Duloxetine Capsule, Delayed Release
Product Images NDC 59651-280

16 FDA label images from Aurobindo Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Duloxetine (NDC 59651-280). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure 1: Kaplan-meier Estimation Of Cumulative Proportion Of Patients With Relapse (mdd Study 5) (Duloxetine Fig1)

Figure 1: Kaplan-meier Estimation Of Cumulative Proportion Of Patients With Relapse (mdd Study 5) (Duloxetine Fig1)
A line graph comparing the proportion of patients with relapse over time (days) for placebo and duloxetine treatment groups. The x-axis represents time from randomization to relapse in days, and the y-axis represents the proportion of patients with relapse. The placebo group shows a higher relapse proportion over time compared to the duloxetine group.*
FDA Label Image

Package Label-principal Display Panel (30 mg (30 Capsules Bottle))

Package Label-principal Display Panel (30 mg (30 Capsules Bottle))
Label for Duloxetine Delayed-Release Capsules USP 20 mg by Aurobindo Pharma Limited. The label indicates a package size of 60 capsules, dosage form delayed release, and provides storage instructions and distributor information for Aurobindo Pharma USA, NJ. The label includes the NDC 59651-279-60, barcode, and usage warnings.*
FDA Label Image

Package Label-principal Display Panel (30 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (30 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Duloxetine Delayed-Release Capsules USP 20 mg by Aurobindo Pharma Limited. The label indicates 100 (10 x 10) unit-dose capsules in a child-resistant package. It includes storage instructions, distributor information (Aurobindo Pharma USA, Inc.), and mentions it is made in India. The NDC is 59651-279-78.*
FDA Label Image

Package Label-principal Display Panel (60 mg (30 Capsules Bottle))

Package Label-principal Display Panel (60 mg (30 Capsules Bottle))
Label for Duloxetine Delayed-Release Capsules USP 30 mg by Aurobindo Pharma Limited, intended for further processing. The capsule is blue and gray, marked with '02'. The label specifies each capsule contains 33.7 mg duloxetine hydrochloride USP equivalent to 30 mg duloxetine. Packaging includes instructions for storage and dispensing, along with distributor information for Aurobindo Pharma USA, Inc.*
FDA Label Image

Package Label-principal Display Panel (60 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (60 mg Blister Carton (10 x 10 Unit-dose))
Packaging label for Duloxetine Delayed-Release Capsules USP 30 mg by Aurobindo Pharma Limited. The label indicates prescription use only and contains 100 unit-dose capsules (10 x 10). It includes dosage strength, storage instructions, and distributor information for Aurobindo Pharma USA, Inc., made in India.*
FDA Label Image

Duloxetine Fig14

Duloxetine Fig14
Label for Duloxetine Delayed-Release Capsules USP 60 mg by Aurobindo Pharma Limited. The label states the capsule contains 67.3 mg of duloxetine hydrochloride USP equivalent to 60 mg duloxetine. It includes dosage, storage instructions, distributor information (Aurobindo Pharma USA, Inc.), and a barcode. The package size is 30 capsules. The label also highlights the Rx only designation and a pharmacist note about dispensing the Medication Guide.*
FDA Label Image

Duloxetine Fig15

Duloxetine Fig15
Packaging label for Duloxetine Delayed-Release Capsules USP 60 mg by Aurobindo Pharma Limited. The package contains 100 unit-dose capsules (10 x 10). It is labeled Rx only with instructions for pharmacists to dispense the Medication Guide separately. Distributed by Aurobindo Pharma USA, Inc., made in India, with storage instructions and child-resistant packaging noted.*
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Figure-2 (Duloxetine Fig2)

Figure-2 (Duloxetine Fig2)
A line graph showing the proportion of patients with relapse over a period of up to 300 days. The graph compares two treatments, a placebo and Duloxetine, tracking relapse proportions over time from randomization. Duloxetine shows a lower relapse proportion compared to placebo.*
FDA Label Image

Figure-3 (Duloxetine Fig3)

Figure-3 (Duloxetine Fig3)
A line graph displaying the percentage of patients improved versus percent improvement in pain from baseline, comparing Duloxetine at 20 mg and 60 mg doses with placebo. The graph includes four lines representing Duloxetine 60 mg BID, Duloxetine 60 mg QD, Duloxetine 20 mg QD, and placebo.*
FDA Label Image

Figure-4 (Duloxetine Fig4)

Figure-4 (Duloxetine Fig4)
A line graph showing percentage of patients improved versus percent improvement in pain from baseline. Three curves compare Duloxetine 60 mg BID, Duloxetine 60 mg QD, and placebo, illustrating patient response differences across pain reduction percentages.*
FDA Label Image

Figure-5 (Duloxetine Fig5)

Figure-5 (Duloxetine Fig5)
A line graph showing the percentage of patients improved versus percent improvement in pain from baseline for Duloxetine 60 mg twice daily, Duloxetine 60 mg once daily, and placebo groups. The vertical axis measures patient improvement percentage from 0 to 100, and the horizontal axis shows percent pain improvement thresholds from >0 to 100. Lines depict higher patient improvement percentages for both Duloxetine dosing regimens compared to placebo across pain improvement percentages.*
FDA Label Image

Figure-6 (Duloxetine Fig6)

Figure-6 (Duloxetine Fig6)
A line graph showing the percent of patients improved by different levels of percent improvement in pain from baseline. The graph compares four groups: Duloxetine 120 mg once daily, Duloxetine 60 mg once daily, Duloxetine 20 mg once daily, and Placebo, with the y-axis representing the percent of patients improved and the x-axis representing percent improvement in pain.*
FDA Label Image

Figure-7 (Duloxetine Fig7)

Figure-7 (Duloxetine Fig7)
A line graph comparing the percentage of patients improved by the percent improvement in pain from baseline (BOCF) for Duloxetine Hydrochloride 60/120 mg once daily versus placebo. The X-axis shows percent improvement in pain from 0 to 100%, and the Y-axis shows the percentage of patients improved from 0 to 100%. Two lines represent Duloxetine and placebo, with Duloxetine showing higher patient improvement percentages across the pain improvement spectrum.*
FDA Label Image

Package Label-principal Display Panel (20 mg (60 Capsules Bottle))

Package Label-principal Display Panel (20 mg (60 Capsules Bottle))
Line chart comparing percentage of patients improved over percent improvement in pain from baseline (BOCF) for Duloxetine 60 mg once daily versus placebo. The x-axis shows percent improvement in pain from >0 to 100%, and the y-axis shows percentage of patients improved from 0 to 100%. Two lines depict patient improvement trends for each group across pain improvement percentages.*
FDA Label Image

Package Label-principal Display Panel (20 mg Blister Carton (10 x 10 Unit-dose))

Package Label-principal Display Panel (20 mg Blister Carton (10 x 10 Unit-dose))
Line graph showing the percentage of patients improved versus percent improvement in pain from baseline (BOCF). It compares duloxetine 60/120 mg once daily with placebo, indicating trends in patient pain improvement at various thresholds.*
FDA Label Image

Chemical Structure (Duloxetine Str)

Chemical Structure (Duloxetine Str)
Chemical structure diagram of Duloxetine Hydrochloride showing its molecular arrangement, including a naphthyl ring, thiophene ring, and amine group with hydrochloride.*

* 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.