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ROSUVASTATIN CALCIUM 20 mg Tablet, 45-count

by PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS · 45 TABLET in 1 BOTTLE (24658-263-45)

NDC 24658-0263-45

🏷️ FDA NDC (as labeled) 24658-263-45 billing pads the product segment with a zero

This package

Contains45-count Cost per ea$0.0449 NADAC Per package$2.02 / 45 tablets Pack sizes2 compare ↓

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

Also comes in: 90 tablets 24658-0263-90

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) 24658-263-45

Product NDC 24658-263

11-digit billing NDC 24658026345

NCPDP billing unit EA — each (per item)

RxCUI 859419, 859424, 859747, 859751

UNII 83MVU38M7Q

UPC 0324658264301, 0324658263458, 0324658262901, 0324658261904

Application # ANDA207752

SPL Set ID 9333c674-5714-41ed-8a16-dc7c3e50b9a4

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 2023-08-23

Route ORAL

Dosage form TABLET

Substance ROSUVASTATIN CALCIUM

GPI-14 39400060100320

GCN Seq No 051785

GCN 19154

HICL code 025009

Ingredient (HICL) Rosuvastatin 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 ROSUVASTATIN CALCIUM 20 MG TAB

FDB brand name Rosuvastatin 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 24658-263-45 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 24658-0263-45. 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

LabelerPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

Application holderBIOCON PHARMA LTD

FDA applicationANDA207752 (ANDA)

Labeler code24658

First marketedAug 2023

Product typeHuman Prescription Drug

Portfolio36 products on file

🔎 All NDCs from PURACAP LABORATORIES LLC DBA BLU PHARMAC...

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 ROSUVASTATIN CALCIUM 20 MG TAB Ingredient Rosuvastatin Calcium

📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

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.

💊 What it looks like

Color Yellow / Pink

ShapeOval

Imprint40;B

Size12 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
UNII O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
UNII 36SFW2JZ0W
Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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

Why might an inactive ingredient be missing?

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

Can inactive ingredients matter?

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.045	$2.02 / 45 tablets
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	$8.55 / 45 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 34% over the last 12 months.

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 mgthis 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	+43%
Crestor 20 mg 00310-7580-90	AstraZeneca	90 tablets	$8.810	AB	Availability likely	+19527%
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 mg 71335-0905-01	Bryant	30 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

🏛️

2023

On the market since

Aug 2023

📍

2026

Currently FDA-listed

3 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	Per unit	Per pack	Marketing start	Status
24658-0263-45 You're viewing this	45 TABLET in 1 BOTTLE (24658-263-45)	$0.0449 / ea	$2.02	2023-08-23	Active
24658-0263-90	90 TABLET in 1 BOTTLE (24658-263-90)	$0.0449 / ea	$4.04	2023-08-23	Active

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

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0449 NADAC).

Pack size FAQ

What quantity is in NDC 24658-0263-45?

NDC 24658-0263-45 is a 45-count package — 45 tablet in 1 bottle.

What is the difference between NDC 24658-0263-45 and NDC 24658-0263-90?

Both are ROSUVASTATIN CALCIUM 20 mg Tablet — the drug itself is identical. NDC 24658-0263-45 is the 45-count package, while NDC 24658-0263-90 is the 90 tablets package.

What NDC number is used to bill for this package of ROSUVASTATIN CALCIUM 20 mg Tablet?

Bill NDC 24658-0263-45 — the 11-digit billing format is 24658026345. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 💬 Patient Medication Information

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Rosuvastatin tablets are an HMG Co-A reductase inhibitor indicated for: • adult patients with primary hyperlipidemia and mixed dyslipidemia as an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDLC ( 1.1 ) • pediatric patients 8 to 17 years of age with heterozygous familial hypercholesterotemia (HeFH] to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy ( 1.2 ) • adult patients with hypertriglyceridemia as an adjunct to diet ( 1.3 ) • adult patients with primary dysbetalipoproteinemia [Type III hyperlipoproteinemia) as an adjunct to diet ( 1.4 ) • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LOL-G, total-G, and ApoB ( 1.5 ) • slowing the progression of atherosclerosis as part of a treatment strategy lo lower total-C and LDL-C as an adjunct to diet ( 1.6 ) • risk reduction of MI, stroke, and arterial revascularization procedures in patients without clinically evident CHD, but with multiple risk factors ( 1.7 ) Limitations of use ( 1.8 ): Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias.

