Labeler · US market

Mayne Pharma Inc.

Mayne Pharma Inc. is a US drug labeler with US FDA registrations covering 38 drug concepts (36 currently active) across 95 packages. It is currently the only active US supplier of 8 drugs. The company files with FDA under 3 name variants, merged into this profile.

Also files as: Mayne Pharma · Mayne Pharma LLC

ACTIVE — US

openFDA · updated weekly

Labeler codes50261 · 51862 · 68308

Active drugs36

Registrations61 active / 63

Packages95

Sole supplier of8 drugs

Portfolio38 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Norethindrone Acetate/Ethinyl Estradiol And Ferrous Fumarate kit	rx	3	11	SUPPLYING
Isotretinoin capsule, liquid filled	rx	8	8	SUPPLYING
Norgestimate And Ethinyl Estradiol kit	rx	2	8	SUPPLYING
Estradiol And Progesterone capsule	rx	4	7	SUPPLYING
Estradiol insert	rx	4	6	SUPPLYING
Norethindrone Acetate/Ethinyl Estradiol kit	rx	2	6	SUPPLYING
Desogestrel And Ethinyl Estradiol kit	rx	1	4	SUPPLYING
Ndac And Ee Tablets And Ferrous Fumarate Tablets kit	rx	1	3	SUPPLYING
Desogestrel/Ethinyl Estradiol And Ethinyl Estradiol kit	rx	1	3	SUPPLYING
Oxymetazoline Hydrochloride cream	rx	2	3	SUPPLYING
Norethindrone And Ethinyl Estradiol kit	rx	1	3	SUPPLYING
Calcipotriene aerosol, foam	rx	2	2	SUPPLYING
Ethynodiol Diacetate And Ethinyl Estradiol Tablets kit	rx	1	2	SUPPLYING
Drospirenone And Estetrol kit	rx	1	2	SUPPLYING
Methylphenidate Hydrochloride capsule, extended release	rx	2	2	SUPPLYING
Norethindrone tablet	rx	2	2	SUPPLYING
Tamoxifen Citrate liquid	rx	1	2	SUPPLYING
Tazarotene aerosol, foam	rx	2	2	SUPPLYING
Halobetasol Propionate aerosol, foam	rx	2	2	SUPPLYING
Metronidazole gel	rx	1	2	SUPPLYING
Tretinoin gel	rx	1	1	SUPPLYING
Clindamycin Phosphate And Benzoyl Peroxide gel	rx	1	1	SUPPLYING
Nortriptyline Hydrochloride capsule	rx	1	1	SUPPLYING
Adapalene And Benzoyl Peroxide gel	rx	1	1	SUPPLYING
Doxycycline capsule	rx	1	1	SUPPLYING
Clobetasol Propionate shampoo	rx	1	1	SUPPLYING
Fluorouracil cream	rx	1	1	SUPPLYING
Dapsone gel	rx	1	1	SUPPLYING
Tazarotene cream	rx	1	1	SUPPLYING
Metronidazole cream	rx	1	1	SUPPLYING
Ivermectin cream	rx	1	1	SUPPLYING
Segesterone Acetate And Ethinyl Estradiol ring	rx	1	1	SUPPLYING
Metronidazole lotion	rx	1	1	SUPPLYING
Ethinyl Estradiol And Levonorgestrel kit	rx	1	0	SUPPLYING
Clonidine patch, extended release	rx	1	0	SUPPLYING
Levonorgestrel And Ethinyl Estradiol kit	rx	3	0	SUPPLYING
Norgestrel And Ethinyl Estradiol kit	rx	1	1	DISCONTINUED
Butalbital, Acetaminophen And Caffeine capsule	rx	1	1	DISCONTINUED

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes50261, 51862, 68308
Filing names3
Drugs (active)36
Drugs (all time)38
US registrations63
Packages95

Recent events

Shortages, recalls, and registration changes across all filing names.

Jun 9, 2022
RECALLRecall (Class II): Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufa…
Jan 14, 2022
RECALLRecall (Class II): Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville,…
Mar 2, 2020
RECALLRecall (Class II): Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-…
Aug 21, 2018
RECALLRecall (Class III): Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Green…
Mar 21, 2018
RECALLRecall (Class III): Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-2…
Nov 9, 2017
RECALLRecall (Class II): Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile (see “Also files as” above); figures cover the entity across all its filing names.