Atorvastatin Calcium
Product Images NDC 71610-094

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Atorvastatin Calcium (NDC 71610-094). 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 80 mg (71610 0094 15)

Bottle Label 80 mg (71610 0094 15)
Label for Atorvastatin Calcium 80 mg tablets, containing 15 tablets. The label includes dosage strength, tablet count, NDC number 71610-0094-15, storage instructions, and indicates it is for prescription use only. The product is manufactured by SciGen Pharmaceuticals Inc. in Hauppauge, NY, and repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN.*
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Aphena Pharma Solutions (TN)

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Figure 1 (F1)

Figure 1 (F1)
A line graph comparing the cumulative incidence percentage over time (up to 3.5 years) for Atorvastatin versus placebo. The solid line represents Atorvastatin, showing a lower cumulative incidence than the dashed line for placebo, with hazard ratio and p-value indicated at the bottom right.*
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Figure 2 (F2)

Figure 2 (F2)
A line graph showing cumulative hazard percentage over time up to 5 years, comparing placebo (dashed line) and atorvastatin (solid line). The y-axis represents cumulative hazard (%) and the x-axis shows time to first primary endpoint through four years of follow-up. The graph includes a hazard ratio (HR) of 0.63 (0.48-0.83) and a p-value of 0.001.*
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Figure 3 (F3)

Figure 3 (F3)
A Kaplan-Meier curve chart comparing the percentage of subjects experiencing a major cardiovascular event over time during a 5-year period for two dosages of atorvastatin: 10 mg (dashed line) and 80 mg (solid line). The x-axis shows time in years to first major cardiovascular endpoint, and the y-axis shows the percentage of subjects experiencing the event. A hazard ratio (HR) of 0.78 with confidence interval 0.69-0.89 and p-value 0.0002 is indicated on the chart.*
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Structural Formula (Sf)

Structural Formula (Sf)
Chemical structure of atorvastatin calcium showing a complex molecular arrangement including multiple phenyl rings, fluorine substitution, hydroxyl groups, and calcium ions. The structure depicts atorvastatin calcium as a dimeric complex with calcium ions (Ca2+).*
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Table 3 (T3)

Table 3 (T3)
A data table showing the frequency of various adverse reactions reported in clinical trials for ATORVASTATIN CALCIUM across different doses (10 mg, 20 mg, 40 mg, 80 mg) compared to placebo. Adverse reactions include nasopharyngitis, arthralgia, diarrhea, pain in extremity, urinary tract infection, dyspepsia, nausea, musculoskeletal pain, muscle spasms, myalgia, insomnia, and pharyngolaryngeal pain.*
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Effect Of Co-administered Drug (T4)

Effect Of Co-administered Drug (T4)
A data table displaying drug interaction effects of various co-administered drugs on Atorvastatin. It lists drugs and dosing regimens alongside Atorvastatin doses (ranging from 10 mg to 80 mg, single dose or multiple days) and shows corresponding changes in AUC and Cmax, reported as fold changes or percentages.*
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Effect Of Atorvastatin (T5)

Effect Of Atorvastatin (T5)
A data table showing the effects of co-administered drugs and dosing regimens on Atorvastatin pharmacokinetics. It details Atorvastatin doses with different drugs, their doses, durations, and changes in AUC and Cmax values, indicating variable pharmacokinetic interactions under specified conditions.*
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Table 6 (T6)

Table 6 (T6)
A data table comparing clinical endpoints for Atorvastatin 10 mg versus Atorvastatin 80 mg among ~5000 patients each. It includes primary and secondary cardiovascular endpoints and all-cause mortality, with counts, percentages, and hazard ratios with 95% confidence intervals for each outcome.*
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Table 7 (T7)

Table 7 (T7)
A data table showing various dose levels including placebo, 10, 20, 40, and 80, with corresponding numerical values for N, TC, LDL-C, Apo B, TG, HDL-C, and Non-HDL-C/HDL-C. The table appears to present comparative data related to these biochemical parameters across the different doses.*
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Table 8 (T8)

Table 8 (T8)
A data table presenting comparative study results of Atorvastatin Calcium 10 mg against Lovastatin 20 mg, Pravastatin 20 mg, and Simvastatin 10 mg on lipid parameters including Total-C, LDL-C, Apo B, TG, HDL-C, and Non-HDL-C/HDL-C ratios across three studies with sample sizes and 95% confidence intervals for differences.*

* 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.