Drug company (FDA labeler)

Upsher-Smith Laboratories, LLC

NDC labeler codes: 0245, 0832, 24979, 80789

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

66Prescription medicines

209Products (NDC)

90FDA applications

0Recalls

Prescription medicines

Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 14 products
TopiramateTopamax, Qudexy XR, Trokendi XR · 12 products
DeflazacortJaythari, Emflaza, Kymbee · 9 products
Morphine sulfateMs Contin, Mitigo, Duramorph · 9 products
Warfarin sodiumJantoven · 9 products
Fluphenazine hydrochlorideFluphenazine Hydrochoride · 8 products
IsotretinoinZenatane, Absorica, Accutane · 8 products
DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 8 products
NifedipineProcardia XL · 6 products
Haloperidol6 products
LisinoprilZestril, Qbrelis · 6 products
Chlorpromazine hydrochloride5 products
NaproxenNaprelan, Rugby All Day Relief · 5 products
TestosteroneVogelxo, Natesto Nasal Gel, Testopel · 5 products
Bethanechol chloride4 products
DoxazosinCardura, Cardura XL · 4 products
EverolimusYulithira, Zortress, Afinitor · 4 products
TadalafilCialis, Tadliq, Adcirca · 4 products
GuanfacineIntuniv · 4 products
CarbamazepineTegretol XR, Equetro, Carbatrol · 3 products
Midodrine hydrochloride3 products
Propafenone hydrochloride3 products
AtenololTenormin · 3 products
Hydrocodone bitartrate and acetaminophenNorco · 3 products
Amiodarone hydrochloridePacerone, Nexterone · 3 products
Galantamine3 products
Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 3 products
VigabatrinSabril, Vigadrone, Vigafyde · 3 products
PitavastatinZypitamag, Livalo · 3 products
Imatinib mesylateGleevec, Imkeldi · 2 products
Brimonidine tartrateAlphagan P, Mirvaso · 2 products
Dimethyl fumarateTecfidera · 2 products
AmantadineGocovri · 2 products
ClobazamSympazan, Onfi · 2 products
BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 products
Methimazole2 products
Potassium citrateUrocit-K · 2 products
Memantine hydrochloride2 products
Terbutaline sulfate2 products
Glatiramer acetateGlatopa, Copaxone · 2 products

Show the other 26 medicines

Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 2 products
Fluvoxamine maleate2 products
DexlansoprazoleDexilant · 2 products
Dicyclomine hydrochloride2 products
MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
CholestyramineQuestran, Prevalite, Cholestyramine Light · 1 product
Valproic acid1 product
NystatinNystop, Klayesta, Nyamyc · 1 product
BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 1 product
RamelteonRozerem · 1 product
Ethacrynic acidEdecrin · 1 product
FluoxetineProzac · 1 product
Megestrol acetate1 product
DifluprednateDifluprednate Ophthalmic Emulsion, Durezol · 1 product
Donepezil hydrochlorideAricept · 1 product
CyclosporineSandimmune, Neoral, Cyclosporine Modified · 1 product
MoxifloxacinVigamox · 1 product
Brimonidine tartrate and timolol maleateCombigan · 1 product
FamotidinePepcid · 1 product
LetrozoleFemara · 1 product
MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 1 product
AnastrozoleArimidex · 1 product
OxybutyninOxytrol · 1 product
SumatriptanImitrex, Tosymra, Zembrace Symtouch · 1 product
Ciprofloxacin and dexamethasone1 product
SorafenibNexavar · 1 product

FDA applications for these products

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
ANDA: Abbreviated New Drug Application: how a generic version is approved.

