Quick answers
- What is Rosuvastatin used for?
- The FDA-approved label (Rosuvastatin calcium, Remedyrepack Inc., September 9, 2026) says: “Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rosuvastatin have a boxed warning?
- No. None of the 157 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Rosuvastatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Rosuvastatin been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started December 31, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Rosuvastatin?
- 44 companies list prescription products of Rosuvastatin in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Proficient Rx LP.
What Rosuvastatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. …
— FDA label: Rosuvastatin calcium, Remedyrepack Inc., effective September 9, 2026. Read the full label on DailyMed →
The FDA has 157 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 157 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 281 in the FDA NDC Directory |
| Brand names | Crestor |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| rosuvastatin 10 mg tablet, film coated | Generic | $0.0355 per tablet |
| rosuvastatin 20 mg tablet, film coated | Generic | $0.0463 per tablet |
| rosuvastatin 40 mg tablet, film coated | Generic | $0.0693 per tablet |
| rosuvastatin 5 mg tablet, film coated | Generic | $0.0316 per tablet |
| rosuvastatin calcium 10 mg tablet | Generic | $0.0355 per tablet |
| rosuvastatin calcium 10 mg tablet, coated | Generic | $0.0355 per tablet |
| rosuvastatin calcium 10 mg tablet, film coated | Generic | $0.0355 per tablet |
| rosuvastatin calcium 10 mg tablet, film coated | Brand: Crestor | $8.81 per tablet |
| rosuvastatin calcium 20 mg tablet | Generic | $0.0463 per tablet |
| rosuvastatin calcium 20 mg tablet, coated | Generic | $0.0463 per tablet |
| rosuvastatin calcium 20 mg tablet, film coated | Generic | $0.0463 per tablet |
| rosuvastatin calcium 20 mg tablet, film coated | Brand: Crestor | $8.80 per tablet |
| rosuvastatin calcium 40 mg tablet | Generic | $0.0693 per tablet |
| rosuvastatin calcium 40 mg tablet, coated | Generic | $0.0693 per tablet |
| rosuvastatin calcium 40 mg tablet, film coated | Generic | $0.0693 per tablet |
| rosuvastatin calcium 40 mg tablet, film coated | Brand: Crestor | $8.81 per tablet |
| rosuvastatin calcium 5 mg tablet | Generic | $0.0316 per tablet |
| rosuvastatin calcium 5 mg tablet, coated | Generic | $0.0316 per tablet |
| rosuvastatin calcium 5 mg tablet, film coated | Generic | $0.0316 per tablet |
| rosuvastatin calcium 5 mg tablet, film coated | Brand: Crestor | $8.81 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions48 products
- Bryant Ranch Prepack24 products
- Proficient Rx LP18 products
- Aphena Pharma Solutions - Tennessee, LLC13 products
- Remedyrepack Inc.12 products
- Preferred Pharmaceuticals Inc.11 products
- NuCare Pharmaceuticals, Inc.10 products
- Quallent Pharmaceuticals Health LLC8 products
- Torrent Pharmaceuticals Limited8 products
- Northwind Health Company, LLC8 products
- Novadoz Pharmaceuticals LLC5 products
- Cadila Pharmaceuticals Limited4 products
- HEC Pharm USA Inc.4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- AiPing Pharmaceutical, Inc.4 products
- Puracap Laboratories LLC dba Blu Pharmaceuticals4 products
- Cranbury Pharmaceuticals, LLC4 products
- Ascend Laboratories, LLC4 products
- Glenmark Pharmaceutials Inc., USA4 products
- Westminster Pharmaceuticals, LLC4 products
- NorthStar RxLLC4 products
- Macleods Pharmaceuticals Limited4 products
- Rising Pharma Holdings, Inc.4 products
- Aurobindo Pharma Limited4 products
- Zhejiang Yongtai Pharmaceutical Co., Ltd4 products
- Biocon Pharma Inc.4 products
- Lifestar Pharma LLC4 products
- Camber Pharmaceuticals, Inc.4 products
- Umedica Laboratories USA Inc.4 products
- AstraZeneca Pharmaceuticals LP4 products
- NorthStar Rx LLC4 products
- Shandong New Time Pharmaceutical Co., Ltd.4 products
- Chartwell RX, LLC4 products
- Accord Healthcare Inc.4 products
- ScieGen Pharmaceuticals, Inc.4 products
- Golden State Medical Supply, Inc.4 products
- American Health Packaging3 products
- AvPAK3 products
- QPharma, Inc.2 products
- Redpharm Drug2 products
- Direct_Rx2 products
- Cardinal Health 107, LLC2 products
- NuCare Pharmaceutials, Inc.1 product
- Coupler LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021366 CRESTOR | Astrazeneca | August 12, 2003 | 31, latest September 23, 2026 2026: Labeling · 2026: Labeling · 2024: Labeling |
Generic approvals (20)
- ANDA079168Chartwell Rx · July 19, 2016
- ANDA079170Aurobindo Pharma Ltd · July 19, 2016
- ANDA079172Glenmark Speclt · July 19, 2016
- ANDA201619Torrent · October 31, 2016
- ANDA206434Accord Hlthcare · October 31, 2016
- ANDA207062Renata · October 31, 2016
- ANDA207408Changzhou Pharm · October 31, 2016
- ANDA207616Hetero Labs Ltd V · October 31, 2016
- ANDA207752Biocon Pharma · October 31, 2016
- ANDA207453Cadila Pharms Ltd · November 23, 2016
- ANDA206465Alkem Labs Ltd · March 21, 2017
- ANDA208898Msn · November 22, 2017
- ANDA206513Zhejiang Jingxin · March 1, 2019
- ANDA207626Umedica · April 9, 2019
- ANDA206381Sciegen Pharms · April 24, 2019
- ANDA207375Shandong · May 7, 2019
- ANDA212059Zhejiang Yongtai · November 4, 2019
- ANDA210667Sunshine · April 1, 2020
- ANDA207296Macleods Pharms · November 6, 2024
- ANDA206603Mankind Pharma · May 16, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 31, 2025 · Class II · Ongoing · D-0292-2026
Out of specification for dissolution.
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 — AvKARE
-
March 13, 2025 · Class II · Ongoing · D-0339-2025
CGMP Deviations
Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# — Glenmark Pharmaceuticals Inc., USA
-
February 7, 2023 · Class II · Terminated · D-0406-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Du — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0404-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0407-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 16729-287-17, UPC 3 167 — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0405-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; Manufactured for: Accord Healthcare, Inc., — Accord Healthcare, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 859419, 859424, 859747, 859751 |
|---|---|
| SPL set ID of the quoted label | cb942007-6ef1-4445-8dbd-6f4972148bf1 |
| FDA labels (SPL) | 157 |
| FDA applications | NDA021366, 20 ANDA |
| Active ingredients (FDA) | ROSUVASTATIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rosuvastatin calcium, Remedyrepack Inc., effective September 9, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →