Tadalafil Tablet, Film Coated
Product Images NDC 75834-249

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 75834-249). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nivagen Pharmaceuticals, 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-10-mg-30s (Tadalafil 10 mg 30s)

Label for Tadalafil Tablets USP 10 mg by Nivagen Pharmaceuticals, Inc. The tablet is film-coated and oral dosing is indicated. The package contains 30 tablets. Storage instructions, warnings, manufacturer details including Umedica Laboratories Pvt. Ltd. in India, and contact information for Nivagen Pharmaceuticals are also shown. The label includes NDC 75834-249-30 and a barcode.*

FDA Label Image

Tadalafil-2-5-mg-30s (Tadalafil 2 5 mg 30s)

Tadalafil Tablets USP 2.5 mg film-coated tablets package label by Nivagen Pharmaceuticals, Inc. Contains 30 tablets for oral use. The label includes dosage strength, storage instructions, manufacturer details, and a barcode. Manufactured by Umedica Laboratories Pvt. Ltd., India.*

FDA Label Image

Tadalafil-20-mg-30s (Tadalafil 20 mg 30s)

Tadalafil 20 mg oral film-coated tablets label from Nivagen Pharmaceuticals, Inc. The label states each tablet contains 20 mg of Tadalafil USP, storage instructions at 25°C with permitted excursions, and warnings to keep out of reach of children and not to split tablets. The package contains 1000 tablets and includes manufacturing information for Umedica Laboratories Pvt. Ltd., India.*

FDA Label Image

Tadalafil-5-mg-30s (Tadalafil 5 mg 30s)

Label for Tadalafil Tablets, USP 5 mg film-coated tablets by Nivagen Pharmaceuticals, Inc. The label states the product is oral dose, contains 30 tablets per package, and includes storage instructions with a child-resistant package warning. It also shows a barcode and manufacturing information by Umedica Laboratories Pvt. Ltd, India.*

FDA Label Image

Tadalafil-figure-1 (Tadalafil Figure 1)

A set of four line graphs showing blood pressure differences (Tadalafil minus Placebo) over time in hours. The graphs display standing systolic BP, standing diastolic BP, supine systolic BP, and supine diastolic BP with measurements from 0 to 96 hours. Each includes error bars indicating variability in the data.*

FDA Label Image

Tadalafil-figure-2 (Tadalafil Figure 2)

A dual plot graph showing the effect of Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg on systolic blood pressure over 24 hours post-dose. The upper plot depicts standing systolic blood pressure changes, and the lower plot shows supine systolic blood pressure changes, both in mmHg, relative to time post-dose (hours).*

FDA Label Image

Tadalafil-figure-3 (Tadalafil Figure 3)

A line graph depicting systolic blood pressure (mmHg) changes over 12 hours after administration of 20 mg tadalafil or placebo combined with 8 mg doxazosin at 08:00 or 20:00. Four curves represent different treatment combinations and times, showing blood pressure variation trends over time.*

FDA Label Image

Tadalafil-figure-4 (Tadalafil Figure 4)

A line graph depicting plasma tadalafil concentrations (µg/L) over time (hours) for three dosing regimens: single 20 mg dose, single 5 mg dose, and once-daily 5 mg dose following 5 consecutive days. The y-axis shows concentration levels, and the x-axis shows time up to 120 hours. Data points include error bars representing variability.*

FDA Label Image

Tadalafil-figure-5 (Tadalafil Figure 5)

A line graph depicting change from baseline in IPSS (International Prostate Symptom Score) total score over a 12-week treatment duration. It compares Tadalafil Tablets 5 mg (solid line with circles) and placebo (dashed line with triangles). The graph shows greater score reduction for Tadalafil at weeks 4, 8, and 12, with a notation indicating P < 0.01 at 12 weeks.*

FDA Label Image

Tadalafil-figure-6 (Tadalafil Figure 6)

A line graph comparing the change from baseline in IPSS total score over 12 weeks of treatment for Tadalafil Tablets 5 mg versus placebo. The x-axis shows treatment duration in weeks; the y-axis shows score change. The graph indicates greater score reduction with Tadalafil 5 mg than placebo, with statistical significance marked at P < 0.01.*

FDA Label Image

Tadalafil-figure-7 (Tadalafil Figure 7)

A line graph showing the least-squares mean change from baseline over weeks of therapy (0, 4, 12, 26) comparing Tadalafil/Finasteride and Placebo/Finasteride. The Tadalafil/Finasteride group shows a larger decrease from baseline over time, with significant differences noted at multiple points, indicated by annotations for p-values <0.001 and <0.05.*

FDA Label Image

Tadalafil-figure-8 (Tadalafil Figure 8)

A line graph comparing the change from baseline in IPSS total score over a 12-week treatment period between Tadalafil tablets 5 mg and placebo groups. The x-axis shows duration of treatment in weeks, and the y-axis shows change from baseline in IPSS total score, with a noted statistical significance at 12 weeks (p<0.01).*

FDA Label Image

Tadalafil-structure (Tadalafil Structure)

Chemical structure of tadalafil, showing its fused ring system with distinct functional groups including methoxy and carbonyl moieties, as presented in the image from the product label.*

* 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.