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Atorvastatin Calcium 40 mg Tablet, 30-count

by NuCare Pharmaceuticals,Inc. · 30 TABLET in 1 BOTTLE (68071-2991-3)

NDC 68071-2991-03

🏷️ FDA NDC (as labeled) 68071-2991-3 billing pads the package segment with a zero

This package

Contains30-count Pack sizes2 compare ↓

Also priced by: Part D plans $0.0927/unit — full pricing hub ↓

Also comes in: 90 tablets 68071-2991-09

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 Dr. Brian Staiger, PharmD

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) 68071-2991-3

Product NDC 68071-2991

11-digit billing NDC 68071299103

RxCUI 617311

UNII 48A5M73Z4Q

UPC 0368071299199

Application # ANDA214659

SPL Set ID fa2d8d38-dbd0-43fd-e053-6294a90a4e94

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 2022-08-29

Route ORAL

Dosage form TABLET

Substance ATORVASTATIN CALCIUM TRIHYDRATE

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 68071-2991-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68071-2991-03. 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

LabelerNuCare Pharmaceuticals,Inc.

Application holderDR REDDYS LABORATORIES LTD

FDA applicationANDA214659 (ANDA)

Labeler code68071

First marketedAug 2022

Product typeHuman Prescription Drug

Portfolio1,015 products on file

🔎 All NDCs from NuCare Pharmaceuticals,Inc.

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

📖 What it is MedlinePlus · NLM

Atorvastatin is used to reduce the risk of heart attack and stroke decrease the amount of cholesterol (a fat-like substance that can build up and clog blood vessels causing heart attacks or strokes or other health problems) Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing how much cholesterol your body makes. This lowers the amount of cholesterol that can build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

Read the full MedlinePlus article ↗

📗 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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Atorvastatin Calcium — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Atorvastatin Calcium (181 interactions) — ranked by severity →

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.

COENZYME Q10 Insufficient Evidence L-CARNITINE Insufficient Evidence

🧪 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

ImprintC3

Size15 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 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 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 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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 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 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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.

