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Atorvastatin Calcium 20 mg Tablet, Film Coated, 90-count — NDC 68071-2687-9 (Billing 68071-2687-09)

by NuCare Pharmaceuticals,Inc. · 90 TABLET, FILM COATED in 1 BOTTLE

This is a package of 90 tablets of Atorvastatin Calcium 20 mg Tablet, Film Coated from NuCare Pharmaceuticals,Inc., no longer marketed (first marketed Dec 2011), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 68071-2687-09
🏷️ FDA NDC (as labeled) 68071-2687-9 billing pads the package segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jun 25, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Atorvastatin Calcium (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0020-2026
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0019-2026
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0017-2026
Class II · Sep 19, 2025 — Failed Dissolution Specifications (Ascend Laboratories, LLC) · FDA recall D-0018-2026
Class II · Mar 17, 2025 — Failed dissolution specifications: lower than specifications (BIOCON PHARMA INC) · FDA recall D-0306-2025
Class II · Mar 16, 2023 — CGMP Deviations (Northwind Pharmaceuticals LLC) · FDA recall D-0548-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Mar 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68071-2687-9
Product NDC 68071-2687
11-digit billing NDC 68071268709
RxCUI 617310
UNII 48A5M73Z4Q
UPC 0368071268799
Application # ANDA076477
SPL Set ID de45a760-4441-182e-e053-2995a90a2ffe
Established class (EPC) HMG-CoA Reductase Inhibitor
Mechanism of action Hydroxymethylglutaryl-CoA Reductase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Mar 2025)
Marketing start 2011-12-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance ATORVASTATIN CALCIUM TRIHYDRATE
Quick answers
  • RxCUI (RxNorm): 617310
Why two NDCs? The FDA registers this code as 68071-2687-9 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68071-2687-09. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the HMG-CoA Reductase Inhibitor class.

Pharmacologic class HMG-CoA Reductase Inhibitor
Drug family (ATC) HMG CoA reductase inhibitors
How it works Hydroxymethylglutaryl-CoA Reductase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It lowers LDL cholesterol and triglycerides when used with diet. It also lowers the risk of heart attack and stroke in adults who have CHD or are at higher risk, including people w...
  • Take it by mouth once a day. Any time of day works, and you can take it with or without food. Pick a time you will remember. If you miss a dose, one label says to skip it and take...
  • Common ones include stuffy nose, joint or muscle aches, diarrhea, upset stomach, and trouble sleeping. Many people have few problems. If muscle pain is unexplained or comes with we...
  • Call for unexplained muscle pain, tenderness or weakness, especially with fever. Also call for yellow skin or eyes, or signs of a serious allergy like facial swelling or a blisteri...
📖 Read our full Atorvastatin guide →
2
Nutrient depletion considerations

