Skip to the answer

Simvastatin

Simvastatin is a statin cholesterol medicine used with diet to lower cholesterol and triglycerides and to reduce the risk of heart attack, stroke and heart-related death in people at high risk.

Brand names FlolipidZocor
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 124 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 5, 2026
Simvastatin 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

Simvastatin (Zocor) is one of the most familiar statins, on the U.S. market since about 1991 and available as a generic. It blocks a liver enzyme needed to make cholesterol, so the liver pulls more LDL (“bad”) cholesterol from the blood, cutting heart attack and stroke risk in people at high risk. Most people tolerate it well, and the side effects they notice are usually mild, like headache, constipation or an upset stomach. Watch for unexplained muscle pain, tenderness or weakness, especially with dark urine, and report it right away, because it can signal muscle damage that rarely becomes rhabdomyolysis (severe breakdown that can harm the kidneys).

Clinical pearls

  • Take it in the evening, and skip grapefruit juice, which raises simvastatin levels and muscle risk.
  • Clarithromycin, erythromycin, several antifungals and HIV protease inhibitors must not be combined with it, so tell every prescriber.
  • Amlodipine, diltiazem, verapamil and amiodarone raise muscle risk and limit how much simvastatin you can safely take.
  • Do not take it if you are pregnant or may become pregnant, and stop it if you conceive.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record1991
Companies listing it with the FDA27
FDA label last updatedMar 28, 2025
FDA’s strongest warning (boxed)None on the label

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

What Simvastatin is used for

▾

Simvastatin is a statin used with diet for several cholesterol-related conditions.

  • Reducing the risk of death from coronary heart disease, non-fatal heart attack, stroke and the need for procedures to restore blood flow, in people at high risk (FloLipid label).
  • Lowering total cholesterol, LDL cholesterol, Apo B and triglycerides, and raising HDL cholesterol, in primary hyperlipidemia and mixed dyslipidemia (FloLipid label).
  • Lowering triglycerides in hypertriglyceridemia, and triglycerides and VLDL in primary dysbetalipoproteinemia (FloLipid label).
  • Lowering total and LDL cholesterol in adults with homozygous familial hypercholesterolemia (FloLipid label).
  • Lowering cholesterol in adolescents 10 to 17 with heterozygous familial hypercholesterolemia after diet alone has not worked (FloLipid label).
  • Zocor and Simvastatin tablets: dosing is described for adults and for children 10 and older with heterozygous familial hypercholesterolemia.

How Simvastatin works

▾

Simvastatin is a prodrug, meaning the body converts it into its active form, simvastatin acid. It blocks HMG-CoA reductase, an enzyme the liver uses to make cholesterol. This lowers cholesterol production, and the liver takes up more LDL cholesterol from the blood. It also lowers VLDL and triglycerides and raises HDL cholesterol.

Simvastatin dosage

▾

Simvastatin is taken by mouth, usually once daily in the evening. Follow your prescriber and your product’s label.

  • Zocor and Simvastatin tablets: once daily in the evening.
  • FloLipid oral suspension: evening, on an empty stomach, shaken well and measured with an accurate device.
  • Missed dose (tablet labels): take it as soon as possible, but do not double the next dose.
  • Cholesterol is usually rechecked about 4 weeks after starting, then periodically.

Dosing details from the FDA-approved label

From the Simvastatin 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.

