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Rosuvastatin Calcium 20 mg Tablet, Film Coated, 180-count

by Bryant Ranch Prepack · 180 TABLET, FILM COATED in 1 BOTTLE (71335-0905-5)

NDC 71335-0905-05

🏷️ FDA NDC (as labeled) 71335-0905-5 billing pads the package segment with a zero

This package

Contains180-count Pack sizes6 compare ↓

Also priced by: Part D plans $0.1900/unit — full pricing hub ↓

Also comes in: 28 tablets 71335-0905-03 30 tablets 71335-0905-01 60 tablets 71335-0905-04 90 tablets 71335-0905-02 120 tablets 71335-0905-06

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 Rosuvastatin Calcium (different manufacturers) — 2 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0339-2025

Class II · Mar 23, 2023 — cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. (Preferred Pharmaceuticals, Inc.) · FDA recall D-0519-2023

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-0905-5

Product NDC 71335-0905

11-digit billing NDC 71335090505

RxCUI 859751

UNII 83MVU38M7Q

Application # ANDA207408

SPL Set ID ebb0c5d6-d816-44fa-8422-82aa63076d55

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 2018-01-08

Route ORAL

Dosage form TABLET, FILM COATED

Substance ROSUVASTATIN CALCIUM

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 71335-0905-5 — 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 → 71335-0905-05. 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 holderCHANGZHOU PHARMACEUTICAL FACTORY

FDA applicationANDA207408 (ANDA)

Labeler code71335

First marketedJan 2018

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

📗 Our plain-language guide HelloPharmacist

Rosuvastatin lowers the amount of LDL — the "bad" cholesterol — and other fats circulating in your blood, while nudging your "good" cholesterol (HDL) a little higher. Depending on...
What exactly is rosuvastatin supposed to do for me?
No — you can take rosuvastatin at any time of day that's easiest for you to remember, and food doesn't change how well it's absorbed. The most important thing is taking it consiste...
Does it matter what time of day I take it, or whether I take it with food?

📖 Read our full Rosuvastatin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

