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Rosuvastatin calcium 10 mg Tablet, Film Coated, 90-count — NDC 71205-0052-90 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rosuvastatin calcium 10 mg Tablet, Film Coated, 90-count — NDC 71205-052-90 (Billing 71205-0052-90)

by Proficient Rx LP · 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 90 tablets of Rosuvastatin calcium 10 mg Tablet, Film Coated from Proficient Rx LP, marketed since Oct 2016 and currently FDA-listed.

NDC 71205-0052-90
🏷️ FDA NDC (as labeled) 71205-052-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1900/unit — full pricing hub ↓
Product page 71205-0052-30 Also comes in: 30 tablets 71205-052-30 60 tablets 71205-052-60
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71205-052-90
Product NDC 71205-052
11-digit billing NDC 71205005290
NCPDP billing unit EA — each (per item)
RxCUI 859747
UNII 83MVU38M7Q
Application # ANDA207752
SPL Set ID d1bd91fd-03fa-4e6c-80c1-ce58b158d8d6
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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 39400060100310
GPI class Rosuvastatin Calcium
GCN Seq No 051784
GCN 19153
HICL code 025009
Ingredient (HICL) Rosuvastatin Calcium
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4D
Therapeutic class — specific (HIC3) Antihyperlipidemic-Hmgcoa Reductase Inhib(Statins)
AHFS code 24:06.08.00
AHFS class Hmg-Coa Reductase Inhibitors
FDB label name ROSUVASTATIN CALCIUM 10 MG TAB
FDB brand name Rosuvastatin Calcium
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051784
  • GCN: 19153
  • GPI-14 (Medi-Span): 39400060100310
  • HICL (First Databank): 025009
  • AHFS class code: 24:06.08.00
  • RxCUI (RxNorm): 859747
Why two NDCs? The FDA registers this code as 71205-052-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71205-0052-90. 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

Label name ROSUVASTATIN CALCIUM 10 MG TAB Ingredient Rosuvastatin Calcium
📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • 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 →
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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71205-0052-30 71205-052-30 Main listing 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-06-01 — Active
71205-0052-60 71205-052-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-06-01 — Active
71205-0052-90 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2018-06-01 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 71205-0052-30?
Both are Rosuvastatin calcium 10 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 90-count one, while NDC 71205-0052-30 is the 30 tablets package.
What NDC number is used to bill for this package of Rosuvastatin calcium 10 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 10 mg 11788-0131-05 AiPing 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 13668-0180-05 Torrent 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 13668-0721-05 TORRENT 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 16714-0989-01 NorthStar 90 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 24658-0262-45 PURACAP 45 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 27808-0156-01 Cranbury 90 tablets $0.036 AB Availability likely —
Rosuvastatin 10 mg 50228-0117-10 ScieGen 1000 tablets $0.036 AB Availability likely —
Rosuvastatin 10 mg 50268-0709-15 AvPAK 1 tablet $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 60687-0245-01 American 1 tablet $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 67877-0440-05 Ascend 500 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 72603-0365-01 NorthStar 90 tablets $0.036 AB Availability likely —
Rosuvastatin Calcium 10 mg 82009-0018-10 Quallent 1000 tablets $0.036 AB Availability likely —
Rosuvastatin 10 mg 16729-0285-15 Accord 90 tablets $0.049 AB FDA listed —
Crestor 10 mg 00310-7570-90 AstraZeneca 90 tablets $8.811 AB Availability likely —
Rosuvastatin Calcium 10 mg 00615-8533-39 NCS 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 31722-0883-31 Camber 100 tablets — AB FDA listed —
Rosuvastatin 10 mg 33342-0262-07 Macleods 30 tablets — — FDA listed —
Rosuvastatin Calcium 10 mg 42677-0302-01 Shandong 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 42708-0190-30 QPharma, 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-2451-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-4738-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5188-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5189-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5745-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5746-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5770-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-5771-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-6637-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 50090-7430-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 50090-7431-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7486-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7487-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7492-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7493-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7967-00 A-S 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 50090-7968-00 A-S 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 51407-0154-90 Golden 90 tablets — AB Discontinued —
Rosuvastatin 10 mg 51407-0849-10 Golden 1000 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 51655-0062-52 Northwind 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 51655-0256-52 Northwind 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 55154-0158-00 Cardinal 1 tablet — AB FDA listed —
Rosuvastatin calcium 10 mg 55700-0998-30 Quality 30 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 57237-0169-05 Rising 500 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 60290-0044-01 Umedica 30 tablets — AB FDA listed —
Rosuvastain Calcium 10 mg 62135-0691-90 Chartwell 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 63187-0864-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 63629-7157-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 65862-0294-05 Aurobindo 500 tablets — AB FDA listed —
Rosuvastatin 10 mg 67046-1627-03 Coupler 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-2407-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-3623-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-3722-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68071-5176-09 NuCare 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 68462-0262-01 Glenmark 100 tablets — AB FDA listed —
Rosuvastatin 10 mg 68788-4057-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 68788-7086-02 Preferred 20 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 68788-8384-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 68788-8775-02 Preferred 20 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 69367-0360-01 Westminster 100 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 69434-0006-02 Zhejiang 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 70377-0007-11 Biocon 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 70518-4143-02 REMEDYREPACK 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 70518-4303-00 REMEDYREPACK 90 tablets — AB FDA listed —
rosuvstatin 10 mg 70756-0054-12 Lifestar 1000 tablets — — FDA listed —
Rosuvastatin calcium 10 mg 71205-0008-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mgthis 71205-0052-90 Proficient 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71205-0820-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71209-0044-04 Cadila 90 tablets — AB FDA listed —
Rosuvastatin 10 mg 71335-0606-01 Bryant 30 tablets — AB Discontinued —
Rosuvastatin Calcium 10 mg 71335-1733-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71335-1890-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71335-2035-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin 10 mg 71335-2539-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71335-9640-01 Bryant 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 71610-0215-45 Aphena 45 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71610-0233-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin 10 mg 71610-0797-15 Aphena 15 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 71610-0801-45 Aphena 45 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 72205-0003-05 Novadoz 500 tablets — AB FDA listed —
Rosuvastatin 10 mg 82009-0189-05 Quallent 500 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 82804-0291-30 Proficient 30 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 72303-0828-01 HEC 90 tablets — AB FDA listed —
Rosuvastatin Calcium 10 mg 67296-2288-09 Redpharm 90 tablets — AB FDA listed —
Rosuvastatin calcium 10 mg 70518-3639-00 REMEDYREPACK 30 tablets — AB Discontinued —
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.

