Duloxetine Capsule, Delayed Release
Product Images NDC 63187-666

9 FDA label images from Proficient Rx Lp · 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 (NDC 63187-666). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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

Figure 1: Kaplan-meier Estimation Of Cumulative Proportion Of Patients With Relapse (mdd Study 5) (Duloxetine Fig1)

Figure 1: Kaplan-meier Estimation Of Cumulative Proportion Of Patients With Relapse (mdd Study 5) (Duloxetine Fig1)
A Kaplan-Meier plot showing the cumulative proportion of patients experiencing relapse over time in days, comparing placebo and Duloxetine treatments for MDD Study 5. The Y-axis represents the proportion of patients with relapse, and the X-axis represents time from randomization to relapse in days. Duloxetine shows a lower relapse proportion than placebo over approximately 200 days.*
FDA Label Image

63187-666-30 (Duloxetine Fig10)

63187-666-30 (Duloxetine Fig10)
Label for Duloxetine 60 mg delayed-release capsules, quantity 30, labeled RX Only. The capsule contains 67.3 mg duloxetine hydrochloride USP equivalent to 60 mg duloxetine. Capsules are blue and green opaque hard gelatin size 1, with white to off-white pellets inside, imprinted with 'X' on the blue cap and '03' on the green body in black ink. Distributed by Citron Pharma LLC and packaged by Proficient Rx LP.*
FDA Label Image

Figure 2: Kaplan-meier Estimation Of Cumulative Proportion Of Patients With Relapse (gad Study 4) (Duloxetine Fig2)

Figure 2: Kaplan-meier Estimation Of Cumulative Proportion Of Patients With Relapse (gad Study 4) (Duloxetine Fig2)
Kaplan-Meier curve showing the cumulative proportion of patients with relapse over time in days from randomization. The graph compares two treatments: placebo, represented by a dashed line, and duloxetine, represented by a solid line. The y-axis measures the proportion of patients with relapse, ranging from 0.0 to 1.0, indicating that the duloxetine group had a lower relapse rate over the study period compared to placebo.*
FDA Label Image

Figure 3: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity (DPNP-1)

Figure 3: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity (DPNP-1)
A chart showing the percentage of patients achieving various levels of pain relief measured by 24-hour average pain severity. The graph compares Duloxetine 60 mg given twice daily (BID), once daily (QD), another 60 mg QD regimen, and a placebo across a range of percent improvement in pain from baseline.*
FDA Label Image

Figure 4: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity (DPNP-2)

Figure 4: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity (DPNP-2)
A line graph depicting the percentage of patients achieving various levels of pain relief according to percent improvement in pain from baseline. The graph compares Duloxetine 60 mg B ID, Duloxetine 60 mg QD, and placebo groups, showing the percentage of patients improved on the y-axis and percent improvement in pain on the x-axis, with Duloxetine groups generally showing higher improvement percentages than placebo.*
FDA Label Image

Figure 7: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity – Clbp-1 (Duloxetine Fig5)

Figure 7: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity – Clbp-1 (Duloxetine Fig5)
A line graph showing the percentage of patients achieving various levels of pain relief based on percent improvement in pain from baseline (BOCF). It compares duloxetine 60 mg/120 mg once daily versus placebo, with the y-axis representing the percentage of patients improved and the x-axis representing percent improvement in pain from >0 to 100%.*
FDA Label Image

Figure 8: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity – Clbp-3 (Duloxetine Fig6)

Figure 8: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity – Clbp-3 (Duloxetine Fig6)
A line chart comparing the percentage of patients achieving various levels of pain relief from baseline. The x-axis represents percent improvement in pain, and the y-axis shows the percentage of patients improved. Two lines compare Duloxetine 60 mg once daily against placebo, illustrating higher improvement percentages for Duloxetine across most levels.*
FDA Label Image

Figure 9: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity – Oa-1 (Duloxetine Fig7)

Figure 9: Percentage Of Patients Achieving Various Levels Of Pain Relief As Measured By 24-hour Average Pain Severity – Oa-1 (Duloxetine Fig7)
A line graph showing the percentage of patients achieving various levels of pain relief measured by 24-hour average pain severity. It compares placebo and Duloxetine 60 mg/120 mg once daily groups across percent improvement in pain from baseline (0-100%). The Duloxetine group generally shows higher percentages of patients with pain improvement compared to placebo.*
FDA Label Image

Structure (Duloxetine Str)

Structure (Duloxetine Str)
Chemical structure of Duloxetine Hydrochloride showing its molecular configuration including aromatic rings and functional groups.*

* 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.