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(from DailyMed)

ATORVASTATIN CALCIUM 20 mg Tablet, Film Coated, 20-count

by Bryant Ranch Prepack · 20 TABLET, FILM COATED in 1 BOTTLE (72162-1712-7)

NDC 72162-1712-07

🏷️ FDA NDC (as labeled) 72162-1712-7 billing pads the package segment with a zero

This package

Contains20-count Pack sizes6 compare ↓

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

Also comes in: 9 tablets 72162-1712-02 28 tablets 72162-1712-04 30 tablets 72162-1712-03 60 tablets 72162-1712-06 90 tablets 72162-1712-09

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) 72162-1712-7

Product NDC 72162-1712

11-digit billing NDC 72162171207

NCPDP billing unit EA — each (per item)

RxCUI 617310

UNII YRZ789OWMI

Application # ANDA090548

SPL Set ID 6c1e9bf3-ef52-4053-933d-5a5f7405e642

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 2012-05-29

Route ORAL

Dosage form TABLET, FILM COATED

Substance ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE

GCN Seq No 029968

GCN 43721

HICL code 012404

Ingredient (HICL) Atorvastatin Calcium

HIC1 code M

Therapeutic class — broad (HIC1) Blood

HIC2 code M4

Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids

HIC3 code M4D

Therapeutic class — specific (HIC3) Antihyperlipidemic-Hmgcoa Reductase Inhib(Statins)

AHFS code 24:06.08.00

AHFS class Hmg-Coa Reductase Inhibitors

FDB label name ATORVASTATIN 20 MG TABLET

FDB brand name Atorvastatin Calcium

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 72162-1712-7 — 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 → 72162-1712-07. 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

LabelerBryant Ranch Prepack

Application holderAPOTEX INC

FDA applicationANDA090548 (ANDA)

Labeler code72162

First marketedMay 2012

Product typeHuman Prescription Drug

Portfolio4,433 products on file

🔎 All NDCs from Bryant Ranch Prepack

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

Label name ATORVASTATIN 20 MG TABLET Ingredient Atorvastatin Calcium

📗 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.

