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rosuvstatin 5 mg Tablet, Film Coated, 1,000-count — NDC 70756-0053-12 package photo
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rosuvstatin 5 mg Tablet, Film Coated, 1,000-count — NDC 70756-053-12 (Billing 70756-0053-12)

by Lifestar Pharma LLC · 1000 TABLET, FILM COATED in 1 BOTTLE

This is a package of 1,000 tablets of rosuvstatin 5 mg Tablet, Film Coated from Lifestar Pharma LLC, marketed since Aug 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 70756-0053-12
🏷️ FDA NDC (as labeled) 70756-053-12 billing pads the product segment with a zero
This package
Contains1,000-count Pack sizes2 compare ↓
Main listing for product 70756-053 · Also comes in: 90 tablets 70756-053-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70756-053-12
Product NDC 70756-053
11-digit billing NDC 70756005312
RxCUI 859419, 859424, 859747, 859751
UNII 83MVU38M7Q
Application # ANDA206603
SPL Set ID a6141eb6-0b38-44f9-9d16-ec7218a51f92
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 2026-08-16
Route ORAL
Dosage form TABLET, FILM COATED
Substance ROSUVASTATIN CALCIUM
Quick answers
  • RxCUI (RxNorm): 859419
Why two NDCs? The FDA registers this code as 70756-053-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 70756-0053-12. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It lowers cholesterol and triglycerides when diet alone isn’t enough. Some tablet labels also include slowing atherosclerosis and lowering the risk of heart attack and stroke in ad...
  • Take one tablet by mouth once a day, at any time, with or without food. Swallow it whole. If you miss a dose, skip it and take your next one as usual, without doubling up.
  • The most common are headache, nausea, muscle aches, tiredness, constipation and joint pain. Most people tolerate it well. Call your doctor if muscle pain, tenderness or weakness is...
  • Some medicines raise rosuvastatin levels and muscle risk, including cyclosporine, gemfibrozil and many antivirals. Tell me about everything you take. If you use an aluminum and mag...
📖 Read our full Rosuvastatin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70756-0053-12 You're viewing this Main listing 1000 TABLET, FILM COATED in 1 BOTTLE 2026-08-16 — Active
70756-0053-90 70756-053-90 90 TABLET, FILM COATED in 1 BOTTLE 2026-08-16 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 1,000-count package — 1000 tablet, film coated in 1 bottle.
How does this package differ from NDC 70756-0053-90?
Both are rosuvstatin 5 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 1,000-count one, while NDC 70756-0053-90 is the 90 tablets package.
What NDC number is used to bill for this package of rosuvstatin 5 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rosuvastatin 5 mg 11788-0130-05 AiPing 500 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 13668-0179-05 Torrent 500 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 13668-0720-05 TORRENT 500 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 16714-0988-01 NorthStar 90 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 24658-0261-90 PURACAP 90 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 27808-0155-01 Cranbury 90 tablets $0.032 AB Availability likely —
Rosuvastatin 5 mg 50228-0116-10 ScieGen 1000 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 57237-0168-05 Rising 500 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 60687-0234-01 American 1 tablet $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 72603-0364-01 NorthStar 90 tablets $0.032 AB Availability likely —
Rosuvastatin Calcium 5 mg 82009-0017-10 Quallent 1000 tablets $0.032 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 $8.814 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 mgthis 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 mg 71335-1330-01 Bryant 30 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 —
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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

What it looks like

Color Yellow / Pink
ShapeOval
ImprintL;56
Size13 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerLifestar Pharma LLC
Application holderMANKIND PHARMA LTD
FDA applicationANDA206603 (ANDA)
Labeler code70756
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio155 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH).

As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia Rosuvastatin tablets are HMG Co-A reductase inhibitor (statin) indicated: (1) To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): reduce LDL-C in adults with primary hypercholesterolemia. reduce LDL-C and slow the progression of atherosclerosis in adults. reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: Primary dysbetalipoproteinemia. Hypertriglyceridemia.

