Drug company (FDA labeler)
Salix Pharmaceuticals, Inc.
NDC labeler code: 65649
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Methylnaltrexone bromideRelistor · 3 products
- RifaximinXifaxan · 2 products
- PlecanatideTrulance Immediate Release · 1 product
- BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 1 product
- ChlorothiazideDiuril · 1 product
- HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 product
- MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| January 19, 2017 | NDA208745 | Plecanatide TRULANCE | Salix |
| July 19, 2016 | NDA208271 | Methylnaltrexone bromide RELISTOR | Salix |
| October 7, 2014 | NDA205613 | Budesonide UCERIS | Salix |
| October 31, 2008 | NDA022301 | Mesalamine APRISO | Salix |
| April 24, 2008 | NDA021964 | Methylnaltrexone bromide RELISTOR | Salix Pharms |
| May 25, 2004 | NDA021361 | Rifaximin XIFAXAN | Salix Pharms |
| June 6, 1984 | ANDA088250 | Hydrocortisone ANUSOL HC | Salix Pharms |
| October 6, 1961 | NDA011870 | Chlorothiazide DIURIL | Salix Pharms |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- 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