PACK CHECK · MARKET FIRST

CRESTORGeneric namerosuvastatin

Reading size

Mainland China pack-name cue可定®Historical or public source cue · verify the current target-market record

How this medicine works

In Clinical Pharmacology, the FDA label describes rosuvastatin as a selective, competitive inhibitor of HMG‑CoA reductase. This mechanism helps explain its drug class; it cannot by itself answer which statin a person should use, whether products can be combined, whether an adjustment is needed or which testing is appropriate.

Read source: United States ↗reviewed 2026-08-20More about its action and precautions →

Check the market, names, dosage form and route together

A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.

Open the complete product-identity record

Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.

Mainland China pack-name cue
可定®
International brand name
CRESTOR
Source-scoped market brand names
  • クレストール · JapanCurrent regulator record ↗
    The current PMDA product page lists CRESTOR (クレストール) 2.5 mg and 5 mg conventional and orally disintegrating tablets; different forms and market records must not be self-interchanged.
  • 可定® · Mainland China (current AstraZeneca China product-portfolio page)Source-scoped evidence ↗
    AstraZeneca China's current cardiovascular, renal and metabolic product-portfolio page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This first-party page establishes brand, generic-name and strength cues, but does not replace NMPA approval records, the current leaflet, approval numbers, packaging or supply verification.

The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.

Generic name
rosuvastatin
Dosage-form class
Dosage form and presentation as documented in the linked primary label
Route
Oral
Package-image status
A source-linked public label image is available below

Mainland China trade-name search cue:可定®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility.

FOR EVERYDAY QUESTIONS

After the leaflet, continue with the question you still need to check

What this pack is

CRESTOR is the brand name in this record; rosuvastatin is the generic name. Read both together with the dosage form (oral tablet).

What this page can show

This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.

What to bring to the next conversation

Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.

PRODUCT PRESENTATION IDENTITY

Strength, pack and device identity

Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.

4 source-backed strength, pack or device records — open the full list

First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.

United States label · DailyMed SPL v14, published 13 May 2026

5 mg per tablet; 90-tablet bottle

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0310-7560-90
Form and route
CRESTOR rosuvastatin film-coated oral tablet · oral
Container
bottle
Listing review
Current label display and NDC Directory listing reviewed 2026-08-20; actual marketing, stock and availability are not established.
rosuvastatin
5 mglabelled amount per tablet; not an individual's tablet count or switching rule
Package
90 tablets per bottle
Labelled appearance
yellow · round biconvex coated tablet · imprint ZD4522 / 5
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v14, published 13 May 2026

10 mg per tablet; 90-tablet bottle

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0310-7570-90
Form and route
CRESTOR rosuvastatin film-coated oral tablet · oral
Container
bottle
Listing review
Current label display and NDC Directory listing reviewed 2026-08-20; actual marketing, stock and availability are not established.
rosuvastatin
10 mglabelled amount per tablet; not an individual's tablet count or switching rule
Package
90 tablets per bottle
Labelled appearance
pink · round biconvex coated tablet · imprint ZD4522 / 10
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v14, published 13 May 2026

20 mg per tablet; 90-tablet bottle

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0310-7580-90
Form and route
CRESTOR rosuvastatin film-coated oral tablet · oral
Container
bottle
Listing review
Current label display and NDC Directory listing reviewed 2026-08-20; actual marketing, stock and availability are not established.
rosuvastatin
20 mglabelled amount per tablet; not an individual's tablet count or switching rule
Package
90 tablets per bottle
Labelled appearance
pink · round biconvex coated tablet · imprint ZD4522 / 20
Open the presentation source ↗reviewed 2026-08-20

United States label · DailyMed SPL v14, published 13 May 2026

40 mg per tablet; 30-tablet bottle

Exact display panel in the cited public label · select to enlarge
Product code
NDC 0310-7590-30
Form and route
CRESTOR rosuvastatin film-coated oral tablet · oral
Container
bottle
Listing review
Current label display and NDC Directory listing reviewed 2026-08-20; actual marketing, stock and availability are not established.
rosuvastatin
40 mglabelled amount per tablet; not an individual's tablet count or switching rule
Package
30 tablets per bottle
Labelled appearance
pink · oval biconvex coated tablet · imprint ZD4522 / 40
Open the presentation source ↗reviewed 2026-08-20

PUBLIC LABEL IMAGE

Appearance and package-text clues

United States · current public-label panel · exact package/label image · DailyMed SPL v14 (published 13 May 2026)Select the image to enlarge; press Escape to close

This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.

