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Atorvastatin Calcium 10 mg Tablet, 90-count — NDC 72189-0531-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Atorvastatin Calcium 10 mg Tablet, 90-count — NDC 72189-531-90 (Billing 72189-0531-90)

by Direct_Rx · 90 TABLET in 1 BOTTLE

This is a package of 90 tablets of Atorvastatin Calcium 10 mg Tablet from Direct_Rx, marketed since Jan 2024 and currently FDA-listed.

NDC 72189-0531-90
🏷️ FDA NDC (as labeled) 72189-531-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.0927/unit — full pricing hub ↓
Product page 72189-0531-30 Also comes in: 30 tablets 72189-531-30
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-531-90
Product NDC 72189-531
11-digit billing NDC 72189053190
NCPDP billing unit EA — each (per item)
RxCUI 617312
UNII A0JWA85V8F
Application # ANDA213853
SPL Set ID 0e24e7cb-1949-6686-e063-6394a90a4760
Established class (EPC) HMG-CoA Reductase Inhibitor
Mechanism of action Hydroxymethylglutaryl-CoA Reductase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-04
Route ORAL
Dosage form TABLET
Substance ATORVASTATIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 029967
GCN 43720
HICL code 012404
Ingredient (HICL) Atorvastatin Calcium
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4D
Therapeutic class — specific (HIC3) Antihyperlipidemic-Hmgcoa Reductase Inhib(Statins)
AHFS code 24:06.08.00
AHFS class Hmg-Coa Reductase Inhibitors
FDB label name ATORVASTATIN 10 MG TABLET
FDB brand name Atorvastatin Calcium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 029967
  • GCN: 43720
  • HICL (First Databank): 012404
  • AHFS class code: 24:06.08.00
  • RxCUI (RxNorm): 617312
Why two NDCs? The FDA registers this code as 72189-531-90 — a 5-3-2 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 product segment → 72189-0531-90. 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

