Drug company (FDA labeler)
Mayne Pharma Inc.
NDC labeler codes: 51862, 68308
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
- MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 3 products
- Nortriptyline hydrochloridePamelor · 1 product
- TazaroteneTazorac, Fabior, Arazlo · 1 product
- IvermectinStromectol, Soolantra · 1 product
- Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 1 product
- FluorouracilFavlyxa, Tolak, Efudex · 1 product
- Adapalene and benzoyl peroxideEpiduo Forte · 1 product
- DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 1 product
- ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 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 |
|---|---|---|---|
| July 15, 2015 | NDA207917 | Adapalene and benzoyl peroxide EPIDUO FORTE | Galderma Labs |
| December 19, 2014 | NDA206255 | Ivermectin SOOLANTRA | Galderma Labs LP |
| May 11, 2012 | NDA202428 | Tazarotene FABIOR | Mayne Pharma |
| August 20, 2010 | ANDA079090 | Clonidine CLONIDINE | DR Reddys Labs SA |
| April 11, 2008 | ANDA077524 | Fluorouracil FLUOROURACIL | DR Reddys Labs SA |
| May 26, 2006 | NDA050805 | Doxycycline ORACEA | Galderma Labs LP |
| June 30, 2005 | NDA021789 | Metronidazole METROGEL | Galderma Labs LP |
| February 5, 2004 | NDA021644 | Clobetasol propionate CLOBEX | Galderma Labs |
| November 24, 1998 | NDA020901 | Metronidazole METROLOTION | Galderma Labs LP |
| September 20, 1995 | NDA020531 | Metronidazole METROCREAM | Galderma Labs LP |
| March 30, 1992 | ANDA073556 | Nortriptyline hydrochloride NORTRIPTYLINE HYDROCHLORIDE | DR Reddys Labs SA |
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