Duloxetine
Product Images NDC 69097-297

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 69097-297). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla 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

Drug (F0da0b67 54e8 43d2 B116 Db3152e885d0 01)

Chemical structure diagram of duloxetine hydrochloride, showing its molecular arrangement including a naphthalene moiety, a thiophene ring, and an amine group with hydrochloride.*

FDA Label Image

Figure-1 (F0da0b67 54e8 43d2 B116 Db3152e885d0 02)

A line graph depicting the proportion of patients with relapse over time from randomization to relapse in days. Two treatment groups are compared: placebo and duloxetine, showing different relapse rates across approximately 0 to 200 days.*

FDA Label Image

Figure-2 (F0da0b67 54e8 43d2 B116 Db3152e885d0 03)

A Kaplan-Meier curve chart comparing the proportion of patients with relapse over time (days) between duloxetine and placebo treatments. The x-axis represents time from randomization to relapse, and the y-axis represents the proportion of patients with relapse. The duloxetine group shows a lower relapse proportion compared to placebo over the observed period.*

FDA Label Image

Figure-3 (F0da0b67 54e8 43d2 B116 Db3152e885d0 04)

A line graph showing the percentage of patients improved plotted against the percent improvement in pain from baseline. The graph compares four groups: Duloxetine 60 mg BID, Duloxetine 60 mg QD, Duloxetine 20 mg QD, and placebo. The y-axis ranges from 0 to 100 percent of patients improved, and the x-axis ranges from 0 to 100 percent improvement in pain from baseline. Vertical dashed lines mark 30 percent and 50 percent improvement thresholds. Duloxetine groups consistently show higher patient improvement percentages than placebo across all pain improvement levels.*

FDA Label Image

Figure-4 (F0da0b67 54e8 43d2 B116 Db3152e885d0 05)

A line graph comparing the percentage of patients improved against percent improvement in pain from baseline for duloxetine 60 mg BID, duloxetine 60 mg QD, and placebo. The X-axis represents percent improvement in pain, and the Y-axis shows the percentage of patients improved. Three lines plot data for duloxetine twice daily, once daily, and placebo, with notable vertical dashed lines at approximately 30% and 50% pain improvement marks.*

FDA Label Image

Figure-5 (F0da0b67 54e8 43d2 B116 Db3152e885d0 06)

A line graph comparing the percentage of patients improved with duloxetine 60/120 mg once daily versus placebo. The x-axis shows percent improvement in pain from baseline (BOCF) and the y-axis shows the percentage of patients improved. Duloxetine consistently shows a higher percentage of patients improved across increasing levels of pain improvement compared to placebo.*

FDA Label Image

Figure-6 (F0da0b67 54e8 43d2 B116 Db3152e885d0 07)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BOCF). It shows two curves: one for Placebo and one for Duloxetine 60/120 mg once daily, depicting patient improvement across increasing pain improvement percentages.*

FDA Label Image

Figure-7 (F0da0b67 54e8 43d2 B116 Db3152e885d0 08)

A line graph comparing the percentage of patients improved versus percent improvement in pain from baseline (BOCF) for duloxetine (DULO 60/120 mg once daily) and placebo. The x-axis shows percent improvement in pain, and the y-axis shows the percentage of patients improved. The graph includes two lines: one for placebo and one for duloxetine doses, showing higher patient improvement percentages with duloxetine overall.*

FDA Label Image

20mg (F0da0b67 54e8 43d2 B116 Db3152e885d0 09)

Label for Duloxetine delayed-release capsules, USP 20 mg with 60 capsules per container. The label states the active quantity, manufacturer details (Inventia Healthcare Private Limited, India), and distributor Cipla USA Inc., Miami, FL. It includes storage instructions, a barcode with pharma code, and a note for pharmacists to dispense the medication guide.*

FDA Label Image

30mg (F0da0b67 54e8 43d2 B116 Db3152e885d0 10)

Label of Duloxetine delayed-release capsules, USP 30 mg by Cipla USA Inc. The label shows the product name and strength prominently with a capsule image, directions to dispense a Medication Guide, package count of 30 capsules, and detailed drug information including dosage form and storage instructions. There are two barcodes and manufacturing details including an address in Miami, FL.*

FDA Label Image

60mg (F0da0b67 54e8 43d2 B116 Db3152e885d0 11)

Label for Duloxetine Delayed-Release Capsules, USP 60 mg by Cipla USA Inc. The label includes strength (60 mg), formulation type (delayed-release capsules), quantity (30 capsules), and manufacturer information. It also features storage instructions, a barcode, and the NDC number 69097-299-02. The label uses black, red, and a special blue color on a white background with a designated space for lot and expiration dates.*

* 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.