Duloxetine Capsule, Delayed Release
Product Images NDC 80425-0441

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Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 80425-0441). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Advanced Rx Of 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

Structure (69d6387b 794f 415d 8013 23cca0a6984f 01)

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Figure 1 (69d6387b 794f 415d 8013 23cca0a6984f 02)

Figure 1 (69d6387b 794f 415d 8013 23cca0a6984f 02)
This text seems to display a chart showing the proportion of patients with relapse over time for both the placebo and duloxetine treatment. The x-axis represents the time from randomization to relapse in days, while the y-axis shows the proportion of patients. The data appears to be analyzed using the Kaplan-Meier estimator method.*
FDA Label Image

Figure 2 (69d6387b 794f 415d 8013 23cca0a6984f 03)

Figure 2 (69d6387b 794f 415d 8013 23cca0a6984f 03)
This text presents data on the proportion of patients experiencing a relapse over time, comparing a placebo treatment to duloxetine. The graph indicates the time from randomization to relapse in days using the Kaplan-Meier estimator method. The number of patients experiencing relapse decreases over time, with a notable distinction between the placebo and duloxetine groups.*
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Figure 1 (69d6387b 794f 415d 8013 23cca0a6984f 04)

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Figure 2 (69d6387b 794f 415d 8013 23cca0a6984f 05)

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Fig 5 (69d6387b 794f 415d 8013 23cca0a6984f 06)

Fig 5 (69d6387b 794f 415d 8013 23cca0a6984f 06)
Percentage of Patients Improved in pain levels with different dosages of Duloxetine (60 mg Twice Daily and 60 mg Once Daily) compared to Placebo treatment. The chart shows the percentage of improvements in pain levels from Baseline for each treatment option.*
FDA Label Image

Fig 6 (69d6387b 794f 415d 8013 23cca0a6984f 07)

Fig 6 (69d6387b 794f 415d 8013 23cca0a6984f 07)
This text provides information on the percentage of patients improved with different doses of Duloxetine and Placebo. The data shows the percentage improvement in pain from baseline with Duloxetine 120 mg twice daily, Duloxetine 60 mg once daily, and Placebo. The chart included in the text indicates the level of improvement for each treatment option.*
FDA Label Image

Fig 7 (69d6387b 794f 415d 8013 23cca0a6984f 08)

Fig 7 (69d6387b 794f 415d 8013 23cca0a6984f 08)
This is a description of the results from a study (Study FM-4) evaluating the percentage of pediatric patients aged 13 to 17 years old with Juvenile Fibromyalgia Syndrome achieving various levels of pain relief at week 12. The study compared the effects of Duloxetine 60mg once daily versus a placebo. The pain relief was measured using the Average Pain Score from the Brief Pain Inventory - Modified short Form: Adolescent Version. Duloxetine-treated patients began with 30mg once daily for 1 week, then titrated to 60mg once daily for 12 weeks as tolerated. The study presents the percentage of patients who experienced improvement in pain, with a range from 0 to 100%.*
FDA Label Image

Figure 8 (69d6387b 794f 415d 8013 23cca0a6984f 09)

Figure 8 (69d6387b 794f 415d 8013 23cca0a6984f 09)
This text provides information on the percentage of patients improved when comparing a placebo to duloxetine 60/120 mg taken once daily. It also includes a graph showing the percent improvement in pain from the baseline.*
FDA Label Image

Figure 9 (69d6387b 794f 415d 8013 23cca0a6984f 10)

Figure 9 (69d6387b 794f 415d 8013 23cca0a6984f 10)
This text provides information on the percentage of patients who showed improvement when treated with Duloxetine 60 mg compared to a placebo. The graph illustrates the percent improvement in pain from baseline using the Last Observation Carried Forward (BOCF) method.*
FDA Label Image

Figure 10 (69d6387b 794f 415d 8013 23cca0a6984f 11)

Figure 10 (69d6387b 794f 415d 8013 23cca0a6984f 11)
Percentage of Patients Improved in a clinical study comparing a placebo with Duloxetine 60/120 mg given once daily. The chart shows the percent improvement in pain from baseline using the BOCF method. Duloxetine showed an 100% improvement, while the placebo showed unknown improvement.*
FDA Label Image

Duloxetine 60mg #30 (Duloxetine HCl Dr 60mg 80425 0389 01)

Duloxetine 60mg #30 (Duloxetine HCl Dr 60mg 80425 0389 01)
This is a description of a prescription medication of DULOXETINE HCL DR 60MG CAPSULE, with a quantity of 30 capsules in the package. The lot number is XX0OOK and it expires on 9/30/2035. This medication is manufactured by Lupin Pharmaceuticals.*
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Duloxetine 60mg #60 (Duloxetine HCl Dr 60mg 80425 0389 02)

Duloxetine 60mg #60 (Duloxetine HCl Dr 60mg 80425 0389 02)
This is a prescription label for DULOXETINE HCL DR 60MG CAPSULE. The medication comes in a quantity of 60 capsules with a lot number XX00O0KK and expiration date 9/30/2025. The pharmacy listed is R S Lupn PHARMACY and the National Drug Code (NDC) is 000000235632.*
FDA Label Image

Duloxetine 60mg # 90 (Duloxetine HCl Dr 60mg 80425 0389 03)

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