11 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 system	Per each	Per 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	$2.78 / 30 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Atorvastatin Calcium 40 mg 00093-5058-10	Teva	1000 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 00480-3587-10	Teva	1000 tablets	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 00904-6292-06	Major	1 tablet	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 16571-0138-09	Rising	90 tablets	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 16714-0175-01	NORTHSTAR	90 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 42385-0942-01	Laurus	100 tablets	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 42571-0174-10	Micro	1000 tablets	$0.037	AB	Discontinued	—
Atorvastatin Calcium 40 mg 43598-0101-05	Dr.	500 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 50228-0453-10	ScieGen	1000 tablets	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 50268-0095-15	AvPAK	1 tablet	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 51079-0210-20	Mylan	1 tablet	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 55111-0123-05	Dr.	500 tablets	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 67877-0513-05	Ascend	500 tablets	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 68084-0099-01	American	1 tablet	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 70377-0079-11	Biocon	90 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 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 72603-0284-01	NorthStar	90 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 75834-0257-01	NIVAGEN	1000 tablets	$0.037	AB	Availability likely	—
Atorvastatin Calcium 40 mg 82009-0003-10	Quallent	1000 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 63304-0829-05	Sun	500 tablets	$0.040	—	FDA listed	—
Atorvastatin Calcium 40 mg 16729-0046-15	Accord	90 tablets	$0.068	AB	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	—
Lipitor 40 mg 58151-0157-77	Viatris	90 tablets	$19.114	AB	Availability likely	—
Atorvastatin Calcium 40 mg 00615-8008-05	NCS	15 tablets	—	AB	Discontinued	—
Atorvastatin Calcium 40 mg 42708-0005-30	QPharma,	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 42708-0108-30	QPharma,	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 42708-0144-30	QPharma,	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 43063-0453-30	PD-Rx	30 tablets	—	AB	FDA listed	—
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 50090-5208-00	A-S	90 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 50090-6440-00	A-S	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 50090-6441-00	A-S	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 50090-7384-00	A-S	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 50090-7385-00	A-S	90 tablets	—	AB	FDA listed	—
atorvastatin calcium 40 mg 50090-7726-00	A-S	30 tablets	—	AB	FDA listed	—
atorvastatin calcium 40 mg 50090-7727-00	A-S	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 50090-7806-00	A-S	30 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 55154-4166-00	Cardinal	1 tablet	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 55154-6646-00	Cardinal	1 tablet	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 55154-7628-00	Cardinal	1 tablet	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 59651-0608-62	Aurobindo	30000 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 60290-0041-01	Umedica	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 60505-2580-00	Apotex	10 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 60760-0726-30	St.	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 60760-0734-30	St.	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 60760-0882-30	St.	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 63187-0109-30	Proficient	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 67046-1529-03	Coupler	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 68071-2302-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mgthis 68071-2991-03	NuCare	30 tablets	—	AB	FDA listed	—
atorvastatin calcium 40 mg 68071-2994-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-3267-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-3595-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-3628-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-3667-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-3882-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 68071-3948-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-4837-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-5091-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68071-5194-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 68788-8094-01	Preferred	100 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68788-8574-09	Preferred	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 68788-8887-01	Preferred	100 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 69097-0899-05	Cipla	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 70518-1322-01	REMEDYREPACK	90 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 70518-3273-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Atorvastatin calcium 40 mg 70518-4321-00	REMEDYREPACK	100 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 70518-4474-00	REMEDYREPACK	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 70518-4592-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
atorvastatin calcium 40 mg 70771-1877-00	Zydus	1000 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 71205-0264-30	Proficient	30 tablets	—	—	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 71209-0092-04	Cadila	90 tablets	—	—	FDA listed	—
Atorvastatin Calcium 40 mg 71335-1011-01	Bryant	30 tablets	—	—	Discontinued	—
Atorvastatin Calcium 40 mg 71335-1126-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 71335-2493-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 71335-2591-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 71335-2697-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 71335-9711-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 71335-9723-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 71610-0163-15	Aphena	15 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 71610-0745-15	Aphena	15 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 72162-2238-09	Bryant	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 72189-0557-30	Direct_rx	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 72789-0089-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 76420-0946-00	Asclemed	1000 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 77771-0453-10	Radha	1000 tablets	—	AB	FDA listed	—
atorvastatin calcium 40 mg 82137-0018-01	Lepu	90 tablets	—	—	FDA listed	—
Atorvastatin Calcium 40 mg 82804-0026-30	Proficient	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 82804-0056-30	Proficient	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 82868-0029-30	Northwind	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 40 mg 82868-0048-30	Northwind	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 87441-0013-01	Unit	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 40 mg 72189-0239-90	DIRECT	90 tablets	—	—	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

🏛️

2022

On the market since

Aug 2022

📍

2026

Currently FDA-listed

4 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

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

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 NDC	Description	Marketing start	Status
68071-2991-09	90 TABLET in 1 BOTTLE (68071-2991-9)	2023-04-25	Active
68071-2991-03 You're viewing this	30 TABLET in 1 BOTTLE (68071-2991-3)	2023-04-25	Active

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

Pack size FAQ

What quantity is in NDC 68071-2991-03?

NDC 68071-2991-03 is a 30-count package — 30 tablet in 1 bottle.

What is the difference between NDC 68071-2991-03 and NDC 68071-2991-09?

Both are Atorvastatin Calcium 40 mg Tablet — the drug itself is identical. NDC 68071-2991-03 is the 30-count package, while NDC 68071-2991-09 is the 90 tablets package.

What NDC number is used to bill for this package of Atorvastatin Calcium 40 mg Tablet?

Bill NDC 68071-2991-03 — the 11-digit billing format is 68071299103. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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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 68071-2991-3, 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: 68071-2991-03, written without dashes as 68071299103. 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 68071-2991-03, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (2991) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (68071-2991-09). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

NuCare Pharmaceuticals,Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~3 min read ▾

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

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

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

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

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

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

LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL…

⏱️ Dosage and Administration ~3 min read ▾

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

2.1Hyperlipidemia and Mixed Dyslipidemia The recommended starting dose of atorvastatin calcium tablets is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin calcium tablets is 10 to 80 mg once daily.

