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Rosuvastatin Calcium 5 mg Tablet, Film Coated, 60-count

by Bryant Ranch Prepack · 60 TABLET, FILM COATED in 1 BOTTLE (71335-1330-4)

NDC 71335-1330-04

🏷️ FDA NDC (as labeled) 71335-1330-4 billing pads the package segment with a zero

This package

Contains60-count Pack sizes4 compare ↓

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

Also comes in: 28 tablets 71335-1330-03 30 tablets 71335-1330-01 90 tablets 71335-1330-02

Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm

🗂️ 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 ↗

⚠️

Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 2022. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-1330-4

Product NDC 71335-1330

11-digit billing NDC 71335133004

RxCUI 859424

UNII 83MVU38M7Q

Application # ANDA208898

SPL Set ID 199df185-dab0-4de1-95f7-a70e57b9c2b1

Established class (EPC) HMG-CoA Reductase Inhibitor

Mechanism of action Hydroxymethylglutaryl-CoA Reductase Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status Discontinued

FDA listing status Discontinued by firm (certified through Feb 2022)

Marketing start 2017-11-22

Route ORAL

Dosage form TABLET, FILM COATED

Substance ROSUVASTATIN CALCIUM

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 71335-1330-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71335-1330-04. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the HMG-CoA Reductase Inhibitor class.

Pharmacologic class HMG-CoA Reductase Inhibitor

Drug family (ATC) HMG CoA reductase inhibitors

How it works Hydroxymethylglutaryl-CoA Reductase Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack

Application holderMSN LABORATORIES PRIVATE LTD

FDA applicationANDA208898 (ANDA)

Labeler code71335

First marketedNov 2017

Product typeHuman Prescription Drug

Portfolio4,433 products on file

🔎 All NDCs from Bryant Ranch Prepack

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist

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

📖 Read our full Rosuvastatin guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

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

COENZYME Q10 Insufficient Evidence

🧪 Full Rosuvastatin nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White

ShapeRound

ImprintR5

Size7 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 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 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII 6HG8UB2MUY
Meglumine is a sugar-alcohol compound used as a solubilizer and pH buffer in medicines. It helps dissolve drugs that don't mix well in water and maintains stable acidity levels in the formulation.
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 O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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 each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.1900	$11.40 / 60 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 5 mg 11788-0130-05	AiPing	500 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 13668-0179-05	Torrent	500 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 13668-0720-05	TORRENT	500 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 16714-0988-01	NorthStar	90 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 24658-0261-90	PURACAP	90 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 27808-0155-01	Cranbury	90 tablets	$0.033	AB	Availability likely	—
Rosuvastatin 5 mg 50228-0116-10	ScieGen	1000 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 57237-0168-05	Rising	500 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 60687-0234-01	American	1 tablet	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 72603-0364-01	NorthStar	90 tablets	$0.033	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 82009-0017-10	Quallent	1000 tablets	$0.033	AB	Availability likely	—
Rosuvastatin 5 mg 16729-0284-15	Accord	90 tablets	$0.035	AB	Availability likely	—
Crestor 5 mg 00310-7560-90	AstraZeneca	90 tablets	$8.811	AB	Availability likely	—
Rosuvastatin Calcium 5 mg 00615-8532-39	NCS	30 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 31722-0882-31	Camber	100 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 33342-0261-07	Macleods	30 tablets	—	—	FDA listed	—
Rosuvastatin Calcium 5 mg 42677-0301-01	Shandong	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-4710-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-5110-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-5468-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 5 mg 50090-6302-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-6989-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 50090-7240-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 50090-7241-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-7489-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-7490-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-7491-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-7973-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-7974-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-7975-00	A-S	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 50090-7976-00	A-S	90 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 51407-0848-10	Golden	1000 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 5 mg 51655-0458-52	Northwind	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 51655-0756-52	Northwind	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 51655-0987-52	Northwind	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 60290-0043-01	Umedica	30 tablets	—	AB	FDA listed	—
Rosuvastain Calcium 5 mg 62135-0690-90	Chartwell	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 63187-0860-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 63629-7158-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 65862-0293-05	Aurobindo	500 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 67877-0439-05	Ascend	500 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 68071-3668-09	NuCare	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 68071-3844-09	NuCare	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 68071-5225-09	NuCare	90 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 5 mg 68462-0261-01	Glenmark	100 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 68788-4078-03	Preferred	30 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 5 mg 68788-8368-03	Preferred	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 68788-8428-02	Preferred	20 tablets	—	AB	Discontinued	—
Rosuvastatin Calcium 5 mg 69367-0359-01	Westminster	100 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 69434-0005-02	Zhejiang	90 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 5 mg 70377-0006-11	Biocon	30 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 70518-4098-01	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
rosuvstatin 5 mg 70756-0053-12	Lifestar	1000 tablets	—	—	FDA listed	—
Rosuvastatin Calcium 5 mg 71205-0355-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 71209-0043-04	Cadila	90 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 71335-0749-01	Bryant	30 tablets	—	AB	Discontinued	—
Rosuvastatin Calcium 5 mg 71335-1017-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mgthis 71335-1330-04	Bryant	60 tablets	—	AB	Discontinued	—
Rosuvastatin calcium 5 mg 71335-1889-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 71335-2440-01	Bryant	30 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 72189-0065-30	DIRECT	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 72205-0027-05	Novadoz	500 tablets	—	AB	FDA listed	—
Rosuvastatin 5 mg 82009-0188-05	Quallent	500 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 5 mg 82804-0234-30	Proficient	30 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 70518-4697-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Rosuvastatin calcium 5 mg 72303-0827-01	HEC	90 tablets	—	AB	FDA listed	—
Rosuvastatin Calcium 5 mg 71335-3172-01	Bryant	30 tablets	—	AB	FDA listed	—

