Tadalafil Tablet, Film Coated
Product Images NDC 43598-573

17 FDA label images from Dr.reddys Laboratories Inc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 43598-573). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr.reddys Laboratories 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

Carton2

Carton2
Carton label for Tadalafil Tablets, USP 5 mg film-coated tablets by Dr. Reddy's Laboratories Inc. The package is for institutional use only, contains 30 tablets in a unit-dose format (3 blister cards of 10 tablets each), and is not child-resistant. The label includes storage instructions, dosage form, strength, NDC 43598-575-31, and distributor information. The design features blue and red text on a white background.*
FDA Label Image

Carton4

Carton4
Packaging label for Tadalafil Tablets, USP 20 mg film-coated tablets by Dr. Reddy's Laboratories Inc. The carton contains 30 tablets divided into three blister cards of 10 unit-dose tablets each. Label states institutional use only, not child-resistant, and includes storage instructions. Made in India.*
FDA Label Image

Container1 (Container1)

Container1 (Container1)
Packaging label for Tadalafil Tablets, USP 2.5 mg film-coated tablets by Dr.Reddy's Laboratories Inc. The label states 30 tablets per container and includes dosage caution that tablets should not be split. The label includes storage instructions, a barcode, QR code for patient information, and maker details indicating the product is made in India and distributed by Dr. Reddy's Laboratories in Princeton, NJ.*
FDA Label Image

Container2 (Container2)

Container2 (Container2)
Tadalafil Tablets, USP 5 mg film-coated tablets in a 30-count package by Dr. Reddy's Laboratories Inc. The label includes dosing instructions, storage conditions, and a QR code linking to the patient information sheet. It states that tablets should not be split and the entire dose should be taken. The product is Rx only and made in India.*
FDA Label Image

Container3 (Container3)

Container3 (Container3)
Label for Tadalafil Tablets USP 10 mg film-coated oral tablets by Dr. Reddy's Laboratories Inc. The package contains 30 tablets. The label includes dosage instructions, storage conditions (20°C to 25°C), warnings to keep out of reach of children, and a QR code for the patient information sheet. The NDC is 43598-574-30.*
FDA Label Image

Container4 (Container4)

Container4 (Container4)
Tadalafil Tablets USP 20 mg film-coated oral tablets in a 30-tablet package by Dr. Reddy's Laboratories Inc. The label includes dosage instructions, warnings about keeping out of children's reach, and a QR code linking to a patient information sheet. The packaging states that tablets should not be split and the entire dose should be taken.*
FDA Label Image

Figure1 (Figure1)

Figure1 (Figure1)
A set of four line graphs showing the difference in blood pressure (Tadalafil minus placebo) over time in hours. The graphs illustrate changes in standing systolic blood pressure, standing diastolic blood pressure, supine systolic blood pressure, and supine diastolic blood pressure, with error bars indicating variability at each time point up to 96 hours.*
FDA Label Image

Figure2 (Figure2)

Figure2 (Figure2)
This is a figure with two line graphs showing Standing Systolic Blood Pressure and Supine Systolic Blood Pressure (mmHg) over 24 hours post-dose. The graphs compare the effects of Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg. The x-axis represents time post-dose in hours, and the y-axis represents systolic blood pressure changes in mmHg.*
FDA Label Image

Figure3 (Figure3)

Figure3 (Figure3)
A line graph depicting the change in systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo combined with doxazosin. The x-axis represents time after administration, and the y-axis shows systolic blood pressure change. Lines represent four groups: 20 mg tadalafil at 08:00, placebo at 08:00, 20 mg tadalafil at 20:00, and placebo at 20:00, all with 8 mg qd doxazosin.*
FDA Label Image

Figure4 (Figure4)

Figure4 (Figure4)
A pharmacokinetic line graph showing plasma tadalafil concentration (µg/L) over time (hours) after different dosing regimens. It compares a single 20-mg dose, a single 5-mg dose, and once-daily 5-mg dosing following 5 consecutive days of administration, with concentration values plotted from 0 to 120 hours.*
FDA Label Image

Figure5 (Figure5)

Figure5 (Figure5)
A line graph titled 'Mean IPSS Changes in BPH Patients by Visit in Study J' comparing change from baseline in IPSS total score over 12 weeks for Tadalafil 5 mg versus placebo. The graph shows two lines, one for Tadalafil 5 mg with filled circles and one for placebo with empty triangles, plotting treatment duration in weeks on the x-axis and change in IPSS score on the y-axis. The Tadalafil line shows a greater decrease in score over time compared to placebo, with a statistical significance marker (p<0.01) at 12 weeks.*
FDA Label Image

Figure6 (Figure6)

Figure6 (Figure6)
A line graph comparing change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg and placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows change from baseline in IPSS total score. Tadalafil 5 mg demonstrates a greater reduction in IPSS score compared to placebo at all measured time points, with statistical significance noted at weeks 4 and 12.*
FDA Label Image

Figure7 (Figure7)

Figure7 (Figure7)
A line graph depicting the least-squares mean change from baseline over 26 weeks of therapy, comparing Tadalafil/Finasteride and Placebo/Finasteride groups. The x-axis represents weeks of therapy (0, 4, 12, 26) and the y-axis shows change from baseline (0 to -7). Two lines show decreasing trends, with Tadalafil/Finasteride showing a greater reduction than Placebo/Finasteride, including annotations for statistical significance at various time points.*
FDA Label Image

Figure8 (Figure8)

Figure8 (Figure8)
A line graph comparing the change from baseline in IPSS total score over 12 weeks of treatment between Tadalafil 5 mg tablets and placebo. The x-axis represents treatment duration in weeks, while the y-axis shows the score change. The graph indicates a greater decrease in score for Tadalafil 5 mg than placebo, with a statistically significant difference (p<0.01) at 12 weeks.*
FDA Label Image

Image1 (Image1)

Image1 (Image1)
Tadalafil 10 mg film-coated tablet label showing a single white rectangular tablet with the imprint 'RDY 10'. The label indicates the oral dosage form and strength, with Dr.Reddys Laboratories Inc as the labeler.*
FDA Label Image

Image2 (Image2)

Image2 (Image2)
Tadalafil 20 mg film-coated tablets packaging label from Dr.Reddys Laboratories Inc. The label shows the product name, strength (20 mg), dosage form (film-coated tablets), and the labeler name. The label uses a white and light blue color scheme with minimal additional text.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure of tadalafil, displaying its molecular framework as depicted in the image.*

* 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.