1.1Hyperlipidemia and Mixed Dyslipidemia Rosuvastatin tablets are indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.

1.2Pediatric Patients with Familial Hypercholesterolemia Rosuvastatin tablets are indicated as an adjunct to diet to: • reduce Total-C, LDL-C and ApoB levels in children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C >190 mg/dL, or >160 mg/dL along with a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors. Pediatric use information for patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) is approved by AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets.

However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.3Hypertriglyceridemia Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.

1.4Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia).

1.5Adult Patients with Homozygous Familial Hypercholesterolemia Rosuvastatin tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.

1.6Slowing of the Progression of Atherosclerosis Rosuvastatin tablets are indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.

1.7Primary Prevention of Cardiovascular Disease In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥50 years old in men and >60 years old in women, hsCRP >2 mg/L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease, rosuvastatin tablets are indicated to: • reduce the risk of stroke • reduce the risk of myocardial infarction • reduce the risk of arterial revascularization procedures

1.8 Limitations of U…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Rosuvasta1in tablets can be taken with or without food, at any time of day. ( 2.1 ) • Dose range: 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. ( 2.1 ) • Adult HoFH: Starting dose 20 mg/day. ( 2.1 ) • Pediatric patients with HeFH: 5 to 10 mg/day for patients 8 to less than 10 years of age, and 5 to 20 mg/day for patients 10 to 17 years of age.

2.1General Dosing Information The dose range for rosuvastatin tablets in adults is 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily.

The maximum rosuvastatin dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see Warnings and Precautions (5.1) ]. Rosuvastatin tablets can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole.

When initiating rosuvastatin tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin tablets starting dose should first be utilized, and only then titrated according to the patient's response and individualized goal of therapy. After initiation or upon titration of rosuvastatin tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

2.2Pediatric Dosing In heterozygous familial hypercholesterolemia, !he recommended dose range is 5 to 10 mg orally once daily in patients 8 to less than 10 years of age, and 510 20 mg orally once daily in patients 10 to 17 years of age. Pediatric use information for patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.3Dosing in Asian Patients In Asian patients, consider initiation of rosuvastatin tablets therapy with 5 mg once daily due to increased rosuvastatin plasma concentrations. The increased systemic exposure should be taken into consideration when treating Asian patients not adequately controlled at doses up to 20 mg/day. [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)].

2.4Use with Concomitant Therapy Patients taking cyclosporine and darolutamide The dose of rosuvastatin tablets should not exceed 5 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.1) , Drug Interactions (7.4) , and Clinical Pharmacology (12.3) ]. Patients taking gemfibrozil Avoid concomitant use of rosuvastatin tablets with gemfibrozil. If concomitant use cannot be avoided, initiate rosuvastatin tablets at 5 mg once daily.

The dose of rosuvastatin tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) and, Drug Interactions (7.2) and Clinical Pharmacology (12.3) ]. Patients taking regorafenib Concomitant use of rosuvastatin tablets and regorafenib, the dose of rosuvastatin tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.5) and Clinical Pharmacology (12.3) ]. Patients taking atazanavir and ritonavir, lopinavir and ritonavir, simeprevir or combination of dasabuvir/ ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir Initiate rosuvastatin tablets therapy with 5 mg once daily.

The dose of rosuvastatin tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.3) and Clinical Pharmacology (12.3) ].

2.5Dosing in Patients with Severe Renal Impairment For patients with severe renal impairment (CL <30 mL/min/1.73 m 2 ) not on hemodialysis, dosing of rosuvastatin tablets should be started at 5 mg once daily and not exceed 10 mg cr once daily [see Use in Specific Populations (8.6) and Clinical Pha…

💊 Dosage Forms and Strengths 90 words ▾

3 DOSAGE FORMS AND STRENGTHS 5 mg: Yellow, round, biconvex, film-coated tablets, debossed with '5' on one side and 'B' on other side. 10 mg: Pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side. 20 mg: Pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side.