Atorvastatin Calcium may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Atorvastatin Calcium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68071-2687-09 You're viewing this Main listing 90 TABLET, FILM COATED in 1 BOTTLE 2022-05-05 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atorvastatin Calcium 20 mg 55111-0122-05 Dr. 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 72603-0283-01 NorthStar 90 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 50228-0452-05 ScieGen 500 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 70756-0248-12 Lifestar 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 82009-0177-10 Quallent 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 51079-0209-20 Mylan 1 tablet $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 33342-0316-10 Macleods 90 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 31722-0425-05 Camber 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 42385-0941-01 Laurus 100 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 43598-0099-05 Dr. 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 43598-0831-05 Dr. 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 00480-3586-10 Teva 1000 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 72205-0023-05 Novadoz 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 42571-0173-10 Micro 1000 tablets $0.028 AB Discontinued —
atorvastatin calcium 20 mg 70710-1775-00 Zydus 1000 tablets $0.028 AB Availability likely —
Atorvastatin calcium 20 mg 72603-0404-02 NorthStar 100 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 67877-0512-05 Ascend 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 70377-0078-11 Biocon 90 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 00093-5059-10 Teva 1000 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 00378-3951-05 Mylan 500 tablets $0.028 AB Availability likely —
Atorvastatin Calcium 20 mg 69097-0945-05 Cipla 90 tablets $0.041 AB FDA listed —
Atorvastatin Calcium 20 mg 68180-0636-02 Lupin 500 tablets $0.041 — Discontinued —
Atorvastatin Calcium 20 mg 16729-0045-15 Accord 90 tablets $0.041 AB FDA listed —
Lipitor 20 mg 58151-0156-77 Viatris 90 tablets $19.073 AB Availability likely —
Atorvastatin Calcium 20 mg 69097-0898-05 Cipla 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71205-0247-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71610-0022-45 Aphena 45 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-5634-00 A-S 30 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 71610-0744-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 82804-0054-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 42708-0141-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 51655-0464-52 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 72189-0587-30 Direct_Rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 76420-0945-00 Asclemed 1000 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 63629-8471-01 Bryant 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-3580-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 70518-4587-00 REMEDYREPACK 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 48433-0008-20 Safecor 1 tablet — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7386-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 67046-1403-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 67046-1453-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mgthis 68071-2687-09 NuCare 90 tablets — — Discontinued —
Atorvastatin Calcium 20 mg 70518-3037-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin calcium 20 mg 70518-4423-00 REMEDYREPACK 100 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71335-1929-01 Bryant 30 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 77771-0452-05 Radha 500 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7529-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 63629-8470-01 Bryant 500 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68788-8625-01 Preferred 100 tablets — AB FDA listed —
atorvastatin calcium 20 mg 82137-0017-01 Lepu 90 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 67046-1526-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 68071-5292-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 68788-4096-03 Preferred 30 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 70518-3339-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin Calcium 20 mg 71335-1507-01 Bryant 30 tablets — AB Discontinued —
Atorvastatin calcium 20 mg 71335-2799-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-5182-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7387-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-7528-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 59651-0607-60 Aurobindo 60000 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 67046-1505-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-2824-09 NuCare 90 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 71335-1010-01 Bryant 30 tablets — — FDA listed —
atorvastatin calcium 20 mg 50090-7723-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 67046-1643-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-3659-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-5168-03 NuCare 30 tablets — AB FDA listed —
atorvastatin calcium 20 mg 70771-1876-00 Zydus 1000 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 71209-0091-04 Cadila 90 tablets — — FDA listed —
Atorvastatin Calcium 20 mg 71335-2393-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin calcium 20 mg 72789-0084-30 PD-Rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 82804-0161-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 42708-0004-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 50090-5181-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 60760-0883-90 St. 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-4840-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68788-8683-01 Preferred 100 tablets — AB FDA listed —
atorvastatin calcium 20 mg 50090-7722-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 68071-3714-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 20 mg 72162-1555-05 Bryant 500 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2011
On the market since
Dec 2011
📍
2026
Currently FDA-listed
15 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA076477 (ANDA)
Labeler code68071
First marketedDec 2011
Product typeHuman Prescription Drug
Portfolio1,015 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.

Atorvastatin calcium tablets are HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in adult patients without CHD, but with multiple risk factors (1.1). Reduce the risk of MI and stroke in adult patients with type 2 diabetes without CHD, but with multiple risk factors (1.1). Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in adult patients with CHD (1.1).

Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2). Reduce elevated TG in adult patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2). Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2).

Reduce elevated total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trial of diet therapy (1.2). Limitations of Use: Atorvastatin calcium tablets have not been studied in Fredrickson Types I and V dyslipidemias (1.3).

1.1Prevention of Cardiovascular Disease in Adults In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke Reduce the risk for revascularization procedures and angina In adult patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to: Reduce the risk of myocardial infarction Reduce the risk of stroke In adult patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to: Reduce the risk of non-fatal myocardial infarction Reduce the risk of fatal and non-fatal stroke Reduce the risk for revascularization procedures Reduce the risk of hospitalization for CHF Reduce the risk of angina

1.2Hyperlipidemia Atorvastatin calcium tablets are indicated: As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in adult patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia ( Fredrickson Types IIa and IIb); As an adjunct to diet for the treatment of adult patients with elevated serum TG levels ( Fredrickson Type IV); For the treatment of adult patients with primary dysbetalipoproteinemia ( Fredrickson Type III) who do not respond adequately to diet; To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable; As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in pediatric patients, 10 years to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) if after an adequate trial of diet therapy the following findings are present: LDL-C remains ≥ 190 mg/dL or LDL-C remains ≥ 160 mg/dL and: there is a positive…

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Dose range: 10 to 80 mg once daily (2.1). Recommended start dose: 10 or 20 mg once daily (2.1). Patients requiring large LDL-C reduction (> 45%) may start at 40 mg once daily (2.1). Pediatric patients with HeFH: starting dose: 10 mg once daily; dose range: 10 to 20 mg/day for patients 10 years to 17 years of age (2.2).

2.1Hyperlipidemia and Mixed Dyslipidemia The recommended starting dose of atorvastatin calcium tablets 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. The dosage range of atorvastatin calcium tablets is 10 to 80 mg once daily.

Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of atorvastatin calcium tablets should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

2.2Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 Years to 17 Years of Age) The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the usual dose range is 10 to 20 mg orally once daily [see Clinical Studies (14.6)] . Doses should be individualized according to the recommended goal of therapy [see Indications and Usage (1.2) and Clinical Pharmacolog y (12)] . Adjustments should be made at intervals of 4 weeks or more.

2.3Homozygous Familial Hypercholesterolemia The dosage of atorvastatin calcium tablets in patients with HoFH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

2.4Concomitant Lipid-Lowering Therapy Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions (5.1) and Drug Interactions (7)] .

2.5Dosage in Patients with Renal Impairment Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin calcium tablets; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)] .

2.6Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, Letermovir, or Certain Protease Inhibitors In patients taking cyclosporine or the HIV protease inhibitor tipranavir plus ritonavir or the hepatitis C virus (HCV) protease inhibitor glecaprevir plus pibrentasvir or letermovir when co-administered with cyclosporine, therapy with atorvastatin calcium tablets should be avoided. In patients with HIV taking lopinavir plus ritonavir, use the lowest dose necessary of atorvastatin calcium tablets. In patients taking clarithromycin, itraconazole, elbasvir plus grazoprevir, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir or letermovir therapy with atorvastatin calcium tablets should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin calcium tablets is used.

In patients taking the HIV protease inhibitor nelfinavir therapy with atorvastatin calcium tablets should be limited to 40 mg [see Warnings and Precautions (5.1) and Drug Interactions (7)].

💊 Dosage Forms and Strengths 135 words ▾

3 DOSAGE FORMS AND STRENGTHS Atorvastatin calcium tablets, USP are white, elliptical, film-coated tablets containing atorvastatin calcium trihydrate, USP equivalent to 10, 20, 40, and 80 mg atorvastatin. Table 1: Atorvastatin calcium Tablet Strengths and Identifying Features Tablet Strength Identifying Features 10 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 12’ on one side and plain on the other side. 20 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 828’ on one side and plain on the other side 40 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 829’ on one side and plain on the other side.

80 mg of atorvastatin white, elliptical, film-coated tablets, debossed with ‘RX 830’ on one side and plain on the other side. Tablets: 10, 20, 40, and 80 mg of atorvastatin (3).

⛔ Contraindications 67 words ▾

4 CONTRAINDICATIONS Active Liver Disease, Which May Include Unexplained Persistent Elevations in Hepatic Transaminase Levels Hypersensitivity to Any Component of This Medication Pregnancy [see Use in Specific Populations (8.1, 8.3)]. Lactation [see Use in Specific Populations (8.2)] . Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4).

Hypersensitivity to any component of this medication (4). Pregnancy (4, 8.1, 8.3). Lactation (4, 8.2).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Risks increase when higher doses are used concomitantly with cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, human immunodeficiency virus (HIV) or hepatitis C virus (HCV) protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported.

Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Atorvastatin calcium therapy should be discontinued if myopathy is diagnosed or suspected (2.6, 5.1, 8.5). Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use.

IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents (5.2). Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter (5.3).

A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the atorvastatin calcium 80 mg group vs. placebo (5.6).

