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Rosuvastatin calcium 40 mg Tablet, Film Coated, 90-count

by Bryant Ranch Prepack · 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1939-2)
NDC 71335-1939-02
🏷️ FDA NDC (as labeled) 71335-1939-2 billing pads the package segment with a zero
This package
Contains90-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1900/unit — full pricing hub ↓
Also comes in: 10 tablets 71335-1939-04 28 tablets 71335-1939-03 30 tablets 71335-1939-01
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

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Rosuvastatin Calcium (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0339-2025
Class II · Mar 23, 2023 — cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. (Preferred Pharmaceuticals, Inc.) · FDA recall D-0519-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71335-1939-2
Product NDC 71335-1939
11-digit billing NDC 71335193902
RxCUI 859419
UNII 83MVU38M7Q
Application # ANDA207752
SPL Set ID 88ab1c85-e864-4879-8489-8365ded78bb5
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 2016-10-31
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 71335-1939-2 — 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 → 71335-1939-02. 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 holderBIOCON PHARMA LTD
FDA applicationANDA207752 (ANDA)
Labeler code71335
First marketedOct 2016
Product typeHuman Prescription Drug
Portfolio4,433 products on file
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

📖 What it is MedlinePlus · NLM

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

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

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 Full Rosuvastatin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

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

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

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

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price systemPer eachPer 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 $17.10 / 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rosuvastatin 40 mg 11788-0133-05 AiPing 500 tablets $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 13668-0182-05 Torrent 500 tablets $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 13668-0723-05 TORRENT 500 tablets $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 16714-0991-01 NorthStar 30 tablets $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 24658-0264-30 PURACAP 30 tablets $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 27808-0158-01 Cranbury 30 tablets $0.069 AB Availability likely —
Rosuvastatin 40 mg 31722-0885-30 Camber 30 tablets $0.069 AB Availability likely —
Rosuvastatin 40 mg 50228-0119-10 ScieGen 1000 tablets $0.069 AB Availability likely —
Rosuvastatin 40 mg 50268-0711-15 AvPAK 1 tablet $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 57237-0171-05 Rising 500 tablets $0.069 AB Availability likely —
Rosuvastain Calcium 40 mg 62135-0693-30 Chartwell 30 tablets $0.069 AB Availability likely —
Rosuvastatin calcium 40 mg 70377-0009-11 Biocon 30 tablets $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 72603-0367-01 NorthStar 30 tablets $0.069 AB Availability likely —
Rosuvastatin Calcium 40 mg 82009-0020-10 Quallent 1000 tablets $0.069 AB Availability likely —
Rosuvastatin 40 mg 16729-0287-10 Accord 30 tablets $0.108 AB FDA listed —
Crestor 40 mg 00310-7590-30 AstraZeneca 30 tablets $8.806 AB Availability likely —
Rosuvastatin Calcium 40 mg 00615-8535-39 NCS 30 tablets — AB FDA listed —
Rosuvastatin 40 mg 33342-0264-07 Macleods 30 tablets — — FDA listed —
Rosuvastatin Calcium 40 mg 42677-0304-01 Shandong 30 tablets — AB FDA listed —
Rosuvastatin calcium 40 mg 50090-5970-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 50090-6611-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 50090-6612-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 50090-7413-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 50090-7414-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin 40 mg 50090-7482-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin 40 mg 50090-7483-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 51407-0156-30 Golden 30 tablets — AB Discontinued —
Rosuvastatin 40 mg 51407-0851-10 Golden 1000 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 60290-0046-01 Umedica 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 65862-0296-05 Aurobindo 500 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 67877-0442-05 Ascend 500 tablets — AB FDA listed —
Rosuvastatin calcium 40 mg 68462-0264-01 Glenmark 100 tablets — AB FDA listed —
Rosuvastatin 40 mg 68788-8649-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 69367-0362-01 Westminster 100 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 69434-0008-01 Zhejiang 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 70518-3651-00 REMEDYREPACK 90 tablets — AB FDA listed —
Rosuvastatin calcium 40 mg 70518-4220-00 REMEDYREPACK 90 tablets — AB FDA listed —
Rosuvastatin 40 mg 70518-4314-00 REMEDYREPACK 100 tablets — AB FDA listed —
rosuvstatin 40 mg 70756-0056-12 Lifestar 1000 tablets — — FDA listed —
Rosuvastatin Calcium 40 mg 71205-0078-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin calcium 40 mg 71205-0176-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 71205-0475-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 71209-0046-01 Cadila 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 71335-1103-01 Bryant 30 tablets — AB Discontinued —
Rosuvastatin calcium 40 mgthis 71335-1939-02 Bryant 90 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 71335-2055-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin 40 mg 71335-2498-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin calcium 40 mg 71610-0078-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin calcium 40 mg 71610-0133-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 71610-0232-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 71610-0793-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin 40 mg 71610-0798-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 72189-0106-30 DIRECT 30 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 72205-0005-05 Novadoz 500 tablets — AB FDA listed —
Rosuvastatin 40 mg 82009-0191-05 Quallent 500 tablets — AB FDA listed —
Rosuvastatin Calcium 40 mg 82804-0176-90 Proficient 90 tablets — AB FDA listed —
Rosuvastatin calcium 40 mg 72303-0830-01 HEC 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