Open the public label source ↗

LABEL READING · NOT A PRESCRIPTION

CRESTOR label reading: separate strength, appearance and combination questions

Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.

This module uses the current U.S. DailyMed SPL v14, published 13 May 2026, as a reading entry point. Different strengths and appearances are identity clues, but they do not decide which statin an individual should use, whether to switch or whether genetic testing is needed.

  • The U.S. label lists 5, 10, 20 and 40 mg as different tablet strengths and describes colour, shape and debossing. Strength, appearance and debossing together help check a product; a single clue or photo cannot authenticate it, establish current market packaging or establish interchangeability.
  • AstraZeneca China's current product-portfolio page lists CRESTOR (可定®) rosuvastatin calcium tablets in 5, 10 and 20 mg strengths, but that does not merge the U.S. 40 mg tablet, Japanese 2.5 mg tablet or Japanese OD tablet into a Chinese package. After seeing the brand name, continue checking the actual pack's generic name, strength per tablet, dosage form, approval number, leaflet version and target market. A company product list is not an individual tablet count or a cross-market conversion table.
  • Atorvastatin and rosuvastatin are both statins, but that does not mean “one of each today” or self-directed alternation is appropriate. Any combination, switch, stop or adjustment needs professional confirmation using the current label, full medicine list, prior reactions and clinical information.
  • The label identifies some co-medications that need avoidance, limits or extra review; that cannot be simplified into a universal “safe/unsafe” list. When starting or stopping any prescription medicine, OTC product, supplement or herb, ask a pharmacist to review it.
  • If a genetic report already exists, a professional can assess whether it is relevant alongside kidney/liver function, prior muscle symptoms and all medicines. OriginDrug does not present universal genetic screening as a prerequisite for self-selecting, stopping or changing a statin.
Open this record's official electronic leaflet ↗

PHARMACOVIGILANCE · OFFICIAL ROUTES

Check safety information in the right market

Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.

Match five details before using a safety record

  1. Brand and generic nameBoth must match the medicine named by the record.
  2. Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
  3. Market and notice dateA record applies only to the country or region and date it names.
  4. Lot, pack and manufacturerRecord these only when the official notice specifically names them.
  5. Current product informationA historical record may have been superseded by the current label.

This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.

This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20

This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.

Markets actually represented by the reviewed product documents
  • United States · 2
  • Japan · 1

This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.

Other official market or version documents for this record

These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.

Reviewed official safety records

A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.

  • FDA Drug Safety Communication: labelling changes for statins in pregnancy and breastfeeding2021-07-20 · On 2021-07-20, FDA issued a class Drug Safety Communication that explicitly lists Lipitor (atorvastatin) and Crestor (rosuvastatin). It concerns U.S. prescribing-information changes around pregnancy and breastfeeding and individualized benefit-risk review; it does not support self-starting, stopping, switching or adjusting any individual medicine. Pregnancy, suspected pregnancy or breastfeeding questions require the exact product, current target-market label and the prescribing team.FDA: 20 Jul 2021 Drug Safety Communication on statins in pregnancy and breastfeeding ↗reviewed 2026-08-22
  • EMA PRAC product-information signal: statins including Crestor (rosuvastatin) and myasthenia gravis / ocular myasthenia2023-02-06 · In its product-information wording extract dated 2023-02-06, EMA's Pharmacovigilance Risk Assessment Committee (PRAC) includes Crestor (rosuvastatin) within the statin class. The document says that, in a few reported cases, statins may induce new-onset or aggravate pre-existing myasthenia gravis or ocular myasthenia, and that recurrence after re-administration of the same or a different statin has been reported. This is a dated EU product-information signal; it does not mean that any Crestor pack, another market, or any individual has this problem, and it does not support self-stopping, switching, reducing, increasing, or alternating treatment. New or worsening muscle-weakness questions need the actual pack and complete medicine list reviewed promptly by the prescribing team or pharmacist; emergencies require local emergency services.EMA PRAC: 6 Feb 2023 product-information safety signal on statins, including atorvastatin and rosuvastatin, and myasthenia gravis ↗reviewed 2026-08-22

Global official safety gateways

  • NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
  • FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
  • FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
  • EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
  • MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
  • PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
  • MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
  • HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
  • Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
  • TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
  • Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
  • Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
  • SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
  • WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
  • Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22

This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.

For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.

PRIVATE FAMILY LIST

Bring this record into a local medicine list

Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.

Add to the family medicine list →

PACK · LABEL · MEDICINE LIST

Six checks for this medicine pack

Use this card to organise questions about CRESTOR (rosuvastatin). Keep the exact pack, its current label and the full medicine list together.

  1. Identify the exact product

    CRESTOR is the brand in this record and rosuvastatin is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.

  2. Read the labelled strength in context

    mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.

  3. Check before splitting or opening

    Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.

  4. Put every product on one list

    Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.

  5. Ask a specific pharmacogenetics question

    Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.

  6. Know when to seek urgent help

    For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.

This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.

MARKET DOCUMENTS · READ SEPARATELY

Enlarged market leaflets and regulator documents

Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.

CO-MEDICATION REVIEW · NOT A TREATMENT DECISION

When LIPITOR / atorvastatin is on the same list: do not treat same-class medicines as interchangeable tablets

Public CRESTOR and LIPITOR labels identify both medicines as statins. That is a class clue only; it does not support taking one of each on the same day, alternating days, milligram conversion, direct replacement or self-adjustment. Have a pharmacist or prescriber review both actual packs, every prescription medicine, OTC product and supplement; this card does not decide which medicine suits someone or advise self-stopping, time-separation, replacement or adjustment of either medicine.

Open the Lipitor / atorvastatin record →

Add both records to this device's family medicine list →

Open the primary source for this co-medication review cue ↗reviewed 2026-08-20

HOW IT WORKS · NOT A TREATMENT PLAN

How rosuvastatin works: it also acts on HMG‑CoA reductase, which does not make it self-interchangeable with another statin

  • The label describes a pathway involving inhibition of HMG‑CoA reductase in cholesterol synthesis and downstream changes including hepatic LDL receptors. Read this as where a medicine acts—not as a personal efficacy ranking or dose formula.
  • Atorvastatin and rosuvastatin are both statins, but a shared pharmacologic class does not prove equal substitution in a given market, formulation, strength or individual situation, and does not support taking one of each on the same day.
  • With concerns about muscle symptoms, interactions, kidney/liver function or an existing pharmacogenomic result, the most useful next step is review of the exact package and complete medicine list against the current label with a professional; a mechanism explanation cannot replace that step.
Open the primary pharmacology source ↗

SOURCE EVIDENCE REGISTER

Source evidence map

Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.

SOURCE-TRACEABLE ARCHIVE

CRESTORrosuvastatin

This page includes an exact current U.S. public-label package panel for CRESTOR, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.

LABEL USE SNAPSHOT

What the cited U.S. label covers

U.S. FDA label snapshot, revised Apr 2026: reduces major cardiovascular events in certain at-risk adults and, as an adjunct to diet and exercise, lowers LDL-C for specified populations, addresses certain dyslipidaemias and slows atherosclerosis progression.

It is source-reading context, not an individual diagnosis, prescription, substitution or purchasing recommendation. Check the current label in the target market.

DOCUMENT TIMELINE

Document timeline

  1. FDA original NDA review entry point

    FDA public review material records CRESTOR® and NDA 021366. It is for historical traceability and does not replace the current label.

    FDA: CRESTOR original NDA review ↗
  2. Reference-drug relationship in an ANDA approval letter

    FDA ANDA 079171 records the CRESTOR® reference-drug relationship stated in that letter. It does not automatically extend to other countries, dosage forms or products.

    FDA: ANDA 079171 approval letter ↗
  3. Current DailyMed SPL v14 published

    DailyMed lists 13 May 2026 as the published date for current CRESTOR SPL v14; target-market status, actual supply and individual use still require separate review.

    DailyMed: current CRESTOR U.S. public label, SPL v14 ↗
  4. Current AstraZeneca China product-portfolio page reviewed

    AstraZeneca China's current cardiovascular, renal and metabolic product page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This node establishes only the brand, generic-name and strength cues currently published by the company; it is not an NMPA approval record, approval number, current leaflet, exact package, stock or sale-eligibility record.

    AstraZeneca China: current cardiovascular, renal and metabolic product portfolio — CRESTOR, 5 mg, 10 mg and 20 mg (reviewed 30 Aug 2026) ↗

MARKET SCOPE

Market-record boundary

United States

Public archive linked

Includes the NDA review, an ANDA letter and a label archive.

Mainland China

Current AstraZeneca China product-portfolio page linked; regulatory record still requires item-by-item verification

The current company page lists CRESTOR (可定®), rosuvastatin calcium tablets, in 5 mg, 10 mg and 20 mg strengths. This dossier has not established an approval number, current leaflet, packaging, stock or sale eligibility from that page, and the record must not be merged with the U.S. 40 mg tablet or Japanese 2.5 mg/OD products.

European Union

Market record not established

No EU approval, holder, strength, leaflet, supply or sale-eligibility conclusion is inferred from U.S., Japanese or Chinese company pages.

Japan

Current PMDA product page linked

The current PMDA page lists 2.5 mg and 5 mg conventional and OD tablets; this applies only to the products on that Japanese regulatory page.

How to read this record

Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.

Keep international and mainland China records separate

This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.

Mainland China trade-name search cue: 可定®
This cue helps read packaging and search official records. It does not establish current approval, holder, strength, originator relationship, supply or sale eligibility.

CDE listed-drug directory ↗ NMPA public query ↗

RECORD FAQ

Record questions

Can rosuvastatin and atorvastatin be alternated on different days?

Do not self-alternate them by day or combine them on the same day. A shared statin class does not establish milligram conversion, alternating use or direct substitution, and rotation can obscure missed or duplicate use, interactions and the source of symptoms. Ask the prescriber or pharmacist to confirm the plan using both actual packs, the prescription, complete medicine list, prior reactions and current target-market labels.

Why can kidney function or population information trigger a separate CRESTOR review?

The current U.S. CRESTOR label sets specific professional-use boundaries for severe renal impairment without haemodialysis and for Asian patients, and identifies renal impairment, age 65 or older, uncontrolled hypothyroidism, certain co-medications and higher dosage as myopathy risk factors. These are professional review cues, not web rules declaring that someone is or is not suited to rosuvastatin or atorvastatin. The exact product, prescription, test results, prior reactions and complete medicine list must be considered together.

The label mentions SLCO1B1. Does everyone need whole-genome screening?

No. The current label's pharmacogenomics section only reports higher rosuvastatin concentrations in very small groups (three to five people per group) with two reduced-function SLCO1B1 alleles, and states that the effect of this polymorphism on efficacy or safety has not been clearly established. That does not mean everyone needs whole-genome screening or turn an existing result directly into a stop, switch or dose plan. A professional should interpret any original report with the full clinical context.

What should an older adult taking many medicines do about muscle pain, weakness or dark urine?

Contact a local healthcare professional promptly and bring the actual packs, prescriptions, OTC products, supplements, herbs and recent medicine changes. The site cannot determine whether a statin, interaction, thyroid condition, kidney function or another cause is responsible, and it does not support abrupt self-stopping, catch-up use, alternating days or switching to atorvastatin. Severe symptoms, fever, marked malaise, clearly dark urine, difficulty walking or altered awareness needs prompt local urgent care.

Can this page rank it against another statin?

No. A comparison must first align the market, label version, dosage form, strength, study population and price-record basis.

READ NEXT

Related reading

Evidence status

The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.

EDITORIAL RECORD

Who prepared and checked this page

Byline
OriginDrug Content Editorial
Review role
Public primary-source verification
Last reviewed
2026-08-30
Source record
6 clickable primary-source entry points are listed with this dossier.

The review role checks source traceability, stated market, document version and product-identity fields. It is not a claim of clinical licensure, prescribing authority or individual pharmacy service. Read the editorial policy.

Search records
Enlarged public-label image