Data / Drug companies / Ezetimibe and simvastatin
Ezetimibe and simvastatin: 8 companies and 27 products in the FDA NDC directory
Ezetimibe and simvastatin is listed in the FDA National Drug Code Directory by 8 companies, with 27 products in commercial distribution. 23 of the products (85.2%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, and the newest product started marketing on March 1, 2024.
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- Companies listing it
- 8
- Products
- 27
- Generic (ANDA) products
- 23 (85.2%)
- Application numbers
- 5
- Routes
- Oral
- Brand names
- Vytorin
- openFDA record search
- api.fda.gov
Companies that list ezetimibe and simvastatin
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Ascend Laboratories, LLC | 4 | tablet | Generic drugs (ANDA) | December 24, 2017 |
| Aurobindo Pharma Limited | 4 | tablet | Generic drugs (ANDA) | March 1, 2024 |
| Dr. Reddy's Laboratories Inc. | 4 | tablet | Generic drugs (ANDA) | November 20, 2018 |
| Glenmark Pharmaceuticals Inc., USA | 4 | tablet | Generic drugs (ANDA) | June 27, 2019 |
| Golden State Medical Supply, Inc. | 4 | tablet | Generic drugs (ANDA) | April 26, 2017 |
| Organon LLC | 4 | tablet | New drug applications (NDA) | June 1, 2021 |
| A-S Medication Solutions | 2 | tablet | Generic drugs (ANDA) | August 19, 2019 |
| NorthStar Rx LLC | 1 | tablet | Generic drugs (ANDA) | August 19, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 27 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 23 | 85.2% |
| New drug applications (NDA) | 4 | 14.8% |
Pharmacologic classes
| Class | Products |
|---|---|
| Dietary Cholesterol Absorption Inhibitor | 27 |
| HMG-CoA Reductase Inhibitor | 27 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.