Tadalafil Tablet, Film Coated
Product Images NDC 65862-853

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 65862-853). 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 (Tadalafil Fig1)

A set of four line graphs showing the mean maximal change in blood pressure (difference between tadalafil and placebo) over time in hours. The charts illustrate standing and supine systolic and diastolic blood pressure responses at various time points up to 96 hours after the last dose of tadalafil 20 mg or placebo.*

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

Tadalafil Tablets USP 2.5 mg film-coated tablets packaging label for once daily use. The carton contains 30 tablets divided into 2 blisters of 15 tablets each. Labeler is Aurobindo Pharma Limited, distributed by Aurobindo Pharma USA, Inc. Instructions note tablets should not be split, and the entire dose should be taken.*

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

Label for Tadalafil Tablets USP 5 mg film-coated tablets by Aurobindo Pharma Limited. The label states the storage conditions (20° to 25°C), dosage form, quantity (30 tablets), and includes distribution information for Aurobindo Pharma USA, Inc. It also includes warnings, dosage instructions, and a barcode on the right side.*

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

Packaging label for Tadalafil Tablets USP 5 mg film-coated tablets by Aurobindo Pharma Limited. The label indicates the product is for once daily use, contains 30 tablets (2 blisters of 15 tablets), and includes instructions not to split tablets and to take the entire dose. The label also features the NDC number 65862-851-32 and barcode.*

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

Label for Tadalafil Tablets USP 10 mg film-coated tablets by Aurobindo Pharma Limited. The label includes dosage information, storage instructions (20° to 25°C), a warning to keep out of reach of children, and notes the package contains 30 tablets. Distributed by Aurobindo Pharma USA, Inc., with product origin stated as Made in India.*

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Tadalafil Fig14

Label for Tadalafil Tablets USP 20 mg film-coated tablets, supplied by Aurobindo Pharma Limited. The label indicates a 30-tablet supply, storage instructions, dosage note to see accompanying literature, and distributor information for Aurobindo Pharma USA in New Jersey. The label includes warnings and barcode details.*

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Figure 2 (Tadalafil Fig2)

Two line graphs depicting mean change from baseline in systolic blood pressure over 24 hours post-dose in a doxazosin study. The top graph shows standing systolic blood pressure changes, and the bottom graph shows supine systolic blood pressure changes, comparing tadalafil 20 mg with doxazosin 8 mg against placebo with doxazosin 8 mg. Both graphs plot blood pressure changes (mmHg) on the vertical axis and time post-dose (hours) on the horizontal axis.*

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Figure 3 (Tadalafil Fig3)

A line graph showing mean change from baseline in systolic blood pressure over 12 hours after administration of 20 mg tadalafil with 8 mg doxazosin or placebo with 8 mg doxazosin at 8:00 and 20:00 times. The y-axis represents systolic BP changes in mmHg, and the x-axis represents time after administration in hours.*

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Figure 4 (Tadalafil Fig4)

A line graph showing plasma tadalafil concentrations (mean ± SD) over time in hours. The graph compares a single 20 mg dose, a single 5 mg dose, and once-daily 5 mg doses following 5 consecutive days of administration. Concentrations are measured in ng/mL with error bars indicating variability.*

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Figure 5 (Tadalafil Fig5)

A line graph titled 'Mean IPSS Changes in BPH Patients by Visit in Study J' comparing Tadalafil 5 mg and placebo over 12 weeks. The y-axis shows change from baseline in IPSS total score, and the x-axis shows treatment duration in weeks. The graph illustrates greater reduction in IPSS score for Tadalafil 5 mg compared to placebo, with a statistically significant difference at 12 weeks.*

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Figure 6 (Tadalafil Fig6)

A line graph illustrating mean IPSS (International Prostate Symptom Score) changes in BPH patients over a 12-week treatment period comparing Tadalafil 5 mg tablets with placebo. The y-axis shows change from baseline in total IPSS score, and the x-axis represents treatment duration in weeks. Tadalafil 5 mg shows greater reduction in IPSS scores compared to placebo, with statistical significance indicated at some points (p<0.01).*

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Figure 7 (Tadalafil Fig7)

A line graph showing mean total IPSS changes over 26 weeks of therapy in BPH patients treated with Tadalafil/Finasteride versus Placebo/Finasteride. The y-axis represents least squares mean change from baseline, with Tadalafil/Finasteride showing greater symptom reduction compared to placebo. Treatment differences are indicated at weeks 4, 12, and 26.*

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Figure 8 (Tadalafil Fig8)

A line graph showing mean IPSS changes over 12 weeks of treatment in ED/BPH patients, comparing Tadalafil 5 mg and placebo. The x-axis represents treatment duration in weeks, and the y-axis shows change from baseline in IPSS total score. The graph indicates greater improvement for Tadalafil 5 mg over placebo, with statistical significance marked at week 12.*

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

Label for Tadalafil Tablets USP 2.5 mg film-coated tablets by Aurobindo Pharma Limited. The label indicates 30 tablets per container, with storage instructions at 20° to 25°C (68° to 77°F). It includes the National Drug Code (NDC) 65862-850-30 and distributor information for Aurobindo Pharma USA, Inc., East Windsor, NJ. The label also contains usage and safety warnings and a barcode.*

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Chemical Structure (Tadalafil Str)

Chemical structure diagram of Tadalafil, showing its molecular framework with benzene rings, nitrogen, oxygen atoms, and double bonds, as part of its defined chemical composition.*

* 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.