Quick answers
- What is Simvastatin used for?
- The FDA-approved label (Zocor, Organon LLC, March 28, 2025) says: “ZOCOR ® 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Simvastatin have a boxed warning?
- No. None of the 110 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Simvastatin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Simvastatin been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started February 7, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Simvastatin?
- 27 companies list prescription products of Simvastatin in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Aphena Pharma Solutions - Tennessee, LLC.
What Simvastatin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZOCOR ® 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. …
— FDA label: Zocor, Organon LLC, effective March 28, 2025. Read the full label on DailyMed →
The FDA has 110 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 110 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 159 in the FDA NDC Directory |
| Brand names | Zocor |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| simvastatin 10 mg tablet, film coated | Generic | $0.0278 per tablet |
| simvastatin 20 mg tablet, film coated | Generic | $0.0324 per tablet |
| simvastatin 20 mg tablet, film coated | Brand: Zocor | $9.73 per tablet |
| simvastatin 40 mg tablet, film coated | Generic | $0.0523 per tablet |
| simvastatin 40 mg tablet, film coated | Brand: Zocor | $9.73 per tablet |
| simvastatin 5 mg tablet, film coated | Generic | $0.0315 per tablet |
| simvastatin 80 mg tablet, film coated | Generic | $0.0908 per tablet |
NADAC list of November 4, 2026; these prices took effect between January 1, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions24 products
- Bryant Ranch Prepack13 products
- Aphena Pharma Solutions - Tennessee, LLC12 products
- NuCare Pharmaceuticals, Inc.10 products
- Northwind Health Company, LLC7 products
- Proficient Rx LP7 products
- Remedyrepack Inc.6 products
- PD-Rx Pharmaceuticals, Inc.6 products
- XLCare Pharmaceuticals, Inc.5 products
- Quallent Pharmaceuticals Health LLC5 products
- NorthStar Rx LLC5 products
- Camber Pharmaceuticals, Inc.5 products
- Aurobindo Pharma Limited5 products
- Golden State Medical Supply, Inc.5 products
- Lupin Pharmaceuticals, Inc.5 products
- Biocon Pharma Inc.5 products
- Accord Healthcare Inc.5 products
- Westminster Pharmaceuticals, LLC4 products
- QPharma, Inc.3 products
- St. Mary's Medical Park Pharmacy3 products
- Coupler LLC3 products
- Preferred Pharmaceuticals Inc.3 products
- Direct_Rx3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- American Health Packaging3 products
- Organon LLC3 products
- Cardinal Health 107, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019766 ZOCOR | Organon | December 23, 1991 | 86, latest August 9, 2023 2023: Labeling · 2023: Labeling · 2022: Labeling |
Generic approvals (6)
- ANDA077691Aurobindo Pharma · December 20, 2006
- ANDA078034Biocon Pharma · December 20, 2006
- ANDA078103Lupin · May 11, 2007
- ANDA078155Accord Hlthcare · February 26, 2008
- ANDA200895Hetero Labs Ltd III · November 25, 2014
- ANDA211394Pharmobedient · November 27, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 7, 2023 · Class II · Terminated · D-0412-2023
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 Healthcare, Inc., Durham — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0408-2023
CGMP Deviations: recalling drug products following an FDA inspection.
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 Healthcare, Inc., Durham, — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0409-2023
CGMP Deviations: recalling drug products following an FDA inspection.
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 Healthcare, Inc., Dur — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0410-2023
CGMP Deviations: recalling drug products following an FDA inspection.
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 Healthcare, Inc., Durham — Accord Healthcare, Inc.
-
February 7, 2023 · Class II · Terminated · D-0411-2023
CGMP Deviations: recalling drug products following an FDA inspection.
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 Healthcare, Inc., Durh — Accord Healthcare, Inc.
-
March 18, 2020 · Class II · Terminated · D-1234-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90 — Aurobindo Pharma USA Inc.
-
July 29, 2019 · Class III · Terminated · D-1842-2019
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99 — Aurobindo Pharma USA Inc.
-
December 22, 2017 · Class III · Terminated · D-0223-2018
Presence of foreign substance: metallic razor blade was found in one bottle.
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055 — Hetero Labs, Ltd. - Unit III
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zocor, Organon LLC, effective March 28, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →