Is Endo USA, Inc. FDA approved?

Endo USA, Inc. holds 3 FDA-registered establishments in the United States. 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 Endo USA, Inc.'s drugs manufactured?

The FDA register lists Cranbury, NJ; Horsham, PA; Rye, NY. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.

What drugs does Endo USA, Inc. make?

33 products are listed under Endo USA, Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; tablet; capsule, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Endo USA, Inc.

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 3
Active NDC listings: 32
Labeller names: 3
Live patents: 38
Shortage listings: 20
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Labelling1Finished drug manufacture2Packaging1sterilize2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Endo USA, Inc.	8 Clarke Drive Suite 6, Cranbury, New Jersey (NJ) 08512, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	2243842119190017
Endo USA, Inc.	102 Witmer Road, Horsham, Pennsylvania (PA) 19044, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3006537159119189998
Endo USA, Inc.	70 High Street, Rye, New York (NY) 10580-1506, United States (USA)	Finished drug manufacture, sterilize	2410861119190377

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Frovatriptan Succinate TabletNeurology	Frova, Tablet, 2.5 mg (NDC 63481-025-09)	To Be Discontinued	-	24 Feb 202624 Feb 2026
Everolimus TabletTransplant	Everolimus, Tablet, 5 mg (NDC 49884-125-91)	To Be Discontinued	-	6 Jan 20266 Jan 2026
Everolimus TabletTransplant	Everolimus, Tablet, 2.5 mg (NDC 49884-119-91)	To Be Discontinued	-	6 Jan 20266 Jan 2026
Everolimus TabletTransplant	Everolimus, Tablet, 10 mg (NDC 49884-128-91)	To Be Discontinued	-	6 Jan 20266 Jan 2026
Everolimus TabletTransplant	Everolimus, Tablet, 7.5 mg (NDC 49884-127-91)	To Be Discontinued	-	6 Jan 20266 Jan 2026
Frovatriptan Succinate TabletNeurology	Frova, Tablet, 2.5 mg (NDC 0603-3718-34)	To Be Discontinued	-	12 Nov 202512 Nov 2025
Acetaminophen; Oxycodone Hydrochloride TabletAnalgesia/Addiction	Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 5 mg (NDC 60951-602-85)	To Be Discontinued	-	3 Nov 20253 Nov 2025
Acetaminophen; Oxycodone Hydrochloride TabletAnalgesia/Addiction	Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 2.5 mg (NDC 63481-627-70)	To Be Discontinued	-	3 Nov 20253 Nov 2025
Acetaminophen; Oxycodone Hydrochloride TabletAnalgesia/Addiction	Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 10 mg (NDC 60951-712-70)	To Be Discontinued	-	3 Nov 20253 Nov 2025
Acetaminophen; Oxycodone Hydrochloride TabletAnalgesia/Addiction	Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 2.5 mg (NDC 60951-701-70)	To Be Discontinued	-	3 Nov 20253 Nov 2025
Acetaminophen; Oxycodone Hydrochloride TabletAnalgesia/Addiction	Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 7.5 mg (NDC 60951-700-70)	To Be Discontinued	-	3 Nov 20253 Nov 2025
Acetaminophen; Oxycodone Hydrochloride TabletAnalgesia/Addiction	Acetaminophen; Oxycodone Hydrochloride, Tablet, 325 mg; 5 mg (NDC 60951-602-70)	To Be Discontinued	-	3 Nov 20253 Nov 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 32.4 mg (NDC 0603-5166-32)	To Be Discontinued	-	31 Oct 202531 Oct 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 16.2 mg (NDC 0603-5165-21)	To Be Discontinued	-	31 Oct 202531 Oct 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 97.2 mg (NDC 0603-5168-21)	To Be Discontinued	-	31 Oct 202531 Oct 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 64.8 mg (NDC 0603-5167-21)	To Be Discontinued	-	31 Oct 202531 Oct 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 64.8 mg (NDC 0603-5167-32)	To Be Discontinued	-	31 Oct 202531 Oct 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 16.2 mg (NDC 0603-5165-32)	To Be Discontinued	-	31 Oct 202531 Oct 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 97.2 mg (NDC 0603-5168-32)	To Be Discontinued	-	31 Oct 202531 Oct 2025
Phenobarbital TabletAnalgesia/Addiction, Neurology, Other	Phenobarbital, Tablet, 32.4 mg (NDC 0603-5166-21)	To Be Discontinued	-	31 Oct 202531 Oct 2025

Catalogue

Drug listings by form and route

32 active NDC listings: 30 human prescription drug, 2 human otc drug. By marketing category: NDA 14, ANDA 13, NDA AUTHORIZED GENERIC 2, OTC MONOGRAPH DRUG 2, BLA 1.

