Is Par Health USA, LLC FDA approved?

Par Health USA, LLC holds 5 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Par Health USA, LLC's drugs manufactured?

At registered sites in India, the United States. The FDA register lists Chennai; Dhar; Navi Mumbai; Rochester, MI. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.

What drugs does Par Health USA, LLC make?

211 products are listed under Par Health USA, LLC in the openFDA NDC Directory, most often as tablet; injection; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Are any Par Health USA, LLC products in shortage?

4 presentations are currently listed in the FDA drug shortage database under Par Health USA, LLC, covering Dexmedetomidine Hydrochloride Injection, Methylprednisolone Acetate Injection.

Par Health USA, LLC

Data as of 2 Oct 2026 · How to read this entry

Request a quote Claim this profile

Registered sites: 5
Active NDC listings: 208
Labeller names: 3
Live patents: 1
Shortage listings: 12
Countries: 2
Base: India

Authorisation

Registered operations

Analytical testing4Active ingredient (API) manufacture1Labelling2Finished drug manufacture3Packaging3sterilize2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Par Active Technologies Private LimitedRegistrant: Par Health USA, LLC	Plot No. 16,17,31 & 32 Sidco Pharmaceutical Complex Alathur, Chengalpattu District, Chennai, TAMIL NADU 603110, India (IND)	Active ingredient (API) manufacture	3003597293650475218
Par Formulations Private LimitedRegistrant: Par Health USA, LLC	9/215, Pudupakkam-Vandalur Main Road, Pudupakkam, Kelambakkam,,, Chennai, Tamil Nadu 603103, India (IND)	Analytical testing, Finished drug manufacture, Packaging	3007027193676159161
Par Formulations Private LimitedRegistrant: Par Health USA, LLC	Plot No. M 82 & M 83, Industrial Area, Dhar, Madhya Pradesh 454775, India (IND)	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3016268582877850053
Par Formulations Private LimitedRegistrant: Par Health USA, LLC	Plot No. 8-A1/2 Kalwa Block, TTC Industrial Area Thane- Belapur Road, MIDC Digha-Airoli, Navi Mumbai, Maharashtra 400708, India (IND)	Analytical testing	3014425346675482528
Par Health USA, LLC	870 Parkdale Road, Rochester, Michigan (MI) 48307, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	1818977119548429

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Dexmedetomidine Hydrochloride InjectionAnesthesia	Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-186-20)	Current	Unavailable	10 Apr 20202 Oct 2026
Dexmedetomidine Hydrochloride InjectionAnesthesia	Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 42023-187-10)	Current	Unavailable	10 Apr 20202 Oct 2026
Methylprednisolone Acetate InjectionRheumatology	Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 42023-240-01)	Current	Unavailable	16 Jun 20222 Oct 2026
Dexmedetomidine Hydrochloride InjectionAnesthesia	Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 42023-146-25)	Current	Available	10 Apr 202018 Aug 2026
Micafungin Sodium InjectionAnti-Infective	Micafungin Sodium, Injection, 10 mg/1 mL (NDC 42023-229-10)	To Be Discontinued	-	11 Sept 202611 Sept 2026
Micafungin Sodium InjectionAnti-Infective	Micafungin Sodium, Injection, 20 mg/1 mL (NDC 42023-230-10)	To Be Discontinued	-	11 Sept 202611 Sept 2026
Lamotrigine Tablet, Extended ReleaseNeurology	Lamotrigine, Tablet, Extended Release, 25 mg (NDC 49884-561-11)	To Be Discontinued	-	29 Apr 202629 Apr 2026
Lamotrigine Tablet, Extended ReleaseNeurology	Lamotrigine, Tablet, Extended Release, 200 mg (NDC 49884-564-11)	To Be Discontinued	-	29 Apr 202629 Apr 2026
Lamotrigine Tablet, Extended ReleaseNeurology	Lamotrigine, Tablet, Extended Release, 50 mg (NDC 49884-562-11)	To Be Discontinued	-	29 Apr 202629 Apr 2026
Lamotrigine Tablet, Extended ReleaseNeurology	Lamotrigine, Tablet, Extended Release, 300 mg (NDC 49884-605-11)	To Be Discontinued	-	29 Apr 202629 Apr 2026
Lamotrigine Tablet, Extended ReleaseNeurology	Lamotrigine, Tablet, Extended Release, 100 mg (NDC 49884-563-11)	To Be Discontinued	-	29 Apr 202629 Apr 2026
Lamotrigine Tablet, Extended ReleaseNeurology	Lamotrigine, Tablet, Extended Release, 250 mg (NDC 49884-604-11)	To Be Discontinued	-	29 Apr 202629 Apr 2026

Catalogue

Drug listings by form and route

208

208 active NDC listings: 208 human prescription drug. By marketing category: ANDA 167, NDA 31, NDA AUTHORIZED GENERIC 6, UNAPPROVED DRUG OTHER 4.