Approved	Application	Medicine	Sponsor
April 30, 2026	ANDA220328	Fluvoxamine maleate FLUVOXAMINE MALEATE	Appco
January 21, 2026	ANDA209064	Cyclosporine CYCLOSPORINE	Twi Pharms
January 6, 2026	ANDA216487	Ciprofloxacin and dexamethasone CIPROFLOXACIN AND DEXAMETHASONE	Upsher Smith Labs
December 31, 2025	ANDA214741	Glatiramer acetate GLATIRAMER ACETATE	Scinopharm Taiwan
August 11, 2025	ANDA216992	Deflazacort DEFLAZACORT	Upsher Smith Labs
July 30, 2025	ANDA217599	Brimonidine tartrate BRIMONIDINE TARTRATE	Upsher Smith Labs
February 11, 2025	ANDA218191	Difluprednate DIFLUPREDNATE	Upsher Smith Labs
November 5, 2024	ANDA216720	Deflazacort DEFLAZACORT	Upsher Smith Labs
October 28, 2024	ANDA218979	Potassium chloride KLOR-CON	Twi Pharms
June 17, 2024	NDA217684	Vigabatrin VIGAFYDE	Pyros Pharms
June 12, 2024	ANDA216772	Brimonidine tartrate BRIMONIDINE TARTRATE	Upsher Smith Labs
December 5, 2023	ANDA217694	Topiramate TOPIRAMATE	Twi Pharms
June 29, 2023	ANDA214749	Vigabatrin VIGABATRIN	Upsher Smith Labs
June 16, 2023	ANDA217655	Famotidine FAMOTIDINE	Somerset Theraps LLC
June 6, 2023	ANDA217533	Mesalamine MESALAMINE	Amta
June 1, 2023	ANDA216782	Dicyclomine hydrochloride DICYCLOMINE HYDROCHLORIDE	Twi Pharms
March 1, 2023	ANDA217377	Diltiazem DILTIAZEM HYDROCHLORIDE	Twi Pharms
December 27, 2022	ANDA217054	Dicyclomine hydrochloride DICYCLOMINE HYDROCHLORIDE	Twi Pharms
December 12, 2022	ANDA215598	Brimonidine tartrate and timolol maleate BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	Upsher Smith Labs
November 15, 2022	ANDA216953	Fluoxetine FLUOXETINE HYDROCHLORIDE	Upsher Smith Labs
November 9, 2022	ANDA209050	Sorafenib SORAFENIB TOSYLATE	Yabao Pharm
October 24, 2022	ANDA213784	Fluphenazine hydrochloride FLUPHENAZINE HYDROCHLORIDE	Upsher Smith Labs
September 16, 2022	ANDA202666	Dexlansoprazole DEXLANSOPRAZOLE	Twi Pharms
June 21, 2022	ANDA212135	Imatinib mesylate IMATINIB MESYLATE	Qilu Pharm Hainan
April 1, 2022	ANDA215848	Fluphenazine hydrochloride FLUPHENAZINE HYDROCHLORIDE	Twi Pharms

