Atorvastatin Calcium
Product Images NDC 10135-651

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Atorvastatin Calcium (NDC 10135-651). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Marlex Pharmaceuticals 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.

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Table 3. Clinical Adverse Reactions Occurring In ≥ 2% In Patients Treated With Any Dose Of Atorvastatin Calcium And At An Incidence Greater Than Placebo Regardless Of Causality (% Of Patients). (Atorvastatin Tablet 01)

A data table listing adverse reaction rates (%) for ATORVASTATIN CALCIUM at various dosages (10 mg, 20 mg, 40 mg, 80 mg) compared to placebo and any dose combined. Common 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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The Structural Formula For Phenylamino Carbonyl]-1h-pyrrole-1-heptanoic Acid, Calcium Salt (2:1). The Empirical Formula Of Atorvastatin Calcium Is C66h68caf2n4o10 And Its Molecular Weight Is 1155.36. (Atorvastatin Tablet 02)

Chemical structure of atorvastatin calcium, showing the detailed molecular arrangement including aromatic rings, hydroxyl groups, and the calcium ion association as indicated by Ca2+.*

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Table 4. Effect Of Co-administered Drugs On The Pharmacokinetics Of Atorvastatin (Atorvastatin Tablet 03)

A data table displaying the effects of various co-administered drugs and dosing regimens on Atorvastatin, listing the dose in mg alongside changes in AUC and Cmax fold or percentage variations for each drug regimen.*

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Table 5. Effect Of Atorvastatin On The Pharmacokinetics Of Co-administered Drugs (Atorvastatin Tablet 04)

A table showing the effects of various co-administered drugs and dosing regimens on the pharmacokinetics of Atorvastatin, detailing changes in AUC and Cmax values for different dosages and durations.*

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Figure 1: Effect Of Atorvastatin Calcium 10 mg/day On Cumulative Incidence Of Non Fatal Myocardial Infarction Or Coronary Heart Dis Ease Death (in Ascot-lla) (Atorvastatin Tablet 05)

A line graph showing cumulative incidence (%) over 3.5 years comparing Atorvastatin (solid line) and placebo (dashed line). The graph indicates a lower cumulative incidence for Atorvastatin compared to placebo, with hazard ratio (HR) 0.64 (0.50-0.83) and p-value 0.0005.*

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Figure 2: Effect Of Atorvastatin Calcium 10 mg/day On Time To Occurrence Of Major Cardiovascular Event (myocardialinfarction, Acute Chd Death, Unstable Angina, Coronary Revascularization, Or Stroke) In Cards (Atorvastatin Tablet 06)

A Kaplan-Meier curve comparing cumulative hazard percentages over time for Atorvastatin versus placebo groups. The X-axis represents time to first primary endpoint through four years of follow-up, while the Y-axis shows cumulative hazard percentage. The graph illustrates a lower cumulative hazard for the Atorvastatin group compared to placebo, including a hazard ratio (HR) of 0.63 with confidence interval (0.48-0.83) and p-value of 0.001.*

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Figure 3: Effect Of Atorvastatin Calcium 80 mg/day Vs. 10 mg/day On Time To Occurrence Of Major Cardiovascular Events (tnt) (Atorvastatin Tablet 07)

A line graph comparing subjects (%) experiencing a major cardiovascular event over time (years) for Atorvastatin 10 mg and 80 mg doses. The y-axis shows the percentage of subjects, and the x-axis represents years to first major cardiovascular endpoint, with Atorvastatin 10 mg indicated by a dashed line and 80 mg by a solid line.*

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Table 6. Overview Of Efficacy Results In Tnt (Atorvastatin Tablet 08)

A data table comparing clinical endpoints between two doses of Atorvastatin, 10 mg and 80 mg. It includes primary and secondary endpoints such as major cardiovascular events, mortality components, and specific outcomes like CHD death, stroke, and all-cause mortality, along with counts, percentages, and hazard ratios with 95% confidence intervals.*

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Table 7. Dose Response In Patients With Primary Hyperlipidemia (adjusted Mean % Change From Baseline)a (Atorvastatin Tablet 09)