  • Usual dosage (FloLipid suspension)
    • Dose range is 5 to 40 mg/day
    • Usual starting dose is 10 or 20 mg once a day in the evening on an empty stomach
    • Maximum: 40 mg/day
    • Shake bottle well for at least 20 seconds before using; measure with an accurate measuring device; use FLOLIPID 40 mg/5 mL for dosages greater than or equal to 40 mg
  • Patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease
    • Recommended starting dose is 40 mg/day
  • 80 mg dose (restricted dosing)
    • Use of the 80-mg dose should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity
    • Patients unable to achieve LDL-C goal on 40 mg should not be titrated to 80 mg but placed on alternative LDL-C-lowering treatment
  • Patients taking verapamil, diltiazem, or dronedarone
    • Dose should not exceed 10 mg/day
    • Maximum: 10 mg/day
  • Patients taking amiodarone, amlodipine or ranolazine
    • Dose should not exceed 20 mg/day
    • Maximum: 20 mg/day
  • Homozygous Familial Hypercholesterolemia
    • 40 mg/day in the evening on an empty stomach
    • Maximum: 20 mg/day (or 40 mg/day for patients who have previously taken 80 mg/day of simvastatin chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide
    • Reduce dose by 50% if initiating lomitapide
  • Adolescents (10 to 17 years of age) with Heterozygous Familial Hypercholesterolemia
    • Usual starting dose is 10 mg once a day in the evening on an empty stomach
    • Dosing range 10 to 40 mg/day
    • Maximum: 40 mg/day
    • Adjustments should be made at intervals of 4 weeks or more
  • Severe renal impairment
    • Start at 5 mg/day and monitor closely
    • No dosage modification necessary in mild to moderate renal impairment
  • Chinese patients taking lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products
    • Caution with simvastatin doses exceeding 20 mg/day
    • Should not receive simvastatin 80 mg with lipid-modifying doses of niacin-containing products
  • Adults (Zocor tablets)
    • 20 mg to 40 mg once daily in the evening
    • Maximum: 40 mg once daily
    • Pediatric patients 10 years and older with HeFH: 10 mg to 40 mg once daily; severe renal impairment (CLcr 15-29 mL/min): starting dosage 5 mg once daily
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Dose range is 5 to 40 mg/day. ( 2.1 ) Shake bottle well for at least 20 seconds before using. ( 2.1 ) Measure FLOLIPID with an accurate measuring device. ( 2.1 ) Recommended usual starting dose is 10 or 20 mg once a day in the evening on an empty stomach. ( 2.1 ) Recommended to use FLOLIPID 40 mg/5 mL for dosages greater than or equal to 40 mg. ( 2.1 ) Recommended starting dose for patients at high risk of CHD is 40 mg/day. ( 2.1 ) Due to the increased risk of myopathy, including rhabdomyolysis, use of the 80-mg dose of FLOLIPID should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. ( 2.2 ) Patients who are currently tolerating the 80-mg dose of FLOLIPID who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction. ( 2.2 ) Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80-mg dose of FLOLIPID, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of FLOLIPID should not be titrated to the 80-mg dose, but should be placed on alternative LDL-Clowering treatment(s) that provides greater LDL-C lowering. ( 2.2 ) Adolescents (10 to 17 years of age) with HeFH: starting dose is 10 mg/day; maximum recommended dose is 40 mg/day. ( 2.5 ) 2.1 Recommended Dosing The usual dosage range is 5 to 40 mg/day. FLOLIPID should be taken in the evening on an empty stomach [see Clinical Pharmacology (12.3) ] . Shake bottle well for at least 20 seconds before using. In patients with CHD or at high risk of CHD, FLOLIPID can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. It is recommended to use FLOLIPID 40 mg/5 mL for dosages greater than or equal to 40 mg. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter. Patients should be advised to measure FLOLIPID with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage.

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

Simvastatin side effects

▾

Most people tolerate simvastatin well. The most common effects in studies were:

Common side effects

  • Upper respiratory infection (cold-like symptoms)
  • Headache
  • Stomach pain
  • Constipation
  • Nausea

When to get medical help

  • Call your doctor right away for unexplained muscle pain, tenderness or weakness, especially with fever or feeling unwell. This can signal a serious muscle problem.
  • Dark urine with muscle symptoms can point to rhabdomyolysis (severe muscle breakdown that can harm the kidneys). Get medical help promptly.
  • Muscle weakness that continues after stopping the medicine needs medical attention, as it can be a rare autoimmune muscle condition.
  • Yellowing of the skin or eyes can signal liver problems. Report it to your doctor.
  • Swelling of the face or throat, hives or trouble breathing can be signs of a severe allergic reaction. Get emergency help.
  • Report memory loss or confusion. Rare cases have been reported and were generally reversible after stopping the statin.
  • Tell your doctor if you become pregnant while taking it. Simvastatin should be stopped.

