Is Upsher-Smith Laboratories, Inc. FDA approved?

Upsher-Smith Laboratories, Inc. holds no registered establishment of its own; 230 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Upsher-Smith Laboratories, Inc. make?

230 products are listed under Upsher-Smith Laboratories, Inc. in the openFDA NDC Directory, most often as tablet; capsule, extended release; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Upsher-Smith Laboratories, Inc.

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

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Registered sites: 0
Active NDC listings: 213
Labeller names: 6
Live patents: 31
Shortage listings: 6
Countries: 0

Alert

Drug shortage listings

Drug	Presentation	Status	Availability	Posted / updated
Morphine Sulfate TabletAnalgesia/Addiction	Morphine Sulfate, Tablet, 30 mg (NDC 0832-0274-11)	To Be Discontinued	-	22 Dec 202522 Dec 2025
Morphine Sulfate TabletAnalgesia/Addiction	Morphine Sulfate, Tablet, 15 mg (NDC 0832-0273-11)	To Be Discontinued	-	22 Dec 202522 Dec 2025
Fluphenazine Hydrochloride TabletNeurology, Psychiatry	Fluphenazine Hydrochloride, Tablet, 2.5 mg (NDC 0832-6004-11)	To Be Discontinued	-	18 Sept 202518 Sept 2025
Fluphenazine Hydrochloride TabletNeurology, Psychiatry	Fluphenazine Hydrochloride, Tablet, 10 mg (NDC 0832-6006-11)	To Be Discontinued	-	18 Sept 202518 Sept 2025
Fluphenazine Hydrochloride TabletNeurology, Psychiatry	Fluphenazine Hydrochloride, Tablet, 5 mg (NDC 0832-6005-11)	To Be Discontinued	-	18 Sept 202518 Sept 2025
Fluphenazine Hydrochloride TabletNeurology, Psychiatry	Fluphenazine Hydrochloride, Tablet, 1 mg (NDC 0832-6003-11)	To Be Discontinued	-	18 Sept 202518 Sept 2025

Catalogue

Drug listings by form and route

213

213 active NDC listings: 213 human prescription drug. By marketing category: ANDA 172, NDA 29, NDA AUTHORIZED GENERIC 11, UNAPPROVED DRUG OTHER 1.

Dosage form	NDCs
tablet	76
capsule, extended release	33
tablet, film coated	26
tablet, extended release	16
tablet, film coated, extended release	15
capsule, liquid filled	8
capsule	5
capsule, delayed release	4
gel	4
solution/ drops	3
suspension	3
tablet, delayed release	3
emulsion	2
gel, metered	2
injection, solution	2

Route	NDCs
oral	196
ophthalmic	6
topical	5
subcutaneous	2
auricular (otic)	1
nasal	1
transdermal	1
vaginal	1

Labeller name on the listing	NDCs
upsher-smith laboratories, llc	196
upsher-smith laboratories, llc	7
upsher-smith laboratories,llc	4
upsher-smith laboratories, inc.	3
upsher-smith laboratories, llc	2
upsher-smith laboratories, llc	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10363224	QUDEXY XRtopiramate	use	Mar 2033
8652527	QUDEXY XRtopiramate	product	Mar 2033
8889190	QUDEXY XRtopiramate	product	Mar 2033
9101545	QUDEXY XRtopiramate	product	Mar 2033
9555005	QUDEXY XRtopiramate	product	Mar 2033
8785426	VOGELXOtestosterone	product	Feb 2034
9295675	VOGELXOtestosterone	product	Feb 2034
9662340	VOGELXOtestosterone	product	Feb 2034

Catalogue

Marketed products

230

Showing 150 of 230.