A data table showing the effects of different doses of a substance compared to placebo on various lipid parameters including TC, LDL-C, Apo B, TG, HDL-C, and the ratio of Non-HDL-C to HDL-C. The table includes sample sizes and percentage changes for doses of 10, 20, 40, and 80 units.*

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Table 8. Mean Percentage Change From Baseline At Endpoint (double-blind, Randomized, Active-controlled Trials) (Atorvastatin Tablet 0a)

A data table comparing the effects of Atorvastatin Calcium 10 mg against other statins (Lovastatin 20 mg, Pravastatin 20 mg, Simvastatin 10 mg) on various lipid parameters including Total-C, LDL-C, Apo B, TG, HDL-C, and Non-HDL-C/HDL-C ratio across three different studies. The table shows mean changes and 95% confidence intervals for differences.*

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Table 9. Combined Patients With Isolated Elevated Tg: Median (min, Max) Percentage Change From Baseline (Atorvastatin Tablet 0b)

A data table displaying lipid profile changes (mean and range) for triglycerides, Total-C, LDL-C, HDL-C, VLDL-C, and non-HDL-C across placebo and three doses of Atorvastatin Calcium (10 mg, 20 mg, 80 mg). The table shows comparative values for each group with sample sizes indicated.*

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Table 10. Open-label Cross Over Study Of 16 Patients With Dysbetalipoproteinemia (fredricks On Type Iii) (Atorvastatin Tablet 0c)

A data table showing median percentage changes with minimum and maximum values at baseline for various lipid measurements, and their median percentage changes after treatment with Atorvastatin Calcium 10 mg and 80 mg. The table includes rows for Total-C, Triglycerides, IDL-C + VLDL-C, and non-HDL-C, with corresponding values for each treatment dose.*

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Table 11. Lipid-altering Effects Of Atorvastatin Calcium In Adolescent Boys And Girls With Heterozygous Familial Hypercholesterolemia Or Severe Hypercholesterolemia (mean Percentage Change From Baseline At Endpoint In Intention-to-treat Population) (Atorvastatin Tablet 0d)

A data table comparing the effects of Placebo and Atorvastatin Calcium on lipid parameters including Total-C, LDL-C, HDL-C, TG, and Apolipoprotein B. The table shows mean changes in these parameters for respective sample sizes (N) for each treatment group.*

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Principal Display Panelndc 10135-0649-10atorvastatin Calcium Tablets10 mg1000 Tabletsrx Only (Atorvastatin Tablet 0e)

Label for Atorvastatin Calcium Tablets 10 mg by Marlex Pharmaceuticals Inc. The label indicates a quantity of 1000 tablets and includes storage instructions to keep at 20° to 25°C in a child-resistant container. It also notes the prescription status (Rx Only) and displays the NDC 10135-0649-10 with a barcode. The label advises dispensing accompanying patient information to each patient.*

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Principal Display Panelndc 10135-0650-05atorvastatin Calcium Tablets20 mg500 Tabletsrx Only (Atorvastatin Tablet 0f)

Packaging label for Atorvastatin Calcium Tablets 20 mg by Marlex Pharmaceuticals, Inc. The label indicates 500 tablets per container, with storage instructions and a barcode. The product is prescription-only and includes manufacturer details for Marlex Pharmaceuticals, Inc., New Castle, DE.*

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Principal Display Panelndc 10135-0651-10atorvastatin Calcium Tablets40 mg1000 Tabletsrx Only (Atorvastatin Tablet 10)

Label for Atorvastatin Calcium Tablets 40 mg by Marlex Pharmaceuticals Inc. The label indicates a quantity of 1000 tablets, with storage instructions, a barcode, and warnings to keep out of reach of children. It is prescription only (Rx Only) and provides manufacturer details from New Castle, DE.*

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Atorvastatin Tablet 11

Label of Atorvastatin Calcium Tablets 80 mg film-coated tablets by Marlex Pharmaceuticals, Inc. The label indicates a prescription-only drug with a package size of 500 tablets. Storage instructions and dispensing guidance are shown, along with manufacturing and distribution details.*

* 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.