Duloxetine Capsule, Delayed Release
Product Images NDC 71610-401

11 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 71610-401). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 20 mg (71610 0401 83)

Bottle Label 20 mg (71610 0401 83)
Label for Duloxetine DR, USP 20 mg delayed-release capsules. The label indicates a package size of 3600 capsules. It includes storage instructions and manufacturer information, stating the product is made by Aurobindo Pharma Limited, repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label also indicates the medication is Rx only.*
FDA Label Image

Bottle Label 30 mg (71610 0402 60)

Bottle Label 30 mg (71610 0402 60)
Label for Duloxetine DR, USP 30 mg delayed-release capsules containing 90 capsules. The label includes storage instructions for room temperature and controlled room temperature, as well as dispensing information. Manufactured by Aurobindo Pharma Limited, packaged by Aphena Pharma Solutions - Tennessee, LLC. The label includes barcode, NDC 71610-0402-60, batch number, and expiration date.*
FDA Label Image

Aphena Pharma Solutions (TN)

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)
Kaplan-Meier survival curve depicting the cumulative proportion of patients experiencing relapse over time in days from randomization, comparing Duloxetine treatment to placebo in a major depressive disorder study. The graph plots proportion of patients with relapse (y-axis) against time in days (x-axis) up to 250 days, showing separate curves for Duloxetine and placebo groups.*
FDA Label Image

Fig2 (Duloxetine Fig2)

Fig2 (Duloxetine Fig2)
A line graph comparing the time from randomization to relapse (in days) between Duloxetine and placebo treatment groups. The x-axis shows days, and the y-axis shows the proportion of patients with relapse. The Duloxetine group shows a lower proportion of relapse over time 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 line graph showing the percentage of patients achieving various levels of pain relief from baseline. The x-axis represents percent improvement in pain from 0 to 100, and the y-axis shows the percentage of patients improved. Four lines compare Duloxetine 60 mg BID, Duloxetine 60 mg QD, Duloxetine 20 mg QD, and placebo over the range.*
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)
Line graph showing the percentage of patients achieving various levels of pain relief from baseline, comparing Duloxetine 60 mg twice daily (BID), Duloxetine 60 mg once daily (QD), and placebo. The x-axis represents percent improvement in pain, and the y-axis shows the percentage of patients improved. Duloxetine treatments show higher percentages of patient improvement than placebo across pain relief levels.*
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 measured by 24-hour average pain severity change from baseline. It compares duloxetine 60 mg/120 mg once daily with placebo across increasing levels of percent improvement in pain from >0 to 100%. Duloxetine shows a consistently higher percentage of patients improved at most levels compared to placebo.*
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 graph showing the percentage of patients achieving various levels of pain relief based on percent improvement from baseline, comparing Duloxetine 60 mg once daily versus placebo. The vertical axis indicates the percentage of patients improved, while the horizontal axis shows increasing thresholds of percent improvement in pain. Duloxetine consistently shows higher patient improvement percentages across the pain relief 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 chart titled 'Percentage of Patients Achieving Various Levels of Pain Relief as Measured by 24-Hour Average Pain Severity' compares the percentage of patients improved against percent improvement in pain from baseline. It shows two data series: placebo and duloxetine 60 mg/120 mg once daily, with duloxetine consistently showing higher percentages of patient improvement across pain relief levels.*
FDA Label Image

Structure (Duloxetine Str)

Structure (Duloxetine Str)
Chemical structure of Duloxetine Hydrochloride, showing the molecular arrangement including a naphthyl group, a thiophene ring, and an amine group bound to hydrochloride.*

* 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.