Brand	Generic name	Form / route	NDC
Amantadine Hydrochloride	amantadine hydrochloride	tablet, oral	0832-0111ANDA
Amantadine Hydrochloride	amantadine hydrochloride	capsule, gelatin coated, oral	0832-1015ANDA
Anastrozole	Anastrozole Tablets	tablet, oral	24979-725ANDA
Baclofen	Baclofen	tablet, oral	0832-1054ANDA
Bethanechol Chloride	Bethanechol Chloride	tablet, oral	0832-0510ANDA
Bethanechol Chloride	Bethanechol Chloride	tablet, oral	0832-0511ANDA
Bethanechol Chloride	Bethanechol Chloride	tablet, oral	0832-0512ANDA
Bethanechol Chloride	Bethanechol Chloride	tablet, oral	0832-0513ANDA
Bexarotene	Bexarotene	capsule, oral	0832-0285ANDA
Brimonidine Tartrate	Brimonidine Tartrate	solution/ drops, ophthalmic	0832-1420ANDA
Brimonidine Tartrate	Brimonidine Tartrate	solution/ drops, ophthalmic	0832-1435ANDA
Brimonidine Tartrate and Timolol Maleate	Brimonidine Tartrate and Timolol Maleate	solution/ drops, ophthalmic	0832-1425ANDA
CYCLOSPORINE	cyclosporine	emulsion, ophthalmic	24979-126ANDA
Carbamazepin	Carbamazepine	tablet, extended release, oral	0832-6023ANDA
Carbamazepine	Carbamazepine	tablet, extended release, oral	0832-6022ANDA
Carbamazepine	Carbamazepine	tablet, extended release, oral	0832-6024ANDA
Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	tablet, film coated, oral	0832-6017ANDA
Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	tablet, film coated, oral	0832-6018ANDA
Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	tablet, film coated, oral	0832-6019ANDA
Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	tablet, film coated, oral	0832-6020ANDA
Chlorpromazine Hydrochloride	Chlorpromazine Hydrochloride	tablet, film coated, oral	0832-6021ANDA
Ciprofloxacin and Dexamethasone	Ciprofloxacin Hydrochloride and Dexamethasone	suspension, auricular (otic)	0832-1430ANDA
Clobazam	Clobazam	tablet, oral	0832-0580ANDA
Clobazam	Clobazam	tablet, oral	0832-0581ANDA
Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	capsule, extended release, oral	24979-035ANDA
Cyclobenzaprine Hydrochloride	Cyclobenzaprine Hydrochloride	capsule, extended release, oral	24979-036ANDA
Deflazacort	Deflazacort	tablet, oral	0832-0814ANDA
Deflazacort	Deflazacort	tablet, oral	0832-0815ANDA
Deflazacort	Deflazacort	tablet, oral	0832-0816ANDA
Deflazacort	Deflazacort	tablet, oral	0832-0817ANDA
Dexlansoprazole delayed release	dexlansoprazole	capsule, delayed release, oral	24979-001ANDA
Dexlansoprazole delayed release	dexlansoprazole	capsule, delayed release, oral	24979-002ANDA
Dicyclomine Hydrochloride	Dicyclomine Hydrochloride	tablet, oral	24979-200ANDA
Dicyclomine Hydrochloride	Dicyclomine Hydrochloride	capsule, oral	24979-201ANDA
Difluprednate	Difluprednate	emulsion, ophthalmic	0832-6054ANDA
Diltiazem Hydrochloride	Diltiazem hydrochloride	capsule, extended release, oral	24979-026ANDA
Diltiazem Hydrochloride	Diltiazem hydrochloride	capsule, extended release, oral	24979-027ANDA
Diltiazem Hydrochloride	Diltiazem hydrochloride	capsule, extended release, oral	24979-028ANDA
Diltiazem Hydrochloride	Diltiazem hydrochloride	capsule, extended release, oral	24979-029ANDA
Diltiazem Hydrochloride	Diltiazem hydrochloride	capsule, extended release, oral	24979-030ANDA
Diltiazem Hydrochloride	diltiazem hydrochloride	capsule, extended release, oral	24979-181ANDA
Diltiazem Hydrochloride	diltiazem hydrochloride	capsule, extended release, oral	24979-182ANDA
Diltiazem Hydrochloride	diltiazem hydrochloride	capsule, extended release, oral	24979-183ANDA
Divalproex Sodium	Divalproex Sodium	tablet, delayed release, oral	0832-7122ANDA
Divalproex Sodium	Divalproex Sodium	tablet, delayed release, oral	0832-7123ANDA
Divalproex Sodium	Divalproex Sodium	tablet, delayed release, oral	0832-7124ANDA
Donepezil Hydrochloride	Donepezil Hydrochloride	tablet, film coated, oral	24979-004ANDA
Doxazosin	Doxazosin Mesylate	tablet, oral	0832-0356ANDA
Doxazosin	Doxazosin Mesylate	tablet, oral	0832-0357ANDA
Doxazosin	Doxazosin Mesylate	tablet, oral	0832-1358ANDA
Doxazosin	Doxazosin Mesylate	tablet, oral	0832-1359ANDA
Ethacrynic Acid	Ethacrynic Acid	tablet, oral	0832-1690ANDA
Exemestane	Exemestane	tablet, oral	0832-0595ANDA
Famotidine	Famotidine	powder, for suspension, oral	0832-6045ANDA
Fluoxetine hydrochloride	Fluoxetine hydrochloride	for solution, oral	0832-6032ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	0832-6003ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	0832-6004ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	0832-6005ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	0832-6006ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	24979-136ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	24979-137ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	24979-138ANDA
Fluphenazine Hydrochloride	Fluphenazine Hydrochloride	tablet, film coated, oral	24979-139ANDA
Fluvoxamine Maleate	Fluvoxamine Maleate	capsule, extended release, oral	0832-6025ANDA
Fluvoxamine Maleate	Fluvoxamine Maleate	capsule, extended release, oral	0832-6026ANDA
Forfivo XL	bupropion hydrochloride	tablet, film coated, extended release, oral	24979-247NDA
Galantamine	galantamine	tablet, film coated, oral	24979-722ANDA
Galantamine	galantamine	tablet, film coated, oral	24979-723ANDA
Galantamine	galantamine	tablet, film coated, oral	24979-724ANDA
Glatiramer Acetate	Glatiramer Acetate Injection	injection, solution, subcutaneous	0832-6084ANDA
Glatiramer Acetate	Glatiramer Acetate Injection	injection, solution, subcutaneous	0832-6085ANDA
Guanfacine Extended-Release	Guanfacine	tablet, extended release, oral	24979-533ANDA
Guanfacine Extended-Release	Guanfacine	tablet, extended release, oral	24979-534ANDA
Guanfacine Extended-Release	Guanfacine	tablet, extended release, oral	24979-536ANDA
Guanfacine Extended-Release	Guanfacine	tablet, extended release, oral	24979-538ANDA
Haloperidol	Haloperidol	tablet, oral	0832-1510ANDA
Haloperidol	Haloperidol	tablet, oral	0832-1520ANDA
Haloperidol	Haloperidol	tablet, oral	0832-1530ANDA
Haloperidol	Haloperidol	tablet, oral	0832-1540ANDA
Haloperidol	Haloperidol	tablet, oral	0832-1550ANDA
Haloperidol	Haloperidol	tablet, oral	0832-1560ANDA
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	tablet, oral	0245-0410ANDA
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	tablet, oral	0245-0411ANDA
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen	tablet, oral	0245-0412ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0245-0570ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0245-0571ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0245-0573ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0245-0575ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0832-8301ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0832-8302ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0832-8303ANDA
Isotretinoin	Isotretinoin	capsule, liquid filled, oral	0832-8304ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1211ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1212ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1213ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1214ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1215ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1216ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1217ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1218ANDA
Jantoven	Warfarin Sodium	tablet, oral	0832-1219ANDA
KLOR-CON	potassium chloride	powder, for solution, oral	0245-0360ANDA
KLOR-CON	potassium chloride	tablet, film coated, extended release, oral	0245-0835ANDA
KLOR-CON	potassium chloride	tablet, film coated, extended release, oral	0245-0836ANDA
KLOR-CON	potassium chloride	tablet, film coated, extended release, oral	0245-5315NDA
KLOR-CON	potassium chloride	tablet, film coated, extended release, oral	0245-5316NDA
KLOR-CON M	potassium chloride	tablet, extended release, oral	0245-5317ANDA
KLOR-CON M	potassium chloride	tablet, extended release, oral	0245-5318ANDA
KLOR-CON M	potassium chloride	tablet, extended release, oral	0245-5319ANDA
KLOR-Con/EF	Potassium Bicarbonate	tablet, effervescent, oral	0245-5326UNAPPROVED DRUG OTHER
KYMBEE	Deflazacort	suspension, oral	0245-0813ANDA
KYMBEE	Deflazacort	tablet, oral	0245-0814ANDA
KYMBEE	Deflazacort	tablet, oral	0245-0815ANDA
KYMBEE	Deflazacort	tablet, oral	0245-0816ANDA
KYMBEE	Deflazacort	tablet, oral	0245-0817ANDA
Letrozole	Letrozole Tablets	tablet, film coated, oral	24979-726ANDA
Megestrol Acetate	Megestrol Acetate	suspension, oral	24979-041ANDA
Memantine Hydrochloride	Memantine Hydrochloride	tablet, film coated, oral	0832-1112ANDA
Memantine Hydrochloride	Memantine Hydrochloride	tablet, film coated, oral	0832-1113ANDA
Mesalamine	Mesalamine	capsule, extended release, oral	0832-6056ANDA
Methimazole	Methimazole	tablet, oral	0832-6072ANDA
Methimazole	Methimazole	tablet, oral	0832-6073ANDA
Midodrine Hydrochloride	midodrine hydrochloride	tablet, oral	0245-0211ANDA
Midodrine Hydrochloride	midodrine hydrochloride	tablet, oral	0245-0212ANDA
Midodrine Hydrochloride	midodrine hydrochloride	tablet, oral	0245-0213ANDA
Morphine Sulfate	Morphine Sulfate	capsule, extended release, oral	0832-0225ANDA
Morphine Sulfate	Morphine Sulfate	capsule, extended release, oral	0832-0226ANDA
Morphine Sulfate	Morphine Sulfate	capsule, extended release, oral	0832-0227ANDA
Morphine Sulfate	Morphine Sulfate	capsule, extended release, oral	0832-0228ANDA
Morphine Sulfate	Morphine Sulfate	capsule, extended release, oral	0832-0229ANDA
Morphine Sulfate	Morphine Sulfate	capsule, extended release, oral	0832-0230ANDA
Morphine Sulfate	Morphine Sulfate	capsule, extended release, oral	0832-0233ANDA
Morphine Sulfate	morphine sulfate	tablet, oral	0832-0273ANDA
Morphine Sulfate	morphine sulfate	tablet, oral	0832-0274ANDA
Moxifloxacin Hydrochloride	Moxifloxacin Hydrochloride	solution, ophthalmic	0832-1410ANDA
Naprelan	Naproxen Sodium	tablet, film coated, extended release, oral	24979-249NDA
Naprelan	Naproxen Sodium	tablet, film coated, extended release, oral	24979-250NDA
Naprelan	Naproxen Sodium	tablet, film coated, extended release, oral	24979-251NDA
Naproxen Sodium	Naproxen Sodium	tablet, film coated, extended release, oral	24979-252NDA AUTHORIZED GENERIC
Naproxen Sodium	Naproxen Sodium	tablet, film coated, extended release, oral	24979-253NDA AUTHORIZED GENERIC
Naproxen Sodium	Naproxen Sodium	tablet, film coated, extended release, oral	24979-254NDA AUTHORIZED GENERIC
Nifedipine	Nifedipine	tablet, extended release, oral	24979-009ANDA
Nifedipine	Nifedipine	tablet, extended release, oral	24979-010ANDA
Nifedipine	Nifedipine	tablet, film coated, extended release, oral	24979-011ANDA
Nyamyc	Nystatin	powder, topical	0832-0465ANDA
Oxybutynin Chloride	Oxybutynin Chloride	tablet, oral	0832-0038ANDA
Pacerone	Amiodarone Hydrochloride	tablet, oral	0245-0144ANDA
Pacerone	Amiodarone Hydrochloride	tablet, oral	0245-0147ANDA
Pacerone	Amiodarone Hydrochloride	tablet, oral	0245-1645ANDA
Pitavastatin	Pitavastatin Calcium	tablet, oral	0832-6048ANDA

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Enquiry

Common questions

Is Upsher-Smith Laboratories, Inc. FDA approved?: Upsher-Smith Laboratories, Inc. holds no registered establishment of its own; 230 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Upsher-Smith Laboratories, Inc. make?: 230 products are listed under Upsher-Smith Laboratories, Inc. in the openFDA NDC Directory, most often as tablet; capsule, extended release; tablet, film coated. 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.