Labeler · US market

Par Health USA, LLC

Par Health USA, LLC is a US drug labeler with US FDA registrations covering 75 drug concepts (69 currently active) across 204 packages. It is currently the only active US supplier of 10 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes0254 · 0603 · 10370 · 42023 · 49884 · 60951

Active drugs69

Registrations139 active / 156

Packages204

Sole supplier of10 drugs

Portfolio75 drugs · US

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

Drug	Type	NDCs	Packages	Status
Prednisone tablet	rx	5	15	SUPPLYING
Dexmethylphenidate Hydrochloride capsule, extended release	rx	8	10	SUPPLYING
Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide tablet, film coated	rx	5	10	SUPPLYING
Risperidone tablet, orally disintegrating	rx	6	8	SUPPLYING
Everolimus tablet	rx	7	7	SUPPLYING
Cholestyramine powder, for suspension	rx	2	6	SUPPLYING
Oxytocin injection	rx	2	6	SUPPLYING
Vasopressin injection	rx	4	6	SUPPLYING
Epinephrine In Sodium Chloride injection	rx	5	5	SUPPLYING
Clonazepam tablet, orally disintegrating	rx	5	5	SUPPLYING
Olanzapine And Fuoxetine capsule	rx	5	5	SUPPLYING
Baclofen tablet	rx	2	5	SUPPLYING
Allopurinol tablet	rx	2	5	SUPPLYING
Lamotrigine tablet, film coated, extended release	rx	4	4	SUPPLYING
Alprazolam tablet, orally disintegrating	rx	4	4	SUPPLYING
Epinephrine injection	rx	2	4	SUPPLYING
Lamotrigine tablet, orally disintegrating	rx	4	4	SUPPLYING
Fluoxetine Hydrochloride tablet, coated	rx	2	4	SUPPLYING
Ketamine Hydrochloride injection	rx	3	3	SUPPLYING
Lamotrigine kit	rx	3	3	SUPPLYING
Dexlansoprazole capsule, delayed release	rx	2	3	SUPPLYING
Minoxidil tablet	rx	2	3	SUPPLYING
Phenylephrine Hydrochloride injection	rx	2	2	SUPPLYING
Lubiprostone capsule, gelatin coated	rx	2	2	SUPPLYING
Aliskiren tablet, film coated	rx	2	2	SUPPLYING
Sapropterin Dihydrochloride powder, for solution	rx	2	2	SUPPLYING
Ephedrine Sulfate injection	rx	1	2	SUPPLYING
Methylprednisolone tablet	rx	1	2	SUPPLYING
Colchicine tablet, film coated	rx	1	2	SUPPLYING
Varenicline Tartrate tablet, film coated	rx	2	2	SUPPLYING
Ursodiol tablet, film coated	rx	2	2	SUPPLYING
Ephedrine Sulfate injection, solution	rx	1	2	SUPPLYING
Neostigmine Methylsulfate injection	rx	2	2	SUPPLYING
Micafungin injection, powder, lyophilized, for solution	rx	2	2	SUPPLYING
Bivalirudin injection, solution	rx	1	2	SUPPLYING
Dexmedetomidine Hydrochloride injection, solution	rx	2	2	SUPPLYING
Estradiol Valerate injection	rx	2	2	SUPPLYING
Argatroban injection	rx	1	2	SUPPLYING
Zolpidem Tartrate Sublingual tablet	rx	2	2	SUPPLYING
Methohexital Sodium injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING

Showing 40 of 75 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 codes0254, 0603, 10370, 42023, 49884, 60951
Filing names1
Drugs (active)69
Drugs (all time)75
US registrations156
Packages204

Recent events

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

Jun 12, 2026
RECALLRecall (Class II): Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Int…
Apr 29, 2026
RESOLVEDShortage resolved: Lamotrigine Tablet, Extended Release (Par Health, Inc.)
Apr 29, 2026
SHORTAGEDrug shortage: Lamotrigine Tablet, Extended Release (Par Health, Inc.)
Jan 6, 2026
RESOLVEDShortage resolved: Everolimus Tablet (Endo Pharmaceuticals, Inc.)
Jan 6, 2026
SHORTAGEDrug shortage: Everolimus Tablet (Endo Pharmaceuticals, Inc.)
Nov 3, 2025
RESOLVEDShortage resolved: Acetaminophen; Oxycodone Hydrochloride Tablet (Endo Pharmaceuticals, Inc.)
Nov 3, 2025
SHORTAGEDrug shortage: Acetaminophen; Oxycodone Hydrochloride Tablet (Endo Pharmaceuticals, Inc.)
Oct 31, 2025
RESOLVEDShortage resolved: Phenobarbital Tablet (Endo Pharmaceuticals, Inc.)

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.