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Pitavastatin

Pitavastatin is a statin cholesterol medicine taken as a tablet, used along with diet to lower LDL (“bad”) cholesterol in adults with primary hyperlipidemia and in people with heterozygous familial hypercholesterolemia (an inherited form of high cholesterol).

Brand names LivaloZypitamagNikita
Drug class Hmg-coa Reductase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 15 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 6, 2026 🚨Recall on record · 3
Pitavastatin at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Pitavastatin is a statin for high cholesterol (adults with primary hyperlipidemia and, with some products, the inherited form called heterozygous familial hypercholesterolemia) that blocks an enzyme the liver needs to make cholesterol, so the liver pulls more LDL cholesterol from the blood; on the market since about 2009 and available as a generic, it is a less common statin often chosen when another has not suited someone. Most people tolerate it well; muscle aches, back or joint pain, and constipation or diarrhea are the usual complaints. Report unexplained muscle pain or weakness promptly, especially with fever, since rarely it signals rhabdomyolysis, severe muscle breakdown that can harm the kidneys.

Clinical pearls

  • Never combine it with cyclosporine, avoid gemfibrozil, and expect a dose limit if you take erythromycin or rifampin.
  • Colchicine, other fibrates and niacin at cholesterol-lowering doses can each add to the muscle risk when combined with it.
  • Take it once a day with or without food, and expect an LDL check as early as 4 weeks after starting.
  • It may harm an unborn baby and breastfeeding is not recommended, so tell your prescriber right away if you become pregnant.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2009
Companies listing it with the FDA14
FDA label last updatedAug 15, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Pitavastatin, written from its FDA label.

What Pitavastatin is used for

▾

Pitavastatin is a statin used with diet to lower LDL cholesterol.

  • Adults with primary hyperlipidemia (high cholesterol)
  • Adults with heterozygous familial hypercholesterolemia (HeFH), an inherited form of high cholesterol, in products labeled for it
  • Children aged 8 years and older with HeFH, for Livalo and some generic pitavastatin tablets
  • Zypitamag is labeled only for adults with primary hyperlipidemia

How Pitavastatin works

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Pitavastatin blocks HMG-CoA reductase, an enzyme the liver uses to make cholesterol. When the liver makes less cholesterol, it takes more LDL out of the blood. Total cholesterol falls, and very low density lipoprotein (VLDL) levels fall too.

Pitavastatin dosage

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Pitavastatin tablets are taken by mouth once daily, with or without food, at the same time each day. Your prescriber may check your LDL cholesterol as early as 4 weeks after you start and adjust your treatment.

  • People with moderate or severe kidney disease, or on hemodialysis, are started on a lower dose.
  • Some medicines, such as erythromycin and rifampin, require a dose limit.
  • If your LDL goal is not reached at the highest recommended dose, your prescriber may add or switch to another treatment.

Follow your prescriber’s directions and your pharmacy label.