Rosuvastatin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

COENZYME Q10 Insufficient Evidence

🧪 Full Rosuvastatin 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	$0.1900	$34.20 / 180 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
Rosuvastatin 20 mg 11788-0132-05	AiPing	500 tablets	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 13668-0181-05	Torrent	500 tablets	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 13668-0722-05	TORRENT	500 tablets	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 16714-0990-01	NorthStar	90 tablets	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 24658-0263-45	PURACAP	45 tablets	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 27808-0157-01	Cranbury	90 tablets	$0.045	AB	Availability likely	—
Rosuvastatin 20 mg 50228-0118-10	ScieGen	1000 tablets	$0.045	AB	Availability likely	—
Rosuvastatin 20 mg 50268-0710-15	AvPAK	1 tablet	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 60687-0256-01	American	1 tablet	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 67877-0441-05	Ascend	500 tablets	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 72603-0366-01	NorthStar	90 tablets	$0.045	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 82009-0019-10	Quallent	1000 tablets	$0.045	AB	Availability likely	—
Rosuvastatin 20 mg 16729-0286-15	Accord	90 tablets	$0.064	AB	FDA listed	—
Crestor 20 mg 00310-7580-90	AstraZeneca	90 tablets	$8.810	AB	Availability likely	—
Rosuvastatin Calcium 20 mg 00615-8534-05	NCS	15 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 31722-0884-31	Camber	100 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 33342-0263-07	Macleods	30 tablets	—	—	FDA listed	—
Rosuvastatin Calcium 20 mg 42677-0303-01	Shandong	90 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 42708-0191-30	QPharma,	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 50090-2449-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 50090-5676-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 50090-6422-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 50090-6519-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 50090-6522-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 50090-6524-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 50090-7004-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 50090-7005-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 50090-7730-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 50090-7793-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 51407-0850-10	Golden	1000 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 51655-0235-52	Northwind	30 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 51655-0309-52	Northwind	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 51655-0996-52	Northwind	30 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 55154-0159-00	Cardinal	1 tablet	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 57237-0170-05	Rising	500 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 60290-0045-01	Umedica	30 tablets	—	AB	FDA listed	—
Rosuvastain Calcium 20 mg 62135-0692-90	Chartwell	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 63187-0865-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 65862-0295-05	Aurobindo	500 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 68071-2379-02	NuCare	120 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 68071-3847-02	NuCare	120 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 68462-0263-01	Glenmark	100 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 68788-4047-02	Preferred	20 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 68788-7612-02	Preferred	20 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 68788-8533-02	Preferred	20 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 68788-8698-02	Preferred	20 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 69367-0361-01	Westminster	100 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 69434-0007-02	Zhejiang	90 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 70377-0008-11	Biocon	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 70518-1819-00	REMEDYREPACK	90 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 70518-4199-00	REMEDYREPACK	90 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 70518-4296-00	REMEDYREPACK	45 tablets	—	AB	FDA listed	—
rosuvstatin 20 mg 70756-0055-12	Lifestar	1000 tablets	—	—	FDA listed	—
Rosuvastatin 20 mg 71205-0044-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 71205-0099-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 71205-0279-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 71205-0390-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 71209-0045-04	Cadila	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 71335-0302-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mgthis 71335-0905-05	Bryant	180 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 71335-1098-01	Bryant	30 tablets	—	AB	Discontinued	—
Rosuvastatin calcium 20 mg 71335-1741-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 71335-2406-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 71335-9669-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 71610-0187-45	Aphena	45 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 71610-0234-15	Aphena	15 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 71610-0796-15	Aphena	15 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 71610-0922-45	Aphena	45 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 72205-0004-05	Novadoz	500 tablets	—	AB	FDA listed	—
Rosuvastatin 20 mg 82009-0190-05	Quallent	500 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 82804-0090-90	Proficient	90 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 20 mg 72303-0829-01	HEC	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 20 mg 67296-2289-09	Redpharm	90 tablets	—	AB	FDA listed	—

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

Where does this data come from?

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

⏳ Availability & generic status

🏛️

2018

On the market since

Jan 2018

📍

2026

Currently FDA-listed

8 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 Rosuvastatin Calcium — the program that covers self-administered drugs. 19 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 Rosuvastatin 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

$119.94M

Claims incl. refills

9.3M

Beneficiaries

7.8M

Spend / beneficiary

$15.47

Spend / claim

$12.87

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 Rosuvastatin Calcium — the ingredient across all brands.

Top reported reactions

Dyspnoea2,778

Fatigue2,694

Pain2,470

Cough2,412

Headache2,118

Nausea1,988

Pneumonia1,881

Reporter sex

Male · 44%

Female · 56%

Unknown · 0%

Serious outcomes

Hospitalization9,256

Death1,404

Life-threatening1,243

Disabling931

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
71335-0905-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-0905-1)	2018-08-23	Active
71335-0905-02	90 TABLET, FILM COATED in 1 BOTTLE (71335-0905-2)	2018-07-11	Active
71335-0905-03	28 TABLET, FILM COATED in 1 BOTTLE (71335-0905-3)	2021-12-27	Active
71335-0905-04	60 TABLET, FILM COATED in 1 BOTTLE (71335-0905-4)	2021-12-27	Active
71335-0905-05 You're viewing this	180 TABLET, FILM COATED in 1 BOTTLE (71335-0905-5)	2021-12-27	Active
71335-0905-06	120 TABLET, FILM COATED in 1 BOTTLE (71335-0905-6)	2021-12-27	Active

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

Pack size FAQ

What quantity is in NDC 71335-0905-05?

NDC 71335-0905-05 is a 180-count package — 180 tablet, film coated in 1 bottle.

What is the difference between NDC 71335-0905-05 and NDC 71335-0905-03?

Both are Rosuvastatin Calcium 20 mg Tablet, Film Coated — the drug itself is identical. NDC 71335-0905-05 is the 180-count package, while NDC 71335-0905-03 is the 28 tablets package.

