Quick answers
- What is Livalo?
- Livalo is a brand name of Pitavastatin, a prescription medicine. The FDA NDC Directory lists 3 Livalo products in 3 strengths and forms.
- Who makes Livalo?
- Kowa Co holds the FDA application for Livalo (NDA022363, approved August 3, 2009).
- Is there a generic or store brand of Livalo?
- Yes. The FDA NDC Directory lists 11 other products with the same active ingredients, strength and form as a Livalo product, 11 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Livalo?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 3 Livalo strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Livalo been recalled?
- FDA enforcement reports list 2 recalls of Livalo products; the newest started February 24, 2025. A recall usually concerns specific lots, not every product.
What Livalo is
Each Livalo product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Pitavastatin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| pitavastatin calcium 1.045 mg tablet, film coated (oral) | Livalo | 3 products, 3 companies | DailyMed |
| pitavastatin calcium 2.09 mg tablet, film coated (oral) | Livalo | 4 products, 4 companies | DailyMed |
| pitavastatin calcium 4.18 mg tablet, film coated (oral) | Livalo | 4 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Pitavastatin →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022363 | Kowa Co | August 3, 2009 | 3 |
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 |
|---|---|---|
| pitavastatin calcium 1.045 mg tablet, film coated | Brand: Livalo | $10.19 per tablet Generic of the same strength and form: $0.8365 per tablet |
| pitavastatin calcium 2.09 mg tablet, film coated | Brand: Livalo | $10.20 per tablet Generic of the same strength and form: $0.9690 per tablet |
| pitavastatin calcium 4.18 mg tablet, film coated | Brand: Livalo | $10.22 per tablet Generic of the same strength and form: $0.9889 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 Livalo
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Livalo products.
- Kowa Pharmaceuticals America, Inc.3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 24, 2025 · Class III · Completed · D-0258-2025
Presence of foreign tablets/capsules
Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only, Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd, Nagoya, 462-0024 Japan, Marketed by Kowa Pharmaceuticals: Kowa Pharmaceuti — Kowa Pharmaceuticals America
-
March 15, 2021 · Class II · Terminated · D-0500-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, — Cardinal Health Inc.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.