5.1Myopathy and Rhabdomyolysis Atorvastatin calcium may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase (CK) above ten times the upper limit of normal) and rhabdomyolysis (with or without acute renal failure secondary to myoglobinuria). Rare fatalities have occurred as a result of rhabdomyolysis with statin use, including atorvastatin calcium. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher atorvastatin calcium dosage [see Drug Interactions (7.1)].

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Atorvastatin calcium exposure may be increased by drug interactions due to inhibition of cytochrome P450 enzyme 3A4 (CYP3A4) and/or transporters (e.g., breast cancer resistant protein [BCRP], organic anion-transporting polypeptide [OATP1B1/OATP1B3] and P-glycoprotein [P-gp]), resulting in an increased risk of myopathy and rhabdomyolysis. Concomitant use of cyclosporine, gemfibrozil, tipranavir plus ritonavir, or glecaprevir plus pibrentasvir with atorvastatin calcium is not recommended.

Atorvastatin calcium dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration (2.6)]. Cases of myopathy/rhabdomyolysis have been reported with atorvastatin coadministered with lipid modifying doses (> 1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir. Consider if the benefit of use of these products outweighs the increased risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1)].

Concomitant intake of large quantities, more than 1.2 liters daily, of grapefruit juice is not recommended in patients taking atorvastatin calcium [see Drug Interactions (7.1)]. Discontinue atorvastatin calcium if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if atorvastatin calcium is discontinued.

Temporarily discontinue atorvastatin calcium in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the atorvastatin dosage.…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] Liver enzyme abnormalities [see Warnings and Precautions (5.3)] Most common adverse reactions (incidence ≥ 2%) in patients treated with atorvastatin calcium in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin calcium vs. 7311 placebo; age range 10 to 93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on atorvastatin calcium and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality.

The five most common adverse reactions in patients treated with atorvastatin calcium that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%). The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) regardless of causality, in patients treated with atorvastatin calcium in placebo controlled trials (n = 8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6%), and urinary tract infection (5.7%).

Table 2 summarizes the frequency of clinical adverse reactions, regardless of causality, reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n = 8755), from seventeen placebo-controlled trials. Table 2. 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). * Adverse Reaction ≥ 2% in any dose greater than placebo Adverse Reaction * Any dose 10 mg 20 mg 40 mg 80 mg Placebo N = 8755 N = 3908 N = 188 N = 604 N = 4055 N = 7311 Nasopharyngitis 8.3 12.9 5.3 7 4.2

8.2Arthralgia 6.9 8.9 11.7 10.6 4.3

6.5Diarrhea 6.8 7.3 6.4 14.1 5.2

6.3Pain in extremity 6 8.5 3.7 9.3 3.1

5.9Urinary tract infection 5.7 6.9 6.4 8 4.1

5.6Dyspepsia 4.7 5.9 3.2 6 3.3

4.3Nausea 4 3.7 3.7 7.1 3.8

3.5Musculoskeletal pain 3.8 5.2 3.2 5.1 2.3

3.6Muscle Spasms 3.6 4.6 4.8 5.1 2.4 3 Myalgia 3.5 3.6 5.9 8.4 2.7

3.1Insomnia 3 2.8 1.1 5.3 2.8

2.9Pharyngolaryngeal pain 2.3 3.9 1.6 2.8 0.7

2.1Other adverse reactions reported in placebo-controlled studies include: Body as a whole : malaise, pyrexia; Digestive system: abdominal discomfort, eructation, flatulence, hepatitis, cholestasis; Musculoskeletal system : musculoskeletal pain, muscle fatigue, neck pain, joint swelling; Metabolic and nutritional system : transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia; Nervous system : nightmare; Respiratory system: epistaxis; Skin and appendages : urticaria; Special senses : vision blurred, tinnitus; Urogenital system: white blood cells urine positive.

Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) In ASCOT [see Clinical Studies (14.1)] involving 10,305 participants (age range 40 to 80 years, 19% women; 94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) treated with atorvastatin calcium 10 mg daily (n = 5,168) or placebo (n = 5,137), the sa…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Drug Interactions that may Increase the Risk of Myopathy/Rhabdomyolysis with atorvastatin calcium (2.6, 5.1, 7.1, 12.3) Interacting Agents Prescribing Recommendations Cyclosporine, tipranavir plus ritonavir, glecaprevir plus pibrentasvir Avoid atorvastatin Clarithromycin, itraconazole, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir Do not exceed 20 mg atorvastatin daily Nelfinavir Do not exceed 40 mg atorvastatin daily Lopinavir plus ritonavir, simeprevir, fibric acid derivatives, erythromycin, azole antifungals, lipid-modifying doses of niacin, colchicine Consider the risk/benefit of concomitant use with atorvastatin Other Lipid-Lowering Medications: Use with fibrate products or lipid-modifying doses (≥ 1 g/day) of niacin increases the risk of adverse skeletal muscle effects.

Caution should be used when prescribing with atorvastatin calcium (7). Rifampin should be simultaneously co-administered with atorvastatin calcium (7.2). Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased (7.3).

Digoxin: Patients should be monitored appropriately (7.3).

7.1Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Atorvastatin is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 3 includes a list of drugs that may increase exposure to atorvastatin 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 3: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [se e 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.

Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin is not recommended. Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (e.g., BCRP, OATP1B1/1B3, P-gp, MRP2, and/or OAT2) [see Clinical Pharmacology (12.3)]. Cases of myopathy and rhabdomyolysis have been reported with concomitant use of ledipasvir plus sofosbuvir with atorvastatin.

Intervention: • Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with atorvastatin is not recommended. • In patients taking lopinavir plus ritonavir, or simeprevir, consider the risk/benefit of concomitant use with atorvastatin. • In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin 20 mg. • In patients taking nelfinavir, do not exceed atorvastatin 40 mg [ see Dosage and Administration (2.6)]. • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin. • Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug.

Examples: Tipranavir plus ritonavir, glecaprevir plus pibrentasvir, lopinavir plus ritonavir, simeprevir, saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, nelfinavir, and ledipasvir plus sofosbuvir. Select Azole Antifungals or Macrolide Antibiotics Clin…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Plasma concentrations markedly increased in patients with chronic alcoholic liver disease (8.6, 12.3). Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with atorvastatin calcium (8.3).

8.1Pregnancy Risk Summary Atorvastatin calcium is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin calcium tablets may cause fetal harm when administered to a pregnant woman. Atorvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [see Contraindications (4)] .

Limited published data on the use of atorvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies in rats and rabbits there was no evidence of embryo-fetal toxicity or congenital malformations at doses up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m 2 ). In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was observed at doses ≥ 6 times the MRHD (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Limited published data on atorvastatin calcium from observational studies, meta-analyses and case reports have not shown an increased risk of major congenital malformations or miscarriage.

Rare reports of congenital anomalies have been received following intrauterine exposure to other HMG-CoA reductase inhibitors. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a ≥ 3 to 4-fold increase in congenital anomalies over the background incidence.

In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Animal Data Atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively.

Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ). In rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight.

At the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. In a study in pregnant rats administered 20, 100, or 225 mg/kg/day from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225 mg/kg/day, a dose at which maternal toxicity was observed. Pup body weight was decreased through postnatal day 21 at 100 mg/kg/day, and through postnatal day 91 at 225 mg/kg/day.

Pup development was delayed (rotorod performance at 100…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Atorvastatin calcium is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit of lipid lowering drugs during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, atorvastatin calcium tablets may cause fetal harm when administered to a pregnant woman. Atorvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [see Contraindications (4)] .

Limited published data on the use of atorvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies in rats and rabbits there was no evidence of embryo-fetal toxicity or congenital malformations at doses up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m 2 ). In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development was observed at doses ≥ 6 times the MRHD (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Limited published data on atorvastatin calcium from observational studies, meta-analyses and case reports have not shown an increased risk of major congenital malformations or miscarriage.

Rare reports of congenital anomalies have been received following intrauterine exposure to other HMG-CoA reductase inhibitors. In a review of approximately 100 prospectively followed pregnancies in women exposed to simvastatin or lovastatin, the incidences of congenital anomalies, spontaneous abortions, and fetal deaths/stillbirths did not exceed what would be expected in the general population. The number of cases is adequate to exclude a ≥ 3 to 4-fold increase in congenital anomalies over the background incidence.

