Duloxetine Capsule, Delayed Release Pellets
Product Images NDC 51991-747

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 51991-747). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Breckenridge Pharmaceutical, 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

Chemical Structure (Duloxetine 01)

FDA Label Image

Figure 1 (Duloxetine 02)

Figure 1 (Duloxetine 02)
The graph shows the proportion of patients who experienced relapse over time after being randomized for treatment with either placebo or duloxetine delayed-release. The x-axis represents the time in days from randomization to relapse, while the y-axis shows the proportion of patients. The line for duloxetine delayed-release is lower, indicating a lower proportion of patients experienced relapse compared to placebo.*
FDA Label Image

Figure 2 (Duloxetine 03)

Figure 2 (Duloxetine 03)
The text describes a graph that shows the proportion of patients with relapse over time from randomization. The graph compares the placebo group to the group taking duloxetine delayed-release capsules. The x-axis is labeled as "Time from Randomization to Relapse (Days)" with intervals of 50. The y-axis shows the proportion of patients with relapse with intervals of 0.02 from 0 to 0.1.*
FDA Label Image

Figure 3 (Duloxetine 04)

FDA Label Image

Figure 4 (Duloxetine 05)

FDA Label Image

Figure 5 (Duloxetine 06)

FDA Label Image

Figure 6 (Duloxetine 07)

FDA Label Image

Figure 8 (Duloxetine 08)

Figure 8 (Duloxetine 08)
The text describes a graph showing the percentage of patients who improved based on a placebo and Duloxetine (DUL) dosage of 60/120 mg per day. The x-axis displays the percentage of improvement in pain from baseline on a scale of 0 to 100. The y-axis displays the percentage of patients improved on a scale of 50 to 80 for both the placebo and DUL medications.*
FDA Label Image

Figure 9 (Duloxetine 09)

Figure 9 (Duloxetine 09)
This is a chart displaying the percentage of patients who have improved after taking either placebo or DUL 60 mg once daily. The numbers on the left represent the percentage of improvement while the numbers on the bottom represent the dosage or treatment. The chart also displays the percentage improvement in pain from the baseline using the "BOCF" method.*
FDA Label Image

Figure 10 (Duloxetine 10)

Figure 10 (Duloxetine 10)
The chart shows the percentage of patients improved in a clinical trial. The vertical axis represents the percentage of improvement in pain from baseline, and the horizontal axis shows the different treatments (placebo, DULB0/120 mg once daily). There is a significant improvement in pain for patients who received DULB0/120 mg once daily compared to the placebo group. The text "faga" and the numbers at the bottom are not meaningful.*
FDA Label Image

Principal Display Panel (20 mg Capsule Bottle Label)

Principal Display Panel (20 mg Capsule Bottle Label)
Each capsule of this medication contains 22.4 mg of duloxetine hydrochloride USP which is equal to 20 mg duloxetine. The recommended storage temperature is 25°C (77° Fahrenheit) with excursions allowed to 15-30°C (59-86°F). It's suggested to refer to accompanying literature regarding dosage. The delayed-release capsules are available in a container holding 90 capsules. The medication guide should be provided separately to each patient dispensed by the pharmacist. The medicine should be kept in a tightly closed container and out of reach of children. This medication is manufactured in Spain by Towa Pharmaceutical Europe, SL and distributed in the US by Breckenridge Pharmaceutical, Inc. The text contains a Datamatrix code and other information about manufacturing batches and expiry date.*
FDA Label Image

Principal Display Panel (30 mg Capsule Bottle Label)

Principal Display Panel (30 mg Capsule Bottle Label)
Each capsule contains 33.7 mg of duloxetine hydrochloride USP equivalent to 30 mg duloxetine. The medication needs to be stored at room temperature, and the accompanying literature should be consulted for dosage. The medication should be kept in a tightly closed container, out of the reach of children. The label includes information on NDC number and manufacturing company. The product should be dispensed with a medication guide, and the provided space may be used for printing batch and expiration information.*
FDA Label Image

Principal Display Panel (60 mg Capsule Bottle Label)

FDA Label Image

Principal Display Panel (40 mg Capsule Bottle Label)

Principal Display Panel (40 mg Capsule Bottle Label)
This is a medication product that comes in capsules containing 44.9 mg of Duloxetine hydrochloride USP, equivalent to 10-40 mg of Duloxetine. The medication should be stored at temperatures between 15-30 °C (59-86°F). Patients are provided with a guide for dosage which is separate from the medication. It is important to dispense the medication in a tightly closed container and keep it out of reach of children. The manufacturer is Towa Pharmaceutical Europe, S.L. located in Martorell (Barcelona), Spain, while the distributor is Breckenridge Pharmaceutical, Inc. located in Berlin, Connecticut. The product was produced in July 2013 and has an expiration date of September 2020.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.