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ATORVASTATIN CALCIUM 40 mg Tablet, 90-count — NDC 72189-0239-90 package photo

ATORVASTATIN CALCIUM 40 mg Tablet, 90-count

by DIRECT RX · 90 TABLET in 1 BOTTLE (72189-239-90)
NDC 72189-0239-90
🏷️ FDA NDC (as labeled) 72189-239-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 72189-239-90
Product NDC 72189-239
11-digit billing NDC 72189023990
RxCUI 617312
UNII 48A5M73Z4Q
Application # ANDA204991
SPL Set ID c3b70f79-45a3-0869-e053-2a95a90a3cdb
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 2021-09-20
Route ORAL
Dosage form TABLET
Substance ATORVASTATIN CALCIUM TRIHYDRATE
Why two NDCs? The FDA registers this code as 72189-239-90 — 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 → 72189-0239-90. 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.

🏭 Manufacturer & labeler

LabelerDIRECT RX
Application holderLUPIN LTD
FDA applicationANDA204991 (ANDA)
Labeler code72189
First marketedSep 2021
Product typeHuman Prescription Drug
Portfolio204 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It mainly lowers your LDL — the "bad" cholesterol — and triglycerides, while nudging your HDL ("good" cholesterol) a little higher. Over time, keeping those numbers in a healthier...
  • What exactly is atorvastatin supposed to do for me?
  • Honestly, no — the cholesterol-lowering effect is the same whether you take it in the morning or at night, and whether you eat beforehand or not. The most important thing is that y...
  • Does it matter what time of day I take it, or whether I eat first?
📖 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.

💊 What it looks like

Color white
ShapeOval
ImprintLU;A18
Size14 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atorvastatin Calcium 40 mg 55111-0123-05 Dr. 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 42571-0174-10 Micro 1000 tablets $0.037 AB Discontinued —
Atorvastatin Calcium 40 mg 70377-0079-11 Biocon 90 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 43598-0101-05 Dr. 500 tablets $0.037 AB Availability likely —
atorvastatin calcium 40 mg 70710-1772-00 Zydus 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 72603-0284-01 NorthStar 90 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 00093-5058-10 Teva 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 50228-0453-10 ScieGen 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 00480-3587-10 Teva 1000 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 72603-0405-02 NorthStar 100 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 51079-0210-20 Mylan 1 tablet $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 67877-0513-05 Ascend 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 42385-0942-01 Laurus 100 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 00378-3952-05 Mylan 500 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 70756-0249-12 Lifestar 1000 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 72205-0024-05 Novadoz 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 82009-0178-10 Quallent 1000 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 31722-0426-05 Camber 500 tablets $0.037 AB Availability likely —
Atorvastatin calcium 40 mg 33342-0317-10 Macleods 90 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 43598-0832-05 Dr. 500 tablets $0.037 AB Availability likely —
Atorvastatin Calcium 40 mg 63304-0829-05 Sun 500 tablets $0.040 — FDA listed —
Atorvastatin Calcium 40 mg 69097-0946-05 Cipla 90 tablets $0.068 AB FDA listed —
Atorvastatin Calcium 40 mg 68180-0637-02 Lupin 500 tablets $0.068 — Discontinued —
Atorvastatin Calcium 40 mg 16729-0046-15 Accord 90 tablets $0.068 AB FDA listed —
Lipitor 40 mg 58151-0157-77 Viatris 90 tablets $19.114 AB Availability likely —
Atorvastatin Calcium 40 mg 69097-0899-05 Cipla 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71205-0264-30 Proficient 30 tablets — — FDA listed —
Atorvastatin Calcium 40 mg 71610-0163-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-5632-00 A-S 30 tablets — — FDA listed —
Atorvastatin calcium 40 mg 50090-5915-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71205-0731-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 71205-0765-30 Proficient 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71610-0745-15 Aphena 15 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 82804-0026-30 Proficient 30 tablets — AB FDA listed —
atorvastatin calcium 40 mg 50090-7726-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 60760-0734-30 St. 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 71335-9711-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 72162-2238-09 Bryant 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mgthis 72189-0239-90 DIRECT 90 tablets — — FDA listed —
Atorvastatin Calcium 40 mg 50090-5208-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7807-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 51655-0465-52 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3667-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-5194-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68788-8574-09 Preferred 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 76420-0946-00 Asclemed 1000 tablets — AB FDA listed —
atorvastatin calcium 40 mg 82137-0018-01 Lepu 90 tablets — — FDA listed —
Atorvastatin Calcium 40 mg 60760-0882-30 St. 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 67046-1529-03 Coupler 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-2991-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 68788-8094-01 Preferred 100 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71209-0092-04 Cadila 90 tablets — — FDA listed —
Atorvastatin calcium 40 mg 68071-2302-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 72789-0089-30 PD-Rx 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 82868-0048-30 Northwind 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-2493-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-9723-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 72189-0557-30 Direct_rx 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 42708-0005-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 70518-3273-00 REMEDYREPACK 30 tablets — AB Discontinued —
Atorvastatin Calcium 40 mg 48433-0009-20 Safecor 1 tablet — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-5207-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3595-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 68071-3948-03 NuCare 30 tablets — AB FDA listed —
atorvastatin calcium 40 mg 70771-1877-00 Zydus 1000 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-1126-01 Bryant 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 77771-0453-10 Radha 1000 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7806-00 A-S 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 60760-0726-30 St. 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3267-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-4837-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7384-00 A-S 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-3628-09 NuCare 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 70518-4592-00 REMEDYREPACK 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 71335-1011-01 Bryant 30 tablets — — Discontinued —
Atorvastatin Calcium 40 mg 42708-0144-30 QPharma, 30 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 50090-7385-00 A-S 90 tablets — AB FDA listed —
atorvastatin calcium 40 mg 50090-7727-00 A-S 90 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 59651-0608-62 Aurobindo 30000 tablets — AB FDA listed —
Atorvastatin Calcium 40 mg 68071-5091-03 NuCare 30 tablets — AB FDA listed —
Atorvastatin calcium 40 mg 70518-4474-00 REMEDYREPACK 90 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