40 mg: Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side. Tablets: 5 mg, 10 mg, 20 mg, and 40 mg ( 3 )

⛔ Contraindications 157 words ▾

4 CONTRAINDICATIONS Rosuvastatin tablets are contraindicated in the following conditions: • Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1) ]. • Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions (5.3) ]. • Pregnancy [see Use in Specific Populations (8.1 , 8.3) ]. • Lactation.

Limited data indicate that rosuvastatin is present in human milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin treatment should not breastfeed their infants [see Use in Specific Populations (8.2) ]. • Known hypersensitivity to product components ( 4 ) • Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 ) • Pregnancy ( 4 , 8.1 , 8.3 ) • Lactation ( 4 , 8.2 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Skeletal muscle effects (e.g., myopathy and rhabdomyolysis) : Risks increase with use of 40 mg dose, advanced age (≥65), hypothyroidism, renal impairment, and combination use with cyclosporine, darolutamide, regorafenib, certain anti-viral medicines or their combinations. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin if signs or symptoms appear.

( 5.1 , 7.4 , 7.5 , 7.7 , 7.8 ) • Immune-Mediated Necrotizing Myopathy (IMNM) : There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment: positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. ( 5.2 ) • Liver enzyme abnormalities : Persistent elevations in hepatic transaminases can occur.

Perform liver enzyme tests before initiating therapy and as clinically indicated thereafler.( 5.3 )

5.1Skeletal Muscle Effects Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including rosuvastatin. These risks can occur at any dose level, but are increased at the highest dose (40 mg). Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age 65 years, inadequately treated hypothyroidism, renal impairment).

The risk of myopathy during treatment with rosuvastatin may be increased with concurrent administration of gemfibrozil, some other lipid-lowering therapies (other fibrates or niacin), cyclosporine, darolutamide, regorafenib, atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of sofosbuvir/velpatasvir/voxilaprevir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, glecaprevir/pibrentasvir, all combinations with ledipasvir (including ledipasvir/sofosbuvir) [see Dosage and Administration (2) and Drug Interactions (7) ].

Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing rosuvastatin with colchicine [see Drug Interactions (7.9) ]. Rosuvastatin therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Rosuvastatin therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).

All patients should be advised to promptly report to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing rosuvastatin.

5.2Immune-Mediated Necrotizing Myopathy There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. Additional neuromuscular and serologic testing may be necessary.

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

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most frequent adverse reactions (rate ≥2%) are headache, myalgia, abdominal pain, asthenia, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact PuraCap Laboratories, LLC DBA Blu Pharmaceuticals at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are discussed in greater detail in other sections of the label: • Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see Warnings and Precautions (5.1 ) ] • Liver enzyme abnormalities (see Warnings and Precautions (5.3) ]

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In the rosuvastatin controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: • myalgia • abdominal pain • nausea The most commonly reported adverse reactions (incidence >2%) in the rosuvastatin controlled clinical trial database of 5394 patients were: • Headache • myalgia • abdominal pain • Asthenia • nausea Adverse reactions reported in >2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 1.

These studies had a treatment duration of up to 12 weeks. Table 1. Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials (% of Patients) 1 Adverse reactions by COSTART preferred term Other 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 [see Warnings and Precautions (5.5) ]; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In the clinical trial, involving 981 participants treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years, 5.6% of subjects treated with rosuvastatin versus 2.8% of placebo-treated subjects discontinued due to adverse reactions.

The most common adverse reactions that led to treatment discontinuation were: myalgia, hepatic enzyme increased, headache, and nausea [see Clinical Studies (14.8) ]. Adverse reactions reported in >2% of patients and at a rate greater than placebo are shown in Table 2. Table 2.

Adverse Reactions Reported in >2% of Patients Treated With Rosuvastatin and > Placebo in a Trial (% of Patients) 1 Adverse reactions by MedDRA preferred term. 2 Frequency recorded as abnormal laboratory value. In the clinical trial, 17,802 participants were treated with rosuvastatin 20 mg (n=8901) or placebo (n=8901) for a mean duration of 2 years.