Label name ATORVASTATIN 10 MG TABLET Ingredient Atorvastatin Calcium
📗 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 · Q2 2026 $0.0927 $8.34 / 90 tablets
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
72189-0531-90 You're viewing this 90 TABLET in 1 BOTTLE 2024-01-04 — Active
72189-0531-30 72189-531-30 Main listing 30 TABLET in 1 BOTTLE 2024-01-04 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet in 1 bottle.
How does this package differ from NDC 72189-0531-30?
Both are Atorvastatin Calcium 10 mg Tablet — the drug itself is identical. This page's package is the 90-count one, while NDC 72189-0531-30 is the 30 tablets package.
What NDC number is used to bill for this package of Atorvastatin Calcium 10 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atorvastatin Calcium 10 mg 00093-5056-10 Teva 1000 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 00378-3950-05 Mylan 500 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 00480-3585-10 Teva 1000 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 00904-6290-06 Major 1 tablet $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 16571-0136-09 Rising 90 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 31722-0424-05 Camber 500 tablets $0.023 AB Availability likely —
Atorvastatin calcium 10 mg 33342-0315-10 Macleods 90 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 42385-0940-01 Laurus 100 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 42571-0172-10 Micro 1000 tablets $0.023 AB Discontinued —
Atorvastatin Calcium 10 mg 43598-0098-05 Dr. 500 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 43598-0830-05 Dr. 500 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 50228-0451-10 ScieGen 1000 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 50268-0093-15 AvPAK 1 tablet $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 51079-0208-20 Mylan 1 tablet $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 55111-0121-05 Dr. 500 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 67877-0511-05 Ascend 500 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 68084-0097-01 American 1 tablet $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 70377-0077-11 Biocon 90 tablets $0.023 AB Availability likely —
atorvastatin calcium 10 mg 70710-1777-00 Zydus 1000 tablets $0.023 AB Availability likely —
Atorvastatin calcium 10 mg 70756-0247-12 Lifestar 1000 tablets $0.023 AB Availability likely —
Atorvastatin calcium 10 mg 72205-0022-05 Novadoz 500 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 72603-0282-01 NorthStar 90 tablets $0.023 AB Availability likely —
Atorvastatin calcium 10 mg 72603-0403-02 NorthStar 100 tablets $0.023 AB Availability likely —
Atorvastatin calcium 10 mg 75834-0255-01 NIVAGEN 1000 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 82009-0001-10 Quallent 1000 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 82009-0176-10 Quallent 1000 tablets $0.023 AB Availability likely —
Atorvastatin Calcium 10 mg 16714-0173-01 NORTHSTAR 90 tablets $0.023 AB Discontinued —
Atorvastatin Calcium 10 mg 16729-0044-15 Accord 90 tablets $0.030 AB FDA listed —
Atorvastatin Calcium 10 mg 69097-0944-05 Cipla 90 tablets $0.030 AB FDA listed —
Lipitor 10 mg 58151-0155-77 Viatris 90 tablets $13.408 AB Availability likely —
Atorvastatin Calcium 10 mg 00615-8006-05 NCS 15 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 42708-0003-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 42708-0014-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 43063-0474-30 PD-Rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 48433-0007-20 Safecor 1 tablet — AB FDA listed —
Atorvastatin Calcium 10 mg 50090-5184-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 50090-5636-00 A-S 30 tablets — — FDA listed —
Atorvastatin Calcium 10 mg 50090-6479-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 50090-6480-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 50090-7574-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 50090-7575-00 A-S 90 tablets — AB FDA listed —
atorvastatin calcium 10 mg 50090-7720-00 A-S 30 tablets — AB FDA listed —
atorvastatin calcium 10 mg 50090-7721-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 51655-0613-52 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 51655-0946-52 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 55154-5884-00 Cardinal 1 tablet — AB FDA listed —
Atorvastatin Calcium 10 mg 55154-6635-00 Cardinal 1 tablet — AB FDA listed —
Atorvastatin Calcium 10 mg 59651-0606-05 Aurobindo 500 tablets — — FDA listed —
Atorvastatin calcium 10 mg 60290-0039-01 Umedica 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 60505-2578-00 Apotex 10 tablets — AB FDA listed —
Atorvastatin calcium 10 mg 60760-0666-30 ST. 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 63629-8469-01 Bryant 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 67046-1442-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 67046-1458-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin calcium 10 mg 67046-1491-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 67046-1677-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 67296-2130-09 Redpharm 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68071-2389-03 NuCare 30 tablets — AB FDA listed —
atorvastatin calcium 10 mg 68071-3546-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68071-3701-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68071-3813-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68071-3868-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68071-3912-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68071-5008-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68071-5198-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin calcium 10 mg 68788-4008-01 Preferred 100 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68788-8684-01 Preferred 100 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 68788-8842-03 Preferred 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 69097-0897-05 Cipla 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 70518-0224-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin calcium 10 mg 70518-3298-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin Calcium 10 mg 70518-4138-00 REMEDYREPACK 90 tablets — AB FDA listed —
Atorvastatin calcium 10 mg 70518-4422-00 REMEDYREPACK 100 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 70518-4550-00 REMEDYREPACK 100 tablets — AB FDA listed —
atorvastatin calcium 10 mg 70771-1875-00 Zydus 1000 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 71205-0246-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 71209-0090-04 Cadila 90 tablets — — FDA listed —
Atorvastatin Calcium 10 mg 71335-1388-01 Bryant 30 tablets — AB Discontinued —
Atorvastatin Calcium 10 mg 71335-1710-01 Bryant 30 tablets — — FDA listed —
Atorvastatin Calcium 10 mg 71335-2241-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 71335-2388-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin calcium 10 mg 71335-2977-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 71335-3144-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 72162-1554-09 Bryant 90 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 72189-0226-30 DIRECT 30 tablets — — FDA listed —
Atorvastatin Calcium 10 mgthis 72189-0531-90 Direct_Rx 90 tablets — AB FDA listed —
Atorvastatin calcium 10 mg 72789-0153-30 PD-Rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 76420-0943-00 Asclemed 1000 tablets — AB FDA listed —
Atorvastatin Calcium 10 mg 77771-0451-10 Radha 1000 tablets — AB FDA listed —
atorvastatin calcium 10 mg 82137-0016-01 Lepu 90 tablets — — FDA listed —
Atorvastatin Calcium 10 mg 82804-0144-30 Proficient 30 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color white
ShapeOval
ImprintATO;10
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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

LabelerDirect_Rx
Application holderUMEDICA LABORATORIES PRIVATE LTD
FDA applicationANDA213853 (ANDA)
Labeler code72189
First marketedJan 2024
Product typeHuman Prescription Drug
Portfolio355 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Patient Medication Information 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 152 words ▾

Atorvastatin calcium tablets is indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia.

Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia

⏱️ Dosage and Administration ~1 min read ▾

2.1Important 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.

2.2Recommended 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.

2.3Recommended 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.

2.4Recommended 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.

2.5Dosage 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)] . Anti-Viral Medications In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed Atorvastatin calcium tablets 20 mg once daily. In patients taking nelfinavir, do not exceed Atorvastatin calcium tablets 40 mg once daily .

Select Azole Antifungals or Macrolide Antibiotics In patients taking clarithromycin or itraconazole, do not exceed Atorvastatin calcium tablets 20 mg once daily. For additional recommendations regarding concomitant use of Atorvastatin calcium tablets with other anti-viral medications, azole antifungals or macrolide antibiotics, see Drug Interactions ( 7.1).

💊 Dosage Forms and Strengths 87 words ▾

Atorvastatin calcium tablets: 10 mg of atorvastatin: White to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "10" on other side. 20 mg of atorvastatin: White to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "20" on other side. 40 mg of atorvastatin: White to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "40" on other side.

80 mg of atorvastatin: White to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "80" on other side.

⛔ Contraindications 44 words ▾

Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3)] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions ( 6.2)].

⚠️ Warnings and Cautions ~2 min read ▾

5.1Myopathy and Rhabdomyolysis Atorvastatin calcium tablets may cause myopathy (muscle pain, tenderness, or weakness associated with elevated creatine kinase [CK]) and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis in patients treated with statins, including atorvastatin calcium tablets. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher atorvastatin calcium tablets dosage [see Drug Interactions ( 7.1) and Use in Specific Populations ( 8.5, 8.6)].

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Atorvastatin calcium tablet sexposure 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 tablets is not recommended.

Atorvastatin calcium tablets dosage modifications are recommended for patients taking certain anti-viral, azole antifungals, or macrolide antibiotic medications [see Dosage and Administration ( 2.5)] . 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 tablets [see Drug Interactions ( 7.1)]. Discontinue atorvastatin calcium tablets if markedly elevated CK levels occur or myopathy is either diagnosed or suspected. Muscle symptoms and CK elevations may resolve if atorvastatin calcium tablets is discontinued.

Temporarily discontinue atorvastatin calcium tablets 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 calcium tablets dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

5.2Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use, including reports of recurrence when the same or a different statin was administered. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase that persists despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents.

Additional neuromuscular and serologic testing may be necessary. Treatment with immunosuppressive agents may be required. Discontinue atorvastatin calcium tablets if IMNM is suspected.

5.3Hepatic Dysfunction Increases in serum transaminases have been reported with use of atorvastatin calcium tablets [see Adverse Reactions ( 6.1)]. In most cases, these changes appeared soon after initiation, were transient, were not accompanied by symptoms, and resolved or improved on continued therapy or after a brief interruption in therapy. Persistent increases to more than three times the ULN in serum transaminases have occurred in approximately 0.7% of p… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1)] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2)] Hepatic Dysfunction [see Warnings and Precautions ( 5.3)] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4)]

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 practice. In the atorvastatin calcium tablets placebo-controlled clinical trial database of 16,066 patients (8755 atorvastatin calcium tablets vs. 7311 placebo; age range 10–93 years, 39% women, 91% White, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, The most common adverse reactions in patients treated with atorvastatin calcium tablets 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%).