Dosing details from the FDA-approved label

From the Pitavastatin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults (general dosing)
    • 2 mg to 4 mg once daily, taken orally with or without food at the same time each day
    • Maximum: 4 mg once daily
    • Assess LDL-C as early as 4 weeks after initiation and adjust the dosage if necessary; for patients requiring a high-intensity statin or unable to reach LDL-C goal on 4 mg daily, prescribe alternative LDL-C-lowering treatment
  • Pediatric patients aged 8 years and older (generic pitavastatin labels)
    • 2 mg to 4 mg daily
    • Maximum: 4 mg once daily
    • Not included in the Zypitamag label, which omits pediatric information
  • Moderate and severe renal impairment (eGFR 30 – 59 and 15 – 29 mL/minute/1.73 m2) and end-stage renal disease receiving hemodialysis
    • Starting dosage 1 mg once daily
    • Maximum: 2 mg once daily
    • No dosage adjustment recommendations for mild renal impairment; Zypitamag is not available in a 1 mg dose, so use an alternative formulation of pitavastatin
  • Patients taking erythromycin
    • Do not exceed 1 mg once daily
    • Maximum: 1 mg once daily
    • Zypitamag is not available in a 1 mg dose; use an alternative formulation
  • Patients taking rifampin
    • Do not exceed 2 mg once daily
    • Maximum: 2 mg once daily
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Take orally once daily with or without food at the same time each day. ( 2.1 ). For patients requiring a high-intensity statin or are unable to achieve their LDL-C goal receiving ZYPITAMAG 4 mg daily, prescribe alternative LDL-C-lowering treatment. ( 2.1 ) Assess LDL-C when clinically appropriate, as early as 4 weeks after initiation of ZYPITAMAG, and adjust the dosage if necessary. ( 2.1 ) Recommended dosage is 2 mg to 4 mg once daily. Maximum recommended dosage is 4 mg once daily. ( 2.2 ) Recommended starting dosage for patients with moderate and severe renal impairment and end-stage renal disease on hemodialysis is 1 mg once daily. ZYPITAMAG is not available in a 1 mg dose; use an alternative formulation of pitavastatin. Maximum recommended dosage is 2 mg once daily. ( 2.3 ) See full prescribing information for ZYPITAMAG dosage modifications due to drug interactions. ( 2.4 ) 2.1 Important Dosage and Administration Information Take ZYPITAMAG orally once daily with or without food at the same time each day. For patients that require a high-intensity statin or are unable to achieve their LDL-C goal receiving ZYPITAMAG 4 mg daily, prescribe alternative LDL-C-lowering treatment. Assess LDL-C when clinically appropriate, as early as 4 weeks after initiating ZYPITAMAG, and adjust the dosage if necessary. 2.2 Recommended Dosage for Adults The recommended dosage range of ZYPITAMAG is 2 mg to 4 mg daily. The maximum recommended dosage is ZYPITAMAG 4 mg once daily. 2.3 Recommended Dosage in Patients with Renal Impairment The recommended starting dosage for patients with moderate and severe renal impairment (estimated glomerular filtration rate 30 – 59 mL/minute/1.73 m 2 and 15 – 29 mL/minute/1.73 m 2 , respectively) and patients with end-stage renal disease receiving hemodialysis is pitavastatin 1 mg once daily. ZYPITAMAG is not available in a 1 mg dose; use an alternative formulation of pitavastatin for the 1 mg dose. The maximum recommended dose for these patients is ZYPITAMAG 2 mg once daily [see Use in Specific Populations ( 8.6 )] . There are no dosage adjustment recommendations for patients with mild renal impairment. 2.4 Dosage Adjustments Due to Drug Interactions In patients taking erythromycin, do not exceed pitavastatin 1 mg once daily [see Drug Interactions ( 7 )] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Pitavastatin side effects

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Most side effects are mild. The most common ones are:

Common side effects

  • Muscle aches (myalgia)
  • Constipation
  • Diarrhea
  • Back pain
  • Pain in the arms or legs
  • Joint pain (arthralgia)
  • Headache
  • Cold or flu-like symptoms

When to get medical help

  • Call your doctor promptly if you have unexplained muscle pain, tenderness or weakness, especially with feeling unwell or fever.
  • Get help if you notice signs of liver problems, such as yellowing of the skin or eyes (jaundice).
  • Seek urgent help for swelling of the face, lips or throat, or a serious rash or hives, which can signal an allergic reaction.
  • Tell your doctor if muscle weakness continues even after stopping a statin, which can be a rare autoimmune muscle problem.
  • Report new or worsening memory loss or confusion to your doctor.

