Labeler · US market

Marlex Pharmaceuticals Inc

Marlex Pharmaceuticals Inc is a US drug labeler with US FDA registrations covering 54 drug concepts (54 currently active) across 189 packages. It is currently the only active US supplier of 7 drugs. The company files with FDA under 2 name variants, merged into this profile.

Also files as: Marlex PHARMACEUTICAL, INC

ACTIVE — US

openFDA · updated weekly

Labeler codes10135

Active drugs54

Registrations107 active / 107

Packages189

Sole supplier of7 drugs

Portfolio54 drugs · US

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

Drug	Type	NDCs	Packages	Status
Venlafaxine Hydrochloride capsule, extended release	rx	3	12	SUPPLYING
Haloperidol tablet	rx	6	12	SUPPLYING
Furosemide tablet	rx	3	9	SUPPLYING
Prednisone tablet	rx	5	9	SUPPLYING
Desvenlafaxine tablet, extended release	rx	2	8	SUPPLYING
Ropinirole tablet, film coated	rx	7	7	SUPPLYING
Prazosin Hydrochloride capsule	rx	3	6	SUPPLYING
Labetalol tablet, film coated	rx	3	6	SUPPLYING
Bisoprolol Fumarate And Hydrochlorothiazide tablet	rx	3	6	SUPPLYING
Metolazone tablet	rx	3	6	SUPPLYING
Hydroxyzine Hydrochloride tablet, film coated	rx	3	6	SUPPLYING
Benztropine Mesylate tablet	rx	3	6	SUPPLYING
Baclofen tablet	rx	2	6	SUPPLYING
Lacosamide tablet, film coated	rx	4	5	SUPPLYING
Alendronate Sodium Tablet tablet	rx	2	5	SUPPLYING
Cetirizine Hydrochloride tablet	otc	1	5	SUPPLYING
Methocarbamol tablet, film coated	rx	2	4	SUPPLYING
Digoxin tablet	rx	2	4	SUPPLYING
Fluphenazine Hydrochloride tablet	rx	4	4	SUPPLYING
Loratadine tablet	rx	1	3	SUPPLYING
Isoniazid tablet	rx	2	3	SUPPLYING
Guaifenesin tablet	otc	2	3	SUPPLYING
Pyrazinamide Tablet tablet	rx	1	3	SUPPLYING
Ezetimibe tablet	rx	1	3	SUPPLYING
Aspirin tablet	otc	1	2	SUPPLYING
Acetazolamide tablet	rx	2	2	SUPPLYING
Lidocaine cream	otc	1	2	SUPPLYING
Acetaminophen tablet	otc	2	2	SUPPLYING
Hydrocortisone Acetate suppository	rx	1	2	SUPPLYING
Magnesium Oxide tablet	otc	2	2	SUPPLYING
Amantadine Hydrochloride tablet	rx	1	2	SUPPLYING
Ethambutol Hydrochloride tablet, film coated	rx	2	2	SUPPLYING
Levocetirizine Dihydrochloride tablet, film coated	rx	1	2	SUPPLYING
Probenecid tablet, film coated	rx	1	2	SUPPLYING
Varenicline Tartrate tablet, film coated	rx	2	2	SUPPLYING
Clotrimazole solution	rx	1	2	SUPPLYING
Potassium Chloride For Oral Solution powder, for solution	rx	1	2	SUPPLYING
Pindolol tablet	rx	2	2	SUPPLYING
Doxepin tablet, film coated	rx	2	2	SUPPLYING
Atenolol And Chlorthalidone Tablet tablet	rx	2	2	SUPPLYING

Showing 40 of 54 drugs by package count.

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 codes10135
Filing names2
Drugs (active)54
Drugs (all time)54
US registrations107
Packages189

Recent events

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

Aug 25, 2023
RECALLRecall (Class I): Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc…
Aug 25, 2023
RECALLRecall (Class II): Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.…
Aug 8, 2013
RECALLRecall (Class II): Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, …

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.