Table 1 summarizes adverse reactions reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium tablets (n=8755), from seventeen placebo-controlled trials. Table 1. Adverse Reactions Occurring in >2% in Patients atorvastatin calcium tablets Treated with Any Dose and Greater than Placebo Adverse Reaction % Placebo N=7311 %10 mg N=3908 %20 mg N=188 %40 mg N=604 %80 mg N=4055 % Any dose N=8755 Nasopharyngitis 8.2 12.9 5.3 7.0 4.2

8.3Arthralgia 6.5 8.9 11.7 10.6 4.3

6.9Diarrhea 6.3 7.3 6.4 14.1 5.2

6.8Pain in extremity 5.9 8.5 3.7 9.3 3.1

6.0Urinary tract infection 5.6 6.9 6.4 8.0 4.1

5.7Dyspepsia 4.3 5.9 3.2 6.0 3.3

4.7Nausea 3.5 3.7 3.7 7.1 3.8

4.0Musculoskeletal pain 3.6 5.2 3.2 5.1 2.3

3.8Muscle Spasms 3.0 4.6 4.8 5.1 2.4

3.6Myalgia 3.1 3.6 5.9 8.4 2.7

3.5Insomnia 2.9 2.8 1.1 5.3 2.8

3.0Pharyngolaryngeal pain 2.1 3.9 1.6 2.8 0.7

2.3Other adverse reactions reported in placebo-controlled trials 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.

Elevations in Liver Enzyme Tests Persistent elevations in serum transaminases, defined as more than 3 times the ULN and occurring on 2 or more occasions, occurred in 0.7% of patients who received atorvastatin calcium tablets in clinical trials. The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively. One patient in clinical trials developed jaundice.

Increases in liver enzyme tests in other patients were not associated with jaundice or other clinical signs or symptoms. Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent liver enzyme elevations continued treatment with a reduced dose of atorvastatin calcium tablets.

Treating to New Targets Study (TNT) In TNT [see Clinical Studies ( 14.1)] involving 10,001 subjects (age range 29–78 years, 19% women; 94% - White, 3% Blacks, 1% Asians, 2% other) with clinically evident CHD treated with atorvastatin calcium tablets 10 mg daily (n=5006) or atorvastatin calcium tablets 80 mg daily (n=4995), In the high-dose atorvastatin calcium tablets group, there were more patients with serio… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7.1Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with atorvastatin calcium tablets Atorvastatin calcium tablets is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin calcium tablets 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 tablets 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 tablets Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets 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 tablets.

Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium tablets are not recommended. Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tablets 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 calcium tablets.

Intervention: Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with atorvastatin calcium tablets 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 calcium tablets 20 mg.

In patients taking nelfinavir, do not exceed atorvastatin calcium tablets 40 mg [see Dosage and Administration ( 2.5)]. Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium tablets. 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 Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium tabletswith select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters [see Clinical Pharmacology ( 12.3)].

Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium tablets 20 mg [see Dosage and Administration ( 2.5)]. Consider the risk/benefit of concomitant use of other azole antifungals or macrolide antibiotics with atorvastatin calcium tablets. Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug.

Examples: Erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole. Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin (≥1 gram/day niacin) with atorvastatin cal… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Discontinue atorvastatin calcium tablets when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Atorvastatin calcium tablets decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, atorvastatin calcium tablets may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology ( 12.1)].

In addition, treatment of hyperlipidemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Published data from prospective and retrospective observational cohort studies with atorvastatin calcium tablets use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in 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 delay were 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 2-4% and 15-20%, respectively.

Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.

There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births.

Animal Data 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 admini… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 34 words ▾

No specific antidotes for atorvastatin calcium tablets are known. Contact Poison Control (1-800-222-1222) for latest recommendations. Due to extensive drug binding to plasma proteins, hemodialysis is not expected to significantly enhance atorvastatin calcium clearance.

