Duloxetine Capsule, Delayed Release
Product Images NDC 85534-0052

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 85534-0052). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hawaii Repack, Inc., 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)

A line graph showing the proportion of patients with relapse over time (days) from randomization. The horizontal axis represents time in days, and the vertical axis represents the proportion of patients with relapse, ranging from 0.0 to 1.0. Two treatments are compared: Placebo (dashed line) and Duloxetine (solid line), with the Placebo group showing a higher relapse proportion over time than the Duloxetine group.*

FDA Label Image

Figure10 (Duloxetine Fig10)

A line graph comparing the percentage of patients improved in pain from baseline (BOCF) between placebo and Duloxetine 60/120 mg once daily. The x-axis represents percent improvement in pain, and the y-axis shows the percentage of patients improved. Two lines depict outcomes for placebo and Duloxetine treatment groups across varying pain improvement percentages.*

FDA Label Image

Figure2 (Duloxetine Fig2)

A Kaplan-Meier curve comparing the proportion of patients with relapse over time between placebo and Duloxetine treatment groups. The x-axis shows time from randomization to relapse in days (0-300), and the y-axis shows the proportion of patients with relapse (0 to 1.0). The plot shows higher relapse proportions for placebo compared to Duloxetine over the observation period.*

FDA Label Image

Figure3 (Duloxetine Fig3)

A line graph showing percentage of patients improved on the y-axis against percent improvement in pain from baseline on the x-axis. The graph compares four groups: Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, Duloxetine 20 mg once daily, and placebo, illustrating patient improvement trends across varying levels of pain improvement.*

FDA Label Image

Figure4 (Duloxetine Fig4)

A line graph depicting the percentage of patients improved versus the percent improvement in pain from baseline. It compares three groups: Duloxetine 60 mg twice daily (BID), Duloxetine 60 mg once daily (QD), and placebo. The graph shows higher patient improvement percentages for both Duloxetine groups compared to placebo across increasing pain improvement intervals.*

FDA Label Image

Figure5 (Duloxetine Fig5)

A line chart depicting the percentage of patients improved versus percent improvement in pain from baseline. It compares three groups: Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, and placebo. The y-axis shows the percentage of patients improved (0 to 100%), and the x-axis shows percent pain improvement divided into increments from >0 to ≥100%. The data indicate trends of patient improvement across different pain improvement percentages for these treatments.*

FDA Label Image

Figure6 (Duloxetine Fig6)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline for duloxetine at 20 mg, 60 mg, and 120 mg once daily doses, and placebo. The x-axis represents percent improvement in pain, while the y-axis shows the percentage of patients improved. Duloxetine doses exhibit higher improvement rates compared to placebo.*

FDA Label Image

Figure7 (Duloxetine Fig7)

A line graph comparing percentage of patients improved by percent improvement in pain from baseline for Duloxetine 60 mg once daily versus placebo. The x-axis represents percent improvement in pain from baseline, ranging from 0 to 100, and the y-axis shows the percentage of patients improved. Two curves illustrate higher improvement percentages for Duloxetine compared to placebo across different pain improvement thresholds.*

FDA Label Image

Figure8 (Duloxetine Fig8)

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

FDA Label Image

Figure9 (Duloxetine Fig9)

A line graph comparing the percentage of patients improved with Duloxetine 60 mg once daily versus placebo. The x-axis shows percent improvement in pain from baseline (BOCF) ranging from >0 to 100%, and the y-axis shows the percentage of patients improved from 0 to 100%. Two lines represent treatment groups: Duloxetine with diamond markers and placebo with cross markers. The graph shows Duloxetine generally having a higher percentage of patient improvement across pain improvement levels.*

FDA Label Image

Structure (Duloxetine Structure)

Chemical structure diagram of Duloxetine hydrochloride showing key molecular components including aromatic rings, a thiophene group, and a chiral center in the molecule.*

FDA Label Image

20 (Label 20mg)

Labels for Duloxetine DR Capsules, USP 20 mg, distributed by Hawaii RePACK, Inc., with quantities of 30, 60, 90, and 120 capsules. The label notes marketing by Ajanta Pharma USA Inc. and describes the capsules as white body color and blue cap color. Each label includes NDC numbers, a QR code, and storage instructions.*

FDA Label Image

30 (Label 30mg)

Label sheet for Duloxetine DR Capsules, USP 30 mg delayed-release oral capsules distributed by Hawaii Repack, Inc. Four separate labels are shown for quantities of 30, 60, 90, and 120 capsules. Each label includes NDC numbers, a barcode, distributor and marketer information, descriptive text about capsule appearance (blue body and blue cap), and storage instructions.*

FDA Label Image

40 (Label 40mg)

Label for Duloxetine DR Capsules USP 40 mg, delayed-release oral capsules. Distributed by Hawaii Repack, Inc. in Honolulu, Hawaii, and marketed by Ajanta Pharma USA Inc. The label includes multiple package sizes: 30, 60, 90, and 120 capsules. Describes the capsules as pink body with a blue cap. Contains caution and storage instructions, barcode, and QR code.*

FDA Label Image

60 (Label 60mg)

Four separate drug labels for Duloxetine DR Capsules, USP 60 mg, distributed by Hawaii Repack, Inc. Each label varies by quantity (30, 60, 90, 120 capsules) with NDC codes 85534-0018-0, 85534-0018-1, 85534-0018-2, and 85534-0018-3 respectively. They note marketing by Ajanta Pharma USA Inc. and describe the capsules as white body and blue cap.*

* 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.