Atorvastatin
Atorvastatin is a statin (HMG-CoA reductase inhibitor) taken with diet to lower cholesterol and triglycerides and to reduce the risk of heart attack and stroke.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 271 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Atorvastatin (Lipitor) is a statin used with a healthy diet to lower cholesterol and cut the risk of heart attack and stroke; it blocks a liver enzyme that makes cholesterol, so the liver pulls more LDL (“bad” cholesterol) from the blood. On the market since the mid-1990s and available generically, it is a common first choice and one of the most prescribed drugs in the U.S. Most people tolerate it well, and the side effects they notice tend to be mild: joint or limb aches, an upset stomach or a stuffy nose. Call your prescriber promptly about unexplained muscle pain or weakness, which can rarely signal serious muscle damage, or about yellowing skin or eyes.
Clinical pearls
- Unlike some older statins, it does not need to be taken at bedtime; any time of day, with or without food, works.
- If you are prescribed clarithromycin, itraconazole, gemfibrozil, cyclosporine or colchicine, mention atorvastatin, since muscle risk rises with these.
- A normal glass of grapefruit juice is fine; the label warns only against very large amounts, over 1.2 liters a day.
- Statins can nudge blood sugar and HbA1c (a longer-term blood sugar average) up, so expect closer checks if you have prediabetes.
Patient information guide — a plain-language walkthrough of Atorvastatin, written from its FDA label.
What Atorvastatin is used for
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Atorvastatin is used with diet for several heart and cholesterol conditions. Uses below come from the atorvastatin calcium tablet labels.
- Lowering the risk of heart attack, stroke, revascularization procedures (procedures to restore blood flow) and angina in adults with multiple risk factors for CHD but no clinically evident CHD
- Lowering the risk of heart attack and stroke in adults with type 2 diabetes and multiple risk factors for CHD
- Lowering the risk of heart attack, stroke, revascularization procedures, hospitalization for heart failure and angina in adults with CHD
- Lowering LDL cholesterol and other lipids in adults with primary hyperlipidemia and mixed dyslipidemia
- Treating high triglycerides (hypertriglyceridemia) and primary dysbetalipoproteinemia in adults
- Lowering cholesterol in homozygous familial hypercholesterolemia, alongside other treatments or if they are unavailable
- Lowering cholesterol in children 10 to 17 with heterozygous familial hypercholesterolemia after diet alone has not worked
It has not been studied where the main problem is high chylomicrons (Fredrickson Types I and V).
How Atorvastatin works
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Atorvastatin blocks HMG-CoA reductase, the liver enzyme that is the key step in making cholesterol. With less cholesterol made, the liver adds more LDL receptors to its surface and clears more LDL from the blood.
It also lowers LDL production and the number of LDL particles.
Atorvastatin dosage
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Atorvastatin tablets are taken by mouth once a day, at any time, with or without food.
- Your prescriber chooses a starting dose based on your goals and adjusts it based on your response.
- Cholesterol is usually rechecked a few weeks after starting or changing the dose.
- If you miss a dose, one tablet label says to skip it and resume your next scheduled dose.
Follow your prescriber and the label on your prescription.
