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Rosuvastatin 20 mg Tablet, Film Coated, 60-count

by Proficient Rx LP · 60 TABLET, FILM COATED in 1 BOTTLE (71205-044-60)

NDC 71205-0044-60

🏷️ FDA NDC (as labeled) 71205-044-60 billing pads the product segment with a zero

This package

Contains60-count Pack sizes3 compare ↓

Also comes in: 30 tablets 71205-0044-30 90 tablets 71205-0044-90

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 (different manufacturers) — 1 · tap to view

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

Class II · Dec 31, 2025 — Out of specification for dissolution. (AvKARE) · FDA recall D-0292-2026

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

🆔 Identity & classification

FDA NDC (as labeled) 71205-044-60

Product NDC 71205-044

11-digit billing NDC 71205004460

RxCUI 859751

UNII 83MVU38M7Q

UPC 0371205044909

Application # ANDA207616

SPL Set ID f42139aa-bb38-4791-b41e-cd8f2c922529

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 2016-10-29

Route ORAL

Dosage form TABLET, FILM COATED

Substance ROSUVASTATIN CALCIUM

GPI-14 39400060100320

GPI class Rosuvastatin Calcium

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 71205-044-60 — 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 → 71205-0044-60. 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

LabelerProficient Rx LP

Application holderHETERO LABS LTD UNIT V

FDA applicationANDA207616 (ANDA)

Labeler code71205

First marketedOct 2016

Product typeHuman Prescription Drug

Portfolio1,723 products on file

🔎 All NDCs from Proficient Rx LP

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

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

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

🌿 Every supplement checked against Rosuvastatin (63 interactions) — ranked by severity →

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 Pink

ShapeRound

ImprintH;R5

Size8 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 68401960MK
Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII 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.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

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

Why might an inactive ingredient be missing?

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

Can inactive ingredients matter?

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

💲 Pricing

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

Price 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 · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 30 tablets 90 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

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 mgthis 71205-0044-60	Proficient	60 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	—

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

🏛️

2016

On the market since

Oct 2016

📍

2026

Currently FDA-listed

10 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.

🔬 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 — the ingredient across all brands.

Top reported reactions

Fatigue14,778

Nausea12,432

Dyspnoea11,981

Diarrhoea11,370

Pain10,909

Headache10,154

Myalgia10,128

Reporter sex

Serious outcomes

Death13,539

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
71205-0044-30	30 TABLET, FILM COATED in 1 BOTTLE (71205-044-30)	2018-06-01	Active
71205-0044-60 You're viewing this	60 TABLET, FILM COATED in 1 BOTTLE (71205-044-60)	2018-06-01	Active
71205-0044-90	90 TABLET, FILM COATED in 1 BOTTLE (71205-044-90)	2018-06-01	Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71205-0044-60?

NDC 71205-0044-60 is a 60-count package — 60 tablet, film coated in 1 bottle.

What is the difference between NDC 71205-0044-60 and NDC 71205-0044-30?

Both are Rosuvastatin 20 mg Tablet, Film Coated — the drug itself is identical. NDC 71205-0044-60 is the 60-count package, while NDC 71205-0044-30 is the 30 tablets package.

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

Bill NDC 71205-0044-60 — the 11-digit billing format is 71205004460. 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)	✓ 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 71205-044-60, 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: 71205-0044-60, written without dashes as 71205004460. 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 71205-0044-60, the first segment (71205) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0044) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) 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 Proficient Rx LP. 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 2 other package presentations of this same product, including 30 tablets (71205-0044-30), 90 tablets (71205-0044-90). 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?

Proficient Rx LP 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 & USAGE Pediatric use information for patients 7 to 17 years of age 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. Rosuvastatin calcium tablet is an HMG Co-A reductase inhibitor indicated for: • adult patients with hypertriglyceridemia as an adjunct to diet ( Error!

Hyperlink reference not valid. ) • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet ( Error! Hyperlink reference not valid. ) • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB ( Error! Hyperlink reference not valid. ) Limitations of use ( Error!

Hyperlink reference not valid. ): Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.

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

1.4Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin calcium 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 calcium 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.