🏛️
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.

📊 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

28,005 reports
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
2019 2021 2023 2026 4,581 0
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 NDCDescription Marketing startStatus
71335-1939-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1939-1) 2022-03-10 Active
71335-1939-02 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1939-2) 2021-09-02 Active
71335-1939-03 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1939-3) 2022-03-10 Active
71335-1939-04 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1939-4) 2022-03-10 Active

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

Pack size FAQ

What quantity is in NDC 71335-1939-02?
NDC 71335-1939-02 is a 90-count package — 90 tablet, film coated in 1 bottle, plastic.
What is the difference between NDC 71335-1939-02 and NDC 71335-1939-04?
Both are Rosuvastatin calcium 40 mg Tablet, Film Coated — the drug itself is identical. NDC 71335-1939-02 is the 90-count package, while NDC 71335-1939-04 is the 10 tablets package.
What NDC number is used to bill for this package of Rosuvastatin calcium 40 mg Tablet, Film Coated?
Bill NDC 71335-1939-02 — the 11-digit billing format is 71335193902. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71335-1939-2, 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: 71335-1939-02, written without dashes as 71335193902. 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 71335-1939-02, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1939) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 10 tablets (71335-1939-04), 28 tablets (71335-1939-03), 30 tablets (71335-1939-01). 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 210 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 have 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 dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see Warnings and Precautions (5.1) ]. Rosuvastatin tablets can be administered as a single dose at any time of day, with or without food.The tablet should be swallowed whole. When initiating rosuvastatin tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin tablets starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy.

After initiation or upon titration of rosuvastatin tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. 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 Clinical Pharmacology (12.3) ].

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

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

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

2.5Dosing in Patients with Severe Renal Impairment For patients with severe renal impairment (CL 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 90 words ▾

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

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

⛔ Contraindications 150 words ▾

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

Pregnancy [see Use in Specific Populations ( 8.1 , 8.3) ]. Lactation. Limited data indicate that rosuvastatin is present in human milk.

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

⚠️ Warnings and Cautions ~2 min read ▾

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

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

Perform liver enzyme tests before initiating therapy and as clinically indicated 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. These risks can occur at any dose level, but are increased at the highest dose (40 mg). Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy (e.g., age ≥65 years, inadequately treated hypothyroidism, renal impairment).

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

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

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

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

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

5.…

🤒 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 frequest adverse reactions (rate ≥2%) are headache, myalgia, abdominal pain, asthenia, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Biocon Pharma Inc. at 1-866-924-6266 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 controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: myalgia abdominal pain nausea The most commonly reported adverse reactions (incidence ≥2%) in the rosuvastatin controlled clinical trial database of 5394 patients were: headache myalgia abdominal pain asthenia nausea Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 1.

These studies had a treatment duration of up to 12 weeks. Table 1. Adverse Reactions Adverse reactions by COSTART preferred term Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials (% of Patients) Adverse Reactions Rosuvastatin 5 mg N=291 Rosuvastatin 10 mg N=283 Rosuvastatin 20 mg N=64 Rosuvastatin 40 mg N=106 Total Rosuvastatin 5 mg to 40 mg N=744 Placebo N=382 Headache 5.5 4.9 3.1 8.5 5.5

5.0Nausea 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

2.4Other adverse reactions reported in clinical studies were abdominal pain, dizziness, hypersensitivity (including rash, pruritus, urticaria, and angioedema) and pancreatitis. The following laboratory abnormalities have also been reported: dipstick-positive proteinuria and microscopic hematuria [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 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 Adverse reactions by MedDRA preferred term. Reported in ≥ 2% of Patients Treated With Rosuvastatin and > Placebo in a Trial (% of Patients) Adverse Reactions Rosuvastatin 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 Frequency recorded as abnormal laboratory value 2.2

0.7In 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 that led to treatment discontinuation.