Dosing details from the FDA-approved label
From the Atorvastatin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb) - adults
- Recommended starting dose is 10 or 20 mg once daily
- Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily
- Dosage range is 10 to 80 mg once daily
- Can be given as a single dose at any time of the day, with or without food
- Maximum: 80 mg once daily
- Lipid levels should be analyzed within 2 to 4 weeks after initiation and/or titration and dosage adjusted accordingly
- Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)
- Recommended starting dose is 10 mg/day
- Usual dose range is 10 mg to 20 mg once daily
- Maximum: 20 mg/day (doses greater than 20 mg have not been studied in this patient population)
- Adjustments should be made at intervals of 4 weeks or more
- Homozygous Familial Hypercholesterolemia
- 10 to 80 mg daily, as an adjunct to other lipid lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable
- Patients with renal impairment
- Dosage adjustment in patients with renal dysfunction is not necessary
- Renal disease does not affect the plasma concentrations nor LDL-C reduction
- Patients taking clarithromycin, itraconazole, or (with HIV) saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir (also elbasvir plus grazoprevir or letermovir in newer labels)
- Therapy should be limited to 20 mg, with appropriate clinical assessment to ensure the lowest dose necessary is employed
- Maximum: 20 mg
- Patients taking nelfinavir (or boceprevir in older label)
- Therapy should be limited to 40 mg
- Maximum: 40 mg
- Patients with HIV taking lopinavir plus ritonavir
- Use the lowest dose necessary
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Take orally once daily with or without food ( 2.1 ). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust dosage if necessary ( 2.1 ). Adults ( 2.2 ): Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily. Patients requiring LDL-C reduction >45% may start at 40 mg once daily. Pediatric Patients Aged 10 Years of Age and Older with HeFH: Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily ( 2.3 ). Pediatric Patients Aged 10 Years of Age and Older with HoFH : Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily ( 2.4 ). See full prescribing information for atorvastatin calcium tablets dosage modifications due to drug interactions ( 2.5 ). 2.1 Important Dosage Information Take atorvastatin calcium tablets orally once daily at any time of the day, with or without food. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary. If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose. 2.2 Recommended Dosage in Adult Patients The recommended starting dosage of atorvastatin calcium tablets is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily. 2.3 Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of atorvastatin calcium tablets is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily. 2.4 Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH The recommended starting dosage of atorvastatin calcium tablets is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. 2.5 Dosage Modifications Due to Drug Interactions Concomitant use of atorvastatin calcium tablets with the following drugs requires dosage modification of atorvastatin calcium tablets [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )] .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Atorvastatin side effects
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Common side effects
- Stuffy or runny nose and sore throat (nasopharyngitis)
- Joint pain
- Diarrhea
- Pain in arms or legs
- Urinary tract infection
- Upset stomach or nausea
- Muscle pain or spasms
- Trouble sleeping
When to get medical help
- Call your doctor promptly for unexplained muscle pain, tenderness or weakness, especially with fever or feeling unwell. This can signal serious muscle damage (rhabdomyolysis).
- Get help for signs of liver problems such as yellowing of the skin or eyes (jaundice).
- Seek urgent care for signs of a severe allergic reaction, such as swelling of the face or throat, or a serious skin rash with blistering.
- Report muscle weakness that continues or gets worse, even after stopping the medicine.
- Tell your doctor about memory loss or confusion; this has been reported rarely and usually reversed after stopping a statin.
- Report new or worsening muscle weakness affecting the eyes or other muscles (myasthenia gravis has been reported rarely).
Most people tolerate atorvastatin well. Common effects reported in studies include:
- Stuffy nose and sore throat
- Joint pain
- Diarrhea
- Pain in arms or legs
- Urinary tract infection
- Upset stomach and nausea
- Muscle pain and spasms
- Trouble sleeping
Call your doctor promptly for unexplained muscle pain or weakness, yellowing of the skin or eyes, or signs of a serious allergic reaction.
Atorvastatin warnings and precautions
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- Muscle damage: rare but serious rhabdomyolysis can injure the kidneys. Risk is higher with age 65 or older, higher doses, kidney problems, uncontrolled underactive thyroid and certain drugs.
- Immune-mediated necrotizing myopathy: a rare autoimmune muscle condition. Weakness can persist after stopping.
- Liver problems: liver enzymes can rise, and rare liver failure has been reported. Alcohol use or liver disease raises risk.
- Blood sugar: HbA1c and fasting glucose can increase.
- Hemorrhagic stroke: in one study, the 80 mg dose was linked to more brain bleeding stroke in people with a recent hemorrhagic stroke.
Atorvastatin interactions
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Some medicines and foods raise atorvastatin levels or change other drugs, so tell your pharmacist about everything you take.