What it looks like

Color Pink
ShapeRound
Imprint10;B
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

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

  • UNII 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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 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.

11 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.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderBIOCON PHARMA LTD
FDA applicationANDA207752 (ANDA)
Labeler code71205
First marketedOct 2016
Product typeHuman Prescription Drug
Portfolio1,729 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. 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 220 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 calcium tablets are an HMG Co‑A reductase inhibitor indicated for: 1. adult patients with hypertriglyceridemia as an adjunct to diet (1.3) 2. adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) 3. adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total‑C, and ApoB (1.5) Limitations of use (1.8) : • Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.

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

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

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

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

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • Rosuvastatin calcium 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 calcium 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 calcium tablets can be administered as a single dose at any time of day, with or without food.The tablet should be swallowed whole. When initiating rosuvastatin calcium tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin calcium tablets starting dose should first be utilized, and only then titrated according to the patient’s response and individualized goal of therapy.

After initiation or upon titration of rosuvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and the dosage adjusted accordingly. Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

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

2.4Use with Concomitant Therapy Patients taking cyclosporine The dose of rosuvastatin calcium tablets should not exceed 5 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.1) , and Clinical Pharmacology (12.3) ] Patients taking gemfibrozil Avoid concomitant use of rosuvastatin calcium tablets with gemfibrozil. If concomitant use cannot be avoided initiate rosuvastatin calcium tablets at 5 mg once daily. The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [see Warnings and Precautions (5.1) , Drug Interactions (7.2) , and Clinical Pharmacology (12.3) ].

Patients taking atazanavir and ritonavir, lopinavir and ritonavir, or simeprevir Initiate rosuvastatin calcium tablets therapy with 5 mg once daily. The dose of rosuvastatin calcium tablets should not exceed 10 mg once daily [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 calcium 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, coated tablets, debossed with '5' on one side and 'B' on other side. 10 mg: Pink, round, biconvex, coated tablets, debossed with '10' on one side and 'B' on other side. 20 mg: Pink, round, biconvex, coated tablets, debossed with '20' on one side and 'B' on other side.

40 mg: Pink, oval, biconvex, 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 160 words ▾

4 CONTRAINDICATIONS Rosuvastatin calcium tablets are contraindicated in the following conditions: • Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactions including rash, pruritus, urticaria, and angioedema have been reported with rosuvastatin calcium tablets [see Adverse Reactions (6.1) ]. • Patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels [see Warnings and Precautions (5.2) ]. • 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) ]. 1.

Known hypersensitivity to product components ( 4 ) 2. Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 ) 3. Pregnancy ( 4 , 8.1 , 8.3 ) 4.

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, atazanavir/ritonavir, lopinavir/ritonavir, or simeprevir. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue rosuvastatin calcium if signs or symptoms appear.