Dosage form	NDCs
tablet	53
injection	30
capsule	21
tablet, film coated	19
tablet, orally disintegrating	19
capsule, extended release	14
tablet, film coated, extended release	7
injection, powder, lyophilized, for solution	6
injection, solution	6
kit	4
powder, for solution	4
powder, for suspension	4
solution	4
tablet, delayed release	3
capsule, delayed release	2

Route	NDCs
oral	153
intravenous	41
intramuscular	14
subcutaneous	5
nasal	2
sublingual	2
cutaneous	1
rectal	1

Labeller name on the listing	NDCs
par health usa, llc	206
par health	1
par pharmaceutical inc.	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7553863	ANTIZOLfomepizole	substance, product	Jun 2027

Catalogue

Marketed products

211

Showing 150 of 211.

Brand	Generic name	Form / route	NDC
ALISKIREN	ALISKIREN	tablet, film coated, oral	49884-424ANDA
ALISKIREN	ALISKIREN	tablet, film coated, oral	49884-425ANDA
ALVIMOPAN	ALVIMOPAN	capsule, oral	0254-3012ANDA
Adrenalin	epinephrine	injection, intramuscular, intravenous, subcutaneous	42023-159NDA
Adrenalin	epinephrine	injection, intramuscular, intravenous, subcutaneous	42023-168NDA
Adrenalin (epinephrine in sodium chloride)	Epinephrine in Sodium Chloride	injection, intravenous	42023-273NDA
Adrenalin (epinephrine in sodium chloride)	Epinephrine in Sodium Chloride	injection, intravenous	42023-315NDA
Adrenalin (epinephrine in sodium chloride)	Epinephrine in Sodium Chloride	injection, intravenous	42023-434NDA
Adrenalin (epinephrine in sodium chloride)	Epinephrine in Sodium Chloride	injection, intravenous	42023-500NDA
Adrenalin (epinephrine in sodium chloride)	Epinephrine in Sodium Chloride	injection, intravenous	42023-721NDA
Allopurinol	allopurinol	tablet, oral	0603-2115ANDA
Allopurinol	allopurinol	tablet, oral	0603-2116ANDA
Alprazolam	alprazolam	tablet, orally disintegrating, oral	49884-110ANDA
Alprazolam	alprazolam	tablet, orally disintegrating, oral	49884-111ANDA
Alprazolam	alprazolam	tablet, orally disintegrating, oral	49884-213ANDA
Alprazolam	alprazolam	tablet, orally disintegrating, oral	49884-214ANDA
Amiloride Hydrochloride	Amiloride Hydrochloride	tablet, oral	49884-117ANDA
Argatroban	Argatroban	injection, intravenous	42023-182ANDA
Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg	Aspirin and Extended - Release Dipyridamole	capsule, oral	49884-007ANDA
Baclofen	Baclofen	tablet, oral	0603-2406ANDA
Baclofen	Baclofen	tablet, oral	0603-2407ANDA
Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride	Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride	capsule, oral	49884-151ANDA
Bivalirudin	Bivalirudin	injection, solution, intravenous	42023-622NDA
Brevital Sodium	methohexital sodium	injection, powder, lyophilized, for solution, intramuscular, intravenous, rectal	42023-105NDA
Buprenorphine Hydrochloride	Buprenorphine Hydrochloride	injection, intramuscular, intravenous	42023-179ANDA
CALCITONIN SALMON	CALCITONIN SALMON	spray, metered, nasal	49884-161ANDA
Calcitonin Salmon	Calcitonin Salmon	injection, solution, intramuscular, subcutaneous	42023-205ANDA
Chlorzoxazone	Chlorzoxazone	tablet, oral	0254-2005ANDA
Chlorzoxazone	Chlorzoxazone	tablet, oral	0254-2053ANDA
Cholestyramine	cholestyramine	powder, for suspension, oral	49884-465ANDA
Cholestyramine	cholestyramine	powder, for suspension, oral	49884-466ANDA
Clonazepam	clonazepam	tablet, orally disintegrating, oral	49884-306ANDA
Clonazepam	clonazepam	tablet, orally disintegrating, oral	49884-307ANDA
Clonazepam	clonazepam	tablet, orally disintegrating, oral	49884-308ANDA
Clonazepam	clonazepam	tablet, orally disintegrating, oral	49884-309ANDA
Clonazepam	clonazepam	tablet, orally disintegrating, oral	49884-310ANDA
Colchicine	Colchicine	capsule, oral	0254-0460ANDA
Colchicine	colchicine	tablet, film coated, oral	49884-171ANDA
Coly-Mycin M	colistimethate	injection, intramuscular, intravenous	42023-107NDA
DOXYCYCLINE	Doxycycline	injection, powder, lyophilized, for solution, intravenous	42023-244ANDA
