Drug
Who makes ezetimibe and simvastatin?
9 companies list ezetimibe and simvastatin as a human prescription drug, including under the names VYTORIN. Forms: tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing ezetimibe and simvastatin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Glenmark Pharmaceuticals Inc., USAIndia | tablet | ANDAANDA208699 | 4 | 9 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA200082 | 4 | 6 |
| Organon LLCNetherlands | tablet | NDANDA021687 | 4 | 4 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA200909 | 4 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA209222 | 4 | 0 |
| Amneal Pharmaceuticals NY LLC | tablet | ANDAANDA208831 | 4 | 0 |
| Dr. Reddys Laboratories Limited | tablet | ANDAANDA200909 | 4 | 0 |
| Northstar Rx, LLC, | tablet | ANDAANDA208699 | 4 | 0 |
| International Medication Systems, Ltd.United States | tablet | ANDAANDA208699, ANDA209222 | 2 | 3 |
Enquiry
Common questions
- Who makes ezetimibe and simvastatin?
- 9 companies list ezetimibe and simvastatin as a human prescription drug in the openFDA NDC Directory, led by Glenmark Pharmaceuticals Inc., USA, Aurobindo Pharma Limited, Organon LLC, Golden State Medical Supply Inc., ASCEND Therapeutics US, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic VYTORIN?
- 8 companies list ezetimibe and simvastatin under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.