1.8Limitations of Use Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE & ADMINISTRATION •Rosuvastatin calcium tablets can be taken with or without food, at any time of day. ( Error! Hyperlink reference not valid. ) •Dose range: 5 to 40 mg once daily. Use 40 mg dose only for patients not reaching LDL-C goal with 20 mg. ( Error! Hyperlink reference not valid. ) •Adult HoFH: Starting dose 20 mg/day ( Error! Hyperlink reference not valid. )

2.1General Dosing Information The dose range for rosuvastatin calcium tablets in adults are 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 calcium tablet dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [ Error! Hyperlink reference not valid. ]. Rosuvastatin calcium 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 calcium tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin calcium 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 calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly.

Pediatric use information for patients 7 to 17 years of age 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 calcium 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 [ Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. )].

2.4Use with Concomitant Therapy Patients taking cyclosporine The dose of rosuvastatin calcium tablets should not exceed 5 mg once daily [ Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. and Error!

Hyperlink reference not valid. ]. Patients taking gemfibrozil Avoid concomitant use of rosuvastatin calcium tablets with gemfibrozil. If concomitant use cannot be avoided, initiate rosuvastatin calcium tablets at 5 mg once daily.

The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [ Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. and Error!

Hyperlink reference not valid. ]. Patients taking atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir Initiate rosuvastatin calcium tablets therapy with 5 mg once daily. The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [ Error!

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2.5Dosing in Patients with Severe Renal Impairment For patients with severe renal impairment (CLcr <30 mL/min/1.73 m2) not on hemodialysis, dosing of rosuvastatin calcium tablets should be started at 5 mg once daily and not exceed 10 mg once daily [ Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. )].

💊 Dosage Forms and Strengths 128 words ▾

3 DOSAGE FORMS & STRENGTHS 5 mg: Light yellow to yellow, round, bevel edged biconvex film coated tablets debossed with "H" on one side and "R3" on the other side. 10 mg: Light pink to pink, round, bevel edged biconvex film coated tablets debossed with "H" on one side and "R4" on the other side. 20 mg: Light pink to pink, round, bevel edged biconvex film coated tablets debossed with "H" on one side and "R5" on the other side.

40 mg: Light pink to pink, oval, bevel edged biconvex film coated tablets debossed with "H" on one side and "R6" on the other side. Tab let s: 5 m g, 10 m g, 20 m g, a nd 40 mg ( Error! Hyperlink reference not valid. )

⛔ Contraindications 188 words ▾

4 CONTRAINDICATIONS Rosuvastatin calcium 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 calcium tablets [ Error! Hyperlink reference not valid. )]. •Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [ Error!

Hyperlink reference not valid. )]. •Pregnancy [ see Use in Specific Populations (8.1, Error! Hyperlink reference not valid. )]. •Lactation. Limited data indicate that rosuvastatin calcium is present in human milk.

Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin calcium tablets treatment should not breastfeed their infants Error! Hyperlink reference not valid. )]. •Known hypersensitivity to product components ( Error! Hyperlink reference not valid. ) •Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( Error!

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⚠️ 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, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. 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 calcium tablets if signs or symptoms appear.

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Hyperlink reference not valid. ) • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter. ( Error!

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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 calcium tablets. These risks can occur at any dose level, but are increased at the highest dose (40 mg). Rosuvastatin calcium tablets 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 calcium tablets may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir [ 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 calcium tablets with colchicine [ Error!

Hyperlink reference not valid. )]. Rosuvastatin calcium tablets therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Rosuvastatin calcium tablets 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).

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; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. 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 calcium tablets.

5.2Liver Enzyme Abnormalities It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin calcium tablets, and if signs or symptoms of liver injury occur. Increases in serum transaminases [AST (SGOT) or ALT (SGPT)] have been reported with HMG-CoA reductase inhibitors, including rosuvastatin calcium tablets. In most cases, the elevations were transient and resolved or improved on continued therapy or after a brief interruption in therapy.