In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Animal Data Atorvastatin crosses the rat placenta and reaches a level in fetal liver equivalent to that of maternal plasma. Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively.

Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ). In rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight.

At the maternally toxic doses of 50 and 100 mg/kg/day in rabbits, there was increased post-implantation loss, and at 100 mg/kg/day fetal body weights were decreased. In a study in pregnant rats administered 20, 100, or 225 mg/kg/day from gestation day 7 through to lactation day 20 (weaning), there was decreased survival at birth, postnatal day 4, weaning, and post-weaning in pups of mothers dosed with 225 mg/kg/day, a dose at which maternal toxicity was observed. Pup body weight was decreased through postnatal day 21 at 100 mg/kg/day, and through postnatal day 91 at 225 mg/kg/day.

Pup development was delayed (rotorod performance at 100 mg/kg/day and acoustic startle at 225 mg/kg/day; pinnae detachment and eye-opening at 225 mg/kg/day). These doses correspond to 6 times (100 mg/kg) and 22 times (225 mg/kg) the human exposure at the MRHD, based on AUC.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Heterozygous Familial Hypercholesterolemia (HeFH) The safety and effectiveness of atorvastatin calcium have been established in pediatric patients, 10 years to 17 years of age, with HeFH as an adjunct to diet to reduce total cholesterol, LDL-C, and apo B levels when, after an adequate trial of diet therapy, the following are present: LDL-C ≥ 190 mg/dL, or LDL-C ≥ 160 mg/dL and a positive family history of FH, or premature CVD in a first, or second-degree relative, or two or more other CVD risk factors are present.

Use of atorvastatin calcium for this indication is supported by evidence from [see Dosage and Administration (2.2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.6)] : A placebo-controlled clinical trial of 6 months duration in 187 boys and postmenarchal girls, 10 years to 17 years of age. Patients treated with 10 mg or 20 mg daily atorvastatin calcium had an adverse reaction profile generally similar to that of patients treated with placebo. In this limited controlled study, there was no significant effect on growth or sexual maturation in boys or on menstrual cycle length in girls.

A three year open-label uncontrolled trial that included 163 pediatric patients 10 to 15 years of age with HeFH who were titrated to achieve a target LDL-C < 130 mg/dL. The safety and efficacy of atorvastatin calcium in lowering LDL-C appeared generally consistent with that observed for adult patients, despite limitations of the uncontrolled study design Advise postmenarchal girls of contraception recommendations, if appropriate for the patient [see Use in Specific Populations (8.1), (8.3)] . The long-term efficacy of atorvastatin calcium therapy initiated in childhood to reduce morbidity and mortality in adulthood has not been established.

The safety and efficacy of atorvastatin calcium have not been established in pediatric patients younger than 10 years of age with HeFH. Homozygous Familial Hypercholesterolemia (HoFH) Clinical efficacy of atorvastatin calcium with dosages up to 80 mg/day for 1 year was evaluated in an uncontrolled study of patients with HoFH including 8 pediatric patients [see Clinical Studies (14.5)].

🧓 Geriatric Use 94 words ▾

8.5Geriatric Use Of the 39,828 patients who received atorvastatin calcium in clinical studies, 15,813 (40%) were ≥ 65 years old and 2,800 (7%) were ≥ 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older adults cannot be ruled out. Since advanced age (≥ 65 years) is a predisposing factor for myopathy, atorvastatin calcium should be prescribed with caution in the elderly.

🆘 Overdosage 47 words ▾

10 OVERDOSAGE There is no specific treatment for atorvastatin calcium overdosage. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, atorvastatin calcium lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin calcium also reduces LDL production and the number of LDL particles.

12.2Pharmacodynamics Atorvastatin calcium, as well as some of its metabolites, are pharmacologically active in humans. The liver is the primary site of action and the principal site of cholesterol synthesis and LDL clearance. Drug dosage, rather than systemic drug concentration, correlates better with LDL-C reduction. Individualization of drug dosage should be based on therapeutic response see Dosage and Administration (2)] .

