Duloxetine
Product Images NDC 50436-0199

12 FDA label images from Unit Dose Services · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 50436-0199). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Figure1 (Duloxetine Fig1)

Figure1 (Duloxetine Fig1)
A line graph showing the proportion of patients with relapse over time from randomization to relapse in days. Two treatments are compared: placebo and Duloxetine, with Duloxetine showing a lower proportion of patients relapsing over the observed period up to approximately 200 days.*
FDA Label Image

Figure10 (Duloxetine Fig10)

Figure10 (Duloxetine Fig10)
A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BOCF) for Duloxetine 60/120 mg once daily against placebo. The y-axis shows the percentage of patients improved, and the x-axis shows the percent improvement in pain from baseline, ranging from 0 to 100%. Two plotted lines represent the placebo group and the Duloxetine group, with Duloxetine showing higher patient improvement percentages across the pain improvement spectrum.*
FDA Label Image

Figure2 (Duloxetine Fig2)

Figure2 (Duloxetine Fig2)
A Kaplan-Meier survival curve chart comparing the proportion of patients with relapse over time (days) from randomization between placebo and Duloxetine treatments. The chart shows relapse proportion on the y-axis and time in days on the x-axis, with separate plotted lines for placebo and Duloxetine groups.*
FDA Label Image

Figure3 (Duloxetine Fig3)

Figure3 (Duloxetine Fig3)
A line chart showing the percentage of patients improved versus percent improvement in pain from baseline. It compares Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, Duloxetine 20 mg once daily, and placebo groups, illustrating patient response rates at various pain improvement thresholds.*
FDA Label Image

Figure4 (Duloxetine Fig4)

Figure4 (Duloxetine Fig4)
A line graph showing the percentage of patients improved plotted against percent improvement in pain from baseline. The graph compares three groups: Duloxetine 60 mg BID, Duloxetine 60 mg QD, and Placebo, with Duloxetine groups showing higher improvement percentages than Placebo across the pain improvement range.*
FDA Label Image

Figure5 (Duloxetine Fig5)

Figure5 (Duloxetine Fig5)
A line graph showing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine 60mg taken once daily, Duloxetine 60mg taken twice daily, and placebo. The graph plots data points indicating the effectiveness of each treatment in pain improvement.*
FDA Label Image

Figure6 (Duloxetine Fig6)

Figure6 (Duloxetine Fig6)
A line graph showing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine at 120 mg, 60 mg, and 20 mg once daily doses, compared with placebo. The graph demonstrates trends of patient improvement at various pain improvement thresholds for each treatment group.*
FDA Label Image

Figure8 (Duloxetine Fig8)

Figure8 (Duloxetine Fig8)
A line graph comparing the percentage of patients improved for Duloxetine 60/120 mg once daily versus placebo. The x-axis represents percent improvement in pain from baseline (BOCF), and the y-axis shows the percentage of patients improved. Two curves depict patient improvement, with Duloxetine consistently showing higher improvement percentages across pain improvement levels.*
FDA Label Image

Figure9 (Duloxetine Fig9)

Figure9 (Duloxetine Fig9)
A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BOCF) for Duloxetine 60 mg once daily and placebo. The x-axis shows percent improvement from 0 to 100, while the y-axis shows percentage of patients improved from 0 to 100. Duloxetine is represented with a solid line and diamonds, placebo with a dotted line and x marks, indicating higher patient improvement percentages with Duloxetine across most pain improvement levels.*
FDA Label Image

Structure (Duloxetine Structure)

Structure (Duloxetine Structure)
Chemical structure diagram of Duloxetine hydrochloride showing its molecular framework including a naphthalene group, a thiophene ring, and a secondary amine with a hydrochloride salt form.*
FDA Label Image

Label Image (Lbl504360198)

Label Image (Lbl504360198)
Duloxetine Hydrochloride delayed-release capsules, 30 mg strength, with a package count of 30 capsules. The label shows the NDC 50436-0198-1, distributed by Ajanta Pharma USA Inc. located in Bridgewater, NJ. The product is dispensed in a tightly closed container, with storage instructions to keep at 25°C and out of reach of children. Label indicates 'RX ONLY' and version 'Rev. 1'. Manufactured by Unit Dose Services, LLC, Dania, FL.*
FDA Label Image

Label Image (Lbl504360199)

Label Image (Lbl504360199)
Duloxetine Hydrochloride Delayed-Release 60 MG capsules, 30 count blister pack. Label shows NDC 50436-0199-1, manufacturer Ajanta Pharma USA Inc., Bridgewater, NJ. Capsules contain 67.3 mg of duloxetine hydrochloride USP equivalent to 60 mg duloxetine. Packaging includes storage instructions and warnings.*

* 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.