Atorvastatin Calcium
Product Images NDC 43353-280

6 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · 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 Atorvastatin Calcium (NDC 43353-280). 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

Bottle Label 40 mg (43353 280 15)

Bottle Label 40 mg (43353 280 15)
The label for Atorvastatin Calcium 40 mg tablets, containing 15 tablets per package. The label displays the product NDC 43353-0280-15 and indicates it is packaged by Aphena Pharma Solutions - Tennessee, LLC located in Cookeville, TN. It includes storage instructions, manufacturer information from Kremers Urban Pharmaceuticals Inc. Princeton, NJ, and states the product is for Rx only.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Chemical Structure (Atorvastatin 01)

Chemical Structure (Atorvastatin 01)
Chemical structure of Atorvastatin Calcium showing its molecular arrangement including aromatic rings, hydroxyl groups, fluorine atom, and calcium ion complex.*
FDA Label Image

Figure 1 (Atorvastatin 02)

Figure 1 (Atorvastatin 02)
A line graph comparing cumulative incidence percentages over approximately 3.5 years for Atorvastatin and placebo groups. The solid line represents Atorvastatin, and the dashed line represents placebo, showing lower cumulative incidence in the Atorvastatin group. The graph includes a hazard ratio (HR=0.64) with confidence interval and a p-value (p=0.0005).*
FDA Label Image

Figure 2 (Atorvastatin 03)

Figure 2 (Atorvastatin 03)
A Kaplan-Meier cumulative hazard plot comparing Atorvastatin and placebo over a period of four years, showing time to first primary endpoint. The y-axis represents cumulative hazard in percentage; the x-axis represents years of follow-up. Atorvastatin shows a lower cumulative hazard than placebo, with hazard ratio (HR) 0.63 (0.48-0.83) and p=0.001.*
FDA Label Image

Figure 3 (Atorvastatin 04)

Figure 3 (Atorvastatin 04)
A line graph comparing the percentage of subjects experiencing an event over time for Atorvastatin 10 mg and 80 mg doses. The x-axis represents time to first major cardiovascular endpoint in years (0 to 5), and the y-axis represents the percentage of subjects experiencing the event (0 to 0.2%). The graph includes a hazard ratio (HR) of 0.78 (0.69-0.89) with a p-value of 0.0002, indicating a statistical measure related to the comparison.*

* 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.