Simvastatin warnings and precautions

▾
  • Muscle damage (myopathy and rhabdomyolysis): Risk rises with dose, age 65 and up, being female, uncontrolled low thyroid, kidney problems and interacting drugs. The 80 mg dose is limited to people who have taken it long-term without muscle problems.
  • Liver enzymes: Liver tests are checked before starting and as needed.
  • Stop and call your doctor for unexplained muscle pain or weakness, especially with fever or feeling unwell.
  • Your doctor may pause simvastatin during a serious illness that could lead to kidney failure, such as sepsis, major surgery or trauma.
  • Rare reports of immune-mediated necrotizing myopathy (an autoimmune muscle disease), memory problems, and higher blood sugar (HbA1c and glucose) have been described.

Simvastatin interactions

▾

Many drugs raise simvastatin levels and the risk of muscle damage.

  • Strong CYP3A4 inhibitors (certain antifungals, antibiotics like erythromycin and clarithromycin, HIV and hepatitis C protease inhibitors, nefazodone, cobicistat): contraindicated because they raise simvastatin levels.
  • Gemfibrozil, cyclosporine, danazol: contraindicated due to higher muscle risk.
  • Grapefruit juice: avoid it, since it raises simvastatin levels.
  • Verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine: the simvastatin dose is capped.
  • Lomitapide: the simvastatin dose is reduced and capped.
  • Niacin (cholesterol-lowering doses): not recommended in Chinese patients, and risk is weighed in others.
  • Other fibrates, colchicine, daptomycin: higher muscle risk, so benefits and risks are weighed.
  • Warfarin-type blood thinners: INR can rise, so it is monitored.
  • Digoxin: levels may rise, so they are monitored.

Interactions listed in the FDA-approved label

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

  • Strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, nelfinavir, ritonavir, boceprevir, telaprevir, cobicistat-containing products, nefazodone): Increases simvastatin exposure and the risk of myopathy and rhabdomyolysis. Contraindicated; if treatment with a CYP3A4 inhibitor is unavoidable, suspend simvastatin during the course of treatment.
  • Cyclosporine, danazol, or gemfibrozil: Risk of myopathy and rhabdomyolysis is increased. Concomitant use is contraindicated.
  • Amiodarone, dronedarone, ranolazine, or calcium channel blockers: Risk of myopathy and rhabdomyolysis is increased. With verapamil, diltiazem, or dronedarone do not exceed simvastatin 10 mg daily; with amiodarone, amlodipine, or ranolazine do not exceed 20 mg daily.
  • Lomitapide: Simvastatin exposure is approximately doubled and the risk of myopathy and rhabdomyolysis is increased. Reduce simvastatin dose by 50% if initiating lomitapide; do not exceed 20 mg daily (or 40 mg daily for patients who previously took 80 mg daily chronically).
  • Daptomycin: Cases of rhabdomyolysis reported; risk of myopathy and rhabdomyolysis may be increased by coadministration. If daptomycin is required, consider temporarily suspending simvastatin during daptomycin treatment.
  • Niacin (lipid-modifying dosages, ≥1 gram/day): Cases of myopathy and rhabdomyolysis observed; risk of myopathy is greater in Chinese patients. Not recommended in Chinese patients; for non-Chinese patients consider whether benefit outweighs risk and monitor for signs and symptoms of myopathy.
  • Fibrates (other than gemfibrozil): Risk of myopathy and rhabdomyolysis is increased. Consider whether benefit outweighs risk; if used together, monitor for signs and symptoms of myopathy.
  • Colchicine: Cases of myopathy and rhabdomyolysis have been reported. Consider whether benefit outweighs risk; if used together, monitor for signs and symptoms of myopathy.
  • Grapefruit juice: Can raise plasma levels of simvastatin and may increase the risk of myopathy and rhabdomyolysis. Avoid grapefruit juice when taking simvastatin.
  • Coumarin anticoagulants: Simvastatin may potentiate the effect of coumarin anticoagulants and increase the INR. Obtain an INR before starting simvastatin and monitor frequently after initiation, dose titration, or discontinuation; once stable, monitor at regularly recommended intervals.
Read the label’s full interactions text

