Spironolactone Tablet, Film Coated
Product Images NDC 67544-310

5 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Spironolactone (NDC 67544-310). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

67544 0310 45

67544 0310 45
Label for Spironolactone 25 mg film-coated tablets, containing 45 tablets per bottle, manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, and packaged by Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN. The label includes storage instructions and a barcode, with the product NDC number 67544-0310-45 and designation RX only.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Spironolactone Structural Formula (C40eeebd 2d7e 4b46 90d9 6174175cdc77 01)

Spironolactone Structural Formula (C40eeebd 2d7e 4b46 90d9 6174175cdc77 01)
Chemical structure of spironolactone, the active ingredient in Spironolactone 25 mg oral film-coated tablets by Aphena Pharma Solutions. The diagram shows the molecular arrangement including characteristic steroid rings and functional groups.*
FDA Label Image

Figure 1. Survival By Treatment Group In The Randomized Spironolactone Evaluation Study (C40eeebd 2d7e 4b46 90d9 6174175cdc77 02)

Figure 1. Survival By Treatment Group In The Randomized Spironolactone Evaluation Study (C40eeebd 2d7e 4b46 90d9 6174175cdc77 02)
A survival probability Kaplan-Meier curve comparing Spironolactone versus placebo over a period of up to 48 months. The graph shows separate lines for Spironolactone (n=522) and placebo (n=841), with the y-axis representing probability and the x-axis representing months. A log-rank p-value of less than 0.001 is noted.*
FDA Label Image

Figure 2. Hazard Ratios Of All-cause Mortality By Subgroup In The Randomized Spironolactone Evaluation Study (C40eeebd 2d7e 4b46 90d9 6174175cdc77 03)

Figure 2. Hazard Ratios Of All-cause Mortality By Subgroup In The Randomized Spironolactone Evaluation Study (C40eeebd 2d7e 4b46 90d9 6174175cdc77 03)
A forest plot depicting hazard ratios (HR) with 95% confidence intervals (CI) for various subgroups in a study comparing spironolactone versus placebo. Subgroups include age, sex, race, LVEF percentage, heart failure type, NYHA class, diabetes status, serum creatinine, creatinine clearance, potassium levels, digoxin, ACEI, and beta blocker use. The plot visually compares spironolactone's effect relative to placebo across these categories.*

* 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.