Drug
Who makes fluvastatin sodium?
3 companies list fluvastatin sodium as a human prescription drug, including under the names Lescol XL. Forms: tablet, extended release; tablet, film coated, extended release. 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 fluvastatin sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sandoz Industrial Products S.AAustria | tablet, extended release | NDA, NDA AUTHORIZED GENERICNDA021192 | 2 | 5 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated, extended release | ANDAANDA079011 | 1 | 6 |
| Lannett Company, LLCUnited States | tablet, film coated, extended release | ANDAANDA209397 | 1 | 1 |
Bulk ingredient listings
- Biocon Biologics LimitedIndia · 1 NDC
- FIS FABBRICA ITALIANA SINTETICI SPAItaly · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
Enquiry
Common questions
- Who makes fluvastatin sodium?
- 3 companies list fluvastatin sodium as a human prescription drug in the openFDA NDC Directory, led by Sandoz Industrial Products S.A, Teva Pharmaceutical Industries Ltd., Lannett Company, 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 Lescol XL?
- 2 companies list fluvastatin sodium 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.
- Who supplies fluvastatin sodium active ingredient?
- 3 companies list fluvastatin sodium as a bulk ingredient, including Biocon Biologics Limited, FIS FABBRICA ITALIANA SINTETICI SPA, MSN Laboratories Private Limited,.