Duloxetine Delayed-release
Product Images NDC 53217-130

9 FDA label images from Aidarex Pharmaceuticals Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Duloxetine Delayed-release (NDC 53217-130). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals 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

Chemical Structure (Duloxetine Dr Usp 1)

Chemical Structure (Duloxetine Dr Usp 1)
Chemical structure diagram showing the molecular structure of duloxetine hydrochloride, the active ingredient in Duloxetine Delayed-Release by Aidarex Pharmaceuticals LLC.*
FDA Label Image

Figure 1 (Duloxetine Dr Usp 2)

Figure 1 (Duloxetine Dr Usp 2)
A Kaplan-Meier survival curve showing the proportion of patients with relapse over time (days) from randomization. Two treatments are compared: Placebo (dashed line) and Duloxetine (solid line). The y-axis represents the proportion of patients relapsed, and the x-axis represents time in days up to 250.*
FDA Label Image

Figure 2 (Duloxetine Dr Usp 3)

Figure 2 (Duloxetine Dr Usp 3)
A Kaplan-Meier survival curve chart comparing the proportion of patients with relapse over time in days from randomization. Two treatments, Placebo (dashed line) and Duloxetine (solid line), are shown. The graph displays the difference in relapse rates between the two groups over approximately 275 days.*
FDA Label Image

Figure 3 (Duloxetine Dr Usp 4)

Figure 3 (Duloxetine Dr Usp 4)
A line graph depicting the percentage of patients improved versus percent improvement in pain from baseline in a clinical trial. Four groups are compared: DULOXETINE DELAYED-RELEASE at 60mg twice daily (BID), 60mg once daily (QD), 20mg once daily (QD), and placebo. The y-axis represents the percentage of patients improved, and the x-axis shows the percent improvement in pain from baseline, ranging from greater than 0 to 100 percent.*
FDA Label Image

Figure 4 (Duloxetine Dr Usp 5)

Figure 4 (Duloxetine Dr Usp 5)
A line graph showing the percentage of patients improved relative to the percent improvement in pain from baseline. It compares three groups: DULOXETINE DELAYED-RELEASE 60mg BID, DULOXETINE DELAYED-RELEASE 60mg QD, and placebo. The vertical axis represents the percentage of patients improved, and the horizontal axis represents percent improvement in pain from baseline.*
FDA Label Image

Figure 7 (Duloxetine Dr Usp 6)

Figure 7 (Duloxetine Dr Usp 6)
A line graph showing the percentage of patients improved plotted against percent improvement in pain from baseline (BOCF). Two data series are shown: Placebo and DULOXETINE DELAYED-RELEASE 60/120 mg once daily. The graph illustrates higher patient improvement percentages with DULOXETINE compared to placebo across various pain improvement levels.*
FDA Label Image

Figure 8 (Duloxetine Dr Usp 7)

Figure 8 (Duloxetine Dr Usp 7)
A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BPCF) for two groups: Placebo and DUL 60 mg once daily. The graph shows both groups' improvement trends, with DUL 60 mg generally yielding higher patient improvement percentages across various pain improvement levels.*
FDA Label Image

Figure 9 (Duloxetine Dr Usp 8)

Figure 9 (Duloxetine Dr Usp 8)
A line graph comparing percentage of patients improved versus percent improvement in pain from baseline (BOCF) between placebo and DULOXETINE DELAYED-RELEASE 60/120 mg once daily. The graph shows two lines, with the DULOXETINE DELAYED-RELEASE line generally above the placebo, indicating higher patient improvement across various pain improvement percentages.*
FDA Label Image

Image Description (Duloxetine Dr Usp 9)

Image Description (Duloxetine Dr Usp 9)
DULOXETINE DR, USP 60MG capsule label showing a package of 30 capsules. The active ingredient is Duloxetine Hydrochloride equivalent to Duloxetine 60 mg, in an orange and green oblong capsule with imprint 'B 748'. The label includes the NDC 53217-0130-30, manufacturer Aidarex Pharmaceuticals LLC, and packaging by Laboratorios Dr. Esteve, S.A. Spain.*

* 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.