⏱️ Dosage and Administration ~3 min read ▾

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

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

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

(2.6)

2.1General Dosage and Administration Information Administer rosuvastatin tablets orally as a single dose at any time of day, with or without food. Swallow the tablets whole. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating rosuvastatin tablets, and adjust the dosage if necessary.

If a dose is missed, advise patients not take an extra dose. Resume treatment with the next dose. When taking rosuvastatin tablets with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin tablets at least 2 hours before the antacid [see Drug Interactions (7.2)] .

2.2Recommended Dosage in Adult Patients The dosage range for rosuvastatin tablets are 5 to 40 mg orally once daily. The recommended dosage of rosuvastatin tablets depends on a patient's indication for usage, LDLC, and individual risk for cardiovascular events.

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

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

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

2.6Dosage Modifications Due to Drug Interactions Table 1 displays dosage modifications for rosuvastatin tablets due to drug interactions [see Warnings and Precautions (5.1) and Drug Interactions (7.1)]. Table 1: Rosuvastatin Tablets Dosage Modifications Due to Drug Interactions Concomitantly Used Drug Rosuvastatin Tablets Dosage Modifications Sofobuvir/velpatasvir/ voxilaprevir or Ledipasvir/sofosbuvir Avoid concomitant use. Gemfibrozil Avoid concomitant use.

If use is unavoidable, initiate at 5 mg once daily and do not exceed 10 mg once daily. Tafamidis Avoid concomitant use. If use is unavoidable, initiate at 5 mg once daily and do not exceed 20 mg once daily.

Belumosudil Do not exceed 5 mg once daily. Cyclosporine Do not exceed 5 mg once daily. Darolutamide Do not exceed 5 mg once daily.

Additional Antiviral Medications o Simeprevir o… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 109 words ▾

3 DOSAGE FORMS AND STRENGTHS Rosuvastatin tablets, USP: 5 mg of rosuvastatin: yellow colored, round shaped, film-coated biconvex tablets. Debossed with '53' on one side and 'L' on other side. 10 mg of rosuvastatin: pink colored, round shaped, film-coated biconvex tablets.

Debossed with '54' on one side and 'L' on other side. 20 mg of rosuvastatin: pink colored, round shaped, film-coated biconvex tablets, debossed with '55' on one side and 'L' on other side. 40 mg of rosuvastatin: pink colored, oval shaped, film-coated biconvex tablets.

Debossed with '56' on one side and 'L' on other side. Tablets: 5 mg, 10 mg, 20 mg, and 40 mg of rosuvastatin. (3)

⛔ Contraindications 65 words ▾

4 CONTRAINDICATIONS Rosuvastatin tablets are contraindicated in patients with: Acute liver failure or decompensated cirrhosis [see Warnings and Precautions (5.3)]. Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin tablets [see Adverse Reactions (6.1)] .

Acute liver failure or decompensated cirrhosis. (4) Hypersensitivity to rosuvastatin or any excipients in rosuvastatin tablets. (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Myopathy and Rhabdomyolysis: Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher rosuvastatin dosage. Asian patients may be at higher risk for myopathy. Discontinue rosuvastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected.

Temporarily discontinue rosuvastatin in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing rosuvastatin dosage. Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

(5.1, 7.1, 8.5, 8.6, 8.8) Immune-Mediated Necrotizing Myopathy (IMNM): Rare reports of IMNM, an autoimmune myopathy, have been reported with statin use. Discontinue rosuvastatin if IMNM is suspected. (5.2) Hepatic Dysfunction: Increases in serum transaminases have occurred, some persistent.

Rare reports of fatal and non-fatal hepatic failure have occurred. Consider testing liver enzymes before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue rosuvastatin tablets.

