Duloxetine Capsule, Delayed Release Pellets
Product Images NDC 85534-0050

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 85534-0050). 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

1 (Image 1)

Chemical structure diagram of Duloxetine, an active pharmaceutical ingredient shown as a 2D molecular formula. The diagram depicts atoms and their bonds arranged in the characteristic structure of Duloxetine.*

FDA Label Image

Figure6 (Image 10)

A line graph showing 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 compared to placebo. The graph shows decreasing patient improvement percentages as pain improvement increases across all treatment groups.*

FDA Label Image

Figure 7 (Image 11)

A line graph comparing the percentage of patients improved against percent improvement in pain from baseline. It shows two lines: one for Duloxetine Delayed-Release 60 mg once daily and one for placebo, illustrating greater patient improvement with Duloxetine across different pain improvement thresholds.*

FDA Label Image

Figure8 (Image 12)

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

FDA Label Image

Figure9 (Image 13)

A line graph comparing the percentage of patients improved over percent improvement in pain from baseline for Duloxetine Delayed-Release 60 mg once daily versus placebo. The x-axis represents percent improvement in pain, and the y-axis shows the percentage of patients improved. Duloxetine shows a higher percentage of patients improved across the range compared to placebo.*

FDA Label Image

Figure10 (Image 14)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BOCF). It shows two lines: one for placebo and one for Duloxetine delayed-release capsules 60/120 mg once daily, indicating higher patient improvement percentages for Duloxetine across various pain improvement thresholds.*

FDA Label Image

1 (Image 15)

The image shows a medication blister pack labeled Duloxetine delayed-release capsules available in 60 mg strength. The capsules contain delayed release pellets and are intended for oral use. The labeler is Hawaii Repack, Inc. The blister pack features typical individual compartments for each capsule.*

FDA Label Image

1 (Image 16)

Chemical structure of Duloxetine, showing its molecular arrangement as presented in the image.*

FDA Label Image

1 (Image 17)

Instructional diagram showing how to open a blister card by peeling back the foil to access capsules.*

FDA Label Image

1 (Image 2)

The label for Duloxetine delayed release pellets capsules, available in 20 mg, 30 mg, and 60 mg strengths, oral route. The packaging is labeled by Hawaii Repack, Inc. The label includes generic and proprietary names and mentions the capsule dosage form with delayed release pellets inside.*

FDA Label Image

1 (Image 3)

Duloxetine delayed release capsules in a foil blister pack with 10 capsules visible. The packaging is labeled by Hawaii Repack, Inc. The image does not specify strength but shows a single blister containing 10 oral capsules.*

FDA Label Image

1 (Image 4)

Chemical structure diagram of duloxetine showing its molecular framework, including aromatic rings, a thiolethyl group, and a secondary amine hydrochloride component, consistent with the active pharmaceutical ingredient duloxetine.*

FDA Label Image

Figure1 (Image 5)

A Kaplan-Meier curve graph showing the proportion of patients with relapse over time in days from randomization, comparing Duloxetine delayed-release capsules to placebo. The X-axis represents time in days up to 250, and the Y-axis shows the proportion of patients with relapse from 0.0 to 1.0. The graph depicts two lines: a solid line for Duloxetine and a dashed line for placebo, illustrating relapse rate differences over time.*

FDA Label Image

Figure2 (Image 6)

A Kaplan-Meier survival curve comparing relapse proportions over time between Duloxetine delayed-release capsules and placebo. The x-axis shows time from randomization to relapse in days (0 to 300), and the y-axis represents the proportion of patients with relapse (0 to 1). The graph includes lines for Duloxetine and placebo treatments, illustrating relapse progression rates for each group.*

FDA Label Image

Figure3 (Image 7)

A line graph depicting the percentage of patients improved versus percent improvement in pain from baseline. Four curves represent different groups: Duloxetine 60mg twice daily (BID), Duloxetine 60mg once daily (QD), Duloxetine 20mg once daily (QD), and Placebo. The y-axis shows the percentage of patients improved, and the x-axis shows percent improvement in pain from baseline, ranging from 0 to 100%.*

FDA Label Image

Figure4 (Image 8)

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine 60 mg BID, Duloxetine 60 mg QD, and placebo. The graph illustrates comparative effectiveness, with Duloxetine dosing regimens showing higher patient improvement percentages across pain improvement levels compared to placebo.*

FDA Label Image

Figure5 (Image 9)

A line chart comparing the 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 y-axis shows percentage of patients improved from 0 to 100, and the x-axis shows increasing percent improvement in pain from baseline ranging from >0 to 100.*

FDA Label Image

20 (Label 20mg)

Package labels for Duloxetine DR Capsules, USP 20mg, distributed by Hawaii RePack, Inc. The labels display quantities of 30, 60, 90, and 120 capsules. Each label shows NDC 85534-0050 with different suffixes for each quantity, and describes the product as blue opaque delayed-release capsules manufactured for Teva Pharmaceuticals. Labels include dose form, drug status RX, distributor address in Honolulu, HI, and barcode and QR codes.*

FDA Label Image

30 (Label 30mg)

The image shows repackaged distribution labels for Duloxetine DR Capsules, USP 30 mg, distributed by HAWAII RePACK, INC located in Honolulu, HI. The labels specify quantities of 30, 60, 90, and 120 capsules. Manufactured for Teva Pharmaceuticals, capsules are described as gray and blue. Each label includes NDC numbers and storage instructions to keep at 20-25°C (68-77°F).*

FDA Label Image

60 (Label 60mg)

The image shows repackaged labels for Duloxetine DR Capsules, USP 60 mg, distributed by Hawaii Repack, Inc. Each label includes the NDC, quantity (30, 60, 90, and 120 counts), and notes that the capsules have a gray body and white top, are delayed-release, and manufactured for Teva Pharmaceuticals. Storage instructions and prescription drug status are also included.*

* 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.