebo over the study period.*

FDA Label Image

Fig10 (Fig10)

A line graph comparing the percentage of patients improved between placebo and Duloxetine 60/120 mg once daily. The x-axis shows percent improvement in pain from baseline (BOCF), and the y-axis shows the percentage of patients improved. Two lines represent placebo (dashed) and Duloxetine (solid), illustrating higher patient improvement percentages with Duloxetine across various pain improvement levels.*

FDA Label Image

Fig2 (Fig2)

A time-to-event curve graph showing the proportion of patients with relapse over time in days following randomization. Two groups are compared: Duloxetine and placebo. The y-axis represents the proportion of patients with relapse, ranging from 0 to 1, while the x-axis shows time from randomization to relapse up to 300 days.*

FDA Label Image

Fig3 (Fig3)

A line graph depicting the percentage of patients improved in relation to the percent improvement in pain from baseline for Duloxetine 60 mg BID, Duloxetine 60 mg QD, Duloxetine 20 mg QD, and placebo. The x-axis shows percent improvement in pain, and the y-axis shows the percentage of patients improved, comparing different dosing regimens of Duloxetine with placebo.*

FDA Label Image

Fig4 (Fig4)

A line graph showing the percentage of patients improved relative to the percent improvement in pain from baseline for Duloxetine 60 mg administered BID and QD, compared to placebo. The x-axis represents percent improvement in pain, while the y-axis shows the percentage of patients improved. The graph includes three data series representing Duloxetine 60 mg BID, Duloxetine 60 mg QD, and placebo outcomes over a range of pain improvement percentages.*

FDA Label Image

Fig5 (Fig5)

A line graph comparing percentage of patients improved versus percent improvement in pain from baseline for Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, and placebo. The graph shows three lines representing these groups, illustrating patient pain improvement outcomes at different thresholds.*

FDA Label Image

Fig6 (Fig6)

A line graph showing percentage of patients improved versus percent improvement in pain from baseline for Duloxetine at 120 mg, 60 mg, 20 mg once daily, and placebo. The graph compares pain improvement distributions among these groups.*

FDA Label Image

Fig8 (Fig8)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline using the BOCF method. It displays two lines: one for placebo and one for Duloxetine 60/120 mg once daily, showing greater patient improvement with Duloxetine across various pain improvement thresholds.*

FDA Label Image

Fig9 (Fig9)

A line chart comparing the percentage of patients improved by percent improvement in pain from baseline (BOCF) for placebo and Duloxetine 60 mg once daily. The chart shows two lines with data points, one for placebo and one for Duloxetine, illustrating patient improvement over a range of pain reduction percentages from 0 to 100%.*

* 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.