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

Bill NDC 71335-0905-05 — the 11-digit billing format is 71335090505. 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	✓ Available
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 71335-0905-5, 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: 71335-0905-05, written without dashes as 71335090505. 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 71335-0905-05, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (0905) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Bryant Ranch Prepack. 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 5 other package presentations of this same product, including 28 tablets (71335-0905-03), 30 tablets (71335-0905-01), 60 tablets (71335-0905-04). 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.

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 🧒 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 Rosuvastatin calcium tablets is indicated: To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.

Reduce LDL-C in adults and pediatric patients aged 8 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 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

Rosuvastatin is an HMG Co-A reductase inhibitor (statin) indicated: (1) To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults.

As an adjunct to diet to reduce LDL-C in adults and pediatric patients aged 8 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 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia.

Hypertriglyceridemia.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take orally with or without food, at any time of day. (2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin calcium tablets, and adjust dosage if necessary. (2.1) Adults: Recommended dosage range is 5 to 40 mg once daily.

(2.1) Pediatric Patients with HeFH : Recommended dosage range is 5 to 10 mg once daily for patients aged 8 to less than 10 years of age, and 5 to 20 mg once daily for patients aged 10 years and older. (2.2) Pediatric Patients with HoFH : Recommended dosage is 20 mg once daily for patients aged 7 years and older. (2.2) Asian Patients: Initiate at 5 mg once daily.

Consider risks and benefits of treatment if not adequately controlled at doses up to 20 mg once daily. (2.4) Patients with Severe Renal Impairment (not on hemodialysis): Initiate at 5 mg once daily; do not exceed 10 mg once daily. (2.5, 5.1, 8.6) See full prescribing information for rosuvastatin dosage and administration modifications due to drug interactions.

(2.6)

2.1General Dosage and Administration Information Administer rosuvastatin calcium tablets orally as a single dose at any time of day, with or without food. The tablet should be swallowed whole. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin calcium tablets, and adjust the dosage if necessary. If a dose is missed, advise patients not take an extra dose. Resume treatment with the next dose.

2.2Recommended Dosage in Adult Patients The dosage range for rosuvastatin calcium tablets is 5 to 40 mg orally once daily. The recommended dose of rosuvastatin calcium tablets depends on a patient’s indication for usage, LDL- C, and individual risk for cardiovascular events.

2.3Recommended Dosage in Pediatric Patients D osage in Pediatric Patients 8 Years of Age and Older with HeFH The recommended dosage range is 5 mg to 10 mg orally once daily in patients aged 8 years to less than 10 years and 5 mg to 20 mg orally once daily in patients aged 10 years and older. D osage in Pediatric Patients 7 Years of Age and Older with HoFH The recommended dosage is 20 mg orally once daily.

2.4Dosing in Asian Patients Initiate rosuvastatin calcium tablets at 5 mg once daily due to increased rosuvastatin plasma concentrations. Consider the risks and benefits of rosuvastatin calcium tablets when treating Asian patients not adequately controlled at doses up to 20 mg once daily [see Warnings and Precautions (5.1) , Use in Specific Populations (8.8) , and Clinical Pharmacology(12.3) ].

2.5Recommended Dosage in Patients with Renal Impairment In patients with severe renal impairment (CL cr less than 30 mL/min/1.73 m 2 ) not on hemodialysis, the recommended starting dosage is 5 mg once daily and should not exceed 10 mg once daily [see W arnings and Precautions (5.1) a nd U se in Specific Populations (8.6) ]. There are no dosage adjustment recommendations for patients with mild and moderate renal impairment.

2.6Dosage and Administration Modifications Due to Drug Interactions Rosuvastatin Calcium Tablets Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for rosuvastatin calcium tablets due to drug interactions [see W arnings and Precautions (5.1) and D rug Interactions (7.1) ]. Table 1: Rosuvastatin Calcium Tablets D osage Modifications Due to Drug Interactions C oncomitantly Used Drug Rosuvastatin Calcium Tablets D osage Modifications Cyclosporine Do not exceed 5 mg once daily. Teriflunomide Do not exceed 10 mg once daily.

