Duloxetine Capsule, Delayed Release
Product Images NDC 27241-164

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 27241-164). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ajanta Pharma Usa 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

Duloxetine 20mg

Label for Duloxetine Delayed-Release Capsules 20 mg by Ajanta Pharma USA Inc. The label shows a package size of 60 capsules with each capsule containing enteric-coated pellets equivalent to 20 mg Duloxetine. It includes storage instructions, an NDC number (27241-097-06), and the statement Rx Only. The capsules are oral dosage form, made in India, and the labeler is based in NJ, USA.*

FDA Label Image

Duloxetine 30mg

Label for Duloxetine Delayed-Release Capsules 30 mg by Ajanta Pharma USA Inc. The label indicates the bottle contains 30 capsules and includes the drug name, strength, and dosage form. It features storage instructions, packaging details, NDC 27241-098-03, and a barcode. The label specifies dispensing instructions for pharmacists and mentions the product is made in India.*

FDA Label Image

Duloxetine 40mg

Label for Duloxetine Delayed-Release Capsules 40 mg, containing 30 capsules per container. The label indicates enteric-coated pellets equivalent to 40 mg Duloxetine Hydrochloride USP per capsule. Manufactured by Ajanta Pharma Limited and marketed by Ajanta Pharma USA Inc. The label includes instructions for pharmacists, storage conditions, and a barcode.*

FDA Label Image

Duloxetine 60mg

Label for Duloxetine Delayed-Release Capsules 60 mg, containing 30 capsules per container. The label includes prescription-only designation, directions for pharmacists to dispense accompanying medication guides, and identifies Ajanta Pharma USA Inc. as the marketer. Storage and usage instructions are also provided, with the product made in India.*

FDA Label Image

Duloxetine Fig1

A Kaplan-Meier curve showing the proportion of patients with relapse over time from randomization (in days) comparing Duloxetine treatment to placebo. The graph indicates relapse rates on the y-axis and days on the x-axis, with separate lines for Duloxetine and placebo groups.*

FDA Label Image

Duloxetine Fig10

A line graph comparing the percentage of patients improved for Duloxetine 60/120 mg once daily versus placebo. The x-axis displays percent improvement in pain from baseline (BOCF) from >0 to 100, while the y-axis shows the percentage of patients improved from 0 to 100. Two lines represent Duloxetine and placebo, with Duloxetine generally showing higher patient improvement percentages across pain improvement levels.*

FDA Label Image

Duloxetine Fig2

A Kaplan-Meier plot showing the proportion of patients with relapse over time from randomization to relapse (in days). The plot compares two treatments: Duloxetine and placebo. The Duloxetine group shows a consistently lower proportion of patients with relapse over approximately 250 days compared to the placebo group.*

FDA Label Image

Duloxetine Fig3

A line graph depicting percent improvement in pain from baseline (x-axis) versus percentage of patients improved (y-axis) for Duloxetine at various dosages (60 mg BID, 60 mg QD, 20 mg QD) compared to placebo. The graph shows trends in patient improvement across different pain improvement thresholds.*

FDA Label Image

Duloxetine Fig4

A line graph depicting the percentage of patients improved versus percent improvement in pain from baseline comparing Duloxetine 60 mg BID, Duloxetine 60 mg QD, and placebo groups. The vertical axis shows the percentage of patients improved, ranging from 0% to 100%. The horizontal axis represents percent improvement in pain from baseline, also from 0% to 100%. Data lines show higher patient improvement percentages for Duloxetine groups compared to placebo as pain improvement increases.*

FDA Label Image

Duloxetine Fig5

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine 60mg twice daily, Duloxetine 60mg once daily, and placebo. The graph shows three distinct lines representing the two Duloxetine dosing regimens and placebo, with the X-axis labeled as percent improvement in pain and the Y-axis as percentage of patients improved.*

FDA Label Image

Duloxetine Fig6

A line graph depicting the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine at 20 mg, 60 mg, and 120 mg once daily doses compared to placebo. The y-axis represents the percentage of patients improved, and the x-axis shows increasing thresholds of percent pain improvement from baseline. Duloxetine lines show higher patient improvement than placebo across all thresholds.*

FDA Label Image

Duloxetine Fig8

A line graph comparing the percentage of patients improved in pain from baseline (BOCF) between placebo and Duloxetine 60/120 mg once daily. The x-axis represents percent improvement in pain from baseline, ranging from greater than 0 to 100%, and the y-axis shows the percentage of patients improved, ranging from 0 to 100%. Two lines are plotted: one for placebo with a lower percentage of improvement, and a higher line for Duloxetine indicating greater patient improvement across pain reduction levels.*

FDA Label Image

Duloxetine Fig9

A line graph comparing the percentage of patients improved with Duloxetine 60 mg once daily versus placebo. The x-axis represents percent improvement in pain from baseline, and the y-axis shows the percentage of patients improved. Duloxetine consistently shows a higher percentage of patients improved across different improvement thresholds compared to placebo.*

FDA Label Image

Duloxetine-structure (Duloxetine Structure)

Chemical structure diagram of duloxetine hydrochloride, showing the molecular arrangement including a naphthalene group, thiophene ring, and hydrochloride (HCl) moiety.*

* 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.