Dosage form	NDCs
injection, powder, lyophilized, for solution	8
tablet	5
capsule, extended release	4
injection	3
suspension	2
tablet, extended release	2
gel	1
implant	1
kit	1
pellet	1
powder, for solution	1
solution, concentrate	1
tablet, coated	1
tablet, film coated, extended release	1

Route	NDCs
oral	15
intravenous	6
intracavernous	3
subcutaneous	3
intramuscular	2
auricular (otic)	1
intravesical	1
transdermal	1

Labeller name on the listing	NDCs
endo usa, inc.	19
endo usa, inc.	10
endo usa	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7776007	SUMAVEL DOSEPROsumatriptan succinate	product	Nov 2026
7718640	AVEEDtestosterone undecanoate	product	Mar 2027
8338395	AVEEDtestosterone undecanoate	use	May 2027
8808737	OPANA ERoxymorphone hydrochloride	use	Jun 2027
7851482	OPANA ERoxymorphone hydrochloride	substance	Jul 2029
8871779	OPANA ERoxymorphone hydrochloride	substance	Nov 2029

Catalogue

Marketed products

Showing 32 of 33.

Brand	Generic name	Form / route	NDC
Aveed	testosterone undecanoate	injection, intramuscular	67979-511NDA
Benztropine Mesylate	benztropine mesylate	tablet, oral	0603-2433ANDA
Benztropine Mesylate	benztropine mesylate	tablet, oral	0603-2434ANDA
Benztropine Mesylate	benztropine mesylate	tablet, oral	0603-2435ANDA
Cortisporin TC	colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate	suspension, auricular (otic)	63481-529NDA
ERTAPENEM	ertapenem sodium	injection, powder, lyophilized, for solution, intramuscular, intravenous	42023-221NDA
Edex	alprostadil	injection, powder, lyophilized, for solution, intracavernous	52244-010NDA
Edex	alprostadil	injection, powder, lyophilized, for solution, intracavernous	52244-020NDA
Edex	alprostadil	injection, powder, lyophilized, for solution, intracavernous	52244-040NDA
Felodipine	Felodipine	tablet, extended release, oral	0603-3581ANDA
Felodipine	Felodipine	tablet, extended release, oral	0603-3582ANDA
Felodipine	Felodipine	tablet, film coated, extended release, oral	0603-3583ANDA
Ganciclovir	Ganciclovir	injection, powder, lyophilized, for solution, intravenous	42023-173ANDA
LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	injection, subcutaneous	42023-259ANDA
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	injection, powder, lyophilized, for solution, intravenous	42023-201NDA
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	injection, powder, lyophilized, for solution, intravenous	42023-202NDA
Levothyroxine Sodium	LEVOTHYROXINE SODIUM ANHYDROUS	injection, powder, lyophilized, for solution, intravenous	42023-203NDA
Magnesium Oxide	Magnesium Oxide	tablet, oral	0603-0209OTC MONOGRAPH DRUG
Magnesium Oxide	Magnesium Oxide	tablet, oral	0603-0213OTC MONOGRAPH DRUG
POSACONAZOLE	posaconazole	suspension, oral	0254-1016NDA AUTHORIZED GENERIC
POSACONAZOLE	posaconazole	tablet, coated, oral	0254-2045NDA AUTHORIZED GENERIC
PREVDUO	neostigmine methylsulfate and glycopyrrolate	injection, intravenous	42023-269NDA
Potassium Chloride	Potassium Chloride	powder, for solution, oral	0603-1554NDA
SUPPRELIN LA	histrelin acetate	implant, subcutaneous	67979-002NDA
Testim	testosterone	gel, transdermal	66887-001NDA
Testopel	testosterone	pellet, subcutaneous	66887-004ANDA
Theo-24	theophylline anhydrous	capsule, extended release, oral	52244-100ANDA
Theo-24	theophylline anhydrous	capsule, extended release, oral	52244-200ANDA
Theo-24	theophylline anhydrous	capsule, extended release, oral	52244-300ANDA
Theo-24	theophylline anhydrous	capsule, extended release, oral	52244-400ANDA
Valstar	valrubicin	solution, concentrate, intravesical	67979-001NDA
XIAFLEX	collagenase clostridium histolyticum	kit	66887-003BLA

Neighbours

Registered in the same town

WuXi Biologics Co., Ltd.Cranbury, NJ · 2 sites
Mentholatum Company, TheHorsham, PA
Taikun Pharmaceutical Technology IncCranbury, NJ
SciSafe, Inc.Cranbury, NJ
CMIC CMO USA CORPORATIONCranbury, NJ
David WoodCranbury, NJ
E-BEAM Services, Inc.Cranbury, NJ
Eurofins S-F Analytical Laboratories, Inc.Horsham, PA
J-star Research Inc.Cranbury, NJ
National Medical Services, Inc. dba NMS LabsHorsham, PA
Primera Analytical Solutions CorporationCranbury, NJ
Tris Pharma, Inc.Cranbury, NJ

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Aurolife Pharma LLC3 sites · 70 NDC
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Enquiry

Common questions

Is Endo USA, Inc. FDA approved?: Endo USA, Inc. holds 3 FDA-registered establishments in the United States. 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 Endo USA, Inc.'s drugs manufactured?: The FDA register lists Cranbury, NJ; Horsham, PA; Rye, NY. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
What drugs does Endo USA, Inc. make?: 33 products are listed under Endo USA, Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; tablet; capsule, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.