Duloxetine
Product Images NDC 43353-106

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 43353-106). 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

Label Graphic- 60mg 30s (43353 0025 30)

Label for Duloxetine HCl Delayed-Release (DR) USP capsules, 60 mg strength, in a package of 30 capsules. Label includes storage instructions, manufacturer listed as Laboratorios Dr. Esteve, S.A., Spain, and repackager Aphena Pharma Solutions - Tennessee, LLC. Marked for RX use only.*

FDA Label Image

Label Graphic- 20mg 3600s (43353 0106 83)

Label for Duloxetine HCl DR USP capsules, 20 mg strength, containing 3600 capsules. The label indicates the product is manufactured by Laboratorios Dr. Esteve, S.A. in Barcelona, Spain, and repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, Tennessee. Storage instructions note to store between 20-25 degrees Celsius, with usage limited to prescription only (Rx Only).*

FDA Label Image

Label Graphic- 30mg 30s (43353 0960 30)

Label for Duloxetine HCl Delayed-Release USP 30 mg capsules featuring 30 capsules per container. The label includes storage instructions, manufacturer information as Laboratorios Dr. Esteve, S.A. in Martorelles (Barcelona), Spain, and repackager Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN 38506. The label also notes the product is RX only and shows the NDC number 43353-0960-30.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Figure 1 (Duloxetine 02)

A line graph showing the percentage of patients improved plotted against percent improvement in pain from baseline for Duloxetine Delayed-Release. Four groups are compared: CYM 60mg BID, CYM 60mg QD, CYM 20mg QD, and placebo, with CYM 60mg doses showing higher improvement percentages than placebo across the pain improvement spectrum.*

FDA Label Image

Figure 2 (Duloxetine 03)

A line graph displaying percentages of patients improved against percent improvement in pain from baseline. It compares three groups labeled CYM 60mg BID, CYM 60mg QD, and Placebo across increasing thresholds of pain improvement from over 0% to 100%.*

FDA Label Image

Figure 3 (Duloxetine 04)

A line graph comparing the percentage of patients improved in pain from baseline (BOCF) for two groups: Placebo and CYM60/120 mg once daily. The x-axis shows percent improvement in pain (0 to 100%), and the y-axis shows the percentage of patients improved (0 to 100%). The plot shows higher patient improvement rates for CYM60/120 mg once daily compared to placebo across various pain improvement thresholds.*

FDA Label Image

Figure 4 (Duloxetine 05)

A line graph showing the percentage of patients improved versus percent improvement in pain from baseline (BOCF). It compares two groups: Placebo and CYM60 mg once daily, with the latter showing higher percentages of patients improved across increasing pain improvement percentages.*

FDA Label Image

Figure 5 (Duloxetine 06)

A line graph comparing the percentage of patients improved with placebo versus CYM60/120 mg once daily. The x-axis represents percent improvement in pain from baseline, and the y-axis shows the percentage of patients improved. Two lines illustrate patient response rates at various improvement thresholds.*

FDA Label Image

Chemical Structure (Image 01)

Chemical structure of duloxetine hydrochloride, showing its fused bicyclic and thiophene rings attached to an amine group with hydrochloride salt.*

* 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.