- Cyclosporine and gemfibrozil: not recommended because of muscle damage risk.
- Some HIV and hepatitis C medicines: some are not recommended and others limit the atorvastatin dose.
- Clarithromycin and itraconazole: atorvastatin dose is limited.
- Niacin (cholesterol-lowering doses), other fibrates and colchicine: higher muscle risk.
- Grapefruit juice (more than 1.2 liters a day): raises atorvastatin levels.
- Rifampin: take together with atorvastatin at the same time.
- Digoxin: levels may rise.
- Oral contraceptives: hormone levels may rise.
Interactions listed in the FDA-approved label
From the Atorvastatin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Cyclosporine or gemfibrozil: Atorvastatin plasma levels were significantly increased with cyclosporine; the risk of myopathy and rhabdomyolysis is increased with concomitant use. Concomitant use is not recommended.
- Anti-viral medications (tipranavir plus ritonavir, glecaprevir plus pibrentasvir, lopinavir plus ritonavir, simeprevir, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, elbasvir plus grazoprevir, letermovir, nelfinavir, ledipasvir plus sofosbuvir): Atorvastatin plasma levels were significantly increased; cases of myopathy and rhabdomyolysis have been reported with ledipasvir plus sofosbuvir. Tipranavir plus ritonavir or glecaprevir plus pibrentasvir not recommended; do not exceed 20 mg with saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir; do not exceed 40 mg with nelfinavir; consider risk/benefit with lopinavir plus ritonavir, simeprevir, or ledipasvir plus
- Select azole antifungals or macrolide antibiotics (erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, voriconazole): Atorvastatin plasma levels were significantly increased due to inhibition of CYP3A4 and/or transporters. With clarithromycin or itraconazole, do not exceed 20 mg; consider risk/benefit with other azole antifungals or macrolide antibiotics; monitor for signs and symptoms of myopathy.
- Niacin (lipid modifying dosages, ≥1 gram/day): Cases of myopathy and rhabdomyolysis have been observed with concomitant use. Consider if the benefit outweighs the increased risk; if used together, monitor for signs and symptoms of myopathy.
- Fibrates (other than gemfibrozil): Fibrates may cause myopathy when given alone; the risk of myopathy and rhabdomyolysis is increased with concomitant use. Consider if the benefit outweighs the increased risk; if used together, monitor for signs and symptoms of myopathy.
- Colchicine: Cases of myopathy and rhabdomyolysis have been reported with concomitant use. Consider the risk/benefit; if used together, monitor for signs and symptoms of myopathy.
- Grapefruit juice: Consumption, especially excessive consumption, more than 1.2 liters/daily, can raise plasma levels of atorvastatin and may increase the risk of myopathy and rhabdomyolysis. Avoid intake of large quantities of grapefruit juice, more than 1.2 liters daily.
- Rifampin: Can lead to variable reductions in atorvastatin plasma concentrations; delayed administration of atorvastatin after rifampin has been associated with a significant reduction in atorvastatin plasma concentrations. Administer atorvastatin calcium and rifampin simultaneously.
- Oral contraceptives: Coadministration increased plasma concentrations of norethindrone and ethinyl estradiol. Consider this when selecting an oral contraceptive.
- Digoxin: When multiple doses of atorvastatin and digoxin were coadministered, steady state plasma digoxin concentrations increased. Monitor patients taking digoxin appropriately.
Read the label’s full interactions text
7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of atorvastatin calcium with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis ( 2.5 , 7.1 ). Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin calcium ( 7.2 ). Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.3 ). Digoxin: May increase digoxin plasma levels; monitor patients appropriately ( 7.3 ). 7.1 Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Atorvastatin calcium is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin calcium plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 2 includes a list of drugs that may increase exposure to atorvastatin calcium and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology ( 12.3 )] . Table 2: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [see Clinical Pharmacology (12.3)]. Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium. Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium is not recommended.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Atorvastatin
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- Do not use with acute liver failure or decompensated cirrhosis, or with allergy to atorvastatin or its ingredients.
- Tell your doctor about liver disease or heavy alcohol use.
- Kidney problems and uncontrolled underactive thyroid raise muscle risk.
- Older adults (65+) have higher muscle risk and need monitoring.
- Pregnancy: may cause fetal harm. Stop when pregnancy is recognized, or discuss with your doctor.
- Breastfeeding is not recommended.
- Children under 10: safety and effectiveness are not established.
Atorvastatin overdose
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No specific antidote for atorvastatin overdose is known. Contact Poison Control at 1-800-222-1222 for the latest advice. Dialysis is not expected to help much because the drug binds strongly to proteins in the blood.
What Atorvastatin does in the body
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Atorvastatin and some of its breakdown products are active. The liver is the main site where it works. How much LDL cholesterol drops depends more on the dose than on the amount in the blood, so dosing is adjusted based on your response.
How your body processes Atorvastatin
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Atorvastatin is absorbed quickly, with peak blood levels in 1 to 2 hours. Only about 14% of the drug reaches the blood unchanged because the gut and liver process much of it first. Food or time of day changes blood levels slightly but not the cholesterol-lowering effect.
The liver breaks it down, partly using the CYP3A4 enzyme, into active products. It leaves mainly through bile, and less than 2% appears in urine. Its half-life is about 14 hours, and its cholesterol-blocking activity lasts 20 to 30 hours.
How to store Atorvastatin
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Store at 20° to 25°C (68° to 77°F). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Atorvastatin
181 supplements and herbal products have documented interactions with Atorvastatin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 9
- Moderate · 136
- Minor · 36
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Atorvastatin has been associated with lower levels of 2 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Atorvastatin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Atorvastatin — the kind of thing our pharmacy team would talk through with you at the counter.
What is atorvastatin for?
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How and when should I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Can I drink grapefruit juice or take other medicines with it?
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Is it safe in pregnancy or while breastfeeding?
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Is Atorvastatin available over the counter?
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When was Atorvastatin first available?
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Who makes Atorvastatin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Atorvastatin on HelloPharmacist
Atorvastatin forms and strengths (how it comes)
Atorvastatin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Atorvastatin Calcium tablets are used with diet to lower LDL cholesterol and triglycerides in adults with high cholesterol.
- Atorvastatin Calcium tablets reduce the risk of heart attack and stroke in adults with CHD or with multiple risk factors for it, including people with type 2 diabetes.
- Atorvastatin Calcium tablets are used in children 10 and older with heterozygous or homozygous familial hypercholesterolemia, as described on the label.
- Atorvastatin Calcium tablets are taken by mouth once daily, at any time of day, with or without food.
- Atorvastatin Calcium tablets: your doctor may recheck cholesterol a few weeks after starting or changing the dose.
Atorvastatin on the U.S. market: products, makers and brands
How Atorvastatin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
108 companies list 1,086 Atorvastatin product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1996. Brand names on the directory include Lipitor, Atorvaliq; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (30) · Granule (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Atorvastatin is used (Medicaid data)
A general measure of how commonly Atorvastatin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Atorvastatin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Atorvastatin prescribed? Of the 1,601 medications we measure, Atorvastatin ranks #4 by Medicaid prescriptions — more than 100% of them.
Utilization by Atorvastatin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
atorvastatin 40 MG Oral Tablet Most dispensed
Summed across the 62 of 463 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617311
atorvastatin 20 MG Oral Tablet
Summed across the 56 of 482 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617310
atorvastatin 10 MG Oral Tablet
Summed across the 53 of 422 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 617312
atorvastatin 80 MG Oral Tablet
Summed across the 55 of 354 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 259255
Other Atorvastatin products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 36 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Atorvastatin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 227 of 1,757 listed Atorvastatin NDCs with Medicaid activity.
Compare Atorvastatin products
A representative set of FDA-listed product records for Atorvastatin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 10 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 20 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 40 mg | Oral | A-S Medication Solutions × 6 listings | ANDA | View NDC → |
| 80 mg | Oral | A-S Medication Solutions × 5 listings | ANDA | View NDC → |
| 10 mg | Oral | Agnitio Inc. | ANDA | View NDC → |
| 20 mg | Oral | Agnitio Inc. | ANDA | View NDC → |
| 40 mg | Oral | Agnitio Inc. | ANDA | View NDC → |
| 80 mg | Oral | Agnitio Inc. | ANDA | View NDC → |
| 10 mg | Oral | August Pharmaceutical, LLC | ANDA | Find on DailyMed ↗ |
| 20 mg | Oral | August Pharmaceutical, LLC | ANDA | Find on DailyMed ↗ |
| 40 mg | Oral | August Pharmaceutical, LLC | ANDA | Find on DailyMed ↗ |
| 80 mg | Oral | August Pharmaceutical, LLC | ANDA | Find on DailyMed ↗ |
| 20 mg | Oral | Bryant Ranch Prepack × 6 listings | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 80 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 10 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 20 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 20 mg | Oral | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Find on DailyMed ↗ |
| 20 mg | Oral | DirectRX × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Direct Rx × 2 listings | ANDA | View NDC → |
| 80 mg | Oral | DirectRx | ANDA | View NDC → |
| 10 mg | Oral | Direct_Rx × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Direct_Rx × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Dr. Reddy's Laboratories Inc × 5 listings | ANDA | View NDC → |
| 20 mg | Oral | Dr. Reddy's Laboratories Inc × 5 listings | ANDA | View NDC → |
| 40 mg | Oral | Dr. Reddy's Laboratories Inc × 5 listings | ANDA | View NDC → |
| 80 mg | Oral | Dr. Reddy's Laboratories Inc × 5 listings | ANDA | View NDC → |
| 10 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 20 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 40 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 80 mg | Oral | Dr. Reddy's Laboratories Limited | ANDA | View NDC → |
| 10 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 80 mg | Oral | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Macleods Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Macleods Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Macleods Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 80 mg | Oral | Macleods Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Mckesson Corporation DBA SKY Packaginng | ANDA | Find on DailyMed ↗ |
| 20 mg | Oral | Mckesson Corporation DBA SKY Packaginng | ANDA | Find on DailyMed ↗ |
| 40 mg | Oral | Mckesson Corporation DBA SKY Packaginng | ANDA | Find on DailyMed ↗ |
| 80 mg | Oral | Mckesson Corporation DBA SKY Packaginng | ANDA | Find on DailyMed ↗ |
| 10 mg | Oral | Nivagen Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | Nivagen Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 40 mg | Oral | Nivagen Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 80 mg | Oral | Nivagen Pharmaceuticals, Inc. × 3 listings | ANDA | View NDC → |
| 10 mg | Oral | Northstar Rx LLC. | ANDA | View NDC → |
| 20 mg | Oral | Northstar Rx LLC. | ANDA | View NDC → |
| 40 mg | Oral | Northstar Rx LLC. | ANDA | View NDC → |
| 80 mg | Oral | Northstar Rx LLC. | ANDA | View NDC → |
| 10 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | NuCare Pharmaceuticals,Inc. × 4 listings | ANDA | View NDC → |
| 40 mg | Oral | NuCare Pharmaceuticals,Inc. × 4 listings | ANDA | View NDC → |
| 80 mg | Oral | NuCare Pharmaceuticals,Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Preferred Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 80 mg | Oral | Preferred Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 20 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 40 mg | Oral | Preferred Pharmaceuticals Inc. | ANDA | View NDC → |
| 40 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 40 mg | Oral | RedPharm Drug, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 20 mg | Oral | Remedyrepack Inc. × 5 listings | ANDA | View NDC → |
| 40 mg | Oral | Remedyrepack Inc. × 5 listings | ANDA | View NDC → |
| 80 mg | Oral | Remedyrepack Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 20 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 40 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 80 mg | Oral | Umedica Laboratories USA Inc. | ANDA | View NDC → |
| 10 mg | Oral | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 80 mg | Oral | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Zydus Pharmaceuticals USA Inc. × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | Zydus Pharmaceuticals USA Inc. × 3 listings | ANDA | View NDC → |
| 40 mg | Oral | Zydus Pharmaceuticals USA Inc. × 3 listings | ANDA | View NDC → |