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

2.2Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 Years to 17 Years of Age) The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the usual dose range is 10 to 20 mg orally once daily [see Clinical Studies ( 14.6 ) ]. Doses should be individualized according to the recommended goal of therapy [see Indications and Usage ( 1.2 ) and Clinical 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) 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, Pharmacokinetics (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, 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 ( 7.1 )].

💊 Dosage Forms and Strengths 132 words ▾

3 DOSAGE FORMS AND STRENGTHS Atorvastatin calcium tablets USP, 10 mg are white to off-white oval shaped, film-coated tablets with ‘C1’ on one side and plain on other side and free from physical defects. Atorvastatin calcium tablets USP, 20 mg are white to off-white oval shaped, film-coated tablets with ‘C2’ on one side and plain on other side and free from physical defects. Atorvastatin calcium tablets USP, 40 mg are white to off-white oval shaped, film-coated tablets with ‘C3’ on one side and plain on other side and free from physical defects.

Atorvastatin calcium tablets USP, 80 mg are white to off-white oval shaped, film-coated tablets with ‘C4’ on one side and plain on other side and free from physical defects. Tablets: 10, 20, 40 and 80 mg of atorvastatin (3) .

⛔ Contraindications 83 words ▾

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

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

⚠️ Warnings and Cautions ~2 min read ▾

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

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

IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents ( 5.2 ) Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter ( 5.3 ) A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the atorvastatin calcium tablets 80 mg group vs. placebo ( 5.6 ) .

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

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

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

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

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the label: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] Liver enzyme abnormalities [see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions (incidence ≥ 2%) in patients treated with atorvastatin calcium tablets in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Dr.

Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the atorvastatin calcium tablets placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin calcium tablets vs. 7,311 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 tablets 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 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%). The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) regardless of causality, in patients treated with atorvastatin calcium tablets 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 tablets (n=8755), from seventeen placebo-controlled trials. Table 2. Clinical Adverse Reactions Occurring in ≥ 2% in Patients Treated with any Dose of Atorvastatin Calcium Tablets and at an Incidence Greater than Placebo Regardless of Causality (% of Patients).

Adverse Reaction* Any dose N=8755 10 mg N=3908 20 mg N=188 40 mg N=604 80 mg N=4055 Placebo 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 tractinfection 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 2.1 * Adverse Reaction ≥ 2% in any dose greater than placebo Other 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 tablets 10…

🔄 Drug Interactions ~2 min read ▾

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

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

Digoxin: Patients should be monitored appropriately ( 7.3 ).

7.1Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Atorvastatin calcium is a substrate of CYP3A4 and transporters (e.g., OATP1B1/1B3, P-gp, or BCRP). Atorvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 3 includes a list of drugs that may increase exposure to atorvastatin and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3) ].

Table 3: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [see Clinical Pharmacology ( 12.3 )] . Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium.

Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium is not recommended 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.

Intervention : • Concomitant use of tipranavir plus ritonavir or glecaprevir plus pibrentasvir with atorvastatin calcium tablets are 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 ( 2.6 )]. • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with atorvastatin calcium. • 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, fo…

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary Atorvastatin calcium tablets are 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 may cause fetal harm when administered to a pregnant woman. Atorvastatin calcium should be discontinued as soon as pregnancy is recognized [see Contraindications ( 4 ) ].

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

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

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

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

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

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

Pup development was delayed (rotarod performance at 100 mg/…

🤰 Pregnancy ~3 min read ▾

Pup development was delayed (rotarod 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.