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-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 tablets are rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin calcium tablets 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 Cmax and AUC, LDL-C reduction is similar whether atorvastatin calcium tablets are given with or without food. Plasma atorvastatin calcium concentrations are lower (approximately 30% for Cmax 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. 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. Elimination Metabolism Atorvastatin calcium is extensively metabolized to ortho- and parahydroxylated derivatives and various beta-oxidation products. In vitroinhibition 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. Invitrostudies 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 Cmax and 30% for AUC) in healthy elderly subjects (age ≥ 65 years) than in young adults. Pediatric: Apparent oral clearance of atorvastatin in pediatric subjects appeared similar to that of adults when scaled allometrically by body weight as the body weight was the only significant… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 161 words ▾

Atorvastatin calcium tablets are supplied as follows: Strength How Supplied NDC Tablet Description 10 mg of atorvastatin bottles of 90 72189-531-90 white to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "10" on other side. bottles of 1000 75834-255-01 bottles of 5000 75834-255-05 bottles of 500 75834-255-50 20 mg of atorvastatin bottles of 90 75834-256-90 white to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "20" on other side. bottles of 1000 75834-256-01 bottles of 5000 75834-256-05 bottles of 500 75834-256-50 40 mg of atorvastatin bottles of 90 75834-257-90 white to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "40" on other side. bottles of 500 75834-257-50 bottles of 2500 75834-257-25 bottles of 1000 75834-257-01 80 mg of atorvastatin bottles of 90 75834-258-90 white to off-white, film-coated, oval shaped tablets "ATO" debossed on one side and "80" on other side. bottles of 500 75834-258-50 bottles of 2000 75834-258-02 bottles of 1000 75834-258-01

📦 Storage and Handling 12 words ▾

Storage Store at controlled room temperature 20°C - 25°C (68°F - 77°F)

📋 Description 163 words ▾

Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Atorvastatin calcium 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 empirical formula of atorvastatin calcium is (C 33H 34FN 2O 5) 2Ca•3H 2O and its molecular weight is 1209.42.

Its structural formula is: [image description] Atorvastatin calcium is a white to off-white powder that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is very slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Atorvastatin calcium tablets, USP for oral use contain atorvastatin 10 mg, 20 mg, 40 mg, or 80 mg (equivalent to 10.359 mg, 20.718 mg, 41.436 mg, or 82.872 mg atorvastatin calcium trihydrate) and the following inactive ingredients: Croscarmellose sodium, NF; Hydroxy propyl cellulose, NF; Lactose monohydrate, NF; Magnesium stearate, NF; Microcrystalline cellulose, NF; Polysorbate 80, NF; Precipitated calcium carbonate, NF; Opadry Complete film coating system YS-1-7040 White (Hypromellose, Macrogol, Talc and Titanium dioxide).

💬 Patient Medication Information ~3 min read ▾

PATIENT INFORMATION (Atorvastatin Calcium (a tor "va stat' in kal' see um) Tablets, USP, for oral use) What is atorvastatin calcium tablets? Atorvastatin calcium tablets is a prescription medicine that contains a cholesterol lowering medicine (statin) called atorvastatin. Atorvastatin calcium tablets is used: to reduce the risk of: heart attack, stroke, certain types of heart surgery and chest pain in adults who do not have heart disease but have other multiple risk factors for heart disease. heart attack and stroke in adults with type 2 diabetes mellitus who do not have heart disease but have other multiple risk factors. heart attack that does not cause death, stroke, certain types of heart surgery, hospitalization for congestive heart failure, and chest pain in adults with heart disease. along with diet to reduce low density lipoprotein cholesterol (LDL-C) or bad cholesterol: in adults with primary hyperlipidemia. in adults and children aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).

This is an inherited condition that causes high levels of bad cholesterol. along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). This is an inherited condition that causes high levels of bad cholesterol. along with diet for the treatment of adults with: primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat). hypertriglyceridemia. It is not known if atorvastatin calcium tablets is safe and effective in children younger than 10 years of age with HeFH or HoFH or in children with other types of hyperlipidemias (other than HeFH or HoFH).

Do not take atorvastatin calcium tablets if you: have liver problems (acute liver failure or decompensated cirrhosis) are allergic to atorvastatin or any of the ingredients in atorvastatin calcium tablets. Stop using atorvastatin calcium tabletsand get medical help right away if you have symptoms of a serious allergic reaction including: swelling of your face, lips, tongue or throat problems breathing or swallowing fainting or feeling dizzy very rapid heartbeat severe skin rash or itching flu-like symptoms including fever, sore throat, cough, tiredness, and joint pain See the end of this leaflet for a complete list of ingredients in Atorvastatin calcium tablets.

Before you take Atorvastatin calcium tablets, tell your doctor about all of your medical conditions, including if you: have unexplained muscle aches or weakness drink more than 2 glasses of alcohol daily have diabetes have thyroid problems have kidney problems had a stroke are pregnant or plan to become pregnant. Atorvastatin calcium tablets may harm your unborn baby. If you become pregnant, stop taking Atorvastatin calcium tablets and call your doctor right away. are breastfeeding or plan to breastfeed.

You and your doctor should decide if you will take Atorvastatin calcium tablets or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take Atorvastatin calcium tablets.

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Atorvastatin calcium tablets and certain other medicines can increase the risk of muscle problems or other side effects. Especially tell your doctor if you take medicines for: your immune system (cyclosporine) cholesterol (gemfibrozil) infections (erythromycin, clarithromycin, itraconazole, ketoconazole, posaconazole, and voriconazole) birth control pills heart failure (digoxin) gout (colchicine) niacin fibrates viruses that treat HIV, AIDS, or hepatitis C (anti-virals) tipranavir plus ritonavir ◦ glecaprevir plus pibrentasvir ledipasvir plus sofosbuvir ◦ simeprevir saquinavir plus ritonavir ◦ darunavir plus ritonavir fosamprenavir ◦ fosamprenavir plus ritonavir elbasvir plus grazoprevir ◦ let… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

Prevention of Cardiovascular Disease In the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), the effect of atorvastatin calcium tablets on fatal and non-fatal coronary heart disease was assessed in 10,305 patients with hypertension, 40–80 years of age (mean of 63 years, 19% women; 95% White, 3% Black, 1% South Asian, 1% other), without a previous myocardial infarction and with total cholesterol (TC) levels ≤251 mg/dL. Additionally, all patients had at least 3 of the following cardiovascular risk factors: male gender (81%), age >55 years (85%), smoking (33%), diabetes (24%), history of CHD in a first-degree relative (26%), TC:HDL >6 (14%), peripheral vascular disease (5%), left ventricular hypertrophy (14%), prior cerebrovascular event (10%), specific ECG abnormality (14%), proteinuria/albuminuria (62%).

In this double-blind, placebo-controlled trial, patients were treated with anti-hypertensive therapy (goal BP <140/90 mm Hg for non-diabetic patients; <130/80 mm Hg for patients with diabetes) and allocated to either atorvastatin calcium tablets 10 mg daily (n=5168) or placebo (n=5137), using a covariate adaptive method which took into account the distribution of nine baseline characteristics of patients already enrolled and minimized the imbalance of those characteristics across the groups. Patients were followed for a median duration of 3.3 years.

The effect of 10 mg/day of atorvastatin calcium tablets on lipid levels was similar to that seen in previous clinical trials. Atorvastatin calcium tablets significantly reduced the rate of coronary events [either fatal coronary heart disease (46 events in the placebo group vs. 40 events in the atorvastatin calcium tablets group) or non-fatal MI (108 events in the placebo group vs.

60 events in the atorvastatin calcium tablets group)] with a relative risk reduction of 36% [(based on incidences of 1.9% for atorvastatin calcium tablets vs. 3.0% for placebo), p=0.0005 (see Figure 1)]. The risk reduction was consistent regardless of age, smoking status, obesity, or presence of renal dysfunction.

