FDA label
What is atorvastatin used for?
The FDA-approved uses of atorvastatin, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Atorvastatin calcium tablets are indicated: To reduce the risk of:; As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:; As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH); As an adjunct to diet for t...”
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Atorvastatin Calcium, tablet, film coated
Indications and Usage, quoted from the label by Mylan Pharmaceuticals Inc. (ANDA091226). Cross-references to other label sections are left out.
Atorvastatin calcium tablets are indicated:
- To reduce the risk of:
- oMyocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
- oMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
- oNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
- As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
- oAdults with primary hyperlipidemia.
- oAdults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
- As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
- As an adjunct to diet for the treatment of adults with:
- oPrimary dysbetalipoproteinemia
- oHypertriglyceridemia
Source: DailyMed label, set id d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d, version 28, effective June 15, 2026. NDC 0378-3950, one of 232 listings for this product.
Atorvastatin Calcium, tablet, film coated
Indications and Usage, quoted from the label by Apotex Corp. (ANDA090548). Cross-references to other label sections are left out.
Atorvastatin Calcium Tablets are indicated:
- To reduce the risk of:
- Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD
- MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD
- Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD
- As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
- Adults with primary hyperlipidemia.
- Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
- As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
- As an adjunct to diet for the treatment of adults with:
- Primary dysbetalipoproteinemia
- Hypertriglyceridemia
Source: DailyMed label, set id d9adb9e4-c495-9530-e5e3-7e3b01d53e4c, version 35, effective September 8, 2026. NDC 60505-2578, one of 67 listings for this product.
Questions
What is atorvastatin used for?
The FDA label says: “Atorvastatin calcium tablets are indicated: To reduce the risk of:; As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:; As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH); As an adjunct to diet for t...”
What drug class is atorvastatin?
FDA lists atorvastatin in the HMG-CoA Reductase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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