A higher percentage of rosuvastatin-treated patients versus placebo-treated patients, 6.6% and 6.2%, respectively, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction that led to treatment discontinuation. In the clinical trial, 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 Warnings and Precautions (5.6) and Clinical Studies (14.9) ].…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Combina1ion of sofosbuvir/velpatasvir/voxilaprevir or ledipasvir/sofosbuvir : Combination increases rosuvastatin exposure. Use with rosuvastatin is not recommended. ( 2.4 , 5.1 , 7.3 , 12.3 ) • Cyclosporine and darolutamide : Combination increases rosuvastatin exposure.

Limit rosuvastatin dose to 5 mg once daily. ( 2.4 , 5.1 , 7.1 , 7.4 , 12.3 ) • Gemfibrozil : Combination should be avoided. If used together, limit rosuvastatin dose to 10 mg once daily.

( 2.4 , 5.1 , 7.2 ) • Atazanavir/ritonavir, lopinavir/ritonavir, simeprevir or combination of dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir : Combination increases rosuvastatin exposure. Limit rosuvastatin dose to 10 mg once daily. ( 2.4 , 5.1 , 7.3 , 12.3 ) • Regorafenib : Combination increases rosuvastatin exposure.

Limit rosuvastatin dose to 10 mg once daily. ( 2.4 , 5.1 , 7.5 ) • Coumarin anticoagulants : Combination prolongs INR Achieve stable INR prior to starting rosuvastatin. Monitor INR frequently until stable upon initiation or alteration of rosuvastatin therapy.

( 5.4 , 7.6 ) • Concomitant lipid-lowering therapies : Use with fibrates or lipid modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with rosuvastatin. ( 5.1 , 7.7 , 7.8 )

7.1Cyclosporine Cyclosporine increased rosuvastatin exposure and may result in increased risk of myopathy. Therefore, in patients taking cyclosporine, the dose of rosuvastatin should not exceed 5 mg once daily [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) , and Clinical Pharmacology (12.3) ].

7.2Gemfibrozil Gemfibrozil significantly increased rosuvastatin exposure. Due to an observed increased risk of myopathy/rhabdomyolysis, combination therapy with rosuvastatin and gemfibrozil should be avoided. If used together, the dose of rosuvastatin should not exceed 10 mg once daily [see Clinical Pharmacology (12.3) ].

7.3Anti-viral Medications Coadministration of rosuvastatin with certain anti-viral drugs has differing effects on rosuvastatin exposure and may increase risk of myopathy. The combination of sofosbuvir/velpatasvir/voxilaprevir which are anti-Hepatitis C virus (anti-HCV) drugs, increases rosuvastatin exposure. Similarly, the combination of ledipasvir/sofosbuvir may significantly increase rosuvastatin exposure.

For these combinations of anti-HCV drugs, concomitant use with rosuvastatin is not recommended. Simeprevir and combinations of dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir, sofosbuvir/velpatasvir and glecaprevir/pibrentasvir which are anti-HCV drugs, increase rosuvastatin exposure. Combinations of atazanavir/ritonavir and lopinavir/ritonavir, which are anti-HIV-1 drugs, increase rosuvastatin exposure [see Table 4 – Clinical Pharmacology (12.3) ].

For these anti-viral drugs, the dose of rosuvastatin should not exceed 10 mg once daily. The combinations of fosamprenavir/ritonavir or tipranavir/ritonavir, which are anti-HIV-1 drugs, produce little or no change in rosuvastatin exposure. No dose adjustment is needed for concomitant use with these combinations [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

7.4Darolutamide Darolutamide increased rosuvastatin exposure more than 5 fold. Therefore, in patients taking darolutamide, the dose of rosuvastatin should not exceed 5 mg once daily [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

7.5Regorafenib Regorafenib increased rosuvastatin exposure and may increase the risk of myopathy. If used together, the dose of rosuvastatin should not exceed 10 mg once daily [see Dosage and Administration (2.4) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

7.6Coumarin Anticoagulants Rosuvastatin significantly increased INR in patients receiving cou…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Females of reproductive potential : Advise females of reproductive to use effective contraception during treatment with rosuvastatin. ( 8.3 ) • Severe renal impairment (not on hemodialysis) : Starting dose is 5 mg, not to exceed 10 mg. ( 2.5 , 5.1 , 8.6 ) • Asian population : Consider 5 mg starting dose. ( 2.3 , 8.8 )

8.1Pregnancy Risk Summary Rosuvastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with rosuvastatin during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin may cause fetal harm when administered to pregnant women. Rosuvastatin should be discontinued as soon as pregnancy is recognized [see Contraindications (4)].