Pitavastatin warnings and precautions

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  • Muscle damage: Myopathy and rare rhabdomyolysis can occur and may injure the kidneys. Risk is higher if you are 65 or older, have kidney disease or uncontrolled hypothyroidism, take certain medicines, or take higher doses.
  • Autoimmune muscle disease: Rare immune-mediated necrotizing myopathy has been reported. Weakness may persist after stopping.
  • Liver problems: Liver enzymes can rise, and rare liver failure has been reported. Heavy alcohol use or past liver disease raises the risk.
  • Blood sugar: HbA1c and fasting glucose can rise.
  • Your doctor may pause the medicine during serious illness, major surgery or trauma that raises the risk of kidney failure from muscle breakdown.

Pitavastatin interactions

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Several medicines raise the risk of muscle damage or change pitavastatin levels.

  • Cyclosporine: must not be combined; it greatly increases pitavastatin exposure.
  • Gemfibrozil: avoid; raises muscle risk.
  • Erythromycin: raises pitavastatin levels, so the dose is limited.
  • Rifampin: raises peak levels, so the dose is limited.
  • Other fibrates, high-dose niacin, colchicine: may raise muscle risk, so benefit and risk are weighed.

Interactions listed in the FDA-approved label

From the Pitavastatin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Cyclosporine: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Concomitant use with pitavastatin is contraindicated.
  • Gemfibrozil: Gemfibrozil may cause myopathy when given alone, and the risk of myopathy and rhabdomyolysis is increased with concomitant use with statins, including pitavastatin. Avoid concomitant use of gemfibrozil with pitavastatin.
  • Erythromycin: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. In patients taking erythromycin, do not exceed pitavastatin 1 mg once daily.
  • Rifampin: Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. In patients taking rifampin, do not exceed pitavastatin 2 mg once daily.
  • Fibrates: Fibrates may cause myopathy when given alone, and the risk of myopathy and rhabdomyolysis is increased with concomitant use with statins, including pitavastatin. Consider if the benefit of using fibrates concomitantly with pitavastatin outweighs the increased risk of myopathy and rhabdomyolysis.
  • Niacin: The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid-modifying doses (≥ 1 g/day) of niacin with pitavastatin. Consider if the benefit of using lipid-modifying doses (≥ 1 g/day) of niacin concomitantly with pitavastatin outweighs the increased risk of myopathy and rhabdomyolysis.
  • Colchicine: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including pitavastatin. Consider the risk/benefit of concomitant use of colchicine with pitavastatin.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with pitavastatin tablets and instructions for preventing or managing drug interactions [see Warnings and Precautions (5.1) , Clinical Pharmacology (12.3) ] . Table 2. Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Pitavastatin Tablets Cyclosporine Clinical Impact: Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: Concomitant use of cyclosporine with pitavastatin tablets is contraindicated [see Contraindications (4) ] . Gemfibrozil Clinical Impact: Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including pitavastatin tablets. Intervention: Avoid concomitant use of gemfibrozil with pitavastatin tablets. Erythromycin Clinical Impact: Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking erythromycin, do not exceed pitavastatin tablets 1 mg once daily [see Dosage and Administration (2.4) ] . Rifampin Clinical Impact: Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. Intervention: In patients taking rifampin, do not exceed pitavastatin tablets 2 mg once daily [see Dosage and Administration (2.4) ] . Fibrates Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including pitavastatin tablets. Intervention: Consider if the benefit of using fibrates concomitantly with pitavastatin tablets outweighs the increased risk of myopathy and rhabdomyolysis.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿126 supplements and herbs with documented Pitavastatin interactions, ranked by severity Check Pitavastatin against a supplement or herb →

Before taking Pitavastatin

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  • Do not use with acute liver failure or decompensated cirrhosis.
  • Do not use if allergic to pitavastatin or its ingredients.
  • Tell your prescriber if you have kidney disease, an underactive thyroid, or past liver disease, or if you drink heavily.
  • Older adults (65 and over) are at higher risk of muscle problems and need careful monitoring.
  • It may cause fetal harm; tell your doctor right away if you become pregnant.
  • Breastfeeding is not recommended.
  • Children under 8 have not been studied for HeFH, and children with other types of high cholesterol have not been studied either.