🧓 Geriatric Use 91 words ▾

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

🆘 Overdosage 45 words ▾

10 OVERDOSAGE There is no specific treatment for atorvastatin 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 clearance.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Atorvastatin calcium is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, atorvastatin 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 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 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 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 is approximately 381 liters. Atorvastatin 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 is likely to be secreted in human milk [see Contraindications, Nursing Mothers (4) and Use in Specific Populations (8.2 ) ]. Metabolism: Atorvastatin 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. Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites. In vitro studies suggest the importance of atorvastatin metabolism by cytochrome P450 3A4, consistent with increased plasma concentrations of atorvastatin 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 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 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 tablets are recovered in urine following oral administration. Specific Populations Geriatric: Plasma concentrations of atorvastatin 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 degree of LDL-lowering at any dose…

🧬 Mechanism of Action 80 words ▾

📦 How Supplied / Storage and Handling 61 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atorvastatin calcium tablets USP, 40 mg are white to off-white oval shaped, film-coated tablets with ‘C3’ on one side and plain on other side and free from physical defects. Bottles of 30 NDC 68071-2991-3 Bottles of 90 NDC 68071-2991-9 Storage Store atorvastatin calcium tablets at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

📋 Description 155 words ▾

11 DESCRIPTION Atorvastatin calcium 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 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 is C 66 H 74 CaF 2 N 4 O 13 and its molecular weight is 1206.408. Its structural formula is: Atorvastatin calcium USP is a white to off-white crystalline powder.

It is freely soluble in methanol and insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium tablets USP, for oral administration contain 10, 20, 40 and 80 mg atorvastatin and the following inactive ingredients: calcium carbonate, croscarmellose sodium, hydroxyl propyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80. The tablet coating contains hypromellose, polyethylene glycol, talc and titanium dioxide.

Atorvastatin calcium tablets meets USP Dissolution Test 5. structure

💬 Information for Patients ~2 min read ▾

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

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

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

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

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

17.4Lactation Advise women not to breastfeed during treatment with atorvastatin calcium [see Contraindications ( 4 ) and Use in Specific Populations ( 8.2 ) ]. Rx only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Issued:07/2022

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

immunosuppressive: Describes something that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

albuminuria: Albumin, a protein from the blood, leaking into the urine; it is a common early sign of kidney damage.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

arthralgia: Joint pain.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

autoimmune: Describes a condition in which the body's defense system mistakenly attacks its own healthy cells or tissues.

BCRP: A protein pump that moves certain drugs out of cells, affecting how much of the drug is absorbed.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

cholestasis: A slowing of bile flow out of the liver; bile is the fluid that helps digest fat, and this backup can cause itching and yellow skin.

CK: A protein measured in a blood test that rises when muscle is being damaged.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatine kinase: A protein measured in a blood test that rises when muscle is being damaged.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyslipidemia: Unhealthy levels of fats, such as cholesterol and triglycerides, in the blood.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

enterohepatic recirculation: A cycle where a medicine passes into the gut with bile, then is reabsorbed back into the blood.

epistaxis: A nosebleed.

eructation: The medical word for burping, or releasing gas from the stomach up through the mouth.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

first-pass metabolism: The breakdown of a swallowed medicine by the liver before it reaches the rest of the body.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

glucuronidation: The process where enzymes attach a sugar-like molecule to a drug so it dissolves in water and leaves the body.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypercholesterolemia: A higher-than-normal level of cholesterol, a type of fat, in the blood.

hyperglycemia: High blood sugar, meaning there is more glucose (sugar) in the blood than normal.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypertriglyceridemia: A higher-than-normal level of triglycerides, a type of fat, in the blood.

hypothyroidism: A condition where the thyroid gland makes too little thyroid hormone, which can slow the body down.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

myopathy: A disease of the muscles that can make them weak, painful, or tender.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

P-gp: A protein pump in cells that pushes certain drugs back out, limiting how much is absorbed or reaches tissues.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

pyrexia: A raised body temperature; a fever.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

retinopathy: Damage to the retina, the light-sensing layer at the back of the eye, which can affect vision.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

TIA: A brief, stroke-like episode from a temporary drop in blood flow to the brain, with symptoms that go away.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 68071-2990-09 · NuCare 68071-2992-01 · NuCare →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Atorvastatin Calcium 40 mg Tablet, 30-count

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