( 5.1 , 7.5 , 7.6 ) • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating therapy and as clinically indicated thereafter. ( 5.2 )

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

The risk of myopathy during treatment with rosuvastatin calcium may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, atazanzvir/ritonavir, lopinavir/ritonavir, or simeprevir [see Dosage and Administration (2) and Drug Interactions (7 )]. Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing rosuvastatin calcium with colchicine [see Drug Interactions (7.7) ].

Rosuvastatin calcium therapy should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected. Rosuvastatin calcium therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures). There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.

IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents. All patients should be advised to promptly report to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing rosuvastatin calcium.

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

There were two cases of jaundice, for which a relationship to rosuvastatin calcium therapy could not be determined, which resolved after discontinuation of therapy. There were no cases of liver failure or irreversible liver disease in these trials. In a pooled analysis of placebo-controlled trials, increases in serum transaminases to >3 times the upper limit of normal occurred in 1.1% of patients taking rosuvastatin calcium versus 0.5% of patients treated with placebo.

There have been rare postmarketing reports of fatal and non-fata…

🤒 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 (5.2) ] 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 calcium controlled clinical trials database (placebo or active-controlled) of 5394 patients with a mean treatment duration of 15 weeks, 1.4% of patients discontinued due to adverse reactions. The most common adverse reactions that led to treatment discontinuation were: 1. myalgia 2. abdominal pain 3. nausea The most commonly reported adverse reactions (incidence ≥2%) in the rosuvastatin calcium controlled clinical trial database of 5394 patients were: 1. headache 2. myalgia 3. abdominal pain 4. asthenia 5. 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 calcium and > Placebo in Placebo-Controlled Trials (% of Patients) Adverse Reactions Rosuvastatin calcium 5 mg N=291 Rosuvastatin calcium 10 mg N=283 Rosuvastatin calcium 20 mg N=64 Rosuvastatin calcium 40 mg N=106 Total Rosuvastatin calcium 5 mg to 40 mg N=744 Placebo N=382 Headache 5.5 4.9 3.1 8.5 5.5

5.0Nausea 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 (5.4) ]; elevated creatine phosphokinase, transaminases, glucose, glutamyl transpeptidase, alkaline phosphatase, and bilirubin; and thyroid function abnormalities. In a clinical trial, involving 981 participants treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1.7 years, 5.6% of subjects treated with rosuvastatin calcium versus 2.8% of placebo-treated subjects discontinued due to adverse reactions.

The most common adverse reactions that led to treatment discontinuation were: myalgia, hepatic enzyme increased, headache, and nausea. Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 2. Table 2.

Adverse Reactions Adverse reactions by MedDRA preferred term. Reported in ≥ 2% of Patients Treated With Rosuvastatin calcium and > Placebo in a Trial (% of Patients) Adverse Reactions Rosuvastatin calcium 40 mg N=700 Placebo N=281 Myalgia 12.7

12.1Arthralgia 10.1

7.1Headache 6.4

5.3Dizziness 4.0

2.8Increased CPK 2.6

0.7Abdominal pain 2.4

1.8ALT >3x ULN 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 reac…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Cyclosporine: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium dose to 5 mg once daily. ( 2.4 , 5.1 , 7.1 , 12.3 ) • Gemfibrozil: Combination should be avoided.

If used together, limit rosuvastatin calcium dose to 10 mg once daily. ( 2.4, 5.1 , 7.2 ) • Atazanavir/ritonavir, lopinavir/ritonavir or simeprevir: Combination increases rosuvastatin exposure. Limit rosuvastatin calcium dose to 10 mg once daily.

( 2.4 , 5.1 , 7.3 , 12.3 ) • Coumarin anticoagulants: Combination prolongs INR. Achieve stable INR prior to starting rosuvastatin calcium. Monitor INR frequently until stable upon initiation or alteration of rosuvastatin calcium therapy.

( 5.3 , 7.4 ) • Concomitant lipid-lowering therapies: Use with fibrates or lipid-modifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with rosuvastatin calcium. ( 5.1 , 7.5 , 7.6 )

7.1Cyclosporine Cyclosporine increased rosuvastatin exposure (AUC) 7‑ fold. Therefore, in patients taking cyclosporine, the dose of rosuvastatin calcium should not exceed 5 mg once daily [see Dosage and Administration (2.4 ) , Warnings and Precautions (5.1) , and Clinical Pharmacology (12.3) ].

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

7.3Protease Inhibitors Coadministration of rosuvastatin with certain protease inhibitors has differing effects on rosuvastatin exposure. Simeprevir, which is a hepatitis C virus (HCV) protease inhibitor, or combinations of atazanavir/ritonavir or lopinavir/ritonavir, which are HIV-1 protease inhibitors, increase rosuvastatin exposure (AUC) up to threefold [see Table 4 – Clinical Pharmacology (12.3) ]. For these protease inhibitors, the dose of rosuvastatin calcium should not exceed 10 mg once daily.

The combinations of fosamprenavir/ritonavir or tipranavir/ritonavir, which are HIV-1 protease inhibitors, produce little or no change in rosuvastatin exposure. Caution should be exercised when rosuvastatin is coadministered with protease inhibitors [see Dosage and administration ( 2.4 ) , Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

7.4Coumarin Anticoagulants Rosuvastatin calcium significantly increased INR in patients receiving coumarin anticoagulants. Therefore, caution should be exercised when coumarin anticoagulants are given in conjunction with rosuvastatin calcium. In patients taking coumarin anticoagulants and rosuvastatin calcium concomitantly, INR should be determined before starting rosuvastatin calcium and frequently enough during early therapy to ensure that no significant alteration of INR occurs [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ].

7.5Niacin The risk of skeletal muscle effects may be enhanced when rosuvastatin calcium is used in combination with lipid-modifying doses (≥1 g/day) of niacin; caution should be used when prescribing with rosuvastatin calcium [see Warnings and Precautions (5.1) ].

7.6Fenofibrate When rosuvastatin calcium was coadministered with fenofibrate, no clinically significant increase in the AUC of rosuvastatin or fenofibrate was observed. Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concomitant use of fenofibrates, caution should be used when prescribing fenofibrates with rosuvastatin calcium [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ].

7.7Colchicine Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors, including rosuvastatin, coadministered with colchicine, and caution should be exercised when prescribing rosuvastatin calcium with colchicin…

👥 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 surf…

🤰 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 100 words ▾

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

🆘 Overdosage 37 words ▾

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rosuvastatin calcium 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 calcium dose. The absolute bioavailability of rosuvastatin is approximately 20%.

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

Rosuvastatin is 88% bound to plasma proteins, mostly albumin. This binding is reversible and independent of plasma concentrations. Metabolism Rosuvastatin is not extensively metabolized; approximately 10% of a radiolabeled dose is recovered as metabolite.

The major metabolite is N-desmethyl rosuvastatin, which is formed principally by cytochrome P450 \ 2C9, and in vitro studies have demonstrated that N-desmethyl rosuvastatin has approximately one-sixth to one-half the HMG-CoA reductase inhibitory activity of the parent compound. Overall, greater than 90% of active plasma HMG-CoA reductase inhibitory activity is accounted for by the parent compound. Excretion Following oral administration, rosuvastatin and its metabolites are primarily excreted in the feces (90%).

The elimination half-life (t 1/2 ) of rosuvastatin is approximately 19 hours. After an intravenous dose, approximately 28% of total body clearance was via the renal route, and 72% by the hepatic route. Specific Populations Race A population pharmacokinetic analysis revealed no clinically relevant differences in pharmacokinetics among Caucasian, Hispanic, and Black or Afro-Caribbean groups.

However, pharmacokinetic studies, including one conducted in the US, have demonstrated an approximate 2-fold elevation in median exposure (AUC and C max ) in Asian subjects when compared with a Caucasian control group. Gender There were no differences in plasma concentrations of rosuvastatin between men and women. Pediatric use information for patients ages 8 to less than 10 years is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets.

However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Geriatric There were no differences in plasma concentrations of rosuvastatin between the nonelderly and elderly populations (age ≥65 years). Renal Impairment Mild to moderate renal impairment (CLcr ≥30 mL/min/1.73 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. Hepatic Impairment In patients with chronic alcohol liver disease, plasma concentrations of rosuvastatin were…

🧬 Mechanism of Action 117 words ▾

12.1Mechanism of Action Rosuvastatin calcium 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 103 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin calcium tablets are supplied as: 1. NDC 71205-052-30: 10 mg. Pink, round, biconvex, coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 30 tablets 2.

NDC 71205-052-60: 10 mg. Pink, round, biconvex, coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 60 tablets 3. NDC 71205-052-90: 10 mg.

Pink, round, biconvex, coated tablets, debossed with '10' on one side and 'B' on other side; bottle of 90 tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture.

📋 Description 163 words ▾

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

Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin calcium tablets for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: crospovidone, dibasic calcium phosphate dihydrate, FD&C Blue No. 2, FD&C Red No.

40, FD&C Yellow No. 6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. In addition to these, the rosuvastatin calcium tablets 5 mg also contain FD&C Yellow No.

5. structural formula

💬 Information for Patients ~1 min read ▾

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

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

Liver Enzymes It is recommended that liver enzyme tests be performed before the initiation of rosuvastatin calcium and if signs or symptoms of liver injury occur. All patients treated with rosuvastatin calcium 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 Biocon Pharma Inc. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

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

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.

About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (71205-0052-30), 60 tablets (71205-0052-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71205-0051-15 · Proficient 71205-0053-30 · Proficient →
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.