Tadalafil Tablet, Film Coated
Product Images NDC 69238-1347

13 FDA label images from Amneal Pharmaceuticals Ny Llc · 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 69238-1347). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny 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

10 (Tadalafil Tablets Usp 1)

10 (Tadalafil Tablets Usp 1)
Chemical structure of Tadalafil, depicted as a two-dimensional molecular diagram showing its rings and bonds.*
FDA Label Image

2.5 mg (Tadalafil Tablets Usp 10)

2.5 mg (Tadalafil Tablets Usp 10)
Tadalafil Tablets USP 2.5 mg film-coated oral tablets in a 30-tablet package. The label states once-daily use, instructs no splitting of tablets, and indicates the entire dose should be taken. Manufactured by Amneal Pharmaceuticals Pvt. Ltd., India, and distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ. Storage instructions and a barcode are also visible.*
FDA Label Image

5 mg (Tadalafil Tablets Usp 11)

5 mg (Tadalafil Tablets Usp 11)
Tadalafil Tablets USP 5 mg film-coated tablets label by Amneal Pharmaceuticals NY LLC. The label states the product contains 5 mg of Tadalafil per tablet, with a bottle count of 30 tablets. The label includes storage instructions, manufacturer and distributor information, and a barcode. The tablets are marked A13 and labeled Rx only.*
FDA Label Image

10 mg (Tadalafil Tablets Usp 12)

10 mg (Tadalafil Tablets Usp 12)
Tadalafil Tablets USP 10 mg film-coated tablets packaging label by Amneal Pharmaceuticals. Contains 30 tablets. The label includes storage instructions, manufacturer and distributor information, and a barcode. Tablets are marked with 'AC 06' and the label specifies that tablets should not be split. Manufactured by Amneal Pharmaceuticals Pvt. Ltd. India and distributed by Amneal Pharmaceuticals LLC, USA.*
FDA Label Image

20 mg (Tadalafil Tablets Usp 13)

20 mg (Tadalafil Tablets Usp 13)
Tadalafil Tablets USP 20 mg film-coated oral tablets packaging label. The label shows a pink section with the dosage strength and the Amneal logo. The label states tablets should not be split and the entire dose should be taken. It includes manufacturer information for Amneal Pharmaceuticals Pvt. Ltd. in India and distributor Amneal Pharmaceuticals LLC in New Jersey. The package contains 30 tablets, marked Rx only.*
FDA Label Image

10 (Tadalafil Tablets Usp 2)

10 (Tadalafil Tablets Usp 2)
A set of four line graphs illustrating blood pressure changes over time comparing Tadalafil to placebo. The graphs show differences in standing systolic, standing diastolic, supine systolic, and supine diastolic blood pressure measured in mmHg over a 96-hour period. Error bars represent variability around mean values.*
FDA Label Image

10 (Tadalafil Tablets Usp 3)

10 (Tadalafil Tablets Usp 3)
Two line graphs showing the effects of Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg on systolic blood pressure over 24 hours post-dose. The top graph depicts standing systolic blood pressure changes in mmHg over time, and the bottom graph shows supine systolic blood pressure changes, also in mmHg, over the same time period.*
FDA Label Image

10 (Tadalafil Tablets Usp 4)

10 (Tadalafil Tablets Usp 4)
A line graph showing changes in systolic blood pressure (mmHg) over 12 hours after administration of 20 mg tadalafil or placebo, each combined with 8 mg doxazosin. Four data series compare blood pressure effects at dosing times of 08:00 and 20:00, illustrating systolic BP trends over time post-dose.*
FDA Label Image

10 (Tadalafil Tablets Usp 5)

10 (Tadalafil Tablets Usp 5)
A pharmacokinetic curve showing plasma tadalafil concentration (mcg/L) over time (hours) for Tadalafil tablets. The graph compares single 20 mg and 5 mg tadalafil doses with once-daily 5 mg tadalafil following 5 consecutive days of administration, illustrating concentration changes up to 120 hours.*
FDA Label Image

10 (Tadalafil Tablets Usp 6)

10 (Tadalafil Tablets Usp 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 x-axis represents treatment duration in weeks, and the y-axis shows the change in score. Tadalafil shows a greater decrease in IPSS score than placebo, with statistical significance at 12 weeks (p<0.01).*
FDA Label Image

10 (Tadalafil Tablets Usp 7)

10 (Tadalafil Tablets Usp 7)
A line graph comparing the change from baseline in IPSS Total Score over a 12-week treatment period for Tadalafil 5 mg and placebo. The x-axis shows duration in weeks, and the y-axis shows change from baseline scores. Tadalafil 5 mg shows a greater decrease in scores compared to placebo, with statistically significant differences marked at weeks 4 and 12 (p<0.01).*
FDA Label Image

10 (Tadalafil Tablets Usp 8)

10 (Tadalafil Tablets Usp 8)
A line chart depicting the least squares mean change from baseline over 26 weeks of therapy comparing Tadalafil/Finasteride versus Placebo/Finasteride. The chart shows greater decreases in measurement values for the Tadalafil/Finasteride group at weeks 4, 12, and 26, with statistical significance indicated at certain points (p<0.001 and p<0.05).*
FDA Label Image

10 (Tadalafil Tablets Usp 9)

10 (Tadalafil Tablets Usp 9)
A line graph showing change from baseline in IPSS Total Score over a 12-week duration of treatment comparing Tadalafil 5 mg and placebo. The graph indicates a greater decrease in IPSS score with Tadalafil 5 mg treatment over time compared to placebo, with data points at 0, 2, 4, 8, and 12 weeks. Statistical significance is noted at 12 weeks (p < 0.01).*

* 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.