Pitavastatin overdose

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No specific treatment for pitavastatin overdose is known. Contact Poison Control at 1-800-222-1222 for the latest advice. Hemodialysis is unlikely to help because the drug is highly protein bound.

What Pitavastatin does in the body

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In a study of 174 healthy people, pitavastatin did not cause a clinically meaningful change in the QTc interval (a heart rhythm measure) or heart rate at daily doses up to 4 times the maximum recommended dose.

How your body processes Pitavastatin

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Pitavastatin reaches peak blood levels about 1 hour after you take it by mouth. A high-fat meal lowers the peak level but does not significantly change the total amount absorbed. It is mostly cleared through the liver by glucuronidation, with minimal processing by cytochrome P450 enzymes, and mostly leaves in the stool. Its half-life is about 12 hours. Levels are higher in women, older adults, and people with kidney or liver impairment.

How to store Pitavastatin

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Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

126

Supplements & herbs that interact with Pitavastatin

126 supplements and herbal products have documented interactions with Pitavastatin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 98
  • Minor · 23
ACTIVATED CHARCOAL Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major WINE Major ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ASHWAGANDHA Moderate +118 more
Every supplement checked against Pitavastatin — ranked by severity The full interaction hub: 5 major · 98 moderate · 23 minor · every one linked to its full report. Check Pitavastatin against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Pitavastatin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

COENZYME Q10 Insufficient Evidence
See the full Pitavastatin nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Pitavastatin: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Pitavastatin — the kind of thing our pharmacy team would talk through with you at the counter.

What is pitavastatin for?

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It lowers LDL, the “bad” cholesterol, along with a healthy diet. It is used in adults with primary hyperlipidemia. Some products, such as Livalo, are also used for inherited high cholesterol (HeFH) in adults and children 8 and older.

How should I take it?

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Take one tablet by mouth once a day, with or without food, at about the same time each day. Your doctor may recheck your cholesterol after about 4 weeks. Follow the directions on your pharmacy label.

What side effects should I expect?

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The most common are muscle aches, constipation, diarrhea, back pain, and pain in the arms or legs. Most are mild. Call your doctor if muscle pain or weakness is unexplained, especially with fever or feeling unwell.

Are there medicines I should avoid with it?

▾
Yes. Cyclosporine must not be taken with it, and gemfibrozil should be avoided. Erythromycin and rifampin require a lower dose limit. Niacin, other fibrates and colchicine can raise muscle risk, so always tell me about any new medicine.

Is it safe in pregnancy or while breastfeeding?

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It may harm an unborn baby, so tell your doctor right away if you become pregnant. Your doctor will usually have you stop it. Breastfeeding is not recommended while you take it.

Does it affect my liver?

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It can raise liver enzymes, usually early on and without symptoms. Your doctor may check your liver tests. Let your doctor know if you drink heavily or have liver disease, and call right away for yellow skin or eyes.

Is Pitavastatin available over the counter?

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No. Pitavastatin is a prescription medicine: every Pitavastatin product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Pitavastatin first available?

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The earliest FDA record we hold for Pitavastatin is from 2009: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Pitavastatin was first used.

Who makes Pitavastatin?

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14 companies currently list Pitavastatin products in the FDA's NDC Directory, including Zydus Lifesciences Limited, Amneal Pharmaceuticals LLC, Aurobindo Pharma Limited. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Pitavastatin on HelloPharmacist

📊Pitavastatin supplement interactions126 checked — ranked by severity 🌿Drug & Supplement CheckerPitavastatin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Pitavastatin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Pitavastatin Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Pitavastatin forms and strengths (how it comes)

Pitavastatin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Pitavastatin inactive ingredients by manufacturer.

