Spironolactone Tablet, Film Coated
Product Images NDC 16729-226

6 FDA label images from Accord Healthcare, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Spironolactone (NDC 16729-226). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare, 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

Principal Display Panel (Spironolactone 100mg 100 Count)

Principal Display Panel (Spironolactone 100mg 100 Count)
Label for Spironolactone Tablets USP 100 mg by Accord Healthcare, Inc. The film-coated tablet container holds 100 tablets. The label includes storage instructions (20° to 25°C, protect from light) and states the product is Rx only. Manufactured by Intas Pharma Limited, India.*
FDA Label Image

Principal Display Panel (Spironolactone 25mg 100 Count)

Principal Display Panel (Spironolactone 25mg 100 Count)
Label for Spironolactone tablets, USP, 25 mg film-coated oral tablets. The label indicates the product contains 100 tablets, is Rx only, and is manufactured for Accord Healthcare, Inc. Storage and dispensing instructions are included, along with batch and barcode information.*
FDA Label Image

Principal Display Panel (Spironolactone 50mg 100 Count)

Principal Display Panel (Spironolactone 50mg 100 Count)
Label for Spironolactone 50 mg film-coated tablets, USP, manufactured for Accord Healthcare, Inc. The label indicates it is for oral use and prescription only, containing 100 tablets. Storage instructions specify controlled room temperature (20° to 25°C) and protection from light. The label includes the NDC number 16729-226-01 and manufacturer information for Intas Pharma Limited, India.*
FDA Label Image

Figure 1. Survival By Treatment Group In The Randomized Spironolactone Evaluation Study (Spironolactone Figure 1)

Figure 1.  Survival By Treatment Group In The Randomized Spironolactone Evaluation Study (Spironolactone Figure 1)
A Kaplan-Meier survival curve chart comparing the probability over time in months between two groups: Spironolactone (n=822) and Placebo (n=841). The chart shows a higher probability in the Spironolactone group over approximately 42 months. A log-rank p-value of less than 0.001 is indicated, suggesting a statistically significant difference between the groups.*
FDA Label Image

Figure 2. Hazard Ratios Of All-cause Mortality By Subgroup In The Randomized Spironolactone Evaluation Study (Spironolactone Figure 2)

Figure 2.  Hazard Ratios Of All-cause Mortality By Subgroup In The Randomized Spironolactone Evaluation Study (Spironolactone Figure 2)
A forest plot depicting subgroup analyses with hazard ratios and 95% confidence intervals for various patient characteristics comparing spironolactone versus placebo. The x-axis ranges from 0.2 to 1.4, indicating relative effect sizes, with labels suggesting 'Spironolactone better' on the left and 'Placebo better' on the right. Subgroups include age, sex, race, LVEF percentage, heart failure type, NYHA class, diabetes status, serum creatinine, creatinine clearance, potassium levels, digoxin use, ACE inhibitor use, and beta blocker use, with corresponding sample sizes and percentages.*
FDA Label Image

Chemical Structure (Spironolactone Structure Image)

Chemical Structure (Spironolactone Structure Image)
Chemical structure of spironolactone displayed as a skeletal formula showing its characteristic rings and functional groups including ketones and thioester moieties.*

* 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.