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Atorvastatin calcium — the ingredient across all brands.

Top reported reactions

Fatigue14,254
Nausea12,774
Diarrhoea11,485
Dyspnoea11,456
Type 2 Diabetes Mellitus11,261
Pain10,300
Headache10,092

Age at onset

Neonate3
Infant4
Child6
Adolescent16
Adult11,619
Elderly16,633

Reporter sex

245,963 reports
Male · 45%
Female · 54%
Unknown · 1%

Serious outcomes

Hospitalization70,080
Death18,692
Disabling7,734
Life-threatening7,358
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 10,953 5,288
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0239-90 You're viewing this 90 TABLET in 1 BOTTLE (72189-239-90) 2021-09-20 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 ✓ Available
Inactive ingredients (structured) ✓ 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.
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 FDA registers it as 72189-239-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0239-90, written without dashes as 72189023990. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0239-90, the first segment (72189) is the labeler code FDA assigned to DIRECT RX; the middle segment (0239) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by DIRECT RX. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DIRECT RX 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.

📄 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage ~2 min read ▾

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.

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 family history of premature cardiovascular disease or • two or more other CVD risk factors are present in the pediatric patient

1.3Limitations of Use Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

⏱️ Dosage and Administration ~2 min read ▾

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 Pharmacology (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 120 words ▾

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.

⛔ Contraindications 38 words ▾

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)].

⚠️ Warnings and Cautions ~2 min read ▾

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. 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. 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. Additional neuromuscular and serologic testing may be necessary.

Treatment with immunosuppressive agents may be required. Consider risk of IMNM carefully prior to initiation of a different statin. If therapy is initiated with a different statin, monitor for signs and symptoms of IMNM.

5.3Liver Dysfunction Statins, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. Persistent elevations (> 3 times the upper limit of normal [ULN] occurring on 2 or more occasions) in serum transaminases occurred in 0.7% of patients who received atorvastatin calcium 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 function tests (LFT) in other patients were not associated with jaundice or other clinical signs…

🤒 Adverse Reactions ~3 min read ▾

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)]

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 safety and tolerability profile of the group treated with atorvastatin calcium was comparable to that of the group treated with placebo during a median of 3.3 years of follow-up. Collaborative Atorvastatin Diabetes Study (CARDS) In CARDS [see Clinical Studies (14.1)] involving 2,838 subjects (age range 39 to 77 years, 32% women; 94.3% Caucasians, 2.4% South Asians, 2.3% Afro-Caribbean, 1% other) with type 2 diabetes treat…

🔄 Drug Interactions ~2 min read ▾

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 ClinicalPharmacology (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 atorvastatinand 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.

Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatinis not recommended. Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatinwith 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 atorvastatinis 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 atorvastatin40 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 Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatinwith 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 atorvastatin20 mg [see Dosage and Administration (2.6)]. Consider the risk/benefit of concomitant use of other azole antifungals or macrolide antibiotics 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: 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. Intervention: Consider if the benefit of using lipid modifying dosages of niacin concomitantly with atorvastatinoutweighs the increased risk of myopathy and rhabdomyolysis.

If concomitant use is decided, monitor patients for signs and symptoms of myopathy particularly during i…

👥 Use in Specific Populations ~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/m2). 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/m2). 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.

8.2Lactation Risk Summary Atorvastatin calcium use is contraindicated during breastfeeding [see…

🆘 Overdosage 45 words ▾

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 ~2 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-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 Cmax 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 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 [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 Cmax and 30% for AUC) in healthy elderly subjects (age ≥ 65 years) than in young adults. Clinical data suggest a greater degre…

📦 How Supplied / Storage and Handling 137 words ▾

Atorvastatin calcium tablets, USP 10 mg are white, elliptical, film-coated tablets, debossed with ‘RX 12’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 20 mg are white, elliptical, film-coated tablets, debossed with ‘RX 828’ on one side and plain on the other side. These are supplied as follows: Atorvastatin calcium tablets, USP 40 mg are white, elliptical, film-coated tablets, debossed with ‘RX 829’ on one side and plain on the other side.

These are supplied as follows: Atorvastatin calcium tablets, USP 80 mg are white, elliptical, film-coated tablets, debossed with ‘RX 830’ on one side and plain on the other side. These are supplied as follows: Storage Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature]. Dispense in tight containers (USP).

📋 Description 167 words ▾

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 (C33H34FN2O5)2Ca•3H2O and its molecular weight is 1209.41. Its structural formula is: [structure] 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.

💬 Patient Medication Information ~3 min read ▾

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 befo…

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