Tadalafil Tablet, Film Coated
Product Images NDC 47335-009

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 47335-009). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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

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

This appears to be a table displaying measurements of blood pressure (systolic and diastolic) for both standing and supine positions, with a comparison between the effectiveness of Tadalafil and a Placebo. The table includes a time measurement in hours. However, the information is not presented in a clear and organized manner, and the symbols and formatting make it difficult to interpret the data accurately.*

FDA Label Image

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

This appears to be a table comparing standing and supine systolic blood pressure readings in relation to two different medications: Tadalafil 20 mg & doxazosin 8 mg and Placebo & doxazosin 8 mg. The time post-dose in hours is also taken into account.*

FDA Label Image

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

The text describes a study evaluating the effects of 20 mg of tadalafil and 8 mg of daily doxazosin on systolic blood pressure over time. The study was conducted using a placebo, and the medication was administered at two different times (8:00 AM and 20:00 PM). There is no further information available in the text.*

FDA Label Image

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

This is a graph depicting the plasma tadalafil concentration (in ug/L) over time (in hours) following different dosages of tadalafil. Specifically, it shows the concentration following a single 20-mg dose, a single 5-mg dose, and a once-daily 5-mg dose for 5 consecutive days. The concentration is highest at around 1-2 hours post-dose for all three dosages and gradually decreases over time.*

FDA Label Image

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

The text describes the change in IPSS total score from baseline after treatment with Tadalafil 5 mg compared to placebo. There is also a graphical representation of the results with a note indicating statistical significance (p<0.01). However, there is no indication of the duration of treatment.*

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

This is a graph showing the change from the baseline in IPSS total score for patients treated with Tadalafil 5 mg versus placebo. The duration of treatment was 12 weeks. There was a statistically significant improvement in IPSS total score for patients treated with Tadalafil 5 mg compared to placebo (p<0.01).*

FDA Label Image

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

The text describes the change in IPSS total score from baseline for Tadalafil 5 mg compared to placebo, with a significant difference (p<0.01). It also includes the duration of treatment in weeks.*

FDA Label Image

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

This is a label for Tadalafil Tablets, USP, in a container of 30 tablets. Each tablet contains 10mg of Tadalafil. The label advises not to split tablets and take the dose as a whole. It is only available with a prescription.*

FDA Label Image

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

This is a label of Tadalafil Tablets, USP which comes in a pack of 30 tablets. The tablets should not be split and the entire dose should be taken. The label also includes the drug code (NDC 47335-012-83) and the prescription-status. Further details of the label can be accessed under full labeling. The code also indicates the manufacturer and the date of manufacture.*

FDA Label Image

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

This text describes a medication called Tadalafil Tablets, USP that comes in a bottle with the National Drug Code 47335-010-83. It suggests not to split the tablets and to take the entire dose as prescribed. The bottle contains 30 tablets and the medication requires a prescription. The text also mentions the possibility of full labeling for the medication.*

FDA Label Image

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

Tadalafil Tablets are a prescription medication for once-daily use, with each box containing 30 tablets in 2 blister cards. The tablets are labeled with specific days of the week for ease of use. The tablets have a film-coating and should be taken without splitting or chewing, at around the same time daily, and no more than once per day. This medication should be kept out of children's reach and stored in permitted temperature ranges. There is more patient information available at sunpharma.com.*

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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.