Prescription medicine
Simvastatin Brand names: Zocor
Simvastatin (Zocor) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.0321 per simvastatin 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the simvastatin FDA label on DailyMed (effective March 28, 2025, Organon LLC); the NDA 19766 record on Drugs@FDA; every simvastatin label on DailyMed.
Highlights of the record
FDA label of March 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZOCOR ® is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
- 40 mg
- 80 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 23, 1991 Zocor, Organon; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first June 23, 2006; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 27 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 23, 2030 Flolipid oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0321 per tablet Simvastatin 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 26 since 2013 0 Class I among all firms' recalls; latest April 6, 2023; 3 more by firms not listed as its makers
- FAERS reports
- 248,728 through July 30, 2026
What is simvastatin used for?
From the label: indications and usageZOCOR ® is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). […]
Conditions named in the indications of simvastatin's FDA labels, with every medicine labeled for each:
From other simvastatin labelsHigh triglycerides: Hypertriglyceridemia.
FDA pharmacologic class: HMG-CoA Reductase Inhibitor.
Source: FDA drug label (ZOCOR), Organon LLC, effective March 28, 2025 (SPL set 8f55d5de-5a4f-4a39-8c84-c53976dd6af9), via openFDA; the full label on DailyMed
Is there a generic for simvastatin (Zocor)?
The FDA approved the first generic simvastatin on June 23, 2006. 16 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists simvastatin from 27 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zocor tablets; a patent listed only for Flolipid oral suspension runs to February 23, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1991 earliest approval on file
- 2006 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for simvastatin (Zocor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0321 per Simvastatin 20 mg tablet, up 5% from $0.0307 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Simvastatin 20 mg tablet (generic)
- Zocor 20 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Simvastatin 10 mg tablet | Generic | $0.0281 per tablet | $0.842 | +0.8% |
| Simvastatin 20 mg tablet | Generic | $0.0321 per tablet | $0.964 | +5% |
| Simvastatin 40 mg tablet | Generic | $0.0538 per tablet | $1.61 | +0.9% |
| Simvastatin 5 mg tablet | Generic | $0.0314 per tablet | $0.941 | -11% |
| Simvastatin 80 mg tablet | Generic | $0.0938 per tablet | $2.81 | -3% |
| Zocor 20 mg tablet | Brand | $9.73 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $291.83 | +3% |
| Zocor 40 mg tablet | Brand | $9.73 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $291.88 | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has simvastatin been recalled?
The FDA's Enforcement Report lists 29 recalls naming simvastatin since 2013: 0 Class I (the most serious), 22 Class II, 7 Class III; 4 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of simvastatin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 6, 2023 | Class II | PD-Rx Pharmaceuticals, Inc. | CGMP deviations. |
| March 23, 2023 | Class II | Preferred Pharmaceuticals, Inc. | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
| March 20, 2023 | Class II | RemedyRepack Inc. | cGMP Deviations |
| March 13, 2023 | Class II | Direct Rx | cGMP deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| March 18, 2020 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed |
| July 29, 2019 | Class III | Aurobindo Pharma USA Inc. | Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B |
| December 22, 2017 | Class III | Hetero Labs, Ltd. - Unit III | Presence of foreign substance: metallic razor blade was found in one bottle. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the simvastatin label say about other medicines?
The simvastatin label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 41 other medicines name simvastatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ZOCOR. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ZOCOR 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see ]. |
| Amlodipine | drug interactions | For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see Dosage and Administration (2.5) ]. |
| Clarithromycin | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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 … |
| Colchicine | drug interactions | Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with ZOCOR. Intervention: Consider if the benefit of using colchicine concomitantly with ZOCOR outweighs the increased risk of myopathy and rhabdomyolysis. … |
| Cyclosporine | contraindications | Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any … |
| Danazol | contraindications | Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any … |
| Daptomycin | drug interactions | Clinical Impact: Cases of rhabdomyolysis have been reported with simvastatin administered with daptomycin. Both ZOCOR and daptomycin can cause myopathy and rhabdomyolysis when given alone and the risk of myopathy and rhabdomyolysis may be increased by … Intervention: If treatment with daptomycin is required, consider temporarily suspending ZOCOR during the course of daptomycin treatment. |
| Darunavir | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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. |
| Digoxin | drug interactions | Obtain INR before ZOCOR initiation and monitor INR during ZOCOR dosage initiation or adjustment. ( 7.2 ) Digoxin: During ZOCOR initiation, monitor digoxin levels. |
| Diltiazem | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ZOCOR. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ZOCOR 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see ]. |
| Dronedarone | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ZOCOR. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ZOCOR 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see ]. |
| Erythromycin | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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 … |
| Ezetimibe | drug interactions | Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with ZOCOR. The risk of myopathy is greater in Chinese patients. … Intervention: Concomitant use of ZOCOR with lipid-modifying dosages of niacin is not recommended in Chinese patients [see ]. For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin … |
| Gemfibrozil | contraindications | Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) ( 4 , 7.1 ) Concomitant use of cyclosporine, danazol or gemfibrozil ( 4 , 7.1 ) Acute liver failure or decompensated cirrhosis ( 4 , 5.3 ) Hypersensitivity to simvastatin or any … |
Every other medicine the simvastatin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Itraconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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 … |
| Ketoconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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 … |
| Lomitapide | drug interactions | Clinical Impact: Simvastatin exposure is approximately doubled with concomitant use of lomitapide and the risk of myopathy and rhabdomyolysis is increased. Intervention: Reduce the dose of ZOCOR by 50% if initiating lomitapide. Do not exceed ZOCOR 20 mg daily (or ZOCOR 40 mg daily for patients who have previously taken an 80 mg daily dosage of ZOCOR chronically) while … |
| Nefazodone | contraindications | … azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see Drug Interactions (7.1) ]. |
| Nelfinavir | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … (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 … |
| Niacin | drug interactions | Niacin Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of lipid modifying dosages of niacin-containing products (≥1 gram/day niacin) with ZOCOR. The risk of myopathy is greater in Chinese patients. … Intervention: Concomitant use of ZOCOR with lipid-modifying dosages of niacin is not recommended in Chinese patients [see ]. For non-Chinese patients, consider if the benefit of using lipid-modifying doses of niacin … |
| Posaconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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 … |
| Ranolazine | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ZOCOR. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ZOCOR 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see ]. |
| Ritonavir | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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 … |
| Verapamil | drug interactions | Amiodarone, Dronedarone, Ranolazine, or Calcium Channel Blockers Clinical Impact: The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, dronedarone, ranolazine, or calcium channel blockers with ZOCOR. Intervention: For patients taking verapamil, diltiazem, or dronedarone, do not exceed ZOCOR 10 mg daily. For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ZOCOR 20 mg daily [see ]. |
| Voriconazole | drug interactions | Strong CYP3A4 inhibitors Clinical Impact: Simvastatin is a substrate of CYP3A4. Concomitant use of strong CYP3A4 inhibitors with ZOCOR increases simvastatin exposure and increases the risk of myopathy and rhabdomyolysis, particularly with higher ZOCOR dosages. … 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 … |
| Warfarin | drug interactions | Coumarin Anticoagulants Clinical Impact: ZOCOR may potentiate the effect of coumarin anticoagulants and increase the INR. The concomitant use of ZOCOR (20 to 40 mg) and coumarin anticoagulants increased the INR from a baseline of 1.7 to 1.8 in healthy subjects and from 2.6 to 3.4 in … Intervention: In patients taking coumarin anticoagulants, obtain an INR before starting ZOCOR and frequently enough after initiation, dose titration, or discontinuation to ensure that no significant alteration in INR … |
Other labels that name simvastatin
- Atazanavir
- Avacopan
- Bempedoic acid
- Cobicistat
- Deferasirox
- Efavirenz
- Elbasvir and grazoprevir
- Eltrombopag
- Ensitrelvir
- Eslicarbazepine
- Etravirine
- Everolimus
- Fluconazole
- Fosamprenavir
- Fostemsavir
- Glecaprevir and pibrentasvir
- Leflunomide
- Lenacapavir
- Letermovir
- Levamlodipine
- Lonafarnib
- Mifepristone
- Nirmatrelvir and ritonavir
- Orforglipron
- Paclitaxel
- Pazopanib
- Quinine
- Ramipril
- Resmetirom
- Sofosbuvir and velpatasvir and voxilaprevir
- Teriflunomide
- Ticagrelor
- Tocilizumab
- Voclosporin
Source: FDA drug label (ZOCOR), Organon LLC, effective March 28, 2025 (SPL set 8f55d5de-5a4f-4a39-8c84-c53976dd6af9), via openFDA; the full label on DailyMed
What do FAERS reports show for simvastatin?
The FDA Adverse Event Reporting System holds 248,728 reports that list simvastatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22,213 are coded as a death and 95,730 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as simvastatin?
12 other medicines are given the same way (oral) and in the same FDA class as simvastatin or labeled mainly for the same use (heart attack and coronary artery disease), the same class first. Heart attack and coronary artery disease lists all 38 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Atorvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Rosuvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 46 labelers | $0.0692 per tablet 40 mg tablet | No current entry |
| Pravastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 37 labelers | $0.058 per tablet 20 mg tablet | No current entry |
| Amlodipine and atorvastatin | Heart attack and coronary artery disease, High cholesterol, High triglycerides | 6 labelers | $1.34 per unit 10-40 mg | No current entry |
| Lovastatin | Heart attack and coronary artery disease, High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Fluvastatin | High cholesterol | 4 labelers | $2.88 per tablet 80 mg tablet | A presentation being discontinued |
| Gemfibrozil | Heart attack and coronary artery disease, High cholesterol | 27 labelers | $0.104 per tablet 600 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as simvastatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does simvastatin compare with medicines for the same use?
10 side-by-side pages set simvastatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to simvastatin
- 12 medicines for the same use
- Other statins
- the pharmacologic class, with prices and generics
- Simvastatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other