| 80 mg | Oral | Zydus Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.) | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Apotex Inc. | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Arch Pharmalabs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Biocon Limited | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Cadila Pharmaceuticals Limited | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Centrient Pharmaceuticals India Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Chromo Laboratories India Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dr. Reddy's Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Dr.Reddys Laboratories Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Drugs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Labs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Jubilant Biosys limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Lee Pharma Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Matrix Pharmacorp Private Limited × 2 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSD International GmbH (Singapore Branch) | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Pharmachem Private Limited × 3 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Mylan Laboratories Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 kg/kg | — | Novartis Pharmaceuticals Corporation | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Professional Compounding Centers of America dba PCCA | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Pure And Cure Healthcare Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Signa S.A. de C.V. | BULK INGREDIENT | View NDC → |
| 25 kg/25 kg | — | Sun Pharmaceutical Industries, Inc. | BULK INGREDIENT | View NDC → |
| 100 kg/100 kg | — | Teva API India Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Upjohn Manufacturing Ireland Unlimited Company | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Willow Birch Pharma, LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Willow Birch Pharma, LLC | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Zhejiang Jiangbei Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zhejiang Lepu Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
Showing 200 of 1,086 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1,086 Atorvastatin NDCs →
Atorvastatin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Atorvastatin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Atorvastatin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Atorvastatin FDA approval history
How Atorvastatin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Atorvastatin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 6 Atorvastatin recalls since July 2021, covering 12 product listings. Three of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories… Lots: Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. A… FDA record D-0020-2026 →
- Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, D… Lots: Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913… FDA record D-0019-2026 →
- Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India… Lots: Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026 FDA record D-0018-2026 →
- Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Labora… Lots: Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. J… FDA record D-0017-2026 →
- Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDI… Lots: Lot#: AVC24035, Exp 03/31/26 FDA record D-0306-2025 →
- Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52 Lots: Lot # F117192201, Exp. Date 4/30/2023 FDA record D-0548-2023 →
- Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., V… Lots: Lot #: U24T0408A, Exp: 03/31/2026 FDA record D-0001-2025 →
- Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthca… Lots: Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2… FDA record D-0374-2023 →
- Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Health… Lots: Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024… FDA record D-0373-2023 →
- Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, Manufactured for: Accord Health… Lots: Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060,… FDA record D-0372-2023 →
- Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healt… Lots: Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613,… FDA record D-0371-2023 →
- Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90 Lots: Lot: T000707, T000756, T000758, T000759, Exp 03/2022; T2100600, T2101075, Exp. 1/2023; T2102802, Exp. 07/2023 FDA record D-0726-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 83367 2 dose forms · 5 strengths
-
Dose form (SCDF) Oral Suspension RxCUI 2630759No current FDA listingClinical drug / strength (SCD) 4 MG/MLRxCUI 2630760 -
Dose form (SCDF) Oral Tablet RxCUI 370621In current FDA listings
Look up RxCUI 83367 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Atorvastatin supply and shortage status
Whether Atorvastatin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Atorvastatin brand names
Atorvastatin is sold under 2 brand names in the FDA directory — Lipitor, Atorvaliq. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Atorvastatin: manufacturers and labelers
40 companies list Atorvastatin products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, NuCare Pharmaceuticals,Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 16 more on the FDA NDC directory.
Atorvastatin drug class (RxNorm)
Atorvastatin belongs to the HMG-CoA Reductase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Atorvastatin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Viatris Specialty LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →