Duloxetine Hydrochloride
Product Images NDC 50436-2996

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Duloxetine Hydrochloride (NDC 50436-2996). 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.jpg (Figure1)

A Kaplan-Meier plot showing the proportion of patients experiencing relapse over time in days from randomization for three groups: Treatment, Placebo, and Duloxetine. The vertical axis represents the proportion of patients with relapse, while the horizontal axis shows days up to 200. The graph compares relapse rates among the groups over the study period.*

FDA Label Image

Figure2.jpg (Figure2)

A line graph comparing the proportion of patients with relapse over time, from randomization up to approximately 270 days, between Duloxetine and Placebo treatments. The x-axis represents time in days, and the y-axis shows the proportion of patients with relapse. The graph illustrates a lower relapse proportion for Duloxetine compared to Placebo.*

FDA Label Image

Figure3.jpg (Figure3)

A line chart depicting the percent of patients improved versus percent improvement in pain from baseline for Duloxetine Hydrochloride at dosages 60mg BID, 60mg QD, 20mg QD, and placebo. The graph compares the efficacy of these treatments in pain improvement, with lines representing different dosages and placebo over a range of 0% to 100% improvement.*

FDA Label Image

Figure4.jpg (Figure4)

A line graph depicting the percentage of patients improved versus the percent improvement in pain from baseline. The graph compares three groups: Duloxetine 60mg BID, Duloxetine 60mg QD, and placebo, showing a higher percentage of patients improved with Duloxetine treatments compared to placebo across various pain improvement levels.*

FDA Label Image

Figure5.jpg (Figure5)

A line graph comparing percent improvement in pain from baseline between placebo and Duloxetine 60/120 mg once daily. The x-axis shows percent improvement in pain from 0 to 100, and the y-axis shows percent of patients improved from 0 to 100. The Duloxetine group consistently shows higher percent of patients improved across the range compared to placebo.*

FDA Label Image

Figure6.jpg (Figure6)

A line graph comparing the percent of patients improved against percent improvement in pain from baseline (BOCF) for Duloxetine Hydrochloride 60 mg once daily versus placebo. The graph shows two lines, one representing placebo and the other Duloxetine, with Duloxetine exhibiting higher patient improvement percentages across various pain improvement thresholds.*

FDA Label Image

Figure7.jpg (Figure7)

A line graph comparing percent improvement in pain from baseline (BOCF) on the horizontal axis with percent of patients improved on the vertical axis. Two lines represent patient groups: one receiving a placebo and the other receiving Duloxetine 60/120 mg once daily. Data points show trends of pain improvement percentages versus patient response rates.*

FDA Label Image

Dulostructure (Dulostructure)

Chemical structure of Duloxetine Hydrochloride showing its molecular arrangement including aromatic rings, oxygen, sulfur atoms, and the hydrochloride salt portion. The structure represents the active ingredient Duloxetine Hydrochloride as labeled.*

FDA Label Image

Label Image (Lbl504362995)

The label for Duloxetine Hydrochloride delayed-release capsules, 20 mg strength, containing 60 capsules per bottle. The label includes the National Drug Code (NDC) 50436-2995-2 and specifies the active ingredient amount as 22.5 mg of Duloxetine Hydrochloride equivalent to 20 mg Duloxetine. Manufactured by Apotex Inc., Ontario, Canada, with packaging by Unit Dose Services in Lewisville, Texas. The label features storage instructions, warnings, lot and expiration placeholders, and a QR code.*

FDA Label Image

Label Image (Lbl504362996)

Duloxetine Hydrochloride delayed-release capsules, 30 mg strength, packaged in a 30-count format. The label indicates the product is manufactured by Apotex Inc., Toronto, Ontario, Canada, with an NDC of 50436-2996-1. It includes storage instructions and a warning to keep out of reach of children. The packaging specifies the capsules are unit dose packages labeled for prescription use only.*

FDA Label Image

Label Image (Lbl504362997)

Duloxetine Hydrochloride Delayed-Release 60 mg capsules in a 30-count unit dose package by Unit Dose Services. The label includes NDC 50436-2997-1 and manufacturing details from Apotex Inc., Toronto, Ontario Canada. Each capsule contains 67.4 mg duloxetine hydrochloride equivalent to 60 mg duloxetine. Storage instructions specify 20-25°C controlled room temperature.*

* 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.