(4, 5.3, 8.7)

5.1Myopathy and Rhabdomyolysis Rosuvastatin may cause myopathy [muscle pain, tenderness, or weakness associated with elevated creatine kinase (CK)] and rhabdomyolysis. Acute kidney injury secondary to myoglobinuria and rare fatalities have occurred as a result of rhabdomyolysis with statins, including rosuvastatin. Risk Factors for Myopathy Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs (including other lipid-lowering therapies), and higher rosuvastatin dosage.

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

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

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

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

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

Additional neuromuscular and serologic testing may be necessary.… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)] Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)] Hepatic Dysfunction [see Warnings and Precautions (5.3)] Proteinuria and Hematuria [see Warnings and Precautions (5.4)] Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.5)] Most frequent adverse reactions (rate ≥2%) are headache, nausea, myalgia, asthenia, and constipation.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of up to 12 weeks.

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

5.5Nausea 3.1 3.8 3.5 6.3 0

3.4Myalgia 1.3 3.1 2.1 6.3 1.9

2.8Asthenia 2.6 2.4 3.2 4.7 0.9

2.7Constipation 2.4 2.1 2.1 4.7 2.8

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

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

12.7Arthralgia 7.1

10.1Headache 5.3

6.4Dizziness 2.8

4.0Increased CPK 0.7

2.6Abdominal pain 1.8

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

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

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

7.6Arthralgia 3.2

3.8Constipation 3.0

3.3Diabetes mellitus 2.3

2.8Nausea 2.3

2.4Pediatric Patients with HeFH In a 12-week controlled study in pediatric patients 10 to 17 years of age with HeFH with rosuvastatin 5 to 20 mg daily [see Use in Specific Populations (8.4) and Clinical Studies (14)] , elevations in serum CK greater than 10 x ULN were observed more frequent… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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

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

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

Table 5: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management: Avoid concomitant use with rosuvastatin. Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Gemfibrozil Prevention or Management: Avoid concomitant use of gemfibrozil with rosuvastatin.

If use is unavoidable, initiate rosuvastatin at 5 mg once daily and do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Gemfibrozil significantly increased rosuvastatin exposure and gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use.

Tafamidis Prevention or Management: Avoid concomitant use of tafamidis with rosuvastatin. If use is unavoidable, initiate rosuvastatin at 5 mg once daily and do not exceed a dosage of rosuvastatin 20 mg once daily. Monitor for signs of myopathy and rhabdomyolysis if used concomitantly with rosuvastatin.

Mechanism and Clinical Effect(s): Tafamidis significantly increased rosuvastatin exposure and tafamidis may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Belumosudil Prevention or Management: In patients taking belumosudil, do not exceed a dosage of rosuvastatin 5 mg once daily.

Mechanism and Clinical Effect(s): Belumosudil increased rosuvastatin exposure more than 4.6-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Cyclosporine Prevention or Management: In patients taking cyclosporine, do not exceed a dosage of rosuvastatin 5 mg once daily.

Mechanism and Clinical Effect(s): Cyclosporine increased rosuvastatin exposure 7-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Darolutamide Prevention or Management: In patients taking darolutamide, do not exceed a dosage of rosuvastatin 5 mg once daily.

Mechanism and Clinical Effect(s): Darolutamide increased rosuvastatin exposure more than 5-fold. The risk of myopathy and rhabdomyolysis is increased with concomitant use. Additional Anti-Viral Medications Prevention or Management:: Simeprevir Dasabuvir/ombitasvir/paritaprevir/ritonavir Elbasvir/grazoprevir Sofosbuvir/velpatasvir Glecaprevir/pibrentasvir Atazanavir/ritonavir Lopinavir/ritonavir Initiate with rosuvastatin 5 mg once daily, and do not exceed a dosage of rosuvastatin 10 mg once daily.

Mechanism and Clinical Effect(s): Rosuvastatin plasma levels were significantly increased with concomitant administration of many anti-viral drugs, which increases the risk of myopathy and rhabdomyolysis. Capmatinib Prevention or Management: In patients taking capmatinib, do not exceed a dosage of rosuvastatin 10 mg once daily. Mechanism and Clinical Effect(s): Capm… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. (8.1) Lactation: Breastfeeding not recommended during treatment with rosuvastatin. (8.2)

8.1Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)].

In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods.

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

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

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

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Discontinue rosuvastatin when pregnancy is recognized. Alternatively, consider the ongoing therapeutic needs of the individual patient. Rosuvastatin decreases synthesis of cholesterol and possibly other biologically active substances derived from cholesterol; therefore, rosuvastatin may cause fetal harm when administered to pregnant patients based on the mechanism of action [see Clinical Pharmacology (12.1)].

In addition, treatment of hypercholesterolemia is not generally necessary during pregnancy. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia for most patients. Available data from case series and prospective and retrospective observational cohort studies over decades of use with statins in pregnant women have not identified a drug-associated risk of major congenital malformations.

Published data from prospective and retrospective observational cohort studies with rosuvastatin use in pregnant women are insufficient to determine if there is a drug-associated risk of miscarriage (see Data) . In animal reproduction studies, no adverse developmental effects were observed in pregnant rats or rabbits orally administered rosuvastatin during the period of organogenesis at doses that resulted in systemic exposures equivalent to human exposures at the maximum recommended human dose (MRHD) of 40 mg/day, based on AUC and body surface area (mg/m 2 ), respectively (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data A Medicaid cohort linkage study of 1152 statin-exposed pregnant women compared to 886,996 controls did not find a significant teratogenic effect from maternal use of statins in the first trimester of pregnancy, after adjusting for potential confounders – including maternal age, diabetes mellitus, hypertension, obesity, and alcohol and tobacco use – using propensity score-based methods.

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

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

In pregnant rats given 2, 10 and 50 mg/kg/day of rosuvastatin from gestation day 7 through lactation day 21 (weaning), decreased pup survival occurred at 50 mg/kg/day (dose equivalent to 12 times the MRHD of 40 mg/day based body surface area). In pregnant rabbits given 0.3, 1, and 3 mg/kg/day of rosuvastatin from gestation day 6 to day 18, decreased fetal viability and maternal mortality was observed at 3 mg/kg/day (dose equivalent to the MRHD of 40 mg/day based on body surface area). Rosuvastatin crosses the placenta in rats and rabbits and is found in fetal tissue and amniotic fluid at 3% and 20%, r… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~1 min read ▾

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

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

🧓 Geriatric Use 105 words ▾

8.5Geriatric Use Of the 10,275 patients in clinical studies with rosuvastatin 3,159 (31%) were 65 years and older, and 698 (6.8%) were 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Advanced age (≥65 years) is a risk factor for rosuvastatin-associated myopathy and rhabdomyolysis.

Dose selection for an elderly patient should be cautious, recognizing the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy and the higher risk of myopathy. Monitor geriatric patients receiving rosuvastatin for the increased risk of myopathy [see Warnings and Precautions (5.1)].

🆘 Overdosage 40 words ▾

10 OVERDOSAGE No specific antidotes for rosuvastatin tablets are known. Hemodialysis does not significantly enhance clearance of rosuvastatin. In the event of overdose, consider contacting the Poison Help line (1 800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

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

12.3Pharmacokinetics 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%.

The AUC of rosuvastatin does not differ following evening or morning drug administration. Effect of food Administration of rosuvastatin with food did not affect the AUC of rosuvastatin. 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 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. The elimination half-life of rosuvastatin is approximately 19 hours. Specific Populations Geriatric Patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years).

Pediatric Patients In a population pharmacokinetic analysis of two pediatric trials involving patients with HeFH 10 to 17 years of age and 8 to 17 years of age, respectively, rosuvastatin exposure appeared comparable to or lower than rosuvastatin exposure in adult patients. Male and Female Patients There were no differences in plasma concentrations of rosuvastatin between males and females. Racial or Ethnic Groups A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among White, Hispanic or Latino ethnicity, 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 White control group. 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 ).

Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Patients with Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. In patients with C… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 25 words ▾

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

📦 How Supplied / Storage and Handling 177 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin tablets, USP are supplied as: 5 mg: Yellow colored, round shaped, film-coated biconvex tablets, debossed with '53' on one side and 'L' on other side. NDC 70756-053-90 bottles of 90 with child-resistant closure NDC 70756-053-12 bottles of 1000 10 mg: Pink colored, round shaped, film-coated biconvex tablets, debossed with '54' on one side and 'L' on other side. NDC 70756-054-90 bottles of 90 with child-resistant closure NDC 70756-054-12 bottles of 1000 20 mg: Pink colored, round shaped, film-coated biconvex tablets, debossed with '55' on one side and 'L' on other side.

NDC 70756-055-90 bottles of 90 with child-resistant closure NDC 70756-055-12 bottles of 1000 40 mg: Pink colored, oval shaped, film-coated biconvex tablets, debossed with '56' on one side and 'L' on other side. NDC 70756-056-30 bottles of 30 with child-resistant closure NDC 70756-056-90 bottles of 90 with child-resistant closure NDC 70756-056-12 bottles of 1000 Storage Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture.

📋 Description 173 words ▾

11 DESCRIPTION Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula: The 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 to off white amorphous powder that is sparingly soluble in methanol, slightly soluble in water and practically insoluble 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 use contain 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: dibasic calcium phosphate anhydrous, crospovidone, ferric oxide red (for 10 mg, 20 mg and 40 mg tablets), ferric oxide yellow (for 5 mg tablets), hypromellose 2910 (15 mpa.s), lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. strucural formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myopathy and Rhabdomyolysis Advise patients that rosuvastatin may cause myopathy and rhabdomyolysis. Inform patients that the risk is also increased when taking certain types of medication and they should discuss all medication, both prescription and over the counter, with their healthcare provider.

Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1), and Drug Interactions (7.1) ]. Hepatic Dysfunction Inform patients that rosuvastatin may cause liver enzyme elevations and possibly liver failure. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice [see Warnings and Precautions (5.3) ].

Increases in HbA1c and Fasting Serum Glucose Levels Inform patients that increases in HbA1c and fasting serum glucose levels may occur with rosuvastatin. Encourage patients to optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices [see Warnings and Precautions (5.5) ]. Pregnancy Advise pregnant patients and patients who can become pregnant of the potential risk to a fetus.

Advise patients to inform their healthcare provider of a known or suspected pregnancy to discuss if rosuvastatin should be discontinued [see Use in Specific Populations (8.1) ] . Lactation Advise patients that breastfeeding during treatment with rosuvastatin is not recommended [see Use in Specific Populations (8.2) ]. Concomitant Use of Antacids When taking rosuvastatin with an aluminum and magnesium hydroxide combination antacid, administer rosuvastatin at least 2 hours before the antacid [see Drug Interactions (7.2)].

Missed Doses If a dose is missed, advise patients not to take an extra dose. Just resume the usual schedule [see Dosage and Administration (2.1)] . Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd.

Mahwah, NJ 07430 USA Made in India Revised: May 2026, V-07

🧬 Pharmacokinetics ~3 min read ▾

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%.

The AUC of rosuvastatin does not differ following evening or morning drug administration. Effect of food Administration of rosuvastatin with food did not affect the AUC of rosuvastatin. 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 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. The elimination half-life of rosuvastatin is approximately 19 hours. Specific Populations Geriatric Patients There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years).

Pediatric Patients In a population pharmacokinetic analysis of two pediatric trials involving patients with HeFH 10 to 17 years of age and 8 to 17 years of age, respectively, rosuvastatin exposure appeared comparable to or lower than rosuvastatin exposure in adult patients. Male and Female Patients There were no differences in plasma concentrations of rosuvastatin between males and females. Racial or Ethnic Groups A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among White, Hispanic or Latino ethnicity, 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 White control group. 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 ).