There was a significantly higher frequency of diabetes mellitus repo…

🔄 Drug Interactions ~2 min read ▾

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

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

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

Limit rosuvastatin dose to 10 mg once daily. ( 2.4 , 5.1 , 7.5 ) Coumarin anticoagulants: Combination prolongs INR. Achieve stable INR prior to starting rosuvastatin.

Monitor INR frequently until stable upon initiation or alteration of rosuvastatin therapy. ( 5.4 , 7.6 ) Concomitant lipid-lowering therapies: Use with fibrates or lipid modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with rosuvastatin .

( 5.1 , 7.5 , 7.6 )

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

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

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

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

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

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

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

7.6Coumarin Anticoagulants Rosuvastatin significantly increased INR in patients receiving coumarin anticoagulan…

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

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

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

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

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

Rosuvastatin administration did not indicate a teratogenic effect in rats at ≤25 mg/kg/day or in rabbits ≤3 mg/kg/day (doses equivalent to the MRHD of 40 mg/day based on AUC and body surface area, respectively). In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC). In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface…

🤰 Pregnancy ~3 min read ▾

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

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

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

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

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

Rosuvastatin administration did not indicate a teratogenic effect in rats at ≤25 mg/kg/day or in rabbits ≤3 mg/kg/day (doses equivalent to the MRHD of 40 mg/day based on AUC and body surface area, respectively). In female rats given 5, 15 and 50 mg/kg/day before mating and continuing through to gestation day 7 resulted in decreased fetal body weight (female pups) and delayed ossification at 50 mg/kg/day (10 times the human exposure at the MRHD dose of 40 mg/day based on AUC). In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area).

In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area).

🧒 Pediatric Use 40 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 98 words ▾

8.5Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin, 3159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients are at higher risk of myopathy and rosuvastatin should be prescribed with caution in the elderly [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

🆘 Overdosage 37 words ▾

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

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

12.3Pharmacokinetics 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 dose. The absolute bioavailability of rosuvastatin is approximately 20%.

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

Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. Elimination Rosuvastatin is primarily eliminated by excretion in the feces.

The elimination half-life of rosuvastatin is approximately 19 hours. Metabolism Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite. The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 \ 2C9, and in vitro studies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound.

Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity is accounted for by the parent compound. Excretion Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%). After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route.

Specific Populations Racial or Ethnic Groups A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among Caucasian, Hispanic, and Black or Afro-Caribbean groups. However, pharmacokinetic studies, including one conducted in the US, have demonstrated an approximate 2-fold elevation in median exposure (AUC and C max ) in Asian subjects when compared 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 impairment (CLcr ≥30 mL/min/1.73 m 2 ) had no influence on plasma concentrations of rosuvastatin. However, plasma concentrations of rosuvastatin increased to a clinically significant extent (about 3-fold) in patients with severe renal impairment (CLcr <30 mL/min/1.73 m 2 ) 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.

Patien…

🧬 Mechanism of Action 116 words ▾

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.

📦 How Supplied / Storage and Handling 87 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets USP are supplied as: 40 mg. Pink, oval, biconvex, film-coated tablets, debossed with '40' on one side and 'B' on other side. NDC: 71335-1939-4: 10 Tablets in a BOTTLE, PLASTIC NDC: 71335-1939-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-1939-2: 90 Tablets in a BOTTLE, PLASTIC NDC: 71335-1939-3: 28 Tablets in a BOTTLE, PLASTIC Storage Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature].

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

📋 Description 147 words ▾

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

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

💬 Information for Patients ~1 min read ▾

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

Concomitant Use of Antacids When taking rosuvastatin with an aluminum and magnesium hydroxide combination antacid, the antacid should be taken at least 2 hours after rosuvastatin administration. Embryofetal Toxicity Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy. [see Contraindications (4) and Use in specific populations ( 8.1 , 8.3 ) ]. Lactation Advise women not to breastfeed during treatment with rosuvastatin [see Contraindications (4) and Use in Specific Populations (8.2) ].

Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin and if signs or symptoms of liver injury occur. All patients treated with rosuvastatin should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. Manufactured for: Biocon Pharma Inc., 485 US Highway 1 S, Suite B305, Iselin, NJ 08830-3009, USA Manufactured by: Recipharm Pharmaservices Private Limited, 34th KM, Tumkur Road, Teppada Begur, Nelamangala Taluk, Bangalore – 562123, India.

Mfg. Lic. No.

KTK/25/460/2001 or Biocon Pharma Limited, Special Economic Zone, Plot No.5, Phase IV, Bommasandra - Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India Mfg. Lic. No.

KTK/25/664/2017 Biocon Pharma Inc.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-1938-01 · Bryant 71335-1940-01 · Bryant →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.