Tadalafil Tablet, Film Coated
Product Images NDC 16714-075

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 16714-075). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rxllc, 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

Spl-tadalafil-figure-1 (Spl Tadalafil Figure 1)

The text seems to be a chart containing blood pressure readings for standing and supine positions, along with a comparison between Tadalafil and Placebo. However, it is difficult to interpret the chart without better organization and additional context.*

FDA Label Image

Spl-tadalafil-figure-2 (Spl Tadalafil Figure 2)

This text includes a table showing the standing and supine systolic blood pressure in mmHg for two different treatments: Tadalafil 20mg and doxazosin 8mg, and placebo and doxazosin 8mg. It also mentions "Time post-dose (h)" which may indicate that the blood pressure was measured at different times after the medication was taken.*

FDA Label Image

Spl-tadalafil-figure-3 (Spl Tadalafil Figure 3)

This appears to be a table displaying the systolic blood pressure readings (in mmHg) at different times after the administration of various medications, including 20mg of tadalafil and 8mg of doxazosin. There are also placebo comparators included in the table. The text does not provide any further context or explanation of the purpose of the table or the study it may be a part of.*

FDA Label Image

Spl-tadalafil-figure-4 (Spl Tadalafil Figure 4)

This is a graph that shows the plasma concentration of Tadalafil (in ug/L) over a duration of 120 hours following different dose protocols. A single 20-mg dose, a single 5-mg dose, and a once-daily 5-mg dose following 5 consecutive days of administration are represented on the graph. The x-axis shows time in hours and the y-axis shows Tadalafil concentration in ug/L.*

FDA Label Image

Spl-tadalafil-figure-5 (Spl Tadalafil Figure 5)

The text describes a graph or chart showing the change from the baseline in the IPSS total score, comparing tadalafil 5mg to a placebo. The graph indicates that there was a statistically significant improvement in the IPSS score with tadalafil compared to the placebo (p<0.01). However, there is no information on the duration of treatment.*

FDA Label Image

Spl-tadalafil-figure-6 (Spl Tadalafil Figure 6)

The text describes the change in IPSS total score between Tadalafil 5 mg and placebo after a 12-week duration of treatment. The graph shows a statistically significant improvement in IPSS total score with tadalafil 5 mg compared to the placebo group (p<0.01).*

FDA Label Image

Spl-tadalafil-figure-8 (Spl Tadalafil Figure 8)

This is a statistical result showing the change from baseline in IPSS total score during treatment with Tadalafil 5 mg and placebo for an unspecified duration of weeks. There was a significant improvement in the Tadalafil group compared to the placebo group with a p-value less than 0.01.*

FDA Label Image

Spl-tadalafil-label-10mg (Spl Tadalafil Label 10mg)

This is a label for 10 mg Tadalafil tablets. It recommends not splitting the tablet and taking the entire dose. The package contains 30 tablets and is set to expire in January 2020. There is also a code, PGLBIG2B 1SS, and reference to DNH/DRUGS/NH/138. There is a company name, NoRTHSTARY, mentioned at the end.*

FDA Label Image

Spl-tadalafil-label-20mg (Spl Tadalafil Label 20mg)

This is a label from NorthStar Healthcare Holdings for Tadalafil Tablets, USP. The label informs the user to not split the tablets and to take the entire dose. It contains 30 tablets per container. The label was created in January 2020.*

FDA Label Image

Spl-tadalafil-label-5mg (Spl Tadalafil Label 5mg)

This is a label for Tadalafil Tablets, USP containing 5 mg, with a caution not to split the tablets and to take the entire dose. The label indicates the quantity of 30 tablets and the manufacturer is Northstar.*

FDA Label Image

Spl-tadalafil-showbox-1 (Spl Tadalafil Showbox 1)

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Spl-tadalafil-structure (Spl Tadalafil Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.