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

Where does this data come from?

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

⏳ Availability & generic status

🏛️

2017

On the market since

Nov 2017

📍

2026

Currently FDA-listed

9 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Rosuvastatin Calcium — the program that covers self-administered drugs. 19 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Rosuvastatin Calcium. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$119.94M

Claims incl. refills

9.3M

Beneficiaries

7.8M

Spend / beneficiary

$15.47

Spend / claim

$12.87

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Rosuvastatin Calcium — the ingredient across all brands.

Top reported reactions

Dyspnoea2,778

Fatigue2,694

Pain2,470

Cough2,412

Headache2,118

Nausea1,988

Pneumonia1,881

Reporter sex

Male · 44%

Female · 56%

Unknown · 0%

Serious outcomes

Hospitalization9,256

Death1,404

Life-threatening1,243

Disabling931

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71335-1330-01	30 TABLET, FILM COATED in 1 BOTTLE (71335-1330-1)	2022-02-09	Discontinued by firm
71335-1330-02	90 TABLET, FILM COATED in 1 BOTTLE (71335-1330-2)	2022-02-09	Discontinued by firm
71335-1330-03	28 TABLET, FILM COATED in 1 BOTTLE (71335-1330-3)	2022-02-09	Discontinued by firm
71335-1330-04 You're viewing this	60 TABLET, FILM COATED in 1 BOTTLE (71335-1330-4)	2022-02-09	Discontinued by firm

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-1330-04?

NDC 71335-1330-04 is a 60-count package — 60 tablet, film coated in 1 bottle.

What is the difference between NDC 71335-1330-04 and NDC 71335-1330-03?

Both are Rosuvastatin Calcium 5 mg Tablet, Film Coated — the drug itself is identical. NDC 71335-1330-04 is the 60-count package, while NDC 71335-1330-03 is the 28 tablets package.

What NDC number is used to bill for this package of Rosuvastatin Calcium 5 mg Tablet, Film Coated?

Bill NDC 71335-1330-04 — the 11-digit billing format is 71335133004. 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 No longer marketed (per FDA listing data)

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.

What does the discontinued status mean for this NDC?

The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 71335-1330-4, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-1330-04, written without dashes as 71335133004. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 71335-1330-04, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1330) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 28 tablets (71335-1330-03), 30 tablets (71335-1330-01), 90 tablets (71335-1330-02). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

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

Do I need a prescription for this product?

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

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

Where does this data come from?

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

📄 Full prescribing information FDA SPL

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

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

🎯 Indications and Usage 217 words ▾

1 INDICATIONS AND 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 tablets are an HMG Co-A reductase inhibitor indicated for: 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 LDL-C, total-C, and ApoB ( 1.5 ) Limitations of use ( 1.8 ): Rosuvastatin tablets has not been studied in Fredrickson Type I and V dyslipidemias.

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.

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

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Rosuvastatin 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)

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 calcium tablets 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 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 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 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 ClinicalPharmacology (12.3) ].

2.4Use with Concomitant Therapy Patients taking cyclosporine and darolutamide The dose of rosuvastatint ablets should not exceed 5mg 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 calcium tablets at 5 mg once daily.

The dose of rosuvastatin tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.2) 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, or 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 cr < 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 once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ].

💊 Dosage Forms and Strengths 98 words ▾

3 DOSAGE FORMS AND STRENGTHS 5 mg: White, round shaped, biconvex, film coated tablets debossed with "R5" on one side and plain on other side. 10 mg: Pink, round shaped, biconvex, film coated tablets debossed with "R10" on one side and plain on other side. 20 mg: Pink, round shaped, biconvex, film coated tablets debossed with "R20" on one side and plain on other side.

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

⛔ Contraindications 152 words ▾

4 CONTRAINDICATIONS Rosuvastatin calcium is 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 [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 calcium is present in human milk.