Limited published data on the use of rosuvastatin are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, there were no adverse developmental effects with oral administration of rosuvastatin during organogenesis at systemic exposures equivalent to a maximum recommended human dose (MRHD) of 40 mg/day in rats or rabbits (based on AUC and body surface area, respectively). In rats and rabbits, decreased pup/fetal survival occurred at 12 times and equivalent, respectively, to the MRHD of 40 mg/day [see Data].

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

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

In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. Animal Data Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, respectively, of the maternal plasma concentration following a single 25 mg/kg oral gavage dose on gestation day 16 in rats. A higher fetal tissue distribution (25% maternal plasma concentration) was observed in rabbits after a single oral gavage dose of 1 mg/kg on gestation day 18.

Rosuvastatin administration did not indicate a teratogenic effect in rats at <25 mg/kg/day or in rabbits <3 mg/kg/day (doses equivalent to the MRHD of 40 mg/day based on AUC and body surface area, respectively). 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 based on body surface area).

8.2 Lacta…

🤰 Pregnancy ~3 min read ▾

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use In children and adolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia, the safety and effectiveness of rosuvastatin as an adjunct to diet to reduce total cholesterol, LDL-C, and ApoB levels when. After an adequate trial of diet therapy, LDLC exceeds 190 mg/dL or when LDL-C exceeds 160 mg/dl and there is a positive family history of premature CVD or two or more other CVD risk factors. were established in one controlled trial and in one open-label, uncontrolled trial [see Clinical Studies (14.7) ].

The long-term efficacy of rosuvastatin therapy initiated In childhood to reduce morbidity and mortality in adulthood has not been established. The safety and effectiveness of rosuvastatin in children and adolescents 10 to 17 years of age with heterozygous familial hypercholesterolemla were evaluated in a controlled clinical trial of 12 weeks duration followed by 40 weeks of open-label exposure. Patients treated with 5 mg, 10 mg, and 20 mg daily rosuvastatin had an adverse experience profile generally similar to that of patients 1reated with placebo.

There was no detectable effect of rosuvastatin on growth, weight, BMI (body mass index), or sexual maturalion [see Clinical Studies (14.7) ] in children and adolescents (10 to 17 years of age). Rosuvastatin has not been studied in controlled clinical trials involving prepubertal patients or patients younger than 10 years of age with heterozygous familial hypercholesterolemia. However, the safety and effectiveness of rosuvastalin were evaluated in a two year open-label uncontrolled trial tha1 included children and ooolescents 8 to 17 years of age with heterozygous familial hypercholesterolemia [see Clinical Studies (14.7) ].

The safety and efficacy of CRESTOR in lowering LDL-C appeared generally consistent with that observed for adult patients, despi1e limitations or the uncon1rolled study design. Although not all adverse reactions identified in the adult population have been observed in the clinical trials of children and adolescent patients, the same warnings and precautions for adults should be considered for children and adolescents. Adolescent females should be counseled on appropriate contraceptive methods while on rosuvastatin therapy [see Use in Specific Populations (8.1) ].

Pediatric use information for patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) is approved for AstraZeneca's CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca's marketing exclusivity rights, this drug product is not labeled with that pediatric information.

🧓 Geriatric Use 98 words ▾

8.5Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin, 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, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are at higher risk of myopathy and rosuvastatin should be prescribed with caution in the elderly [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

🆘 Overdosage 37 words ▾

10 OVERDOSAGE There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis does not significantly enhance clearance of rosuvastatin.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to mevalonate, a precursor of cholesterol. In vivo studies in animals, and in vitro studies in cultured animal and human cells have shown rosuvastatin to have a high uptake into, and selectivity for, action in the liver, the target organ for cholesterol lowering. In in vivo and in vitro studies, rosuvastatin produces its lipid-modifying effects in two ways.