There were two cases of jaundice, for which a relationship to rosuvastatin calcium tablets therapy could not be determined, which resolved after discontinuation of therapy. There were no cases of liver failure or irreversible liver disease in these trials. In a pooled analysis of placebo-controlled trials, inc…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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) [ Error! Hyperlink reference not valid. ] •Liver enzyme abnormalities [ Error! Hyperlink reference not valid. )] Most frequent adverse reactions (rate ≥2%) are headache, myalgia, abdominal pain, asthenia, and nausea.

( Error! Hyperlink reference not valid. ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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 calcium tablets 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 calcium tablets 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 Reactions1 Reported in ≥2% of Patients Treated with Rosuvastatin Calcium Tablets and > Placebo in Placebo-Controlled Trials (% of Patients) Adverse Reactions Rosuvastatin Calcium Tablets 5 mg N=291 Rosuvastatin Calcium Tablets 10 mg N=283 Rosuvastatin Calcium Tablets 20 mg N=64 Rosuvastatin Calcium Tablets 40 mg N=106 Total Rosuvastatin Calcium Tablets 5 mg- 40 mg N=744 Placebo N=382 Headache 5.5 4.9 3.1 8.5 5.5 5 Nausea 3.8 3.5 6.3 0 3.4

3.1Myalgia 3.1 2.1 6.3 1.9 2.8

1.3Asthenia 2.4 3.2 4.7 0.9 2.7

2.6Constipation 2.1 2.1 4.7 2.8 2.4 2.4 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 [ Error!

Hyperlink reference not valid. ]; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In a 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 calcium tablets 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.

Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 2. Table 2. Adverse Reactions1 Reported in ≥2% of Patients Treated with Rosuvastatin Calcium Tablets and > Placebo in a Trial (% of Patients) Adverse Reactions Rosuvastatin Calcium Tablets 40 mg N=700 Placebo N=281 Myalgia 12.7

12.1Arthralgia 10.1

7.1Headache 6.4

5.3 Dizziness 4

2.8Increased CPK 2.6

0.7Abdominal pain 2.4

1.8ALT >3x ULN 2 2.2 0.7 1 Adverse reactions by MedDRA preferred term. 2 Frequency recorded as abnormal laboratory value. In a 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, discontin…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Cyclosporine: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium tablets dose to 5 mg once daily. ( Error!

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Limit rosuvastatin calcium tablets dose to 10 mg once daily. ( Error! Hyperlink reference not valid. , Error!

Hyperlink reference not valid. , Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • Coumarin anticoagulants: Combination prolongs INR.

Achieve stable INR prior to starting rosuvastatin calcium tablets. Monitor INR frequently until stable upon initiation or alteration of rosuvastatin calcium tablets therapy. ( Error!

Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) • 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 calcium tablets.

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7.1Cyclosporine Cyclosporine increased rosuvastatin exposure (AUC) 7‑fold. Therefore, in patients taking cyclosporine, the dose of rosuvastatin calcium tablets should not exceed 5 mg once daily [ Error! Hyperlink reference not valid. ), Error! Hyperlink reference not valid. ), and Error! Hyperlink reference not valid. ].

7.2Gemfibrozil Gemfibrozil significantly increased rosuvastatin exposure. Due to an observed increased risk of myopathy/rhabdomyolysis, combination therapy with rosuvastatin calcium tablets and gemfibrozil should be avoided. If used together, the dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [ Error! Hyperlink reference not valid. ].

7.3Protease Inhibitors Coadministration of rosuvastatin with certain protease inhibitors has differing effects on rosuvastatin exposure. Simeprevir, which is a hepatitis C virus (HCV) protease inhibitor, or combinations of atazanavir/ritonavir or lopinavir/ritonavir, which are HIV-1 protease inhibitors, increase rosuvastatin exposure (AUC) up to threefold [see Table 4 – Error! Hyperlink reference not valid. )].

For these protease inhibitors, the dose of rosuvastatin calcium tablets should not exceed 10 mg once daily. The combinations of fosamprenavir/ritonavir or tipranavir/ritonavir, which are HIV-1 protease inhibitors, produce little or no change in rosuvastatin exposure. Caution should be exercised when rosuvastatin is coadministered with protease inhibitors [ Error!