7 DRUG INTERACTIONS • See full prescribing information for details regarding concomitant use of simvastatin with other drugs or grapefruit juice that increase the risk of myopathy and rhabdomyolysis. ( 2.5 , 7.1 ) • Coumarin Anticoagulants: Obtain INR before simvastatin initiation and monitor INR during simvastatin dosage initiation or adjustment. ( 7.2 ) • Digoxin: During simvastatin initiation, monitor digoxin levels. ( 7.2 ) 7.1 Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Simvastatin Simvastatin is a substrate of CYP3A4 and of the transport protein OATP1B1.Simvastatin exposure can be significantly increased with concomitant administration of inhibitors of CYP3A4 and OATP1B1. Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when used concomitantly with simvastatin and instructions for preventing or managing them [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )]. Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Simvastatin Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with simvastatin increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher simvastatin dosages. Intervention: Concomitant use of strong CYP3A4 inhibitors with simvastatin is contraindicated [see Contraindications ( 4 )]. If treatment with a CYP3A4 inhibitor is unavoidable, suspend simvastatin during the course of strong CYP3A4 inhibitor treatment. Examples: Select azole anti-fungals (e.g., itraconazole, ketoconazole, posaconazole, and voriconazole), select macrolide antibiotics (e.g., erythromycin and clarithromycin), select HIV protease inhibitors (e.g., nelfinavir, ritonavir, and darunavir/ritonavir), select HCV protease inhibitors (e.g., boceprevir and telaprevir), cobicistat-containing products, and nefazodone.

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.

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

Before taking Simvastatin

▾
  • Do not use if you have active liver disease or unexplained persistent liver enzyme elevations.
  • Do not use if you are pregnant or may become pregnant. Stop it if you become pregnant.
  • Breastfeeding is not recommended during treatment.
  • Do not use if you are allergic to any component of the medicine.
  • Be cautious with kidney problems (including severe kidney impairment, which calls for a lower starting dose with the tablets) or uncontrolled low thyroid.
  • Adults 65 and older have a higher risk of muscle problems.
  • Children 10 and older with heterozygous familial hypercholesterolemia have been studied. Safety and effectiveness are not established under age 10.

Simvastatin overdose

▾

Only a few overdose cases have been reported. The highest dose taken was 3.6 g, and all patients recovered without lasting effects. Supportive care is the recommended treatment. Call poison control or seek emergency care if too much is taken.

What Simvastatin does in the body

▾

By blocking cholesterol production in the liver, simvastatin increases LDL receptors, so more LDL cholesterol is pulled from the blood. This lowers LDL and total cholesterol, and VLDL also falls. The maximum LDL reduction is usually reached by about 4 weeks and is maintained after that.

How your body processes Simvastatin

▾

Simvastatin is converted in the body to its active form. The liver removes much of the drug on first pass, so little reaches the general circulation. Levels of total drug and metabolites peak at about 4 hours and fall to about 10% of peak by 12 hours. Most of a dose leaves in the feces (60%) and a smaller part in urine (13%). With the oral suspension, a high-fat meal changed drug levels: simvastatin fell 18% and its active form rose 44%. Simvastatin is processed by CYP3A4, which is why many interactions occur.

How to store Simvastatin

▾

Store between 41°F to 86°F (5°C to 30°C).

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

183

Supplements & herbs that interact with Simvastatin

183 supplements and herbal products have documented interactions with Simvastatin 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 · 8
  • Moderate · 139
  • Minor · 36
ACTIVATED CHARCOAL Major APPLE Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major ST. JOHN'S WORT Major SWEET ORANGE Major WINE Major +175 more
Every supplement checked against Simvastatin — ranked by severity The full interaction hub: 8 major · 139 moderate · 36 minor · every one linked to its full report. Check Simvastatin 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.

2

Nutrient depletion considerations

Simvastatin has been associated with lower levels of 2 nutrients 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.