First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

12.2Pharmacodynamics Rosuvastatin dose dependently reduces elevated LDL-cholesterol and reduces total cholesterol and triglycerides and increases HDL cholesterol [see Clinical Studies (14) ]. A therapeutic response to rosuvastatin is evident within 1 week of commencing therapy and 90% of maximum response 1s usually achieved in 2 weeks. The maximum response is usually achieved by 4 weeks and is maintained after that.

Individualization of drug dosage should be based on the therapeutic response [see Dosage and Administration (2) ].

12.3Pharmacokinetics Absorption 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 max proportion to rosuvastatin dose. The absolute bioavailability of rosuvastatin is approximately 20%.

Administration of rosuvastatin with food did not affect the AUC of rosuvastatin. The AUC of rosuvastatin does not differ following evening or morning drug administration. Distribution 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. Elimination Rosuvastatin is primarily eliminated by excretion in the feces.

The elimination half-life of rosuvastatin is approximately 19 hours. Metabolism 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. Excretion 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.

Specific Populations Racial 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 max with a Caucasian control group. Male and Female Patients There were no differences in plasma concentrations of rosuvastatin between men and women.

Pediatric 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. Geriatric Patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age >65 years). Patients with Renal Impairme…

🧬 Mechanism of Action 116 words ▾

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP are supplied as: • NDC 24658-261-90: 5 mg. Yellow, round, biconvex, film-coated tablets, debossed with '5'· on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-261-05: 5 mg, Yellow, round, biconvex, film-coated tablets, debossed with ‘5’ on one side and ‘B’ on other side; bottle of 500 tablets. • NDC 24658-262-45: 10 mg. Pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 45 tablets • NDC 24658-262-90: 10 mg.

Pink, round, biconvex, film-coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-262-05: 10 mg, Pink, round, biconvex, film-coated tablets, debossed with ‘10’ on one side and ‘B’ on other side; bottle of 500 tablets • NDC 24658-263-45: 20 mg. Pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 45 tablets • NDC 24658-263-90: 20 mg. Pink, round, biconvex, film-coated tablets, debossed with '20' on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-263-05: 20 mg, Pink, round, biconvex, film-coated tablets, debossed with ‘20’ on one side and ‘B’ on other side; bottle of 500 tablets • NDC 24658-264-30: 40 mg.

Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 30 tablets • NDC 24658-264-45: 40 mg. Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 45 tablets • NDC 24658-264-90: 40 mg. Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side; bottle of 90 tablets • NDC 24658-264-05: 40mg, Pink, oval, biconvex, film-coated tablets, debossed with ‘40’ on one side and ‘B’ on other side; bottle of 500 tablets Storage Store at 20· to 25°C (6B0 to 77°F). [See USP controlled room temperature).

Protect from moisture.

📋 Description 146 words ▾

11 DESCRIPTION Rosuvastatin calcium USP is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium USP is bis[(E)-7-[4(4-fluorophenyl)-6-isopropyl-2[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The empirical formula for rosuvastatin calcium USP is (C 22 H 27 FN 3 O 6 S) 2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium USP is a white to off-white powder that is soluble in dimethyl formamide, dimethyl sulphoxide, acetonitrile and acetone, slightly soluble in water and methanol.

Rosuvastatin calcium USP is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, dibasic calcium phosphate dihydrate, iron oxide yellow, iron oxide red, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. structure-formula.jpg

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients should be instructed not to take 2 doses of rosuvastatin tablets within 12 hours of each other. Skeletal Muscle Effects Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing rosuvastatin.

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. Embryofetal Toxicity Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy. [see Contraindications (4) and Use in Specific Populations (8.1 , 8.3) ]. Lactation Advise women not to breastfeed during treatment with rosuvastatin [see Contraindications (4) and Use in Specific Populations (8.2) ].

Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin and if signs or symptoms of liver injury occur. All patients treated with rosuvastatin should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Greenvale, NY 11548 USA’ Manufactured by: PuraCap Caribe Dorado, PR 00646 USA Rev.

