Tadalafil Tablet, Film Coated
Product Images NDC 35573-463

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 35573-463). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Burel Pharmaceuticals, Llc, 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

Chemical Structure (Tadalafil 1)

Chemical Structure (Tadalafil 1)
Chemical structure of tadalafil, representing the molecular arrangement of the active ingredient in the drug.*
FDA Label Image

Carton (Tadalafil 10)

Carton (Tadalafil 10)
Packaging label for Tadalafil Tablets, USP 2.5 mg oral film-coated tablets by Burel Pharmaceuticals, LLC. The label indicates 30 tablets packaged in 2 blisters of 15 tablets each, for once daily use. The label includes dosage instructions, storage conditions, manufacturer details, and a barcode.*
FDA Label Image

5 mg (Tadalafil 11)

5 mg (Tadalafil 11)
Tadalafil 5 mg film-coated tablets label from Burel Pharmaceuticals, LLC. The label indicates a package count of 30 tablets with directions emphasizing the tablets should not be split and that the entire dose should be taken. Manufacturer is VKT Pharma Private Limited, India. Storage instructions and a barcode are also visible.*
FDA Label Image

10 mg (Tadalafil 12)

10 mg (Tadalafil 12)
Tadalafil Tablets USP 10 mg film-coated tablets label from Burel Pharmaceuticals, LLC. The label shows the product name, strength, a 30-tablet count, and directions indicating tablets should not be split and to take the entire dose. Storage instructions, warnings, the marketing company in Mason, OH, and manufacturer details in Srikakulam, India, are included along with a barcode and Rx only designation.*
FDA Label Image

20 mg (Tadalafil 13)

20 mg (Tadalafil 13)
Label for Tadalafil Tablets USP 20 mg film-coated tablets by Burel Pharmaceuticals, LLC. The label indicates a package of 30 tablets, with storage instructions, dosage guidance, and manufacturing details from VKT Pharma Private Limited in India. It includes a barcode and cautions to keep out of children's reach and not to split tablets.*
FDA Label Image

Tadalafil-tablets-figure-1 (Tadalafil 2)

Tadalafil-tablets-figure-1 (Tadalafil 2)
Four line graphs depicting the difference in blood pressure measurements between tadalafil and placebo over a 96-hour period. The graphs show Standing Systolic, Standing Diastolic, Supine Systolic, and Supine Diastolic blood pressure differences (in mmHg) with time in hours on the x-axis and difference on the y-axis, including error bars.*
FDA Label Image

Tadalafil-tablets-figure-2 (Tadalafil 3)

Tadalafil-tablets-figure-2 (Tadalafil 3)
Two line graphs illustrating the effects on systolic blood pressure (BP) over 24 hours post-dose. The top graph shows standing systolic BP with lines for tadalafil 20 mg & doxazosin 8 mg and placebo & doxazosin 8 mg. The bottom graph shows supine systolic BP with the same groups. Both graphs plot systolic BP change (mmHg) on the vertical axis against time post-dose (hours) on the horizontal axis.*
FDA Label Image

Tadalafil-tablets-figure-3 (Tadalafil 4)

Tadalafil-tablets-figure-3 (Tadalafil 4)
A line graph showing the change in systolic blood pressure (mmHg) over time (hours) after administration of tadalafil or placebo combined with doxazosin. Four data series compare 20 mg tadalafil and placebo given at different times (08:00 and 20:00), all combined with 8 mg once daily doxazosin, with systolic blood pressure measured for up to 12 hours.*
FDA Label Image

Tadalafil-tablets-figure-4 (Tadalafil 5)

Tadalafil-tablets-figure-4 (Tadalafil 5)
A line graph depicting plasma tadalafil concentration (µg/L) over time (hours) for three dosing regimens: a single 20-mg dose, a single 5-mg dose, and once-daily 5-mg dosing following five consecutive days of administration. The graph shows concentration peaks and declines with error bars for variability.*
FDA Label Image

Table 5 (Tadalafil 6)

Table 5 (Tadalafil 6)
A line graph comparing change from baseline in IPSS total score over 12 weeks of treatment between tadalafil 5 mg and placebo groups. The y-axis shows the change in IPSS score, and the x-axis shows treatment duration in weeks, indicating greater improvement with tadalafil 5 mg versus placebo.*
FDA Label Image

Table 6 (Tadalafil 7)

Table 6 (Tadalafil 7)
A line graph comparing the change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg and placebo groups. The x-axis represents treatment duration in weeks, and the y-axis shows change in score. Tadalafil shows a greater reduction in score than placebo throughout the period, with significant differences indicated (p<0.01).*
FDA Label Image

Tadalafil-tablets-figure-7 (Tadalafil 8)

Tadalafil-tablets-figure-7 (Tadalafil 8)
A line graph depicting least-squares mean change from baseline over 26 weeks of therapy comparing Tadalafil/Finasteride and Placebo/Finasteride groups. The graph plots data points at weeks 0, 4, 12, and 26, showing a greater reduction for the Tadalafil/Finasteride group. Statistical significance markers (p<0.001, p<0.05) are noted next to some data points.*
FDA Label Image

Image 8 (Tadalafil 9)

Image 8 (Tadalafil 9)
A line graph comparing change from baseline in IPSS total score over treatment duration in weeks for Tadalafil 5 mg versus placebo. The graph shows a greater decrease in IPSS score with Tadalafil 5 mg across 0 to 12 weeks versus placebo, with significant differences indicated at multiple time points.*

* 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.