Evidence & significance mix
  • Higher significance · 1
  • Unrated · 1
BETA-CAROTENE Insignificant Depletion COENZYME Q10 Insufficient Evidence
See the full Simvastatin 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.

Simvastatin: pharmacist answers to common questions

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

What is simvastatin for?

▾
It’s a statin that lowers cholesterol and triglycerides when diet alone isn’t enough. It also lowers the risk of heart attack, stroke and heart-related death in people at high risk, such as those with coronary heart disease or diabetes.

When and how should I take it?

▾
Take it once a day in the evening, as your prescriber directs. If you use FloLipid liquid, take it on an empty stomach and shake the bottle well. Use a proper measuring device, not a kitchen teaspoon. If you miss a tablet dose, take it when you remember, but never double up.

What side effects should I expect?

▾
The most common are cold-like symptoms, headache, stomach pain, constipation and nausea. Call your doctor if you notice muscle pain, tenderness or weakness you can’t explain, especially with fever, or if your skin or eyes turn yellow.

Can I drink grapefruit juice?

▾
Avoid it. Grapefruit juice can raise simvastatin levels in your blood and increase the risk of muscle damage.

Do I need to tell you about my other medicines?

▾
Yes, always. Some antifungals, antibiotics like clarithromycin, HIV medicines, gemfibrozil and cyclosporine can’t be combined with simvastatin. Heart medicines such as amlodipine, diltiazem and verapamil limit how high the dose can go. Tell me about any blood thinner like warfarin or digoxin too, since those need monitoring.

Is it safe in pregnancy?

▾
No. Simvastatin may harm an unborn baby, so it’s not for people who are or may become pregnant, and breastfeeding isn’t recommended. If you get pregnant while taking it, stop it and call your doctor right away.

Is Simvastatin available over the counter?

▾
No. Simvastatin is a prescription medicine: every Simvastatin 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 Simvastatin first available?

▾
The earliest FDA record we hold for Simvastatin is from 1991: 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 Simvastatin was first used.

Who makes Simvastatin?

▾
27 companies currently list Simvastatin products in the FDA's NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC. 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 Simvastatin on HelloPharmacist

📊Simvastatin supplement interactions183 checked — ranked by severity 🌿Drug & Supplement CheckerSimvastatin vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Simvastatin NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Simvastatin 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.

Simvastatin forms and strengths (how it comes)

Simvastatin 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.

Tablet

By mouth
Brands Zocor
How this form is used
What it may be used for
  • Zocor and Simvastatin tablets are used for lowering LDL cholesterol in adults.
  • Zocor and Simvastatin tablets include dosing for children 10 and older with heterozygous familial hypercholesterolemia.
Important instructions
  • Zocor and Simvastatin tablets are taken by mouth once daily in the evening.
  • If you miss a dose of Zocor or Simvastatin tablets, take it as soon as possible. Do not double the next dose.
  • Zocor and Simvastatin tablet labels recommend a cholesterol check as early as 4 weeks after starting.
  • Zocor and Simvastatin tablet labels list a lower starting dose for people with severe kidney impairment.
Available strengths 5 strengths
5 mg 10 mg 20 mg 40 mg 80 mg
343 FDA-listed product records ⓘ

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

How Simvastatin 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.

27 companies list 159 Simvastatin product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1991. Brand names on the directory include Flolipid, Zocor; the rest are generics.

1
Dose forms ⓘ
27
Labelers (makers, repackagers, distributors)
2
Brand names
159
FDA-listed product records ⓘ
1991
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

A-S Medication Solutions15%
Bryant Ranch Prepack8%
Aphena Pharma Solutions - Tennessee, LLC8%
NuCare Pharmaceuticals,Inc.6%
Northwind Health Company, LLC4%
Proficient Rx LP4%
Other makers54%

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

How widely Simvastatin is used (Medicaid data)

A general measure of how commonly Simvastatin 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 Simvastatin 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.

1,357,663
Medicaid prescriptions filled (Q1–Q4 2025)
$11.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Simvastatin prescribed? Of the 1,601 medications we measure, Simvastatin ranks #137 by Medicaid prescriptions — more than 91% of them.