Steady-state plasma concentrations of rosuvastatin in patients on chronic hemodialysis were approximately 50% greater compared with healthy volunteer subjects with normal renal function. Patients with Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were modestly increased. In patients with Child-Pugh A disease, C max and AUC were increased by 60% and 5%, respectively, as compared with patients with normal liver function.

In patients with Child-Pugh B disease, C max and AUC were increased 100% and 21%, respectively, compared with patients with normal liver function. Drug Interaction Studies Rosuvastatin is a substrate for certain transporter proteins including the hepatic uptake transporter organic anion-transporting polyprotein 1B1 (OATP1B1) and efflux transporter breast cancer resistance protein (BCRP). Concomitant administration of rosuvastatin with medications that are inhibitors of these transporter proteins (e.g., cyclosporine, certain HIV proteas… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 65 words ▾

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

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Primary Prevention of CV Disease In the Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study, the effect of rosuvastatin on the occurrence of major CV disease events was assessed in 17,802 males (≥50 years) and females (≥60 years) who had no clinically evident CV disease, LDL-C levels <130 mg/dL and hsCRP levels ≥2 mg/L. The study population had an estimated baseline coronary heart disease risk of 11.6% over 10 years based on the Framingham risk criteria and included a high percentage of patients with additional risk factors such as hypertension (58%), low HDL-C levels (23%), cigarette smoking (16%), or a family history of premature CHD (12%).

Patients had a median baseline LDL-C of 108 mg/dL and hsCRP of 4.3 mg/L. Patients were randomly assigned to placebo (n=8901) or rosuvastatin 20 mg once daily (n=8901) and were followed for a mean duration of 2 years. The JUPITER study was stopped early by the Data Safety Monitoring Board due to meeting predefined stopping rules for efficacy in rosuvastatin-treated subjects.

The primary end point was a composite end point consisting of the time-to-first occurrence of any of the following major CV events: CV death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or an arterial revascularization procedure. Rosuvastatin significantly reduced the risk of major CV events (252 events in the placebo group vs. 142 events in the rosuvastatin group) with a statistically significant (p<0.001) relative risk reduction of 44% and absolute risk reduction of 1.2% (see Figure 1).

The risk reduction for the primary end point was consistent across the following predefined subgroups: age, sex, race, smoking status, family history of premature CHD, body mass index, LDL-C, HDL-C, and hsCRP levels. Figure 1. Time to First Occurrence of Major Cardiovascular Events in JUPITER The individual components of the primary end point are presented in Figure 3.

Rosuvastatin significantly reduced the risk of nonfatal myocardial infarction, nonfatal stroke, and arterial revascularization procedures. There were no significant treatment differences between the rosuvastatin and placebo groups for death due to CV causes or hospitalizations for unstable angina. Rosuvastatin significantly reduced the risk of myocardial infarction (6 fatal events and 62 nonfatal events in placebo-treated subjects vs.

9 fatal events and 22 nonfatal events in rosuvastatin-treated subjects) and the risk of stroke (6 fatal events and 58 nonfatal events in placebo-treated subjects vs. 3 fatal events and 30 nonfatal events in rosuvastatin -treated subjects). In a post-hoc subgroup analysis of JUPITER subjects (rosuvastatin=725, placebo=680) with a hsCRP ≥2 mg/L and no other traditional risk factors (smoking, BP ≥140/90 or taking antihypertensives, low HDL-C) other than age, after adjustment for high HDL-C, there was no significant treatment benefit with rosuvastatin treatment.

Figure 2. Major CV Events by Treatment Group in JUPITER At one year, rosuvastatin increased HDL-C and reduced LDL-C, hsCRP, total cholesterol and serum triglyceride levels (p<0.001 for all versus placebo). Primary Hypercholesterolemia in Adults Rosuvastatin reduces Total-C, LDL-C, ApoB, non-HDL-C, and TG, and increases HDL-C, in adult patients with hypercholesterolemia and mixed dyslipidemia.

