Tadalafil Tablet
Product Images NDC 27241-112

13 FDA label images from Ajanta Pharma Usa Inc. · 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 27241-112). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ajanta Pharma Usa 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 10mg

Tadalafil 10mg
Label for Tadalafil Tablets, USP 10 mg oral tablets, containing 30 tablets per package. Manufactured by Ajanta Pharma USA Inc. The label notes the tablets contain FD&C Yellow No. 5 (Tartrazine) as a color additive, includes storage instructions, and states the tablets should not be split. Also displays NDC 27241-113-03 and barcode.*
FDA Label Image

Tadalafil 2 5mg

Tadalafil 2 5mg
Packaging label for Tadalafil Tablets, USP 2.5 mg oral tablets, marketed by Ajanta Pharma USA Inc. The label indicates a package of 30 tablets with directions for once daily use. It includes storage instructions, a warning to keep out of reach of children, and states the tablets should not be split. The label also shows an NDC number and barcode.*
FDA Label Image

Tadalafil 20mg

Tadalafil 20mg
Label for Tadalafil Tablets, USP 20 mg oral tablets, packaged as 30 tablets per bottle. The label includes storage instructions, a warning to keep out of reach of children, and the note that the tablets should not be split and the entire dose should be taken. Marketed by Ajanta Pharma USA Inc., made in India. The label also features the NDC 27241-114-03 and a barcode.*
FDA Label Image

Tadalafil 5mg

Tadalafil 5mg
Label for Tadalafil Tablets USP 5 mg, film-coated tablets, packaged in a container of 30 tablets. The label includes dosage instructions, storage conditions (20° to 25°C with permitted excursions), and a warning to keep out of reach of children. Marketed by Ajanta Pharma USA Inc., Bridgewater, NJ, made in India. The label also specifies that tablets should not be split and the entire dose should be taken. NDC 27241-112-03 is visible along with a barcode.*
FDA Label Image

Tadalafil Fig8

Tadalafil Fig8
A line chart comparing changes from baseline in IPSS total score over 12 weeks of treatment with Tadalafil 5 mg tablets versus placebo. The x-axis shows treatment duration in weeks, and the y-axis shows change from baseline in IPSS score. The Tadalafil group shows a greater decrease in score over time compared to placebo, with statistical significance noted at 12 weeks (p<0.01).*
FDA Label Image

Tadalafil Figure1

Tadalafil Figure1
Four line graphs depicting blood pressure changes over time comparing Tadalafil and placebo. The graphs show differences in standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure measured in mmHg from 0 to 96 hours after dosing.*
FDA Label Image

Tadalafil Figure2

Tadalafil Figure2
Two line graphs showing standing and supine systolic blood pressure (mmHg) versus time post-dose (hours). The top graph compares Tadalafil 20 mg with doxazosin 8 mg to placebo with doxazosin 8 mg in standing systolic blood pressure. The bottom graph shows the same comparison for supine systolic blood pressure over 24 hours.*
FDA Label Image

Tadalafil Figure3

Tadalafil Figure3
A line graph depicting systolic blood pressure (mmHg) changes over time (hours) after administration of tadalafil or placebo combined with doxazosin. The x-axis represents time post-dose up to 12 hours, and the y-axis shows systolic blood pressure changes from -20 to +20 mmHg. The graph compares 20 mg tadalafil versus placebo at two different times with 8 mg doxazosin coadministration.*
FDA Label Image

Tadalafil Figure4

Tadalafil Figure4
A line graph showing plasma tadalafil concentration (μg/L) over time (hours) for three dosing regimens: single 20-mg tadalafil dose, single 5-mg tadalafil dose, and once-daily 5-mg tadalafil following 5 consecutive days of administration. Concentrations peak early and decline over time, with detailed error bars indicating variability.*
FDA Label Image

Tadalafil Figure5

Tadalafil Figure5
A line graph showing the change from baseline in IPSS total score over a 12-week treatment period comparing Tadalafil 5 mg with placebo. The graph shows Tadalafil 5 mg results in a greater decrease in score over time, with statistical significance indicated (p<0.01).*
FDA Label Image

Tadalafil Figure6

Tadalafil Figure6
A line graph comparing the change from baseline in IPSS Total Score over 12 weeks of treatment with Tadalafil 5 mg versus placebo. The x-axis represents treatment duration in weeks, and the y-axis shows the change from baseline. Data points indicate significant improvement with Tadalafil compared to placebo (*p<0.01).*
FDA Label Image

Tadalafil Figure7

Tadalafil Figure7
A line graph depicting the least-squares mean change from baseline over 26 weeks of therapy. It compares treatment with Tadalafil/Finasteride versus Placebo/Finasteride, showing a greater reduction for Tadalafil/Finasteride at 4, 12, and 26 weeks. Statistical significance is indicated with p-values (a p<0.001, b p<0.05).*
FDA Label Image

Tadalafil Structure

Tadalafil Structure
Chemical structure of Tadalafil. The image shows a detailed molecular diagram depicting the arrangement of atoms and bonds consistent with the tadalafil molecule.*

* 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.