Where Simvastatin ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #137 of 1,601
#132 Zolpidem 1,428,857 Rx #133 Glipizide 1,400,626 Rx #134 Buprenorphine Buccal (... 1,379,027 Rx #135 Buprenorphine 1,379,027 Rx #136 Chlorhexidine 1,373,852 Rx #137 Simvastatin 1,357,663 Rx #138 Tretinoin 1,345,058 Rx #139 Tretinoin Topical 1,344,781 Rx #140 Dapagliflozin 1,339,664 Rx #141 Benztropine 1,314,428 Rx #142 Diphenhydramine 1,303,409 Rx

Utilization by Simvastatin 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 20 mg oral tablet is the most-dispensed Simvastatin product — about 49% of these Medicaid prescriptions.

simvastatin 20 MG Oral Tablet Most dispensed

671,949 Medicaid prescriptions (Q1–Q4 2025) 49% of Simvastatin prescriptions shown $5.6M gross reimbursement (before rebates) ≈ $8.36 per prescription (gross)

Summed across the 16 of 236 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312961

simvastatin 40 MG Oral Tablet

371,819 Medicaid prescriptions (Q1–Q4 2025) 27% of Simvastatin prescriptions shown $3.5M gross reimbursement (before rebates) ≈ $9.54 per prescription (gross)

Summed across the 15 of 248 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198211

simvastatin 10 MG Oral Tablet

260,069 Medicaid prescriptions (Q1–Q4 2025) 19% of Simvastatin prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $8.43 per prescription (gross)

Summed across the 16 of 190 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 314231

simvastatin 5 MG Oral Tablet

33,828 Medicaid prescriptions (Q1–Q4 2025) 2% of Simvastatin prescriptions shown $311,404 gross reimbursement (before rebates) ≈ $9.21 per prescription (gross)

Summed across the 7 of 103 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312962

simvastatin 80 MG Oral Tablet

19,998 Medicaid prescriptions (Q1–Q4 2025) 1% of Simvastatin prescriptions shown $240,917 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 8 of 127 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 200345

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 Simvastatin, 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 62 of 904 listed Simvastatin NDCs with Medicaid activity.

Compare Simvastatin products

A representative set of FDA-listed product records for Simvastatin — 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 97 of 159 products — FDA National Drug Code Directory. See every product, package size and price: browse all 159 Simvastatin NDCs →

Simvastatin side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Simvastatin — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Simvastatin are fatigue, nausea, dyspnoea; about 72% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

262,987
Reports mentioning it
72%
Reported as serious
12
Distinct effects shown
Most reported effects
Fatigue
14,525
Nausea
14,114
Dyspnoea
13,227
Diarrhoea
12,585
Dizziness
11,831
Pain
9,874
Asthenia
9,794
Fall
9,738
Headache
9,530
Myalgia
9,062
Age groups
Elderly · 19,530Adult · 9,678Neonate · 94Child · 39Infant · 26Adolescent · 20

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Simvastatin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Simvastatin FDA approval history

How Simvastatin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Simvastatin was first approved by the FDA in 1991 (Brand: ZOCOR · Organon); the first generic version was approved in 2006. It remains available in U.S. pharmacies today.

1991
Brand approved
Brand: ZOCOR · Organon
2006
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Simvastatin 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 one Simvastatin recall since July 2021, covering 5 product listings. It is no longer listed as ongoing. 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.