🧪 Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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	$1.85 / 20 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 20 mg 00093-5059-10	Teva	1000 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 00378-3951-05	Mylan	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 00480-3586-10	Teva	1000 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 00904-6291-06	Major	1 tablet	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 16571-0137-09	Rising	90 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 31722-0425-05	Camber	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin calcium 20 mg 33342-0316-10	Macleods	90 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 42385-0941-01	Laurus	100 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 42571-0173-10	Micro	1000 tablets	$0.028	AB	Discontinued	—
Atorvastatin Calcium 20 mg 43598-0099-05	Dr.	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 43598-0831-05	Dr.	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 50228-0452-05	ScieGen	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 50268-0094-15	AvPAK	1 tablet	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 51079-0209-20	Mylan	1 tablet	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 55111-0122-05	Dr.	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 67877-0512-05	Ascend	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 68084-0098-01	American	1 tablet	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 70377-0078-11	Biocon	90 tablets	$0.028	AB	Availability likely	—
atorvastatin calcium 20 mg 70710-1775-00	Zydus	1000 tablets	$0.028	AB	Availability likely	—
Atorvastatin calcium 20 mg 70756-0248-12	Lifestar	1000 tablets	$0.028	AB	Availability likely	—
Atorvastatin calcium 20 mg 72205-0023-05	Novadoz	500 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 72603-0283-01	NorthStar	90 tablets	$0.028	AB	Availability likely	—
Atorvastatin calcium 20 mg 72603-0404-02	NorthStar	100 tablets	$0.028	AB	Availability likely	—
Atorvastatin calcium 20 mg 75834-0256-01	NIVAGEN	1000 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 82009-0002-10	Quallent	1000 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 82009-0177-10	Quallent	1000 tablets	$0.028	AB	Availability likely	—
Atorvastatin Calcium 20 mg 16714-0174-01	NORTHSTAR	90 tablets	$0.029	AB	Discontinued	—
Atorvastatin Calcium 20 mg 16729-0045-15	Accord	90 tablets	$0.041	AB	FDA listed	—
Atorvastatin Calcium 20 mg 69097-0945-05	Cipla	90 tablets	$0.041	AB	FDA listed	—
Lipitor 20 mg 58151-0156-77	Viatris	90 tablets	$19.114	AB	Availability likely	—
Atorvastatin Calcium 20 mg 00615-8007-05	NCS	15 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 42708-0004-30	QPharma,	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 42708-0013-30	QPharma,	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 42708-0141-30	QPharma,	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 43063-0496-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 48433-0008-20	Safecor	1 tablet	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-5181-00	A-S	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-5182-00	A-S	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-5634-00	A-S	30 tablets	—	—	FDA listed	—
Atorvastatin Calcium 20 mg 50090-6481-00	A-S	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-6482-00	A-S	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-7386-00	A-S	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-7387-00	A-S	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-7528-00	A-S	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 50090-7529-00	A-S	90 tablets	—	AB	FDA listed	—
atorvastatin calcium 20 mg 50090-7722-00	A-S	30 tablets	—	AB	FDA listed	—
atorvastatin calcium 20 mg 50090-7723-00	A-S	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 51655-0464-52	Northwind	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 51655-0920-26	Northwind	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 55154-6634-00	Cardinal	1 tablet	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 55154-7630-00	Cardinal	1 tablet	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 59651-0607-60	Aurobindo	60000 tablets	—	AB	FDA listed	—
Atorvastatin calcium 20 mg 60290-0040-01	Umedica	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 60505-2579-00	Apotex	10 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 60760-0883-90	St.	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 63187-0108-30	Proficient	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 63629-8470-01	Bryant	500 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 63629-8471-01	Bryant	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 67046-1403-03	Coupler	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 67046-1453-03	Coupler	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 20 mg 67046-1505-03	Coupler	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 67046-1526-03	Coupler	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 67046-1643-03	Coupler	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68071-2824-09	NuCare	90 tablets	—	—	FDA listed	—
Atorvastatin calcium 20 mg 68071-2967-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68071-3580-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68071-3659-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68071-3714-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68071-3891-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68071-4840-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68071-5168-03	NuCare	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 20 mg 68071-5292-09	NuCare	90 tablets	—	AB	FDA listed	—
Atorvastatin calcium 20 mg 68788-4096-03	Preferred	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68788-8625-01	Preferred	100 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68788-8683-01	Preferred	100 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 68788-8693-01	Preferred	100 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 69097-0898-05	Cipla	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 70518-0186-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 70518-3037-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Atorvastatin calcium 20 mg 70518-3339-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Atorvastatin calcium 20 mg 70518-3783-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Atorvastatin calcium 20 mg 70518-4423-00	REMEDYREPACK	100 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 70518-4587-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
atorvastatin calcium 20 mg 70771-1876-00	Zydus	1000 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 71205-0247-30	Proficient	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 71209-0091-04	Cadila	90 tablets	—	—	FDA listed	—
Atorvastatin Calcium 20 mg 71335-1010-01	Bryant	30 tablets	—	—	FDA listed	—
Atorvastatin Calcium 20 mg 71335-1051-01	Bryant	30 tablets	—	AB	Discontinued	—
Atorvastatin Calcium 20 mg 71335-1507-01	Bryant	30 tablets	—	AB	Discontinued	—
Atorvastatin Calcium 20 mg 71335-1929-01	Bryant	30 tablets	—	—	FDA listed	—
Atorvastatin calcium 20 mg 71335-2213-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 71335-2393-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 71335-2404-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 20 mg 71335-2799-01	Bryant	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 71610-0022-45	Aphena	45 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 71610-0744-15	Aphena	15 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 72162-1555-05	Bryant	500 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mgthis 72162-1712-07	Bryant	20 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 72189-0291-90	DirectRX	90 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 72189-0587-30	Direct_Rx	30 tablets	—	AB	FDA listed	—
Atorvastatin calcium 20 mg 72789-0084-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 76420-0945-00	Asclemed	1000 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 77771-0452-05	Radha	500 tablets	—	AB	FDA listed	—
atorvastatin calcium 20 mg 82137-0017-01	Lepu	90 tablets	—	—	FDA listed	—
Atorvastatin Calcium 20 mg 82804-0054-30	Proficient	30 tablets	—	AB	FDA listed	—
Atorvastatin Calcium 20 mg 82804-0161-30	Proficient	30 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2012

On the market since

May 2012

📍

2026

Currently FDA-listed

14 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
72162-1712-02	9 TABLET, FILM COATED in 1 BOTTLE (72162-1712-2)	2023-05-08	Active
72162-1712-03	30 TABLET, FILM COATED in 1 BOTTLE (72162-1712-3)	2023-05-08	Active
72162-1712-04	28 TABLET, FILM COATED in 1 BOTTLE (72162-1712-4)	2023-05-08	Active
72162-1712-06	60 TABLET, FILM COATED in 1 BOTTLE (72162-1712-6)	2023-05-08	Active
72162-1712-07 You're viewing this	20 TABLET, FILM COATED in 1 BOTTLE (72162-1712-7)	2023-05-08	Active
72162-1712-09	90 TABLET, FILM COATED in 1 BOTTLE (72162-1712-9)	2023-05-08	Active

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72162-1712-07?