12.3Pharmacokinetics Absorption: Atorvastatin calcium is rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin calcium dose. The absolute bioavailability of atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%.

The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/or hepatic first-pass metabolism. Although food decreases the rate and extent of drug absorption by approximately 25% and 9%, respectively, as assessed by C max and AUC, LDL-C reduction is similar whether atorvastatin calcium is given with or without food. Plasma atorvastatin calcium concentrations are lower (approximately 30% for C max and AUC) following evening drug administration compared with morning.

However, LDL-C reduction is the same regardless of the time of day of drug administration [see Dosage and Administration (2)]. Distribution: Mean volume of distribution of atorvastatin calcium is approximately 381 liters. Atorvastatin calcium is ≥ 98% bound to plasma proteins.

A blood/plasma ratio of approximately 0.25 indicates poor drug penetration into red blood cells. Based on observations in rats, atorvastatin calcium is likely to be secreted in human milk [see Contraindications (4) and Use in Specific Populations (8.2)] . Metabolism: Atorvastatin calcium is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products.

In vitro inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin calcium. Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites. In vitro studies suggest the importance of atorvastatin calcium metabolism by cytochrome P450 3A4, consistent with increased plasma concentrations of atorvastatin calcium in humans following co-administration with erythromycin, a known inhibitor of this isozyme [see Drug Interactions (7.1)] .

In animals, the ortho-hydroxy metabolite undergoes further glucuronidation. Excretion: Atorvastatin calcium and its metabolites are eliminated primarily in bile following hepatic and/or extra-hepatic metabolism; however, the drug does not appear to undergo enterohepatic recirculation. Mean plasma elimination half-life of atorvastatin calcium in humans is approximately 14 hours, but the half-life of inhibitory activity for HMG-CoA reductase is 20 to 30 hours due to the contribution of active metabolites.

Less than 2% of a dose of atorvastatin calcium is recovered in urine following oral administration. Specific Populations Geriatric: Plasma concentrations of atorvastatin calcium are higher (approximately 40% for C max and 30% for AUC) in healthy elderly subjects (age ≥ 65 years) than in young adults. Clinic…

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, atorvastatin calcium lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL; atorvastatin calcium also reduces LDL production and the number of LDL particles.

📦 How Supplied / Storage and Handling 10 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NDC 68071-2687-9 bottles of 90

📋 Description 185 words ▾

11 DESCRIPTION Atorvastatin calcium trihydrate, USP is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.

Atorvastatin calcium trihydrate, USP is [R-(R * ,R * )]-2-(4-fluorophenyl)-ß, δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate. The molecular formula of atorvastatin calcium trihydrate, USP is (C 33 H 34 FN 2 O 5 ) 2 Ca•3H 2 O and its molecular weight is 1209.41. Its structural formula is: Atorvastatin calcium trihydrate, USP is a white to off-white crystalline powder.

Atorvastatin calcium trihydrate, USP is freely soluble in methanol, slightly soluble in alcohol, insoluble in water, acetonitrile and aqueous solution of pH 4 and below and very slightly soluble in pH 7.4 phosphate buffer. Atorvastatin calcium tablets, USP for oral administration contain atorvastatin calcium trihydrate, USP equivalent to 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium carbonate; croscarmellose sodium; hydroxypropyl cellulose; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polysorbate 80; simethicone emulsion; talc, and titanium dioxide.

Meets USP dissolution test 1. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking atorvastatin calcium tablets should be advised that cholesterol is a chronic condition and they should adhere to their medication along with their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program as appropriate, and periodic testing of a fasting lipid panel to determine goal attainment. Patients should be advised about substances they should not take concomitantly with atorvastatin [see Warnings and Precautions (5.1)] .

Patients should also be advised to inform other healthcare professionals prescribing a new medication that they are taking atorvastatin calcium tablets.

17.1Muscle Pain All patients starting therapy with atorvastatin calcium tablets should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing atorvastatin calcium tablets. The risk of this occurring is increased when taking certain types of medication or consuming larger quantities (> 1 liter) of grapefruit juice. They should discuss all medication, both prescription and over the counter, with their healthcare professional.