Class II Feb 7, 2023 · Terminated · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
  • Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Hea… Lots: Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/… FDA record D-0412-2023 →
  • Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord H… Lots: Batches: a) P2103713, P2103692, Exp. Date 5/31/2023, P2104950, P2104984, P2104969, P2104996, P2105274, P2105314, P2105316, Exp. Date 7/31/2023, R2101074, R2101077, R2101078, R2101079, R2101083, R2101084, R2101117, Exp. Date 8/31/2023, R210… FDA record D-0411-2023 →
  • Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Hea… Lots: Batches: a) P2102261, P2102284, P2102319, Exp. Date 3/31/2023, P2103536, Exp. Date 5/31/2023, P2104344, P2104342, P2104355, P2104356, P2104296, P2104380, Exp. Date 6/30/2023, R2200238, R2200239, Exp. Date 1/31/2024, R2200383, Exp. Date 2/2… FDA record D-0410-2023 →
  • Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord… Lots: Batches: a) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P21024… FDA record D-0409-2023 →
  • Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Heal… Lots: Batches: a) R2100818, Exp. Date 6/30/2023; R2100964, Exp. Date 6/30/2023; R2100824, Exp. Date 6/30/2023; R2100820, Exp. Date 6/30/2023; R2100822, Exp. Date 6/30/2023; R2101201, Exp. Date 9/30/2023; R2101198, Exp. Date 9/30/2023; R2101199,… FDA record D-0408-2023 →

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) Simvastatin RxCUI 36567 3 dose forms · 11 strengths
  1. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 757701 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 757702 20 MG RxCUI 757703 40 MG RxCUI 757704 80 MG RxCUI 757705
  2. Dose form (SCDF) Oral Suspension RxCUI 1790678 No current FDA listing
    Clinical drug / strength (SCD) 4 MG/ML RxCUI 1790679 8 MG/ML RxCUI 1944264
  3. Dose form (SCDF) Oral Tablet RxCUI 373888 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 312962 10 MG RxCUI 314231 20 MG RxCUI 312961 40 MG RxCUI 198211 80 MG RxCUI 200345

Look up RxCUI 36567 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 Simvastatin 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 80 mg $0.094 per tablet NDC details & price history
Tablet, Film Coated · Oral 5 mg $0.031 per tablet NDC details & price history
Tablet, Film Coated 5 mg $0.031 per tablet NDC details & price history
Tablet, Film Coated 80 mg $0.094 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.

Simvastatin brand names

Simvastatin is sold under 2 brand names in the FDA directory — Flolipid, Zocor. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Flolipid Zocor

Who makes Simvastatin: manufacturers and labelers

27 companies list Simvastatin products with the FDA. By number of product records, the largest are A-S Medication Solutions, Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

A-S Medication Solutions 24 Bryant Ranch Prepack 13 Aphena Pharma Solutions - Tennessee, LLC 12 NuCare Pharmaceuticals,Inc. 10 Northwind Health Company, LLC 7 Proficient Rx LP 7 PD-Rx Pharmaceuticals, Inc. 6 Remedyrepack Inc. 6 Accord Healthcare, Inc. 5 Aurobindo Pharma Limited 5 Biocon Pharma Inc, 5 Camber Pharmaceuticals, Inc. 5 Golden State Medical Supply, Inc. 5 Lupin Pharmaceuticals, Inc. 5 NorthStar Rx LLC 5 Quallent Pharmaceuticals Health LLC 5 XLCare Pharmaceuticals Inc. 5 Westminster Pharmaceuticals, LLC 4 American Health Packaging 3 Coupler LLC 3 Direct_Rx 3 NCS HealthCare of KY, LLC dba Vangard Labs 3 Organon LLC 3 Preferred Pharmaceuticals, Inc. 3

…and 3 more on the FDA NDC directory.

Simvastatin drug class (RxNorm)

Simvastatin belongs to the HMG-CoA Reductase Inhibitor class.

Pharmacologic class HMG-CoA Reductase Inhibitor
Drug family (ATC) Dipeptidyl peptidase 4 (DPP-4) inhibitors, 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 Simvastatin 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 Mar 28, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Simvastatin.
📈
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 Simvastatin after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
124
Finished products in the current FDA directory
159
Companies listing them (makers, repackagers, distributors)
27
FDA labeler codes behind them ⓘ
32
Linked representative label ⓘ
Organon LLC
Linked label effective
Mar 28, 2025
Composite sections available
23
Linked SPL Set ID
8f55d5de-5a4f-4a39-8c84-c53976dd6af9
Linked SPL Document ID
11256523-425c-48e8-afe1-e3a4e28c892e
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. Organon LLC 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 →