Is Genus Lifesciences Inc. FDA approved?

Genus Lifesciences Inc. holds 2 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 Genus Lifesciences Inc.'s drugs manufactured?

The FDA register lists Allentown, PA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Genus Lifesciences Inc. make?

46 products are listed under Genus Lifesciences Inc. in the openFDA NDC Directory, most often as tablet; solution; cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Genus Lifesciences Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 46
Labeller names: 2
Live patents: 7
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling2Finished drug manufacture2Packaging2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Genus Lifesciences Inc.	514 North 12th Street, Allentown, Pennsylvania (PA) 18102, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003851100113290444
Genus Lifesciences Inc.	700 North Fenwick Street, Allentown, Pennsylvania (PA) 18109, United States (USA)	Labelling, Finished drug manufacture, Packaging	3014677161080270217

Catalogue

Drug listings by form and route

46 active NDC listings: 46 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 20, ANDA 19, NDA 5, NDA AUTHORIZED GENERIC 2.

Dosage form	NDCs
tablet	27
solution	13
cream	1
powder, for solution	1
solution/ drops	1
suspension	1
syrup	1
tincture	1

Route	NDCs
oral	41
topical	3
auricular (otic)	1
ophthalmic	1

Labeller name on the listing	NDCs
genus lifesciences	25
genus lifesciences inc.	21

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8460641	VERDESOdesonide	product	Aug 2027
8734847	TIVORBEXindomethacin	product	Apr 2030
8992982	TIVORBEXindomethacin	product	Apr 2030
9089471	TIVORBEXindomethacin	use	Apr 2030

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Acetaminophen and Codeine Phosphate	Acetaminophen and Codeine Phosphate	solution, oral	64950-374ANDA
Butalbital, Acetaminophen and Caffeine	Butalbital, Acetaminophen, and Caffeine	solution, oral	64950-290ANDA
Carbinoxamine Maleate	Carbinoxamine Maleate	tablet, oral	64950-211ANDA
Carbinoxamine Maleate	Carbinoxamine Maleate	solution, oral	64950-243ANDA
Ciprofloxacin Otic	Ciprofloxacin	solution/ drops, auricular (otic)	64950-381ANDA
Clemastine Fumarate	Clemastine Fumarate	tablet, oral	64950-268ANDA
Clemastine Fumarate	Clemastine Fumarate	syrup, oral	64950-324ANDA
Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate	solution, ophthalmic	64950-390ANDA
Flurbiprofen	Flurbiprofen	tablet, oral	64950-218ANDA
HALOG	Halcinonide Topical	solution, topical	64950-127NDA
Halog	Halcinonide Cream	cream, topical	64950-126NDA
Hydrocodone Bitartrate and Acetaminophen	hydrocodone bitartrate and acetaminophen	solution, oral	64950-343ANDA
Hydrocodone Bitartrate and Acetaminophen	hydrocodone bitartrate and acetaminophen	solution, oral	64950-373ANDA
Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide	tablet, oral	64950-206NDA AUTHORIZED GENERIC
Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide	solution, oral	64950-371NDA AUTHORIZED GENERIC
Isoniazid	isoniazid	tablet, oral	64950-216ANDA
Isoniazid	isoniazid	tablet, oral	64950-217ANDA
Isosorbide Mononitrate	Isosorbide Mononitrate	tablet, oral	64950-250ANDA
Isosorbide Mononitrate	Isosorbide Mononitrate	tablet, oral	64950-251ANDA
Meperidine Hydrochloride	Meperidine Hydrochloride	tablet, oral	64950-214ANDA
Metoclopramide	Metoclopramide Hydrochloride	solution, oral	64950-344ANDA
NYSTATIN	NYSTATIN	suspension, oral	64950-372ANDA
Opium	morphine	tincture, oral	64950-258UNAPPROVED DRUG OTHER
Oxycodone Hydrochloride	Oxycodone Hydrochloride	solution, oral	64950-354NDA
PHENAZOPYRIDINE HYDROCHLORIDE	PHENAZOPYRIDINE HYDROCHLORIDE	tablet, oral	64950-550UNAPPROVED DRUG OTHER
PHENAZOPYRIDINE HYDROCHLORIDE	PHENAZOPYRIDINE HYDROCHLORIDE	tablet, oral	64950-551UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-571UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-572UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-573UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-574UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-575UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-576UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-577UNAPPROVED DRUG OTHER
PHENOBARBITAL	PHENOBARBITAL	tablet, oral	64950-578UNAPPROVED DRUG OTHER
Potassium Chloride	Potassium Chloride	solution, oral	64950-320NDA
Potassium Chloride	Potassium Chloride	powder, for solution, oral	64950-321NDA
Promethazine Hydrochloride and Phenylephrine Hydrochloride	promethazine hydrochloride and phenylephrine hydrochloride	solution, oral	64950-345ANDA
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-170UNAPPROVED DRUG OTHER
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-171UNAPPROVED DRUG OTHER
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-172UNAPPROVED DRUG OTHER
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-173UNAPPROVED DRUG OTHER
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-174UNAPPROVED DRUG OTHER
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-175UNAPPROVED DRUG OTHER
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-179UNAPPROVED DRUG OTHER
RenThyroid	LEVOTHYROXINE and LIOTHYRONINE	tablet, oral	64950-180UNAPPROVED DRUG OTHER
Silver Nitrate	Silver Nitrate	solution, topical	64950-378UNAPPROVED DRUG OTHER

Neighbours

Registered in the same town

FOCUS Scientific ServicesAllentown, PA
Fisher Clinical ServicesAllentown, PA
Sharp Packaging Services, LLCAllentown, PA
Specialty Formulations and Manufacturing LLCAllentown, PA

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Enquiry

Common questions

Is Genus Lifesciences Inc. FDA approved?: Genus Lifesciences Inc. holds 2 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 Genus Lifesciences Inc.'s drugs manufactured?: The FDA register lists Allentown, PA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Genus Lifesciences Inc. make?: 46 products are listed under Genus Lifesciences Inc. in the openFDA NDC Directory, most often as tablet; solution; cream. 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.