Drug company (FDA labeler)
Mayne Pharma
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
- IsotretinoinZenatane, Absorica, Accutane · 8 products
- TazaroteneTazorac, Fabior, Arazlo · 2 products
- Oxymetazoline hydrochlorideRhofade, Upneeq · 2 products
- CalcipotrienePellix, Calcitrene, Sorilux · 2 products
- Halobetasol propionateBryhali, Lexette, Ultravate · 2 products
- Clindamycin phosphate and benzoyl peroxideOnexton, Acanya, Neuac · 1 product
- Tamoxifen citrateSoltamox · 1 product
- Segesterone acetate and ethinyl estradiolAnnovera · 1 product
- DapsoneAczone · 1 product
- TretinoinRetin-A, Retin-A Micro, Altreno · 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 |
|---|---|---|---|
| August 20, 2024 | ANDA209610 | Clindamycin phosphate and benzoyl peroxide CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | Padagis Israel |
| October 13, 2023 | ANDA212383 | Dapsone DAPSONE | Encube |
| August 22, 2023 | ANDA215609 | Tretinoin TRETINOIN MICROSPHERE | Encube |
| August 11, 2023 | ANDA215266 | Halobetasol propionate HALOBETASOL PROPIONATE | Padagis Israel |
| September 21, 2021 | ANDA212333 | Isotretinoin ISOTRETINOIN | Upsher Smith Labs |
| April 12, 2021 | ANDA213571 | Isotretinoin ISOTRETINOIN | Upsher Smith Labs |
| August 10, 2018 | NDA209627 | Segesterone acetate and ethinyl estradiol ANNOVERA | Mayne Pharma |
| December 22, 2017 | ANDA208662 | Tazarotene TAZAROTENE | Cosette Pharms Nc |
| January 18, 2017 | NDA208552 | Oxymetazoline hydrochloride RHOFADE | Mayne Pharma |
| May 11, 2012 | NDA202428 | Tazarotene FABIOR | Mayne Pharma |
| January 19, 2012 | ANDA076485 | Isotretinoin MYORISAN | Upsher Smith Labs |
| October 6, 2010 | NDA022563 | Calcipotriene SORILUX | Mayne Pharma |
| October 29, 2005 | NDA021807 | Tamoxifen citrate SOLTAMOX | Mayne Pharma Commrcl |
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.
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