The effect of atorvastatin calcium tablets was seen regardless of baseline LDL levels. Figure 1: Effect of atorvastatin calcium tablets 10 mg/day on Cumulative Incidence of Non-Fatal Myocardial Infarction or Coronary Heart Disease Death (in ASCOT-LLA) [image description] Atorvastatin calcium tablets also significantly decreased the relative risk for revascularization procedures by 42% (incidences of 1.4% for atorvastatin calcium tablets and 2.5% for placebo). Although the reduction of fatal and non-fatal strokes did not reach a pre-defined significance level (p=0.01), a favorable trend was observed with a 26% relative risk reduction (incidences of 1.7% for atorvastatin calcium tablets and 2.3% for placebo).

There was no significant difference between the treatment groups for death due to cardiovascular causes (p=0.51) or noncardiovascular causes (p=0.17). In the Collaborative Atorvastatin Diabetes Study (CARDS), the effect of atorvastatin calcium tablets on cardiovascular disease (CVD) endpoints was assessed in 2838 subjects (94% white, 2% Black, 2% South Asian, 1% other; 68% male), ages 40–75 with type 2 diabetes based on WHO criteria, without prior history of cardiovascular disease and with LDL ≤160 mg/dL and triglycerides (TG) ≤ 600 mg/dL.

In addition to diabetes, subjects had 1 or more of the following risk factors: current smoking (23%), hypertension (80%), retinopathy (30%), or microalbuminuria (9%) or macroalbuminuria (3%). No subjects on hemodialysis were enrolled in the trial. In this multicenter, placebo-controlled, double-blind clinical trial, subjects were randomly allocated to either atorvastatin calcium tablets 10 mg daily (1429) or placebo (1411) in a 1:1 ratio and were followed for a median duration of 3.9 years.

The primary endpoint was the occurrence of any of the major cardiovascular events: myocardial infarction, acute CHD death, unstable angina, coronary revascularization,… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a 2-year carcinogenicity study in rats at dose levels of 10, 30, and 100 mg/kg/day, 2 rare tumors were found in muscle in high-dose females: in one, there was a rhabdomyosarcoma and, in another, there was a fibrosarcoma. This dose represents a plasma AUC (0-24) value of approximately 16 times the mean human plasma drug exposure after an 80 mg oral dose. A 2-year carcinogenicity study in mice given 100, 200, or 400 mg/kg/day resulted in a significant increase in liver adenomas in high-dose males and liver carcinomas in high-dose females.

These findings occurred at plasma AUC (0–24) values of approximately 6 times the mean human plasma drug exposure after an 80 mg oral dose. Invitro,atorvastatin was not mutagenic or clastogenic in the following tests with and without metabolic activation: the Ames test with Salmonella typhimuriumand Escherichia coli,the HGPRT forward mutation assay in Chinese hamster lung cells, and the chromosomal aberration assay in Chinese hamster lung cells. Atorvastatin was negative in the in vivomouse micronucleus test.

In female rats, atorvastatin at doses up to 225 mg/kg (56 times the human exposure) did not cause adverse effects on fertility. Studies in male rats performed at doses up to 175 mg/kg (15 times the human exposure) produced no changes in fertility. There was aplasia and aspermia in the epididymis of 2 of 10 rats treated with 100 mg/kg/day of atorvastatin for 3 months (16 times the human AUC at the 80 mg dose); testis weights were significantly lower at 30 and 100 mg/kg and epididymal weight was lower at 100 mg/kg.

Male rats given 100 mg/kg/day for 11 weeks prior to mating had decreased sperm motility, spermatid head concentration, and increased abnormal sperm. Atorvastatin caused no adverse effects on semen parameters, or reproductive organ histopathology in dogs given doses of 10, 40, or 120 mg/kg for 2 years.

📄 Package Label / Principal Display Panel 2 words ▾

72189-0531-90

72189-531-30

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.

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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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
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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.
← 72189-0530-06 · Direct 72189-0532-35 · Direct_Rx →
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.