In a multicenter, double-blind, placebo-controlled study in patients with hypercholesterolemia, rosuvastatin given as a single daily dose (5 to 40 mg) for 6 weeks significantly reduced Total-C, LDL-C, non-HDL-C, and ApoB, across the dose range (Table 10). Table 10: Lipid-Modifying Effect of Rosuvastatin in Adult Patients with Hypercholesterolemia (Adjusted Mean % Change from Baseline at Week 6) Dose N Total- C LDL- C Non-HDL- C ApoB TG HDL- C Placebo 13 -5 -7 -7 -3 -3 3 Rosuvastatin 5 mg 17 -33 -45 -44 -38 -35 13 Rosuvastatin 10 mg 17 -36 -52 -48 -42 -10 14 Rosuvastati… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 104-week carcinogenicity study in rats at dose levels of 2, 20, 60, or 80 mg/kg/day by oral gavage, the incidence of uterine stromal polyps was significantly increased in females at 80 mg/kg/day at systemic exposure 20 times the human exposure at 40 mg/day based on AUC. Increased incidence of polyps was not seen at lower doses. In a 107-week carcinogenicity study in mice given 10, 60, or 200 mg/kg/day by oral gavage, an increased incidence of hepatocellular adenoma/carcinoma was observed at 200 mg/kg/day at systemic exposures 20 times the human exposure at 40 mg/day based on AUC.

An increased incidence of hepatocellular tumors was not seen at lower doses. Mutagenesis Rosuvastatin was not mutagenic or clastogenic with or without metabolic activation in the Ames test with Salmonella typhimurium and Escherichia coli , the mouse lymphoma assay, and the chromosomal aberration assay in Chinese hamster lung cells. Rosuvastatin was negative in the in vivo mouse micronucleus test.

Impairment of Fertility In rat fertility studies with oral gavage doses of 5, 15, 50 mg/kg/day, males were treated for 9 weeks prior to and throughout mating and females were treated 2 weeks prior to mating and throughout mating until gestation day 7. No adverse effect on fertility was observed at 50 mg/kg/day (systemic exposures up to 10 times the human exposure at 40 mg/day based on AUC). In testicles of dogs treated with rosuvastatin at 30 mg/kg/day for one month, spermatidic giant cells were seen.

Spermatidic giant cells were observed in monkeys after 6-month treatment at 30 mg/kg/day in addition to vacuolation of seminiferous tubular epithelium. Exposures in the dog were 20 times and in the monkey 10 times the human exposure at 40 mg/day based on body surface area. Similar findings have been seen with other drugs in this class.

📄 Patient Package Insert ~3 min read ▾

SPL PATIENT PACKAGE INSERT PATIENT INFORMATION Rosuvastatin (roe-SOO-va-STAT-in) tablets for oral use <br/> Read this Patient Information carefully before you start taking rosuvastatin tablets and each time you get a refill. If you have any questions about rosuvastatin tablets, ask your healthcare provider. Only your healthcare provider can determine if rosuvastatin tablets are right for you. <br/> What are rosuvastatin tablets? <br/> Rosuvastatin tablets are prescription medicine that contains a cholesterol-lowering medicine called rosuvastatin.

