Quick answers
- What is Lovastatin used for?
- The FDA-approved label (Lovastatin, Remedyrepack Inc., July 23, 2026) says: “Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lovastatin have a boxed warning?
- No. None of the 55 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lovastatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lovastatin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started February 19, 2019 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Lovastatin?
- 17 companies list prescription products of Lovastatin in the FDA NDC Directory, including Proficient Rx LP, Bryant Ranch Prepack and NuCare Pharmaceuticals, Inc..
What Lovastatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Therapy with lovastatin should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been …
— FDA label: Lovastatin, Remedyrepack Inc., effective July 23, 2026. Read the full label on DailyMed →
The FDA has 55 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 55 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 72 in the FDA NDC Directory |
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 |
|---|---|---|
| lovastatin 10 mg tablet | Generic | $0.0353 per tablet |
| lovastatin 20 mg tablet | Generic | $0.0453 per tablet |
| lovastatin 40 mg tablet | Generic | $0.0548 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Proficient Rx LP10 products
- Bryant Ranch Prepack9 products
- NuCare Pharmaceuticals, Inc.7 products
- A-S Medication Solutions6 products
- Preferred Pharmaceuticals Inc.5 products
- PD-Rx Pharmaceuticals, Inc.5 products
- Northwind Health Company, LLC4 products
- Teva Pharmaceuticals USA, Inc.3 products
- Carlsbad Technology, Inc.3 products
- Lupin Pharmaceuticals, Inc.3 products
- Golden State Medical Supply, Inc.3 products
- BluePoint Laboratories3 products
- Remedyrepack Inc.3 products
- Boswell Pharmacy Services LLC d/b/a BPS Wholesale2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Legacy Pharmaceutical Packaging, LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA075551Teva · December 17, 2001
- ANDA075991Carlsbad · June 5, 2002
- ANDA078296Lupin · November 1, 2007
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.
-
February 19, 2019 · Class III · Terminated · D-1584-2019
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories. — American Health Packaging
-
February 13, 2019 · Class III · Terminated · D-0513-2019
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count (NDC 68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lu — Lupin Pharmaceuticals 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) | 197903, 197904, 197905 |
|---|---|
| SPL set ID of the quoted label | 9438d8a0-ca5b-4676-aab9-d0241ccff6c9 |
| FDA labels (SPL) | 55 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | LOVASTATIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lovastatin, Remedyrepack Inc., effective July 23, 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 →