Labeler · US market

Padagis US LLC

Padagis US LLC is a US drug labeler with US FDA registrations covering 39 drug concepts (36 currently active) across 93 packages. It is currently the only active US supplier of 6 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes0574

Active drugs36

Registrations58 active / 63

Packages93

Sole supplier of6 drugs

Portfolio39 drugs · US

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

Drug	Type	NDCs	Packages	Status
Lenalidomide capsule	rx	6	6	SUPPLYING
Tretinoin cream	rx	3	6	SUPPLYING
Loteprednol Etabonate suspension/ drops	rx	2	5	SUPPLYING
Activated Charcoal suspension	otc	2	5	SUPPLYING
Morphine Sulfate suppository	rx	4	4	SUPPLYING
Tretinoin gel	rx	2	4	SUPPLYING
Methylphenidate patch	rx	4	4	SUPPLYING
Testosterone Cypionate injection, solution	rx	2	4	SUPPLYING
Hydromorphone Hydrochloride tablet, extended release	rx	4	4	SUPPLYING
Atropa Belladonna And Opium suppository	rx	2	4	SUPPLYING
Clotrimazole lozenge	rx	1	3	SUPPLYING
Nystatin powder	rx	1	3	SUPPLYING
Ciclopirox gel	rx	1	3	SUPPLYING
Spironolactone suspension	rx	1	3	SUPPLYING
Tobramycin And Dexamethasone suspension/ drops	rx	1	3	SUPPLYING
Hydrocortisone Acetate suppository	rx	2	2	SUPPLYING
Brinzolamide suspension/ drops	rx	1	2	SUPPLYING
Estradiol spray	rx	1	2	SUPPLYING
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, And Dextromethorphan Hydrobromide syrup	rx	1	2	SUPPLYING
Bromocriptine Mesylate tablet	rx	1	2	SUPPLYING
Bisacodyl suppository	otc	1	2	SUPPLYING
Hydromorphone Hydrochloride suppository	rx	1	1	SUPPLYING
Prochlorperazine suppository	rx	1	1	SUPPLYING
Lidocaine And Prilocaine cream	rx	1	1	SUPPLYING
Podofilox solution	rx	1	1	SUPPLYING
Aspirin suppository	otc	1	1	SUPPLYING
Paroxetine capsule	rx	1	1	SUPPLYING
Tofacitinib Citrate tablet, film coated, extended release	rx	1	1	SUPPLYING
Budesonide capsule	rx	1	1	SUPPLYING
Amiloride Hydrochloride tablet	rx	1	1	SUPPLYING
Podophyllum Resin tincture	rx	1	1	SUPPLYING
Midazolam Hydrochloride syrup	rx	1	1	SUPPLYING
Acetylcysteine injection	rx	1	1	SUPPLYING
Podofilox gel	rx	1	1	SUPPLYING
Trospium Chloride tablet, film coated	rx	1	1	SUPPLYING
Trospium Chloride capsule, extended release	rx	1	1	SUPPLYING
Benazepril Hydrochloride And Hydrochlorothiazide tablet	rx	2	2	DISCONTINUED
Methazolamide tablet	rx	2	2	DISCONTINUED
Flavoxate Hydrochloride tablet, film coated	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 codes0574
Filing names1
Drugs (active)36
Drugs (all time)39
US registrations63
Packages93

Recent events

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

May 15, 2026
RESOLVEDShortage resolved: Activated Charcoal Oral Suspension (Padagis US LLC)
May 15, 2026
SHORTAGEDrug shortage: Activated Charcoal Oral Suspension (Padagis US LLC)
Nov 3, 2025
RESOLVEDShortage resolved: Scopolamine Transdermal System (Padagis US LLC)
Nov 3, 2025
SHORTAGEDrug shortage: Scopolamine Transdermal System (Padagis US LLC)
Mar 3, 2025
SHORTAGEDrug shortage: Bacitracin Ophthalmic Ointment (Padagis US LLC)
Feb 28, 2025
SHORTAGEDrug shortage: Methylphenidate Film, Extended Release (Noven Pharmaceuticals, Inc.)
Feb 6, 2025
RECALLRecall (Class II): Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham,…
Oct 11, 2024
RECALLRecall (Class III): Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 5542…

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; figures cover the entity across all its filing names.