Tadalafil Tablet, Film Coated
Product Images NDC 65862-852

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 65862-852). 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.

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Figure 1 (Tadalafil Fig1)

The text appears to be a table or figure illustrating changes in blood pressure in response to sublingual nitroglycerin after taking Tadalafil or a placebo. It shows standing systolic and diastolic blood pressure, supine systolic and diastolic blood pressure, and the difference between them over a period of 96 hours. The table provides point estimates with 90% CI.*

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Package Label-principal Display Panel (5 mg (30 Tablets Bottle))

This appears to be a product description for Tadalafil tablets USP, a medication with dosages available in both 2.5mg and 25mg. The tablets should not be split, and the full dose should be taken. The instructions caution to keep the medication out of the reach of children and away from hot/cold temperatures. The text contains several errors and is difficult to read in parts.*

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Package Label-principal Display Panel (5 mg Blister Carton (2x15 Unit-dose))

Each tablet of this medication contains 5mg of Tadalafil USP and is distributed by Aurobindo Pharma USA, Inc. The normal dosage is to be determined by accompanying literature. The medication should be kept in a tight container and not be split. Note that it should be kept out of reach from children. This batch of 30 tablets is manufactured in India and has a product code of TS/DRUGS/22/2009.*

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Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Tadalafil Tablets USP is a medication available with a prescription that comes in the form of 30 tablets and intended for once-daily oral administration. The tablets should not be split and should be taken in their entirety. The medication card contains 2 cards of 15 tablets held with the weekdays, the center tablet in the card is the starting tablet. It should be taken every day at the same time, about mealtimes, and should not be taken more than once per day. After taking the SOth table, another box may be started. The bulk of the text is illegible and random characters.*

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Package Label-principal Display Panel (20 mg (30 Tablets Bottle))

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Tadalafil Fig14

This is a description of Tadalafil Tablets, a prescription medication. Each bottle contains 30 tablets that should not be split and the entire dose should be taken as prescribed. Tadalafil Tablets are used to treat erectile dysfunction in men and the usual dosage should be followed as directed by the accompanying medical literature. The tablets are dispensed in a tight container and should be stored between 20° to 25°C (66° to 77°F). The label warns the product should be kept out of reach of children. The manufacturer of this product is Aurobindo Pharma USA, Inc. The code located below the manufacturer address is TS/DRUGS/22/2000.*

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Figure 2 (Tadalafil Fig2)

This is a chart that shows the mean change from baseline in systolic blood pressure. The chart is related to a study about doxazosin and tadalfil, where different doses were administered and compared to a placebo.*

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Figure 3 (Tadalafil Fig3)

This text describes the medication dosages given to patients as part of a study. It includes the dosage of two different drugs, tadalafil and doxazosin, given at different times of the day. The text also includes a graph showing the mean change in systolic blood pressure over time after administration of tadalafil or placebo.*

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Figure 4 (Tadalafil Fig4)

The text describes a graph (Figure 4), indicating the plasma concentration of tadalafil, a medication used to treat erectile dysfunction, over time. The graph shows the concentration levels after a single dose of 20 mg, as well as multiple daily doses of 5 mg, over the course of 120 hours. The x-axis represents the time in hours, while the y-axis represents the concentration of tadalafil in milligrams per liter. There is also some numerical data presented in the text, including 500 and 2, which are unclear without additional context.*

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Figure 5 (Tadalafil Fig5)

The given text describes a study on BPH patients who were administered Tatalafil 5 mg and Placebo. The study analyzes the change from the baseline in the IPSS total score during the duration of treatment (weeks). The results of the study are visually presented in Figure 5.*

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Figure 6 (Tadalafil Fig6)

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Figure 7 (Tadalafil Fig7)

The figure shows the mean total IPSS changes in BPH patients taking Tadalafil for once daily use along with Finasteride over a period of 26 weeks of therapy. The x-axis shows the duration of therapy in weeks, and the y-axis shows the LS Mean Change from Baseline in IPSS scores. The graph indicates a significant reduction in IPSS scores in patients taking Tadalafil and Finasteride compared to those taking a Placebo/Finasteride combination. This reduction was seen as early as week 4, and the effect continued to increase up to week 26. The differences between the treatment groups were statistically significant, with p<0.05 or p<0.001.*

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Figure 8 (Tadalafil Fig8)

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Package Label-principal Display Panel (2.5 mg Blister Carton (2x15 Unit-dose))

Each film-coated tablet contains Tadalafil USP 2.5 mg. It is suggested to take one tablet daily, and the accompanying literature should be consulted for dosage. The tablets should not be split, and the entire dose should be taken. It is advised to keep out of reach of children and store at 20° to 25°C (68° to 77°F) in a tight container. The tablets are manufactured by Aurobindo Pharma USA, Inc. and distributed by them as well. The product is not available for printing purposes beyond the specified area.*

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Chemical Structure (Tadalafil Str)

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