Atorvastatin Calcium
Product Images NDC 43353-892

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

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Atorvastatin Calcium (NDC 43353-892). 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 40mg (43353 826)

Bottle Label 40mg (43353 826)
Label for Atorvastatin Calcium 40 mg tablets, containing 15 tablets. The label shows the product name, strength, and quantity. It includes storage instructions and manufacturer information, noting Pfizer Ireland Pharmaceuticals as the manufacturer and Aphena Pharma Solutions - Tennessee, LLC as the repackager. The label also indicates the product is Rx only and displays relevant barcodes and lot/batch numbers.*
FDA Label Image

Bottle Label 80mg (43353 827)

Bottle Label 80mg (43353 827)
Label for Atorvastatin Calcium 80 mg tablets, containing 15 tablets per package. The label shows the product name, strength, and quantity, and notes the manufacturer as Pfizer Ireland Pharmaceuticals in Dublin, Ireland. It is repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. Storage instructions and barcode are also visible.*
FDA Label Image

Bottle Label 20mg (43353 892)

Bottle Label 20mg (43353 892)
Label for Atorvastatin Calcium 20 mg tablets, package containing 45 tablets. The label shows the manufacturer as Pfizer Ireland Pharmaceuticals, Dublin, Ireland, and repackager Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN. It includes storage instructions and indicates the product is for prescription use only.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Chemical Structure (Atorvastatin 01)

Chemical Structure (Atorvastatin 01)
Chemical structure diagram of atorvastatin calcium, showing its molecular arrangement including phenyl rings, fluorophenyl group, hydroxyl groups, and calcium ion coordination with three water molecules.*
FDA Label Image

Figure 1 (Atorvastatin 02)

Figure 1 (Atorvastatin 02)
A line graph showing cumulative incidence (%) on the y-axis against years on the x-axis up to 3.5 years. Two lines compare Atorvastatin and placebo groups, with Atorvastatin showing a lower cumulative incidence. The graph includes a hazard ratio (HR=0.64 [0.50-0.83]) and a p-value (p=0.0005).*
FDA Label Image

Figure 2 (Atorvastatin 03)

Figure 2 (Atorvastatin 03)
A Kaplan-Meier curve showing cumulative hazard over time comparing Atorvastatin with placebo. The graph plots cumulative hazard percentage on the vertical axis against time in years on the horizontal axis, covering up to four years of follow-up for time to first primary endpoint. Atorvastatin shows a lower cumulative hazard compared to placebo, with a hazard ratio (HR) of 0.63 (95% CI: 0.48 to 0.83) and a p-value of 0.001.*
FDA Label Image

Figure 3 (Atorvastatin 04)

Figure 3 (Atorvastatin 04)
A Kaplan-Meier curve comparing Atorvastatin 10 mg versus 80 mg showing the percentage of subjects experiencing the first major cardiovascular event over a 5-year period. The graph includes hazard ratio (HR) and p-value indicating statistical analysis.*
FDA Label Image

Greenstone Logo (Atorvastatin 05)

* 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.