Dantrium	dantrolene sodium	injection, intravenous	42023-123NDA
Dantrium	dantrolene sodium	capsule, oral	42023-124NDA
Daptomycin	Daptomycin	injection, powder, lyophilized, for solution, intravenous	42023-295NDA
Delestrogen	estradiol valerate	injection, intramuscular	42023-110NDA
Delestrogen	estradiol valerate	injection, intramuscular	42023-111NDA
Dexlansoprazole	Dexlansoprazole	capsule, delayed release, oral	49884-147ANDA
Dexlansoprazole	Dexlansoprazole	capsule, delayed release, oral	49884-148ANDA
Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	injection, solution, concentrate, intravenous	42023-146ANDA
Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	injection, solution, intravenous	42023-186ANDA
Dexmedetomidine Hydrochloride	Dexmedetomidine Hydrochloride	injection, solution, intravenous	42023-187ANDA
Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-048ANDA
Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-049ANDA
Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-248ANDA
Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-333ANDA
Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-339ANDA
Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-546ANDA
Dexmethylphenidate Hydrochloride Extended-Release	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-428ANDA
Dexmethylphenidate Hydrochloride Extended-Release	Dexmethylphenidate Hydrochloride	capsule, extended release, oral	49884-430ANDA
Diazoxide	Diazoxide	suspension, oral	0254-1010ANDA
Diclofenac Potassium	Diclofenac Potassium	powder, for solution, oral	49884-905ANDA
Doxylamine Succinate and Pyridoxine Hydrochloride	Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg	tablet, delayed release, oral	49884-186ANDA
ENDOCET	Oxycodone and Acetaminophen	tablet, oral	60951-602ANDA
ENDOCET	Oxycodone and Acetaminophen	tablet, oral	60951-700ANDA
ENDOCET	Oxycodone and Acetaminophen	tablet, oral	60951-701ANDA
ENDOCET	Oxycodone and Acetaminophen	tablet, oral	60951-712ANDA
EPHEDRINE SULFATE	Ephedrine Sulfate	injection, intravenous	42023-243NDA
ETHACRYNATE SODIUM	ethacrynate sodium	injection, powder, for solution, intravenous	42023-157ANDA
Ephedrine Sulfate	Ephedrine Sulfate	injection, solution, intravenous	42023-216NDA
Everolimus	Everolimus	tablet, oral	49884-158ANDA
Everolimus	Everolimus	tablet, oral	49884-159ANDA
Everolimus	Everolimus	tablet, oral	49884-160ANDA
Everolimus	Everolimus	tablet, oral	49884-283ANDA
Fluoxetine	Fluoxetine	tablet, film coated, oral	49884-468ANDA
Fluphenazine Decanoate	Fluphenazine Decanoate	injection, solution, intramuscular, subcutaneous	42023-129ANDA
Fluvoxamine Maleate	Fluvoxamine Maleate	capsule, extended release, oral	10370-175ANDA
Fluvoxamine Maleate	Fluvoxamine Maleate	capsule, extended release, oral	10370-176ANDA
Glycerol Phenylbutyrate	Glycerol Phenylbutyrate oral	liquid, oral	49884-264ANDA
Glycopyrrolate	Glycopyrrolate	solution, oral	49884-042ANDA
Glycopyrrolate	glycopyrrolate	tablet, oral	49884-065ANDA
Glycopyrrolate	glycopyrrolate	tablet, oral	49884-066ANDA
Hydroxyurea	Hydroxyurea	capsule, oral	49884-724ANDA
Ibuprofen and famotidine	Ibuprofen and famotidine	tablet, oral	49884-366ANDA
Isosorbide Dinitrate	isosorbide dinitrate	tablet, oral	49884-009ANDA
Isosorbide Dinitrate	isosorbide dinitrate	tablet, oral	49884-020ANDA
Isosorbide Dinitrate	isosorbide dinitrate	tablet, oral	49884-021ANDA
Isosorbide Dinitrate	isosorbide dinitrate	tablet, oral	49884-022ANDA
Isosorbide Dinitrate	Isosorbide Dinitrate	tablet, oral	49884-556ANDA
Ketalar	ketamine hydrochloride	injection, intramuscular, intravenous	42023-113NDA
Ketalar	ketamine hydrochloride	injection, intramuscular, intravenous	42023-114NDA
Ketalar	ketamine hydrochloride	injection, intramuscular, intravenous	42023-115NDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	49884-484ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	49884-485ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	49884-486ANDA
Lamotrigine	Lamotrigine	tablet, orally disintegrating, oral	49884-487ANDA
