Drug company (FDA labeler)
Advanz Pharma (US) Corp.
NDC labeler code: 59212
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
- DigoxinLanoxin · 3 products
- PrednisoloneOrapred ODT · 3 products
- TriamtereneDyrenium · 2 products
- Pilocarpine hydrochlorideSalagen, Qlosi · 2 products
- ZonisamideZonegran, Zonisade · 2 products
- Tranylcypromine sulfateParnate · 1 product
- Alfuzosin hydrochlorideUroxatral · 1 product
- Hydroxychloroquine sulfatePlaquenil, Sovuna · 1 product
- AlitretinoinPanretin · 1 product
- Etonogestrel and ethinyl estradiolNuvaring, Enilloring, Eluryng · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 1, 2006 | NDA021959 | Prednisolone ORAPRED ODT | Advanz Pharma |
| June 12, 2003 | NDA021287 | Alfuzosin hydrochloride UROXATRAL | Advanz Pharma |
| October 3, 2001 | NDA021187 | Etonogestrel and ethinyl estradiol NUVARING | Organon USA Organon |
| March 27, 2000 | NDA020789 | Zonisamide ZONEGRAN | Advanz Pharma |
| February 2, 1999 | NDA020886 | Alitretinoin PANRETIN | Advanz Pharma |
| September 30, 1997 | NDA020405 | Digoxin LANOXIN | Advanz Pharma |
| March 22, 1994 | NDA020237 | Pilocarpine hydrochloride SALAGEN | Advanz Pharma |
| August 10, 1964 | NDA013174 | Triamterene DYRENIUM | Advanz Pharma |
| February 21, 1961 | NDA012342 | Tranylcypromine sulfate PARNATE | Advanz Pharma |
| April 18, 1955 | NDA009768 | Hydroxychloroquine sulfate PLAQUENIL | Advanz Pharma |
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