Rosuvastatin tablets are used: reduce the risk of major adverse cardiovascular (CV) events, such as death from cardiovascular disease, heart attack, stroke, or the need for procedures to improve blood flow to the heart called arterial revascularization in adults at increased risk for these events. along with diet and exercise to lower the level of low-density lipoprotein (LDL-C) cholesterol or "bad" cholesterol: in adults with primary hypercholesterolemia. and slow the buildup of fatty deposits (plaque) in the walls of blood vessels in adults. in adults and children 8 years of age and older with high blood cholesterol due to heterozygous familial hypercholesterolemia (HeFH) (an inherited condition that causes high levels of LDL-C). along with other cholesterol lowering treatments or alone if such treatments are unavailable in adults and children 7 years of age and older with homozygous familial hypercholesterolemia (HoFH) (an inherited condition that causes high levels of LDL-C). along with diet for the treatment of adults with: primary dysbetalipoproteinemia (an inherited condition that causes high levels of cholesterol and fat). hypertriglyceridemia It is not known if rosuvastatin tablets are safe and effective in children younger than 8 years of age with HeFH or children younger than 7 years of age with HoFH or in children with other types of hypercholesterolemias (other than HeFH or HoFH). <br/> <br/> Before you take rosuvastatin tablets, tell your healthcare provider about all of your medical conditions, including if you: have unexplained muscle aches or weakness. have or have had kidney problems. have or have had liver problems. drink more than 2 glasses of alcohol daily. have thyroid problems. are of Asian descent. are pregnant or think you may be pregnant, or are planning to become pregnant.

If you become pregnant while taking rosuvastatin tablets, call your healthcare provider right away to discuss your rosuvastatin tablets treatment. are breastfeeding. Rosuvastatin can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take rosuvastatin tablets.

Do not breastfeed while taking rosuvastatin tablets. <br/> <br/> Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider who prescribes rosuvastatin tablets if another healthcare provider increases the dose of another medicine you are taking. Rosuvastatin tablets may affect the way other medicines work, and other medicines may affect how rosuvastatin tablets works.

Especially tell your healthcare provider if you take: coumarin anticoagulants (medicines that prevent blood clots, such as warfarin) antacids (medicines you take for heartburn that contain aluminum and magnesium hydroxide Taking rosuvastatin tablets with certain medicines may increase the risk of muscle problems.. Especially tell your healthcare provider if you take: cyclosporine (a medicine for your immune system) teriflunomide (a medicine used to treat relapsing remitting multiple sclerosis) enasidenib (a medicine used to treat acute myeloid leukemia) capmatinib (a medicine for the treatment of non-small cell lung cancer) fostamatinib (a medicine used to treat low platelet counts) febuxostat (a medicine used to treat and prevent high blood levels of uric acid) gemfibrozi… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 19 words ▾

RECENT MAJOR CHANGES Indications and Usage (1) 04/2026 Dosage and Administration, Dosage Modifications Due to Drug Interactions (2.6) 04/2026

📄 Package Label / Principal Display Panel 151 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-053-90 Rosuvastatin Tablets, USP 5 mg 90 Tablets Rx only NDC 70756-053-12 Rosuvastatin Tablets, USP 5 mg 1000 Tablets Rx only 5 mg 90 label 5 mg 1000 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-054-90 Rosuvastatin Tablets, USP 10 mg 90 Tablets Rx only NDC 70756-054-12 Rosuvastatin Tablets, USP 10 mg 1000 Tablets Rx only 10 mg 90 label 10 mg 1000 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-055-90 Rosuvastatin Tablets, USP 20 mg 90 Tablets Rx only NDC 70756-055-12 Rosuvastatin Tablets, USP 20 mg 1000 Tablets Rx only 20 mg 90 label 20 mg 1000 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70756-056-30 Rosuvastatin Tablets, USP 40 mg 30 Tablets Rx only NDC 70756-056-90 Rosuvastatin Tablets, USP 40 mg 90 Tablets Rx only NDC 70756-056-12 Rosuvastatin Tablets, USP 40 mg 1000 Tablets Rx only 40 mg 30 label 40 mg 90 label 40 mg 1000 label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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Active ingredient / dosage form / route ✓ Available
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Package photos ✓ Available
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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?
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Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (70756-0053-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Lifestar Pharma LLC 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.
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Where does this data come from?
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← 70756-0052-11 · Lifestar 70756-0054-12 · Lifestar →
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.