Tadalafil Tablet, Film Coated
Product Images NDC 68382-899

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Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 68382-899). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals 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

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 01)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 01)
Chemical structure diagram of the active ingredient Tadalafil showing its molecular framework with rings and bonds, consistent with the compound used in the prescription drug Tadalafil.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 02)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 02)
This figure consists of four line graphs showing the difference in blood pressure (BP) measurements between Tadalafil and placebo over 96 hours. The graphs represent standing systolic BP, standing diastolic BP, supine systolic BP, and supine diastolic BP, each plotted against time in hours. Error bars indicate variability at each time point.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 03)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 03)
A dual-line chart depicting the effect of Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg on standing and supine systolic blood pressure (BP) over 24 hours post-dose. The upper graph shows standing systolic BP changes, while the lower graph shows supine systolic BP changes, both in mmHg over time.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 04)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 04)
Line graph showing the effect of 20 mg tadalafil with 8 mg doxazosin versus placebo with 8 mg doxazosin on systolic blood pressure (mmHg) over 12 hours post administration. Four data series compare tadalafil and placebo given at 08:00 and 20:00, illustrating changes in systolic BP over time.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 05)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 05)
A line graph displaying plasma tadalafil concentration (µg/L) over time (hours). It compares three dosing regimens: single 20 mg dose, single 5 mg dose, and once-daily 5 mg dose after 5 consecutive days. Error bars indicate variability at each time point during the measurement period up to 120 hours.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 06)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 06)
Line graph comparing change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg and placebo. The x-axis represents duration of treatment in weeks (0, 4, 8, 12), and the y-axis shows change from baseline in IPSS total score, with scores decreasing over time. The graph shows a greater decline in score for Tadalafil 5 mg compared to placebo, indicating improvement. Statistical significance (p<0.01) is noted.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 07)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 07)
A line graph comparing the change from baseline in IPSS Total Score over a 12-week treatment period between Tadalafil 5 mg and placebo groups. The x-axis represents treatment duration in weeks, and the y-axis shows the change from baseline score. The graph indicates a greater reduction in scores with Tadalafil 5 mg compared to placebo, with a significance level of p<0.01.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 08)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 08)
A line graph comparing the least-squares mean change from baseline over 26 weeks of therapy between two treatment groups: Tadalafil/Finasteride and Placebo/Finasteride. The graph shows a greater reduction in the measured variable for the Tadalafil/Finasteride group at multiple time points, with statistical significance indicated at weeks 4, 12, and 26.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 09)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 09)
A line graph illustrating the change from baseline in IPSS Total Score over 12 weeks of treatment. The graph compares Tadalafil 5 mg (solid line with circles) versus placebo (dashed line with triangles), showing greater score reduction with Tadalafil 5 mg. Time in weeks is on the x-axis and change in score on the y-axis, with a statistical significance noted at 12 weeks (p < 0.01).*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 10)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 10)
Tadalafil Tablets, USP 2.5 mg film-coated oral tablet label by Zydus Pharmaceuticals USA Inc. The label states 30 tablets per package and includes dosing instructions, storage conditions, and manufacturer information from Cadila Healthcare Ltd., India, with distribution by Zydus Pharmaceuticals USA Inc., Pennington, NJ. The tablet is shown in gray with an imprint.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 11)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 11)
Label for Tadalafil Tablets, USP 5 mg oral film-coated tablets by Zydus Pharmaceuticals USA Inc. The label includes dosage form and strength, tablet image with imprint "B97", quantity of 30 tablets, prescription status (Rx only), storage instructions, manufacturer details (Cadila Healthcare Ltd., India), and distributor information (Zydus Pharmaceuticals USA, Pennington, NJ).*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 12)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 12)
Label for Tadalafil Tablets, USP 10 mg oral film-coated tablets by Zydus Pharmaceuticals USA Inc. The label includes dosage information, storage instructions, a barcode, and states the package contains 30 tablets. The product is prescription only and the label specifies the tablets should not be split.*
FDA Label Image

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 13)

Tadalafil Tablets (Bf07616c 918b 40b7 8ffb 7c6a12cd64e5 13)
Tadalafil Tablets, USP 20 mg film-coated oral tablets in a 30 tablet Rx-only package. The label shows a brown, oval tablet marked with '899'. The labeler is Zydus Pharmaceuticals USA Inc., with manufacturing by Cadila Healthcare Ltd. Storage and dosage information is provided alongside the NDC 63882-899-06 barcode.*

* 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.