Lamotrigine	Lamotrigine	kit	49884-880ANDA
Lamotrigine	Lamotrigine	kit	49884-881ANDA
Lamotrigine	Lamotrigine	kit	49884-882ANDA
Lamotrigine Extended-Release	lamotrigine	tablet, film coated, extended release, oral	10370-207ANDA
Lamotrigine Extended-Release	lamotrigine	tablet, film coated, extended release, oral	10370-208ANDA
Lamotrigine Extended-Release	lamotrigine	tablet, film coated, extended release, oral	10370-256ANDA
Lamotrigine Extended-Release	lamotrigine	tablet, film coated, extended release, oral	10370-334ANDA
Lidocaine	lidocaine	patch, cutaneous	0603-1880NDA AUTHORIZED GENERIC
Lubiprostone	Lubiprostone	capsule, gelatin coated, oral	0254-3028NDA AUTHORIZED GENERIC
Lubiprostone	Lubiprostone	capsule, gelatin coated, oral	0254-3029NDA AUTHORIZED GENERIC
MethylPREDNISolone	methylprednisolone	tablet, oral	0603-4593ANDA
Micafungin	Micafungin	injection, powder, lyophilized, for solution, intravenous	42023-229NDA
Micafungin	Micafungin	injection, powder, lyophilized, for solution, intravenous	42023-230NDA
Midodrine Hydrochloride	Midodrine Hydrochloride	tablet, oral	49884-814ANDA
Midodrine Hydrochloride	Midodrine Hydrochloride	tablet, oral	49884-849ANDA
Midodrine Hydrochloride	Midodrine Hydrochloride	tablet, oral	49884-874ANDA
Minoxidil	Minoxidil	tablet, oral	49884-256ANDA
Minoxidil	Minoxidil	tablet, oral	49884-257ANDA
Mycophenolate Mofetil	mycophenolate mofetil	injection, powder, lyophilized, for solution, intravenous	42023-172ANDA
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	injection, intravenous	42023-188ANDA
NEOSTIGMINE METHYLSULFATE	NEOSTIGMINE METHYLSULFATE	injection, intravenous	42023-189ANDA
Naloxone Hydrochloride	Naloxone Hydrochloride	injection, intramuscular, intravenous, subcutaneous	42023-224ANDA
Nascobal	cyanocobalamin	spray, nasal	49884-270NDA
Nitisinone	Nitisinone	capsule, oral	0254-3020ANDA
Nitisinone	Nitisinone	capsule, oral	0254-3021ANDA
Nitisinone	Nitisinone	capsule, oral	0254-3022ANDA
Olanzapine and Fluoxetine	olanzapine and fuoxetine	capsule, oral	49884-250ANDA
Olanzapine and Fluoxetine	olanzapine and fuoxetine	capsule, oral	49884-251ANDA
Olanzapine and Fluoxetine	olanzapine and fuoxetine	capsule, oral	49884-252ANDA
Olanzapine and Fluoxetine	olanzapine and fuoxetine	capsule, oral	49884-253ANDA
Olanzapine and Fluoxetine	olanzapine and fuoxetine	capsule, oral	49884-277ANDA
Omega-3-acid ethyl esters	Omega-3-acid ethyl esters	capsule, oral	0254-3010ANDA
PRAZIQUANTEL	PRAZIQUANTEL	tablet, film coated, oral	49884-231ANDA
Penicillamine	penicillamine	capsule, oral	49884-146ANDA
Perphenazine	perphenazine	tablet, film coated, oral	0603-5060ANDA
Perphenazine	perphenazine	tablet, film coated, oral	0603-5061ANDA
Perphenazine	perphenazine	tablet, film coated, oral	0603-5062ANDA
Perphenazine	perphenazine	tablet, film coated, oral	0603-5063ANDA
Phenobarbital	phenobarbital	tablet, oral	0603-5165UNAPPROVED DRUG OTHER
Phenobarbital	phenobarbital	tablet, oral	0603-5166UNAPPROVED DRUG OTHER
Phenobarbital	phenobarbital	tablet, oral	0603-5167UNAPPROVED DRUG OTHER
Phenobarbital	phenobarbital	tablet, oral	0603-5168UNAPPROVED DRUG OTHER
Phenylephrine hydrochloride	Phenylephrine hydrochloride	injection, intravenous	42023-214ANDA
Phenylephrine hydrochloride	Phenylephrine hydrochloride	injection, intravenous	42023-215ANDA
Pimozide	Pimozide	tablet, oral	49884-347ANDA
Pimozide	Pimozide	tablet, oral	49884-348ANDA
Pitocin	oxytocin	injection, intravenous	42023-116NDA
Pitocin	oxytocin	injection, intravenous	42023-130NDA
Posaconazole	Posaconazole	injection, intravenous	42023-195ANDA
Prednisone	Prednisone	tablet, oral	0603-5335ANDA
Prednisone	Prednisone	tablet, oral	0603-5336ANDA
Prednisone	Prednisone	tablet, oral	0603-5337ANDA
Prednisone	Prednisone	tablet, oral	0603-5338ANDA
Prednisone	Prednisone	tablet, oral	0603-5339ANDA
Propranolol Hydrochloride	propranolol hydrochloride	tablet, oral	0603-5482ANDA
Propranolol Hydrochloride	propranolol hydrochloride	tablet, oral	0603-5483ANDA