Enasidenib Do not exceed 10 mg once daily. Capmatinib Do not exceed 10 mg once daily. Fostamatinib Do not exceed 20 mg once daily.

Febuxostat Do not exceed 20 mg once daily. Gemfibrozil Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 10 mg once daily.

Tafamidis Avoid concomitant use. If used concomitantly, initiate at 5 mg once daily and do not exceed 20 mg once daily. Antiviral Medications Sofbuvir/velpatasvir/v…

💊 Dosage Forms and Strengths 101 words ▾

3 DOSAGE FORMS AND STRENGTHS Rosuvastatin calcium tablets: 5 mg of rosuvastatin: pink, round, biconvex, coated tablets. Debossed as ‘CY’ on one side and ‘5’ on other side. 10 mg of rosuvastatin: yellow, round, biconvex, coated tablets.

Debossed as ‘CY’ on one side, and ‘10’ on other side. 20 mg of rosuvastatin: yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘20’ on other side..

40 mg of rosuvastatin: pink, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘40’ on other side. Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin.

(3)

⛔ Contraindications 75 words ▾

4 CONTRAINDICATIONS Rosuvastatin calcium tablets is contraindicated in the following conditions: Acute liver failure or decompensated cirrhosis [see W arnings and Precautions (5.3) ]. Hypersensitivity to rosuvastatin or any excipients in rosuvastatin calcium tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin calcium tablets [ see A dverse Reactions (6.1) ] .

Acute liver failure or decompensated cirrhosis. (4) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin 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 rosuvastatin dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected.

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

( 5.1, 7.1, 8.5, 8.6, 8.8) Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin 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 rosuvastatin.

(4, 5.3, 8.7)

5.1Myopathy and Rhabdomyolysis Rosuvastatin 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 with statins, including rosuvastatin. 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 rosuvastatin dosage.

Asian patients on rosuvastatin may be at higher risk for myopathy [see D rug Interactions (7.1) and U se in Specific Populations (8.8) ]. The myopathy risk is greater in patients taking rosuvastatin 40 mg daily compared with lower rosuvastatin dosages. Steps to Prevent or Reduce the Risk of Myopathy and Rhabdomyolysis The concomitant use of rosuvastatin with cyclosporine or gemfibrozil is not recommended.

Rosuvastatin dosage modifications are recommended for patients taking certain antiviral medications, darolutamide, and regorafenib [see D osage and Administration (2.6) ]. Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see D rug I nteractions (7.1) ] . Discontinue rosuvastatin if markedly elevated CK levels occur or if myopathy is either diagnosed or suspected.

Muscle symptoms and CK elevations may resolve if rosuvastatin is discontinued. Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis (e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy). Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the rosuvastatin dosage.

Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.

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

Additional neuromuscular and serologic testing may be necessary…

🤒 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 W arnings and Precautions (5.1) ] Immune-Mediated Necrotizing Myopathy [see W a rnings and Precautions (5.2) ] Hepatic Dysfunction [ see W arnings and Precautions (5.3) ] Proteinuria and Hematuria [see W arnings and Precautions (5.4) ] Increases in HbA1c and Fasting Serum Glucose Levels [see W arnings and Precautions (5.5) ] Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma at 1-732-940-0358 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, 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. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of up to 12 weeks.

Table 2: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials A d verse Reactions P l acebo N= 382 % Rosuvastatin 5 mg N= 291 % Rosuvastatin 10 mg N= 283 % Rosuvastatin 20 mg N= 64 % Rosuvastatin 40 mg N= 106 % T otal Rosuvastatin 5 mg-40 mg N= 744 % Headache 5.0 5.5 4.9 3.1 8.5

5.5Nausea 3.1 3.8 3.5 6.3 0

3.4Myalgia 1.3 3.1 2.1 6.3 1.9

2.8Asthenia 2.6 2.4 3.2 4.7 0.9

2.7Constipation 2.4 2.1 2.1 4.7 2.8

2.4Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In the METEOR study, patients were treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years.

Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3. Table 3: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the METEOR Trial A d verse Reactions P l acebo N= 281 % Rosuvastatin 40 mg N= 700 % Myalgia 12.1

12.7Arthralgia 7.1

10.1Headache 5.3

6.4Dizziness 2.8

4.0Increased CPK 0.7

2.6Abdominal pain 1.8

2.4ALT greater than 3x ULN 1 0.7 2.2 1 Frequency recorded as abnormal laboratory value. In the JUPITER study, patients were treated with rosuvastatin 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years. In JUPITER, there was a significantly higher frequency of diabetes mellitus reported in patients taking rosuvastatin (2.8%) versus patients taking placebo (2.3%).

Mean HbA1c was significantly increased by 0.1% in rosuvastatin-treated patients compared to placebo-treated patients. The number of patients with a HbA1c >6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients [see Clinical Studies (14) ] . Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 4.

Table 4: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in the JUPITER Trial A d verse Reactions P l acebo N= 8901 % Rosuvastatin 20 mg N= 8901 % Myalgia 6.6

7.6Arthralgia 3.2

3.8Constipation 3.0

3.3Diabetes mellitus 2.3

2.8Nausea 2.3

2.4Pediatric Patients with HeFH In a 12-week controlled study in pediatric patients 10 to 17 years of age with HeFH with rosuvastatin 5 to 20 mg daily [ see U se in Specific Populations (8.4) and Clinical Studies (14) ] , elevations in serum CK greater than 10 x UL…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS See full prescribing information for details regarding concomitant use of rosuvastatin with other drugs that increase the risk of myopathy and rhabdomyolysis. (2.6, 7.1) Aluminum and Magnesium Hydroxide Combination Antacids : Administer rosuvastatin at least 2 hours after the antacid. (2.6, 7.2) Wafarin: Obtain INR prior to starting rosuvastatin.

Monitor INR frequently until stable upon initiation, dose titration or discontinuation. (7.3)

7.1Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Rosuvastatin is a substrate of CYP2C9 and transporters (such as OATP1B1, BCRP). Rosuvastatin plasma levels can be significantly increased with concomitant administration of inhibitors of CYP2C9 and transporters. Table 5 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with rosuvastatin and instructions for preventing or managing them [see W arnings and Precautions (5.1) and Clinical Pharmacology ( 12.3) ].

Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin C yclosporine Clinical Impact: Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine or gemfibrozil with rosuvastatin. I ntervention: If used concomitantly, do not exceed a dose of rosuvastatin 5 mg once daily .

Teriflunomide Clinical Impact: Teriflunomide increased rosuvastatin exposure more than 2.5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. I ntervention: In patients taking teriflunomide, do not exceed a dose of rosuvastatin 10 mg once daily .

Enasidenib Clinical Impact: Enasidenib increased rosuvastatin exposure more than 2.4-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Intervention: In patients taking enasidenib, do not exceed a dose of rosuvastatin 10 mg once daily C apmatinib Clinical Impact: Capmatinib increased rosuvastatin exposure more than 2.1-fold.

The risk of myopathy and rhabdomyolysis is increased with concomitant use. I ntervention: In patients taking capmatinib, do not exceed a dose of rosuvastatin 10 mg once daily . F ostamatinib Clinical Impact: Fostamatinib increased rosuvastatin exposure more than 2.0-fold.

The risk of myopathy and rhabdomyolysis is increased with concomitant use. I ntervention: In patients taking fostamatinib, do not exceed a dose of rosuvastatin 20 mg once daily . Fe buxostat Clinical Impact: Febuxostat increased rosuvastatin exposure more than 1.9-fold.

The risk of myopathy and rhabdomyolysis is increased with concomitant use. I ntervention: In patients taking febuxostat, do not exceed a dose of rosuvastatin 20 mg once daily . Gemfibrozil Clinical Impact: Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone.