Because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin calcium 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 ) Preganancy ( 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 calcium tablets 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 elevations in 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 thereafter. ( 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 tablets. These risks can occur at any dose level, but are increased at the highest dose (40 mg). Rosuvastatin calcium 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 ros uvastatin calcium 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 calcium with colchicine [see Drug Interactions (7.9) ]. Rosuvastatin calcium therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Rosuvastatin calcium 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 calcium.

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…

🤒 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) [see Warnings and Precautions (5.1)] Liver enzyme abnormalities [see Warnings and Precautions (5.3)] Most frequent adverse reactions (rate ≥2%) are headache, myalgia, abdominal pain, asthenia, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 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 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 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 and > Placebo in Placebo-Controlled Trials (% of Patients) Adverse Reactions Rosuvastatin calcium 5 mg N=291 Rosuvastatin calcium 10 mg N=283 Rosuvastatin calcium 20 mg N=64 Rosuvastatin calcium 40 mg N=106 Total Rosuvastatin calcium 5 mg to 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 [see Warnings and Precautions (5.5 )]; 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 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 Reactions 1 Reported in ≥ 2% of Patients Treated with Rosuvastatin calcium and > Placebo in a Trial (% of Patients) Adverse Reactions Rosuvastatin calcium 40 mg N=700 Placebo N=281 Myalgia 12.7

12.1Arthralgia 10.1

7.1Headache 6.4

5.3Dizziness 4.0

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, discontinued study medication due to an adverse event, irrespective of treatment causality. Myalgia was the most common adverse reaction…

🔄 Drug Interactions ~2 min read ▾

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

Limit rosuvastatin calcium 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 calcium 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 calcium dose to 10 mg once daily. ( 2.4 , 5.1 , 7.3 , 12.3 ) Regorafenib: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium dose to 10 mg once daily.

( 2.4 , 5.1 , 7.5 ) Coumarin anticoagulants: Combination prolongs INR. Achieve stable INR prior to starting rosuvastatin calcium. Monitor INR frequently until stable upon initiation or alteration of rosuvastatin calcium 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 calcium. ( 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 calcium 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 calcium and gemfibrozil should be avoided. If used together, the dose of rosuvastatin calcium 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 calcium 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 calcium 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 calcium 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 calcium should not exceed 10 mg once daily [ see Dosage and Administration (2.4), Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)]. 7.6…

👥 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. ( 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 ) 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.

8.1Pregnancy Risk Summary Rosuvastatin calcium 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 calcium during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, rosuvastatin calcium may cause fetal harm when administered to pregnant women. Rosuvastatin calcium 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 2-4% and 15-20%, 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…

🤰 Pregnancy ~3 min read ▾

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 100 words ▾

8.5Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin calcium, 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 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 calcium is evident within 1 week of commencing therapy and 90% of maximum response is 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 proportion to rosuvastatin calcium dose. The absolute bioavailability of rosuvastatin is approximately 20%.

Administration of rosuvastatin calcium 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 with a Caucasian control group. Male and Female Patients 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 patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥ 65 years).

Patients with Renal Impairment Mild to moderate renal impai…

🧬 Mechanism of Action 116 words ▾

📦 How Supplied / Storage and Handling 97 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets, USP are supplied as: 5 mg: White, round shaped, biconvex, film coated tablets debossed with "R5" on one side and plain on other side. NDC: 71335-1330-1: 30 Tablets in a BOTTLE NDC: 71335-1330-2: 90 Tablets in a BOTTLE NDC: 71335-1330-3: 28 Tablets in a BOTTLE NDC: 71335-1330-4: 60 Tablets in a BOTTLE Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Protect from moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 175 words ▾

11 DESCRIPTION Rosuvastatin calcium, USP is a synthetic lipid-lowering agent for oral administration. The chemical name for rosuvastatin calcium is bis [(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2 [methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3R,5S)-3, 5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The molecular 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 is a white amorphous powder that is sparingly soluble in water and Methanol, and slightly soluble in ethanol.

Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, hypromellose, lactose monohydrate magnesium stearate, mannitol, meglumine, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Additionally, 10 mg, 20 mg and 40 mg tablets contain FD&C red No.

40/allura red AC aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake and FD&C yellow No.6/sunset yellow FCF aluminum lake. Meets USP Dissolution Test 2.

💬 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 tablets.

Concomitant Use of Antacids When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin 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. [see Contraindications (4) and Use in Specific Populations (8.1 , 8.3 )]. Lactation Advise women not to breastfeed during treatment with rosuvastatin calcium [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 tablets and if signs or symptoms of liver injury occur. All patients treated with rosuvastatin 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 by: MSN Laboratories Private Limited Telangana – 509 228, INDIA Distributed by: Novadoz Pharmaceuticals LLC Piscataway, NJ 08854-3714 Issued on: February 2021

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.

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

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

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

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

arthralgia: Joint pain.

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

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

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

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.

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.

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.

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.

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.

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 Calcium 5 mg Tablet, Film Coated, 60-count

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