NDC 72162-1712-07 is a 20-count package — 20 tablet, film coated in 1 bottle.

What is the difference between NDC 72162-1712-07 and NDC 72162-1712-02?

Both are ATORVASTATIN CALCIUM 20 mg Tablet, Film Coated — the drug itself is identical. NDC 72162-1712-07 is the 20-count package, while NDC 72162-1712-02 is the 9 tablets package.

What NDC number is used to bill for this package of ATORVASTATIN CALCIUM 20 mg Tablet, Film Coated?

Bill NDC 72162-1712-07 — the 11-digit billing format is 72162171207. 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

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	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
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 72162-1712-7, 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: 72162-1712-07, written without dashes as 72162171207. The Identity section at the top of this page lists every form of this code.

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In 72162-1712-07, the first segment (72162) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1712) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.

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Does this product come in other package sizes?

Yes — the FDA directory lists 5 other package presentations of this same product, including 9 tablets (72162-1712-02), 28 tablets (72162-1712-04), 30 tablets (72162-1712-03). 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?

Bryant Ranch Prepack 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.

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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 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage ~1 min read ▾

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

Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia Hypertriglyceridemia Atorvastatin calcium tablets are an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.

MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD. As an adjunct to diet to reduce low-density lipoprotein (LDL-C) in: Adults with primary hyperlipidemia.

Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.

Hypertriglyceridemia.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Take orally once daily with or without food ( 2.1 ). Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium, and adjust dosage if necessary ( 2.1 ). Adults ( 2.2 ): Recommended starting dosage is 10 or 20 mg once daily; dosage range is 10 mg to 80 mg once daily.

Patients requiring LDL-C reduction >45% may start at 40 mg once daily. Pediatric Patients Aged 10 Years of Age and Older with HeFH: Recommended starting dosage is 10 mg once daily; dosage range is 10 to 20 mg once daily ( 2.3 ). Pediatric Patients Aged 10 Years of Age and Older with HoFH: Recommended starting dosage is 10 to 20 mg once daily; dosage range is 10 to 80 mg once daily ( 2.4 ).

See full prescribing information for atorvastatin calcium tablets dosage modifications due to drug interactions ( 2.5 ).

2.1Important Dosage Information Take atorvastatin calcium tablet orally once daily at any time of the day, with or without food. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating atorvastatin calcium tablets, and adjust the dosage if necessary. If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose.

2.2Recommended Dosage in Adult Patients The recommended starting dosage of atorvastatin calcium is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily. Patients who require reduction in LDL-C greater than 45% may be started at 40 mg once daily.

2.3Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HeFH The recommended starting dosage of atorvastatin calcium is 10 mg once daily. The dosage range is 10 mg to 20 mg once daily.

2.4Recommended Dosage in Pediatric Patients 10 Years of Age and Older with HoFH The recommended starting dosage of atorvastatin calcium is 10 mg to 20 mg once daily. The dosage range is 10 mg to 80 mg once daily.

2.5Dosage Modifications Due to Drug Interactions Concomitant use of atorvastatin with the following drugs requires dosage modification of atorvastatin [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )] . Anti-Viral Medications In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium 20 mg once daily. In patients taking nelfinavir, do not exceed atorvastatin calcium 40 mg once daily.

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

💊 Dosage Forms and Strengths 119 words ▾

3 DOSAGE FORMS AND STRENGTHS Atorvastatin calcium tablets, USP: 10 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “A10” on the other side. 20 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side. 40 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV40” on the other side.

80 mg of atorvastatin calcium tablets, USP: white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV80” on the other side. Tablets: 10 mg; 20 mg; 40 mg 80 mg of atorvastatin ( 3 ).

⛔ Contraindications 71 words ▾

4 CONTRAINDICATIONS Acute liver failure or decompensated cirrhosis [see Warnings and Precautions ( 5.3 )] Hypersensitivity to atorvastatin or any excipients in atorvastatin calcium tablets. Hypersensitivity reactions, including anaphylaxis, angioneurotic edema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported [see Adverse Reactions ( 6.2 )] . Acute liver failure or decompensated cirrhosis ( 4 ).