The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with rosuvastatin. I ntervention: Avoid concomitant use of gemfibrozil with rosuvastatin. If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 10 mg once daily .

Tafamidis Clinical Impact: Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of tafamidis with rosuvastatin. I ntervention: Avoid concomitant use of tafamidis with rosuvastatin.

If used concomitantly, initiate rosuvastatin at 5 mg once daily and do not exceed a dose of rosuvastatin 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin . A n t i-Vi r a l Medications Clinical Impact: Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis.

I ntervention: Sofosbuvir/velpatasvir/vox…

👥 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 rosuvastatin. (8.2)

8.1Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin 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 rosuvastatin 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 rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (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. Da ta H uman Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score- based methods.

The relative risk of congenital malformations between the group with statin use and the group with no statin use in the first trimester was 1.07 (95% confidence interval 0.85 to 1.37) after controlling for confounders, particularly pre-existing diabetes mellitus. There were also no statistically significant increases in any of the organ-specific malformations assessed after accounting for confounders. In the majority of pregnancies, statin treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified.

Study limitations include reliance on physician coding to define the presence of a malformation, lack of control for certain confounders such as body mass index, use of prescription dispensing as verification for the use of a statin, and lack of information on non-live births. A nimal Data In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC).

In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of rosuvastatin as an adjunct to diet to reduce LDL-C have been established in pediatric patients 8 years of age and older with HeFH. Use of rosuvastatin for this indication is based on one 12-week controlled trial with a 40-week open-label extension period in 176 pediatric patients 10 years of age and older with HeFH and one 2-year open-label, uncontrolled trial in 175 pediatric patients 8 years of age and older with HeFH [see Clinical Studies (14) ] . In the 1-year trial with a 12-week controlled phase, there was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturation in patients aged 10 to 17 years.

The safety and effectiveness of rosuvastatin as an adjunct to other LDL-C-lowering therapies to reduce LDL-C have been established pediatric patients 7 years of age and older with HoFH. Use of rosuvastatin for this indication is based on a randomized, placebo-controlled, cross-over study in 14 pediatric patients 7 years of age and older with HoFH [ see Clinical Studies (14) ] . The safety and effectiveness of rosuvastatin have not been established in pediatric patients younger than 8 years of age with HeFH, younger than 7 years of age with HoFH, or in pediatric patients with other types of hyperlipidemia (other than HeFH or HoFH).

🧓 Geriatric Use 108 words ▾

8.5Geriatric Use Of the total number of rosuvastatin-treated patients in clinical studies, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Advanced age (≥65 years) is a risk factor for rosuvastatin-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 rosuvastatin for the increased risk of myopathy [see W arnings and Precautions (5.1) ].

🆘 Overdosage 24 words ▾

10 OVERDOSAGE No specific antidotes for rosuvastatin are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. Contact Poison Control (1-800-222-1222) for latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

12.2Pharmacodynamics Inhibition of HMG-CoA reductase by rosuvastatin accelerates the expression of LDL-receptors, followed by the uptake of LDL-C from blood to the liver, leading to a decrease in plasma LDL-C and total cholesterol. Sustained inhibition of cholesterol synthesis in the liver also decreases levels of very-low-density lipoproteins. The maximum LDL-C reduction of rosuvastatin is usually achieved by 4 weeks and is maintained after that.

12.3Pharmacokinetics A bsorption In clinical pharmacology studies in man, peak plasma concentrations of rosuvastatin were reached 3 to 5 hours following oral dosing. Both C max and AUC increased in approximate proportion to rosuvastatin dose. The absolute bioavailability of rosuvastatin is approximately 20%.

The AUC of rosuvastatin does not differ following evening or morning drug administration. E ffect of food Administration of rosuvastatin with food did not affect the AUC of rosuvastatin. D istribution Mean volume of distribution at steady-state of rosuvastatin is approximately 134 liters.

Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. E limination Me tabolism Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite.

The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 \ 2C9, and in vitro studies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound. Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity is accounted for by the parent compound. Exc retion Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%).