Neighbours

Registered in the same town

Sandoz Industrial Products S.ANavi Mumbai, IND · 2 sites
Felix Pharmaceuticals PVT LimitedDhar, IND · 2 sites
SGS North America Inc.Navi Mumbai, IND
Lupin LimitedDhar, IND
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Rochester, MI
Glenmark Pharmaceuticals Inc., USADhar, IND
Piramal Healthcare (Canada) LimitedNavi Mumbai, IND
Indoco Remedies LimitedNavi Mumbai, IND
Ipca Laboratories LimitedDhar, IND
Macleods Pharmaceuticals LimitedDhar, IND
NATCO PHARMA LIMITEDChennai, IND
Rubicon Research Canada LimitedDhar, IND

Compare

Comparable companies in India

Macleods Pharmaceuticals Limited5 sites · 390 NDC
Unichem Laboratories Limited, India5 sites · 272 NDC
Strides Pharma Science Limited5 sites · 230 NDC
Torrent Pharma, Inc.5 sites · 184 NDC
Micro Labs Limited5 sites · 141 NDC
Matrix Pharmacorp Private Limited5 sites · 122 NDC
NATCO PHARMA LIMITED5 sites · 108 NDC
LAURUS LABS LIMITED5 sites · 87 NDC
Encube Ethicals Limited5 sites · 77 NDC
SHILPA MEDICARE LIMITED5 sites · 4 NDC

Enquiry

Common questions

Is Par Health USA, LLC FDA approved?: Par Health USA, LLC holds 5 FDA-registered establishments across 2 countries. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Par Health USA, LLC's drugs manufactured?: At registered sites in India, the United States. The FDA register lists Chennai; Dhar; Navi Mumbai; Rochester, MI. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
What drugs does Par Health USA, LLC make?: 211 products are listed under Par Health USA, LLC in the openFDA NDC Directory, most often as tablet; injection; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Are any Par Health USA, LLC products in shortage?: 4 presentations are currently listed in the FDA drug shortage database under Par Health USA, LLC, covering Dexmedetomidine Hydrochloride Injection, Methylprednisolone Acetate Injection.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.