Tadalafil
Product Images NDC 76519-1226

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 76519-1226). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by H.j. Harkins Company, 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

1225 Label (76519 1225 Ppac Label)

TADALAFIL 20MG tablets packaging label showing the proprietary name, strength, and dosage form. The label includes comparison information to Cialis, lot number AB00CD, expiration placeholder 00/00, and manufacturer TEVA with NDC 00093-3019-56. A caution statement about federal law and safe storage instructions is present at the top. The label also contains multiple barcodes and a repack label by H.J. Harkins Co., Inc., Grover Beach, CA.*

FDA Label Image

1226 Label (76519 1226 Ppac Label)

TADALAFIL 5MG tablet prescription drug label showing the product name, strength, dosage form, and reference to brand name CIALIS. The label includes NDC 76519-1226-XX, manufacturer TEVA with NDC 00093-3017-56, expiration and lot number placeholders, caution statements, barcodes, and repackager information for H.J. Harkins Company, Inc. Packaging specifies use as directed by physician.*

FDA Label Image

1227 Label (76519 1227 Ppac Label)

Label for TADALAFIL 10MG tablets from H.J. Harkins Company, Inc. The label includes the proprietary name, strength (10MG), dosage form (tablet), placeholder for quantity, lot number AB00CD, and expiration 00/00. The label shows manufacturer as TEVA with NDC 00093-3018-56. Safety caution and usage instructions are also present.*

FDA Label Image

Description Image (Descriptionimage)

Chemical structure of tadalafil, showing its characteristic fused ring system including an indole moiety and a substituted piperazine ring.*

FDA Label Image

Figure 1 (Figure1)

A set of four line graphs illustrating the differences in standing and supine systolic and diastolic blood pressure (BP) over time in hours, comparing Tadalafil versus placebo. The y-axes represent BP difference in mmHg, and the x-axes represent time from 0 to 96 hours.*

FDA Label Image

Figure 2 (Figure2)

Two line graphs showing changes in standing and supine systolic blood pressure over 24 hours post-dose. The top graph compares Tadalafil 20 mg with doxazosin 8 mg (solid line) versus placebo with doxazosin 8 mg (dotted line). The bottom graph shows similar comparisons for supine systolic blood pressure. Both graphs plot blood pressure changes against time in hours after dosing.*

FDA Label Image

Figure 3 (Figure3)

A line graph showing the effect of 20 mg tadalafil combined with 8 mg doxazosin versus placebo on systolic blood pressure over 12 hours. The y-axis represents systolic BP in mmHg, and the x-axis shows time after administration in hours. Multiple lines compare blood pressure changes at 08:00 and 20:00 dosing times of tadalafil and placebo with doxazosin.*

FDA Label Image

Figure 4 (Figure4)

A line graph showing plasma tadalafil concentration (mcg/L) over time (hours) for three dosing regimens: single 20 mg dose, single 5 mg dose, and once-daily 5 mg dose following 5 consecutive days of administration. The graph includes error bars representing variability in concentration at each time point.*

FDA Label Image

Figure 5 (Figure5)

A line graph comparing the change from baseline in IPSS Total Score over 12 weeks between Tadalafil 5 mg and placebo. The x-axis represents duration of treatment in weeks (0, 4, 8, 12), and the y-axis shows change from baseline in IPSS score, ranging approximately from 0 to -6. Tadalafil 5 mg shows a greater decrease in IPSS score compared to placebo, with a noted statistical significance at 12 weeks (p < 0.01).*

FDA Label Image

Figure 6 (Figure6)

A line graph comparing change from baseline in IPSS total score over treatment duration (up to 12 weeks) between Tadalafil 5 mg and placebo. The x-axis represents weeks of treatment, and the y-axis shows the change from baseline in IPSS total score. The graph indicates greater reduction with Tadalafil 5 mg over time, with some points marked as statistically significant (p<0.01).*

FDA Label Image

Figure 7 (Figure7)

A line graph showing least-squares mean change from baseline over 26 weeks of therapy comparing Tadalafil/Finasteride versus Placebo/Finasteride. The x-axis represents weeks of therapy (0, 4, 12, 26), and the y-axis represents least-squares mean change from baseline, ranging from 0.0 to -7.0. The graph plots two lines: a solid line for Tadalafil/Finasteride showing greater decrease and a dashed line for Placebo/Finasteride. Statistical significance annotations with p-values are noted on the graph.*

FDA Label Image

Figure 8 (Figure8)

A line graph comparing the change from baseline in IPSS Total Score over a 12-week treatment duration between Tadalafil 5 mg and placebo groups. The y-axis measures the change in score, and the x-axis represents weeks of treatment. Data points indicate a greater score reduction with Tadalafil than placebo, with statistical significance at p<0.01 noted.*

* 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.