Drug company (FDA labeler)
Sebela Pharmaceuticals Inc.
NDC labeler code: 54766
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
- Hydrocortisone acetate and pramoxine hydrochlorideAnalpram Hc, Pramosone, Pramosone Cream · 2 products
- Alosetron hydrochlorideLotronex · 2 products
- AuranofinRidaura · 1 product
- Naftifine hydrochlorideNaftin · 1 product
- Difenoxin and atropine sulfateMotofen · 1 product
- AzathioprineImuran, Azasan · 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 |
|---|---|---|---|
| June 27, 2013 | NDA204286 | Naftifine hydrochloride NAFTIN | Legacy |
| February 9, 2000 | NDA021107 | Alosetron hydrochloride LOTRONEX | Legacy |
| May 24, 1985 | NDA018689 | Auranofin RIDAURA | Legacy |
| July 14, 1978 | NDA017744 | Difenoxin and atropine sulfate MOTOFEN, MOTOFEN HALF-STRENGTH | Legacy |
| June 5, 1978 | ANDA085979 | Hydrocortisone acetate and pramoxine hydrochloride PRAMOSONE | Legacy |
| June 5, 1978 | ANDA085980 | Hydrocortisone acetate and pramoxine hydrochloride PRAMOSONE | Legacy |
| March 20, 1968 | NDA016324 | Azathioprine IMURAN | Legacy |
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