Hypersensitivity to atorvastatin or any excipient in atorvastatin calcium tablets ( 4 ).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher atorvastatin calcium dosage. Discontinue atorvastatin calcium tablets if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue atorvastatin calcium in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis.

Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing atorvastatin calcium dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever ( 2.5 , 5.1 , 7.1 , 8.5 , 8.6 ). Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use.

Discontinue atorvastatin calcium tablets if IMNM is suspected ( 5.2 ). Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent. Rare reports of fatal and non-fatal hepatic failure have occurred.

Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue atorvastatin calcium tablets ( 5.3 ).

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

Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis Atorvastatin calcium 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 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. 5)] . Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir [see Adverse Reactions ( 6.1 )] .

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 tablets if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.

Muscle symptoms and CK elevations 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 starting or…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions ( 5.1 )] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.3 )] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (incidence ≥ 5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 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 practice. In the atorvastatin calcium placebo-controlled clinical trial database of 16,066 patients (8,755 atorvastatin calcium vs. 7,311 placebo; age range 10 to 93 years, 39% female, 91% White, 3% Black or African American, 2% Asian, 4% other) with a median treatment duration of 53 weeks, the 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%).

Table 1 summarizes adverse reactions reported in ≥ 2% and at a rate greater than placebo in patients treated with atorvastatin calcium (n=8,755), from seventeen placebo-controlled trials. Table 1: Adverse Reactions Occurring in ≥ 2% in Patients Atorvastatin Calcium-Treated with any Dose and Greater than Placebo Adverse Reaction % Placebo N=7,311 % 10 mg N=3,908 % 20 mg N=188 % 40 mg N=604 % 80 mg N=4,055 % Any dose N=8,755 Nasopharyngitis 8.2 12.9 5.3 7.0 4.2

8.3Arthralgia 6.5 8.9 11.7 10.6 4.3

6.9Diarrhea 6.3 7.3 6.4 14.1 5.2

6.8Pain in extremity 5.9 8.5 3.7 9.3 3.1

6.0Urinary tract infection 5.6 6.9 6.4 8.0 4.1

5.7Dyspepsia 4.3 5.9 3.2 6.0 3.3

4.7Nausea 3.5 3.7 3.7 7.1 3.8

4.0Musculoskeletal pain 3.6 5.2 3.2 5.1 2.3

3.8Muscle spasms 3.0 4.6 4.8 5.1 2.4

3.6Myalgia 3.1 3.6 5.9 8.4 2.7

3.5Insomnia 2.9 2.8 1.1 5.3 2.8

3.0Pharyngolaryngeal pain 2.1 3.9 1.6 2.8 0.7

2.3Other adverse reactions reported in placebo-controlled trials include: Body as a Whole : malaise, pyrexia Digestive System : abdominal discomfort, eructation, flatulence, hepatitis, cholestasis Musculoskeletal System : musculoskeletal pain, muscle fatigue, neck pain, joint swelling Metabolic and Nutritional System : transaminases increase, liver function test abnormal, blood alkaline phosphatase increase, creatine phosphokinase increase, hyperglycemia Nervous System : nightmare Respiratory System : epistaxis Skin and Appendages : urticaria Special Senses : vision blurred, tinnitus Urogenital System : white blood cells urine positive Elevations in Liver Enzyme Tests Persistent elevations in serum transaminases, defined as more than 3 times the ULN and occurring on 2 or more occasions, occurred in 0.7% of patients who received atorvastatin calcium in clinical trials.

The incidence of these abnormalities was 0.2%, 0.2%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively. One patient in clinical trials developed jaundice. Increases in liver enzyme tests in other patients were not associated with jaundice or other clinical signs or symptoms.

Upon dose reduction, drug interruption, or discontinuation, transaminase levels returned to or near pretreatment levels without sequelae. Eighteen of 30 patients with persistent liver enzyme elevations continued treatment with a reduced dose of atorvastatin calcium. Treating to New Targets Study (TNT) In TNT, [see Clinical Studies ( 14.1 )] 10,001 patients (age range 29 to 78 years, 19% female…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of atorvastatin calcium with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis ( 2.5 , 7.1 ). Rifampin: May reduce atorvastatin plasma concentrations. Administer simultaneously with atorvastatin ( 7.2 ).

Oral Contraceptives: May increase plasma levels of norethindrone and ethinyl estradiol; consider this effect when selecting an oral contraceptive ( 7.3 ). Digoxin: May increase digoxin plasma levels; monitor patients appropriately ( 7.3 ).