After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. The elimination half-life of rosuvastatin is approximately 19 hours. Specific Populations Ge riatric Patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years).

Pe diatric Patients In a population pharmacokinetic analysis of two pediatric trials involving patients with heterozygous familial hypercholesterolemia 10 to 17 years of age and 8 to 17 years of age, respectively, rosuvastatin exposure appeared comparable to or lower than rosuvastatin exposure in adult patients. M ale and Female Patients There were no differences in plasma concentrations of rosuvastatin between men and women. R acial or Ethnic Groups A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among Caucasian, Hispanic, and Black or Afro-Caribbean groups.

However, pharmacokinetic studies, including one conducted in the US, have demonstrated an approximate 2-fold elevation in median exposure (AUC and C max ) in Asian subjects when compared with a Caucasian control group. P atients with Renal Impairment Mild to moderate renal impairment (CL cr ≥30 mL/min/1.73 m 2 ) had no influence on plasma concentrations of rosuvastatin. However, plasma concentrations of rosuvastatin increased to a clinically significant extent (about 3-fold) in patients with severe renal impairment (CL cr <30 mL/min/1.73 m 2 ) not receiving hemodialysis compared with healthy subjects (CL cr >80 mL/min/1.73 m 2 ).

Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. P atients with Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were m…

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action Rosuvastatin is an inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin 20mg tablets are supplied as Yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘20’ on other side. NDC 71335-0905-1: 30 Tablets in a BOTTLE NDC 71335-0905-2: 90 Tablets in a BOTTLE NDC 71335-0905-3: 28 Tablets in a BOTTLE NDC 71335-0905-4: 60 Tablets in a BOTTLE NDC 71335-0905-5: 180 Tablets in a BOTTLE NDC 71335-0905-6: 120 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc.

Burbank, CA 91504

📋 Description 167 words ▾

11 DESCRIPTION Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The empirical formula for rosuvastatin calcium is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol.

Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: anhydrous dibasic calcium phosphate, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin; in addition, the 5 mg and 40 mg strengths contain ferric oxide red, and the 10 mg and 20 mg strength contain ferric oxide yellow.

Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). My opathy and Rhabdomyolysis Advise patients that rosuvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication 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 W arnings and Precautions (5.1) , and D rug Interactions ( 7.1) ]. He patic Dysfunction Inform patients that rosuvastatin 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 W arnings and Precautions (5.3) ].

I ncreases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [ see W arnings and P recautions (5.5) ]. P regnancy 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 rosuvastatin should be discontinued [see U se in Specific Populations (8.1) ] . Lactation Advise patients that breastfeeding during treatment with rosuvastatin is not recommended [ see U se in Specific Populations (8.2) ]. Concomitant Use of Antacids When taking rosuvastatin with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin administration [see Drug Interactions (7.2) ] .

M issed Doses If a dose is missed, advise patients not take an extra dose. Just resume the usual schedule [see General Dosage and Administration Information (2.1) ] . Manufactured by: Changzhou Pharmaceutical Factory No.518 Laodong East Road Changzhou, Jiangsu, China, 213018 Distributed by: Tris Pharma, Inc.

Monmouth Junction, NJ 08852 www.trispharma.com LB8492 Rev. 07 August 2023

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.

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.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

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.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

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.

asthenia: Unusual weakness or lack of physical strength and energy.

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.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

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

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.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

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.

crosses the placenta: When a substance passes from a pregnant mother's blood, through the placenta, and into the developing baby.

CYP2C9: A liver enzyme that breaks down certain medicines, including some blood thinners and anti-inflammatory drugs.

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

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.

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.

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

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

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

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.

hematuria: Blood in the urine.

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.

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.

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.

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.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

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.

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.

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

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

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.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

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.

proteinuria: Protein leaking into the urine, which can be a sign that the kidneys' filters are damaged.

pruritus: Itching of the skin.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

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.

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.

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.

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 ↗

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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.

Rosuvastatin Calcium 20 mg Tablet, Film Coated, 180-count

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