17.2Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of atorvastatin calcium tablets and if signs or symptoms of liver injury occur. All patients treated with atorvastatin calcium tablets should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.

17.3Embryofetal Toxicity Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) and Use in Specific Populations (8.1, 8.3)].

17.4Lactation Advise women not to breastfeed during treatment with atorvastatin calcium tablets [see Contraindications (4) and Use in Specific Populations (8.2)] . All trademarks are property of their respective owners. Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 December 2020 FDA-12

💬 Patient Medication Information ~3 min read ▾

Patient Medication Information Atorvastatin (a TORE va sta tin) Calcium Tablets Rx only Read the Patient Information that comes with atorvastatin calcium tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

If you have any questions about atorvastatin calcium tablets, ask your doctor or pharmacist. What are Atorvastatin Calcium Tablets? Atorvastatin calcium tablets are a prescription medicine that lowers cholesterol in your blood.

It lowers the LDL-C ("bad" cholesterol) and triglycerides in your blood. It can raise your HDL-C ("good" cholesterol) as well. Atorvastatin calcium tablets are for adults and children over 10 whose cholesterol does not come down enough with exercise and a low-fat diet alone.

Atorvastatin calcium tablets can lower the risk for heart attack, stroke, certain types of heart surgery, and chest pain in patients who have heart disease or risk factors for heart disease such as: age, smoking, high blood pressure, low HDL-C, heart disease in the family. Atorvastatin calcium tablets can lower the risk for heart attack or stroke in patients with diabetes and risk factors such as: eye problems, kidney problems, smoking, or high blood pressure. Atorvastatin calcium tablets start to work in about 2 weeks.

What is Cholesterol? Cholesterol and triglycerides are fats that are made in your body. They are also found in foods.

You need some cholesterol for good health, but too much is not good for you. Cholesterol and triglycerides can clog your blood vessels. It is especially important to lower your cholesterol if you have heart disease, smoke, have diabetes or high blood pressure, are older, or if heart disease starts early in your family.

Who Should Not Take Atorvastatin Calcium Tablets? Do not take atorvastatin calcium tablets if you: are pregnant or think you may be pregnant, or are planning to become pregnant. Atorvastatin calcium tablets may harm your unborn baby.

If you get pregnant, stop taking atorvastatin calcium tablets and call your doctor right away. are breast feeding. Atorvastatin calcium can pass into your breast milk and may harm your baby. have liver problems. are allergic to atorvastatin calcium tablets or any of its ingredients. The active ingredient is atorvastatin calcium, USP.

See the end of this leaflet for a complete list of ingredients in atorvastatin calcium tablets. Atorvastatin calcium tablets dosing has not been established in children under 10 years of age. Before You Start Atorvastatin Calcium Tablets Tell your doctor if you: have muscle aches or weakness drink more than 2 glasses of alcohol daily have diabetes have a thyroid problem have kidney problems Some medicines should not be taken with atorvastatin calcium tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Atorvastatin calcium tablets and certain other medicines can interact causing serious side effects. Especially tell your doctor if you take medicines for: your immune system cholesterol infections birth control heart failure HIV or AIDS hepatitis C virus anti-virals Know all the medicines you take.

Keep a list of them with you to show your doctor and pharmacist. How Should I Take Atorvastatin Calcium Tablets? Take atorvastatin calcium tablets exactly as prescribed by your doctor.

Do not change your dose or stop atorvastatin calcium tablets without talking to your doctor. Your doctor may do blood tests to check your cholesterol levels during your treatment with atorvastatin calcium tablets. Your dose of atorvastatin calcium tablets may be changed based on these blood test results.

Take atorvastatin calcium tablets each day at any time of day at about the same time each day. Atorvastatin calcium tablets can be taken with or without food. Don't break atorvastatin calcium tablets before taking.…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Atorvastatin Calcium — the program that covers self-administered drugs. 26 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Atorvastatin Calcium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$194.53M
Claims incl. refills
18.7M
Beneficiaries
14.7M
Spend / beneficiary
$13.26
Spend / claim
$10.38
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
NuCare Pharmaceuticals,Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68071-2681-06 · NuCare 68071-2690-03 · NuCare →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.