7.1Drug 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 calcium plasma levels can be significantly increased with concomitant administration of inhibitors of CYP3A4 and transporters. Table 2 includes a list of drugs that may increase exposure to atorvastatin and may increase the risk of myopathy and rhabdomyolysis when used concomitantly and instructions for preventing or managing them [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

Table 2: Drug Interactions that may Increase the Risk of Myopathy and Rhabdomyolysis with Atorvastatin Calcium Cyclosporine or Gemfibrozil Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium and cyclosporine, an inhibitor of CYP3A4 and OATP1B1 [see Clinical Pharmacology ( 12.3 )] . Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium.

Intervention: Concomitant use of cyclosporine or gemfibrozil with atorvastatin calcium is not recommended. Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium 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 is not recommended. In patients taking lopinavir plus ritonavir, or simeprevir, consider the risk/benefit of concomitant use with atorvastatin. In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed atorvastatin calcium 20 mg.

In patients taking nelfinavir, do not exceed atorvastatin calcium 40 mg [see Dosage and Administration ( 2.5 )] . 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, fosamprenavir plus ritonavir, elbasvir plus grazoprevir, letermovir, nelfinavir, and ledipasvir plus sofosbuvir. Select Azole Antifungals or Macrolide Antibiotics Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of atorvastatin calcium with select azole antifungals or macrolide antibiotics, due to inhibition of CYP3A4 and/or transporters [see Clinical Pharmacology ( 12.3 )] .

Intervention: In patients taking clarithromycin or itraconazole, do not exceed atorvastatin calcium 20 mg [see Dosage and Administration ( 2.5 )] . Consider the risk/benefit of concomitant use of other azole antifungals or macrolide antibiotics with atorvastatin c…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. ( 8.1 ). Lactation: Breastfeeding not recommended during treatment with atorvastatin calcium tablets ( 8.2 ).

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

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

Published data from prospective and retrospective observational cohort studies with atorvastatin calcium tablets use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data). In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered atorvastatin at doses that resulted in up to 30 and 20 times, respectively, the human exposure at the maximum recommended human dose (MRHD) of 80 mg, based on body surface area (mg/m 2 ).

In rats administered atorvastatin during gestation and lactation, decreased postnatal growth and development delay were observed at doses ≥ 6 times the MRHD (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Human Data A Medicaid cohort linkage study of 1,152 statin-exposed pregnant women compared to 8,86,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods. The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus.

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

Animal Data Atorvastatin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 300 mg/kg/day and 100 mg/kg/day, respectively. Atorvastatin was not teratogenic in rats at doses up to 300 mg/kg/day or in rabbits at doses up to 100 mg/kg/day. These doses resulted in multiples of about 30 times (rat) or 20 times (rabbit) the human exposure at the MRHD based on surface area (mg/m 2 ).

In rats, the maternally toxic dose of 300 mg/kg resulted in increased post-implantation loss and decreased fetal body weight. At the maternally toxic doses of 50 and…

🤰 Pregnancy ~3 min read ▾

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, 10…

🧒 Pediatric Use 188 words ▾

8.4Pediatric Use The safety and effectiveness of atorvastatin calcium as an adjunct to diet to reduce LDL-C have been established pediatric patients 10 years of age and older with HeFH. Use of atorvastatin calcium for this indication is based on a double-blind, placebo-controlled clinical trial in 187 pediatric patients 10 years of age and older with HeFH. In this limited controlled trial, there was no significant effect on growth or sexual maturation in the males or females or on menstrual cycle length in females.

The safety and effectiveness of atorvastatin calcium as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established pediatric patients 10 years of age and older with HoFH. Use of atorvastatin calcium for this indication is based on a trial without a concurrent control group in 8 pediatric patients 10 years of age and older with HoFH [see Clinical Studies ( 14 )]. The safety and effectiveness of atorvastatin calcium have not been established in pediatric patients younger than 10 years of age with HeFH or HoFH, or in pediatric patients with other types of hyperlipidemia (other than HeFH or HoFH).

🧓 Geriatric Use 117 words ▾

8.5Geriatric Use Of the total number of atorvastatin calcium-treated patients in clinical trials, 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 patients and younger patients. Advanced age (≥65 years) is a risk factor for atorvastatin calcium tablets-associated myopathy and rhabdomyolysis.

Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving atorvastatin calcium tablets for the increased risk of myopathy [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 33 words ▾

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics Atorvastatin, 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 is rapidly absorbed after oral administration; maximum plasma concentrations occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin dose. The absolute bioavailability of atorvastatin (parent drug) is approximately 14% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%.

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

However, LDL-C reduction is the same regardless of the time of day of drug administration. 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. Elimination 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 is recovered in urine following oral administration.

Specific Populations Geriatric Plasma concentrations of atorvastatin are higher (approximately 40% for C max and 30% for AUC) in healthy elderly subjects (age ≥65 years) than in young adults. Pediatric Apparent oral clearance of atorvastatin in pediatric subjects appeared similar to that of adults when scaled allometrically by body weight as the body weight was the only significant covariate in atorvastatin population PK model with data including pediatric HeFH patients (ages 10 years to 17 years of age, n…

🧬 Mechanism of Action 81 words ▾

📦 How Supplied / Storage and Handling 136 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Atorvastatin calcium tablets, USP are supplied as white to off-white, oval, biconvex film-coated tablets of atorvastatin calcium containing 20 mg atorvastatin. Atorvastatin calcium tablets, USP 20 mg, are available for oral administration as white to off-white, oval, biconvex film-coated tablets, engraved “APO” on one side, “ATV20” on the other side. NDC 72162-1712-2: 9 Tablets in a Bottle NDC 72162-1712-3: 30 Tablets in a Bottle NDC 72162-1712-4: 28 Tablets in a Bottle NDC 72162-1712-6: 60 Tablets in a Bottle NDC 72162-1712-7: 20 Tablets in a Bottle NDC 72162-1712-9: 90 Tablets in a Bottle Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container [see USP]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 178 words ▾

11 DESCRIPTION Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. The drug substance used in atorvastatin calcium tablets, USP is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate.

The empirical formula of atorvastatin calcium propylene glycol solvate is C 66 H 68 CaF 2 N 4 O 10 * C 3 H 8 O 2 and its molecular weight is 1231.46 g/mol. Its structural formula is: Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol.

Atorvastatin calcium tablets, USP for oral administration contain atorvastatin 10, 20, 40, or 80 mg (equivalent to 11, 22, 44 or 88 mg atorvastatin calcium) and the following inactive ingredients: calcium acetate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate (vegetable source), microcrystalline cellulose, polyethylene glycol, sodium carbonate, and titanium dioxide.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis Advise patients that atorvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication or consuming large quantities of grapefruit juice and they should discuss all medication, both prescription and over the counter, with their healthcare provider.

Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] . Hepatic Dysfunction Inform patients that atorvastatin calcium tablets may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions ( 5.3 )] .

Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with atorvastatin calcium tablets. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions ( 5.4 )] . Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus.

Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if atorvastatin calcium tablets should be discontinued [see Use in Specific Populations ( 8.1 )] . Lactation Advise patients that breastfeeding is not recommended during treatment with atorvastatin calcium tablets [see Use in Specific Populations ( 8.2 )] . Missed Doses If a dose is missed, advise patients not to take the missed dose and resume with the next scheduled dose.

All registered trademarks in this document are the property of their respective owners. APOTEX INC. ATORVASTATIN CALCIUM TABLETS, USP 10 mg, 20 mg, 40 mg, and 80 mg Manufactured By Manufactured For Apotex Inc.

Apotex Corp. Toronto, Ontario Weston, Florida Canada, M9L 1T9 USA, 33326 Rev. 24

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

case series: A report describing what happened to a small group of patients, with no comparison group.

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.

acute kidney injury: A sudden drop in kidney function over hours or days, which is often reversible if the cause is treated.

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.

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

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

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.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

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.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

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.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

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.

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

edema: Swelling caused by extra fluid trapped in the body's tissues.

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.

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.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

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

excipient: An inactive ingredient added to a medicine to bind, preserve, flavor, or shape it.

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.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

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.

HbA1c: A blood test showing average blood sugar over the past two to three months; also called A1C or glycated hemoglobin.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

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

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.

hyperbilirubinemia: A higher-than-normal level of bilirubin in the blood, which can cause yellowing of the skin or eyes.

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.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pyrexia: A raised body temperature; a fever.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

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

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

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

statistically significant: A result unlikely to be due to chance alone, suggesting a real difference between the groups being compared.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

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.

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.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

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.

ULN: 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 ↗

← 72162-1709-02 · Bryant 72162-1715-02 · Bryant →

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 20 mg Tablet, Film Coated, 20-count

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