Tablet

By mouth
Brands Livalo Zypitamag
How this form is used
What it may be used for
  • Livalo is used with diet to lower LDL-C in adults with primary hyperlipidemia.
  • Livalo is also used in adults and children aged 8 and older with heterozygous familial hypercholesterolemia.
  • Zypitamag is used with diet to lower LDL-C in adults with primary hyperlipidemia.
Important instructions
  • Livalo is taken by mouth once daily, with or without food, at the same time each day.
  • Zypitamag is taken by mouth once daily, with or without food, at the same time each day.
  • Zypitamag does not come in a 1 mg tablet; people who need that lower starting dose for kidney problems need a different pitavastatin product.
Available strengths 6 strengths
1 mg 1.045 mg 2 mg 2.09 mg 4 mg 4.18 mg
75 FDA-listed product records ⓘ

Pitavastatin on the U.S. market: products, makers and brands

How Pitavastatin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

14 companies list 42 Pitavastatin product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2009. Brand names on the directory include Livalo, Zypitamag, Nikita; the rest are generics.

1
Dose forms ⓘ
14
Labelers (makers, repackagers, distributors)
4
Brand names
42
FDA-listed product records ⓘ
2009
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (7) · Granule (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Zydus Lifesciences Limited12%
Amneal Pharmaceuticals LLC7%
Aurobindo Pharma Limited7%
AvKARE7%
Camber Pharmaceuticals, Inc.7%
Golden State Medical Supply, Inc.7%
Other makers52%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Pitavastatin is used (Medicaid data)

A general measure of how commonly Pitavastatin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Pitavastatin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

8,812
Medicaid prescriptions filled (Q1–Q4 2025)
$1.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pitavastatin prescribed? Of the 1,601 medications we measure, Pitavastatin ranks #948 by Medicaid prescriptions — more than 41% of them.

Where Pitavastatin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #948 of 1,601
#943 Vincristine Injection 9,198 Rx #944 Calcium, Magnesium, Po... 9,091 Rx #945 Aminophylline 9,002 Rx #946 Estradiol Topical 8,927 Rx #947 Eptinezumab-jjmr Injec... 8,909 Rx #948 Pitavastatin 8,812 Rx #949 Balsalazide 8,799 Rx #950 Selexipag 8,761 Rx #951 Nitroglycerin Topical 8,740 Rx #952 Fulvestrant Injection 8,707 Rx #953 Fulvestrant 8,707 Rx

Utilization by Pitavastatin product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 4 mg oral tablet is the most-dispensed Pitavastatin product — about 45% of these Medicaid prescriptions.

pitavastatin calcium 4 MG Oral Tablet Most dispensed

3,958 Medicaid prescriptions (Q1–Q4 2025) 45% of Pitavastatin prescriptions shown $521,173 gross reimbursement (before rebates) ≈ $132 per prescription (gross)

Summed across the 9 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861652

pitavastatin calcium 2 MG Oral Tablet

3,853 Medicaid prescriptions (Q1–Q4 2025) 44% of Pitavastatin prescriptions shown $484,926 gross reimbursement (before rebates) ≈ $126 per prescription (gross)

Summed across the 9 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861648

pitavastatin calcium 1 MG Oral Tablet

1,001 Medicaid prescriptions (Q1–Q4 2025) 11% of Pitavastatin prescriptions shown $119,884 gross reimbursement (before rebates) ≈ $120 per prescription (gross)

Summed across the 7 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 861643

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pitavastatin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 25 of 55 listed Pitavastatin NDCs with Medicaid activity.

