Tadalafil
Product Images NDC 50436-0644

13 FDA label images from Unit Dose Services · 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 50436-0644). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Camber1jpj (Camber1jpg)

FDA Label Image

Label Image (Lbl504360644)

Label Image (Lbl504360644)
Packaging label for Tadalafil 5 mg tablets, containing 30 tablets. The label states each film-coated tablet contains 5 mg of tadalafil USP. It includes dispensing and storage warnings, manufacturer details as Hetero Labs Limited, Hyderabad, India, and packaging by Unit Dose Services, LLC, Dania, FL. The label shows NDC 50436-0644-1 and notes the product is prescription only (RX ONLY).*
FDA Label Image

Lbl504360645

Lbl504360645
Tadalafil 10 mg tablets packaging label by Unit Dose Services. The label states each film-coated tablet contains 10 mg of tadalafil USP, with a quantity of one tablet per unit dose pouch. It is labeled for prescription use (Rx only), includes storage and handling instructions, and lists manufacturers and repackagers including Biscaltier Pharmaceuticals, Hetero Labs Limited, and Unit Dose Services. A QR code and unique product codes are also visible.*
FDA Label Image

Lbl504366460

Lbl504366460
Tadalafil 20 mg tablets, labeled by Unit Dose Services. The label states each foam-coated tablet contains 20 mg of Tadalafil USP. It is an RX-only product and packaged as one tablet per unit dose pouch. The label includes packaging information, storage instructions (keep at controlled room temperature), and warnings to keep out of reach of children. Manufacturer details and repackaging information are also provided.*
FDA Label Image

Tadalafilfigure1.jpg (Tadalafilfigure1)

Tadalafilfigure1.jpg (Tadalafilfigure1)
A set of four line graphs showing blood pressure changes over time comparing Tadalafil to placebo. The graphs depict differences in standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure measured in mmHg over a 0 to 96-hour period.*
FDA Label Image

Tadalafilfigure2.jpg (Tadalafilfigure2)

Tadalafilfigure2.jpg (Tadalafilfigure2)
This figure consists of two line graphs showing the effect of Tadalafil 20 mg combined with doxazosin 8 mg versus placebo with doxazosin 8 mg on systolic blood pressure (BP) over 24 hours post-dose. The top graph shows standing systolic BP changes; the bottom graph shows supine systolic BP changes, both measured in mmHg over time in hours.*
FDA Label Image

Tadalafilfigure4.jpg (Tadalafilfigure4)

Tadalafilfigure4.jpg (Tadalafilfigure4)
Line graph showing the effect on systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo in combination with doxazosin, measured at 08:00 and 20:00 dosing times. The graph compares changes in systolic BP for 20 mg tadalafil plus 8 mg doxazosin and placebo plus 8 mg doxazosin at both morning and evening doses.*
FDA Label Image

Tadalafilfigure5.jpg (Tadalafilfigure5)

Tadalafilfigure5.jpg (Tadalafilfigure5)
A pharmacokinetic line graph showing plasma tadalafil concentration (mcg/L) versus time (hours). It compares three dosing regimens: a single 20-mg dose, a single 5-mg dose, and once-daily 5-mg tadalafil following five consecutive days of administration. The graph displays plasma concentration changes over a 120-hour period with error bars indicating variability.*
FDA Label Image

Tadalfilfigure6.jpg (Tadalafilfigure6)

Tadalfilfigure6.jpg (Tadalafilfigure6)
A line graph showing changes from baseline in IPSS total score over 12 weeks of treatment with Tadalafil 5 mg compared to placebo. The x-axis represents treatment duration in weeks, and the y-axis shows the change in IPSS score. Tadalafil shows a greater decrease in IPSS score over time, with statistical significance indicated (p<0.01).*
FDA Label Image

Tadalafilfigure7.jpg (Tadalafilfigure7)

Tadalafilfigure7.jpg (Tadalafilfigure7)
A line graph depicting the change from baseline in IPSS total score over a 12-week treatment duration. Two lines compare Tadalafil 5 mg and Placebo, showing greater score reductions for Tadalafil. Data points at 0, 1, 4, 8, and 12 weeks are plotted, with statistical significance indicated at week 4 for Tadalafil versus Placebo.*
FDA Label Image

Tadalafilfigure8 (Tadalafilfigure8)

Tadalafilfigure8 (Tadalafilfigure8)
Line graph depicting the least-squares mean change from baseline over 26 weeks of therapy for two treatments: Tadalafil/Finasteride and Placebo/Finasteride. The y-axis measures change levels, and the x-axis shows therapy duration in weeks. Data points with statistical significance indications are shown at weeks 4, 12, and 26.*
FDA Label Image

Tadalfilfigure9.jpg (Tadalafilfigure9)

Tadalfilfigure9.jpg (Tadalafilfigure9)
A line graph showing the change from baseline in IPSS total score over a 12-week treatment duration. The graph compares Tadalafil (solid line with circles) and placebo (dashed line with triangles), indicating statistical significance at multiple time points (p<0.01). The x-axis represents the duration of treatment in weeks, and the y-axis shows the change in IPSS total score.*
FDA Label Image

Tadalafilstructure.jpg (Tadalafilstructure)

* 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.