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7.4Coumarin Anticoagulants Rosuvastatin calcium tablets significantly increased INR in patients receiving coumarin anticoagulants. Therefore, caution should be exercised when coumarin anticoagulants are given in conjunction with rosuvastatin calcium tablets. In patients taking coumarin anticoagulants and rosuvastatin calcium tablets concomitantly, INR should be determined before starting rosuvastatin calcium tablets and frequently enough during early therapy to ensure that no significant alteration of INR occurs [ Error!

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7.5Niacin The risk of skeletal muscle effects may be enhanced when rosuvastatin calcium tablets are used in combination with lipid-modifying doses (≥1 g/day) of niacin; caution should be used when prescribing with rosuvastatin calcium tablets [ see Warnings and Precaut…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Females of reproductive potential: Advise females of reproductive potential to use effective contraception during treatment with rosuvastatin calcium tablets ( Error! Hyperlink reference not valid. ) • Severe renal impairment (not on hemodialysis): Starting dose is 5 mg, not to exceed 10 mg. ( Error!

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( Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ) See 17 for PATIENT COUNSELING INFORMATION and FDA- approved patient labeling.

Pediatric use information for patients ages 7 to 17 years of age 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.

8.1Pregnancy Risk Summary Rosuvastatin calcium tablets are 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 calcium tablets during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin calcium tablets may cause fetal harm when administered to pregnant women. Rosuvastatin calcium tablets should be discontinued as soon as pregnancy is recognized [ Error!

Hyperlink reference not valid. ]. 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 fe…

🤰 Pregnancy ~3 min read ▾

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).

🧒 Pediatric Use 39 words ▾

8.4Pediatric Use Pediatric use information for patients 7 to 17 years of age 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 104 words ▾

8.5Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin calcium tablets, 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 calcium tablets should be prescribed with caution in the elderly [see Warnings and Precautions (5.1) and Error!

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🆘 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 calcium tablets are 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.

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

Administration of rosuvastatin calcium tablets 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. 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%).

The elimination half-life (t 1/2 ) of rosuvastatin is approximately 19 hours. After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. Specific Populations Race 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. Gender There were no differences in plasma concentrations of rosuvastatin between men and women. Pediatric use information for patients ages 8 to less than 10 years 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 There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years). Renal Impairment Mild to moderate renal impairment (CLcr ≥30 mL/min/1.73 m2) 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 (CLcr <30 mL/min/1.73 m2) not receiving hemodialysis compared with healthy subjects (CLcr >80 mL/min/1.73 m 2 ). Hemodialysis Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations…

🧬 Mechanism of Action 118 words ▾

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin Calcium Tablets are supplied as: 20 mg: Light pink to pink, round, bevel edged biconvex film coated tablets debossed with 'H' on one side and 'R5' on the other side. They are supplied as follows. Bottle of 30 Tablets NDC 71205-044-30 Bottle of 90 Tablets NDC 71205-044-90 Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

📋 Description 167 words ▾

11 DESCRIPTION Rosuvastatin calcium is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (methylsulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula: The molecular 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 to almost white powder that is sparingly soluble in methanol.

Rosuvastatin calcium is a hydrophilic compound with a partition coefficient of 1.14 by HPLC. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. structure

💬 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 calcium 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 calcium tablets.

Concomitant Use of Antacids When taking rosuvastatin calcium tablets with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin calcium tablets 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. [ Error! Hyperlink reference not valid. and Error!

Hyperlink reference not valid. , Error! Hyperlink reference not valid. )]. Lactation Advise women not to breastfeed during treatment with rosuvastatin calcium tablets [ Error!

Hyperlink reference not valid. and Error! Hyperlink reference not valid. )]. Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin calcium tablets and if signs or symptoms of liver injury occur.

All patients treated with rosuvastatin calcium tablets should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by: HETERO TM HETERO LABS LIMITED 2038142 Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India.

Barcode Revised: July 2016 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 camber1.jpg hetero

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 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.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

pooled analysis: Combining the results of several separate studies into one larger group to look at the overall pattern.

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.

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 20 mg Tablet, Film Coated, 60-count

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