09-2023-00 MF0261REV09/23B BP0214-01

💬 Patient Medication Information ~3 min read ▾

Patient Information Rosuvastatin (roe soo” va stat' in) Tablets USP Read this Patient Information carefully before you start taking rosuvastatin tablets and each time you get a refill. If you have any questions about rosuvastatin tablets, ask your doctor. Only your doctor can determine if rosuvastatin tablets are right for you.

What are rosuvastatin tablets? Rosuvastatin tablets are a prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin calcium. • Rosuvastatin tablets are used along with diet to: o lower the level of your “bad” cholesterol (LDL) o increase the level of your “good” cholesterol (HDL) o lower the level of fat in your blood (triglycerides) o slow the buildup of fatty deposits (plaque) in the walls of blood vessels • Rosuvastatin tablets are used to treat: o adults who cannot control their cholesterol levels by diet and exercise alone. o children 8 to 17 years of age with heterozygous familial hypercholesterolemia (an inherited condition that causes high levels of LDL) Rosuvastatin tablets are not approved for use in children with heterozygous familial hypercholesterolemia younger than 8 years of age.

Rosuvastatin tablets are used to reduce the risk of heart attacks and strokes in men 50 years of age and older and women 60 years of age and older who do not have known heart disease but do have certain additional risk factors. It is not known if rosuvastatin tablets are safe and effective in people who have Fredrickson Type I and V dyslipidemias. Pediatric use information for patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets.

However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Who should not take rosuvastatin tablets? Do not take rosuvastatin tablets if you: • are allergic to rosuvastatin calcium or any of the ingredients in rosuvastatin tablets.

See the end of this leaflet for a complete list of ingredients in rosuvastatin tablets. • have liver problems. • are pregnant or think you may be pregnant, or are planning to become pregnant. Rosuvastatin tablets may harm your unborn baby. If you become pregnant, stop taking rosuvastatin tablets and call your doctor right away.

If you are not planning to become pregnant you should use effective birth control (contraception) while you are taking rosuvastatin tablets. • are breastfeeding. Medicines like rosuvastatin tablets can pass into your breast milk and may harm your baby. What should I tell my doctor before and while taking rosuvastatin tablets?

Tell your doctor if you: • have unexplained muscle aches or weakness • have or have had kidney problems • have or have had liver problems • drink more than 2 glasses of alcohol daily • have thyroid problems • are 65 years of age or older • are of Asian descent • are pregnant or think you may be pregnant, or are planning to become pregnant • are breastfeeding Tell your doctor about all the medicines you take , including prescription and overthe- counter medicines, vitamins, and herbal supplements. Talk to your doctor before you start taking any new medicines.

Taking rosuvastatin tablets with certain other medicines may affect each other causing side effects. Rosuvastatin tablets may affect the way other medicines work, and other medicines may affect how rosuvastatin tablets work. Especially tell your doctor if you take: • cyclosporine (a medicine for your immune system) • gemfibrozil (a fibric acid medicine for lowering cholesterol) • darolutamide (a medicine for the treatment of prostate cancer) • regorafenib (a medicine used to treat cancer of the colon and rectum) • anti-viral medicines including certain HIV or hepatitis C virus drugs such as: o opinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, simeprevir o combination of ▪ sofosbuvir/velpatasvir/voxilaprevir ▪ dasabuvir/ombitasvir/paritaprevir/ritonavir ▪ elba…

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

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

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

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

in vivo: In a living person or animal rather than in a laboratory dish.

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

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

active-controlled: Describes a study that compares a new medicine against another medicine already known to work, instead of a dummy pill.

adjunctive therapy: A medicine added alongside a main treatment to help it work better.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

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.

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).

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.

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.

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.

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

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

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

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

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.

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

efficacy: How well a treatment works under the controlled conditions of a clinical study.

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.

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.

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.

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

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

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

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.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

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.

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.

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.

myositis: Swelling and irritation of muscle tissue that can cause pain, tenderness, or weakness.

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.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

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

pruritus: Itching of the skin.

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

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

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.

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.

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, 45-count

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