Compare Pitavastatin products

A representative set of FDA-listed product records for Pitavastatin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 42 of 42 products — FDA National Drug Code Directory. See every product, package size and price: browse all 42 Pitavastatin NDCs →

Pitavastatin recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Pitavastatin recalls since July 2021, covering 6 product listings. Three of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Feb 3, 2026 · Annora Pharma Private Limited
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
  • Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, Ind… Lots: Lot #: A252487, Exp 05/31/2027 FDA record D-0391-2026 →
Ongoing Class III Jun 26, 2025 · AvKARE
Failed Impurity/Degradation Specifications
  • Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90 Lots: Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026 FDA record D-0529-2025 →
  • Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90 Lots: Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026; FDA record D-0528-2025 →
Ongoing Class III Jun 11, 2025 · Orient Pharma Co., Ltd. Yunlin Plant
Failed Impurities/Degradation Specifications.
  • Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 0… Lots: P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027. FDA record D-0527-2025 →
  • Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 0… Lots: P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp… FDA record D-0526-2025 →
Class III Feb 24, 2025 · Completed · Kowa Pharmaceuticals America
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 Pharmaceutic… Lots: Lot#: 3231300, Exp 8/2027 FDA record D-0258-2025 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Pitavastatin RxCUI 861634 1 dose form · 8 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 861642 In current FDA listings
    Clinical drug / strength (SCD) calcium 1 MG RxCUI 861643 calcium 2 MG RxCUI 861648 calcium 4 MG RxCUI 861652 magnesium 2 MG RxCUI 2001262 magnesium 4 MG RxCUI 2001266 sodium 1 MG RxCUI 2689112 sodium 2 MG RxCUI 2689121 sodium 4 MG RxCUI 2689125

Look up RxCUI 861634 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Pitavastatin costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 2 mg $0.954 per tablet NDC details & price history
Tablet, Film Coated · Oral 4 mg $1.03 per tablet NDC details & price history
Tablet, Film Coated · Oral 2.09 mg $0.954 per tablet NDC details & price history
Tablet, Film Coated · Oral 4.18 mg $1.03 per tablet NDC details & price history
Tablet, Film Coated · Oral 1 mg $0.904 per tablet NDC details & price history
Tablet, Film Coated · Oral 1.045 mg $0.904 per tablet NDC details & price history
Tablet · Oral 4 mg $1.03 per tablet NDC details & price history
Tablet · Oral 2 mg $0.954 per tablet NDC details & price history
Tablet · Oral 1 mg $0.904 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Pitavastatin brand names

Pitavastatin is sold under 3 brand names in the FDA directory — Livalo, Zypitamag, Nikita. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Livalo Zypitamag Nikita

Who makes Pitavastatin: manufacturers and labelers

14 companies list Pitavastatin products with the FDA. By number of product records, the largest are Zydus Lifesciences Limited, Amneal Pharmaceuticals LLC, Aurobindo Pharma Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Zydus Lifesciences Limited 5 Amneal Pharmaceuticals LLC 3 Aurobindo Pharma Limited 3 AvKARE 3 Camber Pharmaceuticals, Inc. 3 Golden State Medical Supply, Inc. 3 Kowa Pharmaceuticals America, Inc. 3 Mylan Pharmaceuticals Inc. 3 Teva Pharmaceuticals, Inc. 3 Upsher-Smith Laboratories, LLC 3 XLCare Pharmaceuticals Inc. 3 Zydus Pharmaceuticals USA Inc. 3 Medicure International Inc 2 NorthStar RxLLC 2

Pitavastatin drug class (RxNorm)

Pitavastatin belongs to the HMG-CoA Reductase Inhibitor class.

Pharmacologic class HMG-CoA Reductase Inhibitor
Drug family (ATC) HMG CoA reductase inhibitors
How it works Hydroxymethylglutaryl-CoA Reductase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Pitavastatin page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pitavastatin.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pitavastatin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
15
Finished products in the current FDA directory
42
Companies listing them (makers, repackagers, distributors)
14
FDA labeler codes behind them ⓘ
14
Linked representative label ⓘ
Mylan Pharmaceuticals Inc.
Linked label effective
Aug 15, 2024
Composite sections available
23
Linked SPL Set ID
26b5e5e8-45cd-4a98-9af4-2d04c1130881
Linked SPL Document ID
44bb6612-917c-4457-952a-5751ea607867
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Mylan Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →