Quick answers
- What is Fluvastatin used for?
- The FDA-approved label (Lescol XL, Sandoz Inc, December 13, 2023) says: “LESCOL XL is indicated: • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluvastatin have a boxed warning?
- No. None of the 11 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fluvastatin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated January 27, 2026). Ask your pharmacist about alternatives.
- Has Fluvastatin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started May 29, 2014 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fluvastatin?
- 5 companies list prescription products of Fluvastatin in the FDA NDC Directory, including Bryant Ranch Prepack, Teva Pharmaceuticals USA, Inc. and Mylan Pharmaceuticals Inc..
What Fluvastatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LESCOL XL is indicated: • To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. • As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. …
— FDA label: Lescol XL, Sandoz Inc, effective December 13, 2023. Read the full label on DailyMed →
The FDA has 11 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 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet, extended release · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Lescol XL |
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 |
|---|---|---|
| fluvastatin sodium 20 mg capsule | Generic | $2.64 per capsule |
| fluvastatin sodium 40 mg capsule | Generic | $3.00 per capsule |
| fluvastatin sodium 80 mg tablet, extended release | Generic | $2.87 per tablet |
| fluvastatin sodium 80 mg tablet, extended release | Brand: Lescol XL | $13.06 per tablet |
| fluvastatin sodium 80 mg tablet, film coated, extended release | Generic | $2.87 per tablet |
NADAC list of November 4, 2026; these prices took effect between February 18, 2026 and October 21, 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.
- Bryant Ranch Prepack5 products
- Teva Pharmaceuticals USA, Inc.3 products
- Mylan Pharmaceuticals Inc.2 products
- Sandoz Inc2 products
- Lannett Company, Inc.1 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 |
|---|---|---|---|
| NDA021192 LESCOL XL | Sandoz | October 6, 2000 | 18, latest November 28, 2023 2023: Labeling · 2020: Labeling · 2017: Labeling |
Generic approvals (4)
- ANDA090595Mylan Pharms Inc · April 11, 2012
- ANDA078407Teva Pharms · June 12, 2012
- ANDA079011Teva Pharms USA · January 27, 2016
- ANDA209397Beijing · April 26, 2021
Shortage status
To be discontinued · updated January 27, 2026 · first posted January 27, 2026
| Product | Lescol XL, Tablet, Extended Release, 80 mg (NDC 66758-211-31) |
|---|---|
| Company | Sandoz Inc. |
Ask your pharmacist whether your product is affected and what the options are.
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.
-
May 29, 2014 · Class II · Terminated · D-1430-2014
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56 — Teva Pharmaceuticals USA
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) | 310404, 310405, 360507, 687048 |
|---|---|
| SPL set ID of the quoted label | 726ea2db-f1b0-4b73-a515-02157db88a42 |
| FDA labels (SPL) | 11 |
| FDA applications | NDA021192, 4 ANDA |
| Active ingredients (FDA) | FLUVASTATIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lescol XL, Sandoz Inc, effective December 13, 2023; 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 →