Show the other 65 applications

Approved	Application	Medicine	Sponsor
September 21, 2021	ANDA212333	Isotretinoin ISOTRETINOIN	Upsher Smith Labs
April 13, 2021	ANDA213311	Carbamazepine CARBAMAZEPINE	Cspc Ouyi
April 12, 2021	ANDA213571	Isotretinoin ISOTRETINOIN	Upsher Smith Labs
February 11, 2021	ANDA214182	Everolimus EVEROLIMUS	Biocon Pharma
February 10, 2021	ANDA212616	Moxifloxacin MOXIFLOXACIN HYDROCHLORIDE	Upsher Smith Labs
October 26, 2020	ANDA213815	Ramelteon RAMELTEON	Appco
October 14, 2020	ANDA210382	Dimethyl fumarate DIMETHYL FUMARATE	Twi Pharms
June 25, 2020	ANDA212744	Propafenone hydrochloride PROPAFENONE HYDROCHLORIDE	Upsher Smith Labs
June 19, 2020	ANDA211832	Terbutaline sulfate TERBUTALINE SULFATE	Twi Pharms
February 19, 2020	ANDA212417	Ethacrynic acid ETHACRYNIC ACID	Upsher Smith Labs
January 8, 2020	ANDA211061	Haloperidol HALOPERIDOL	Appco
September 23, 2019	ANDA209390	Testosterone TESTOSTERONE	Twi Pharms
July 22, 2019	ANDA210610	Morphine sulfate MORPHINE SULFATE	Upsher Smith Labs
March 26, 2019	ANDA210420	Tadalafil TADALAFIL	Qilu Pharm Hainan
January 25, 2019	NDA210884	Sumatriptan TOSYMRA	Tonix Meds
November 14, 2018	ANDA205869	Letrozole LETROZOLE	Pharmobedient
November 9, 2018	ANDA206037	Anastrozole ANASTROZOLE	Pharmobedient
October 22, 2018	ANDA209687	Clobazam CLOBAZAM	Upsher Smith Labs
August 30, 2018	ANDA205231	Diltiazem DILTIAZEM HYDROCHLORIDE	Twi Pharms
June 21, 2018	ANDA210196	Vigabatrin VIGADRONE	Bora
April 17, 2018	ANDA209013	Doxazosin DOXAZOSIN MESYLATE	Somerset Theraps LLC
January 12, 2018	ANDA209688	Potassium chloride POTASSIUM CHLORIDE	Twi Pharms
October 23, 2017	ANDA209662	Potassium chloride KLOR-CON	Upsher Smith Labs
March 24, 2017	ANDA206484	Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Upsher Smith Labs
February 3, 2017	ANDA205955	Pitavastatin PITAVASTATIN CALCIUM	Sawai USA
July 31, 2015	ANDA090043	Memantine hydrochloride MEMANTINE HYDROCHLORIDE	Upsher Smith Labs
June 2, 2015	ANDA201408	Guanfacine GUANFACINE HYDROCHLORIDE	Twi Pharms
October 29, 2014	ANDA203104	Donepezil hydrochloride DONEPEZIL HYDROCHLORIDE	Twi Pharms
August 27, 2014	ANDA203139	Megestrol acetate MEGESTROL ACETATE	Twi Pharms
June 4, 2014	NDA204399	Testosterone VOGELXO	Upsher Smith Labs
April 3, 2014	ANDA203126	Nifedipine NIFEDIPINE	Twi Pharms
March 11, 2014	NDA205122	Topiramate QUDEXY XR	Upsher Smith Labs
June 3, 2013	ANDA202104	Morphine sulfate MORPHINE SULFATE	Upsher Smith Labs
January 31, 2013	ANDA091281	Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE	Twi Pharms Inc
January 19, 2012	ANDA076485	Isotretinoin MYORISAN	Upsher Smith Labs
November 10, 2011	NDA022497	Bupropion FORFIVO XL	Twi Pharms
February 6, 2009	ANDA077604	Galantamine GALANTAMINE HYDROBROMIDE	Yabao Pharm
July 29, 2008	ANDA078182	Divalproex sodium DIVALPROEX SODIUM	Upsher Smith Labs
June 1, 2005	ANDA040633	Bethanechol chloride BETHANECHOL CHLORIDE	Upsher Smith Labs
June 1, 2005	ANDA040634	Bethanechol chloride BETHANECHOL CHLORIDE	Upsher Smith Labs
June 1, 2005	ANDA040635	Bethanechol chloride BETHANECHOL CHLORIDE	Upsher Smith Labs
June 1, 2005	ANDA040636	Bethanechol chloride BETHANECHOL CHLORIDE	Upsher Smith Labs
May 20, 2005	NDA021806	Metronidazole VANDAZOLE	Teva Pharms
May 3, 2005	ANDA065183	Nystatin NYSTATIN	Upsher Smith Labs
February 18, 2005	ANDA040547	Methimazole METHIMAZOLE	Aiping Pharm Inc
November 3, 2004	ANDA076725	Midodrine hydrochloride ORVATEN	Beijing Yiling
October 2, 2003	ANDA040416	Warfarin sodium JANTOVEN	Upsher Smith Labs
December 16, 2002	ANDA076186	Amantadine AMANTADINE HYDROCHLORIDE	Upsher Smith Labs
November 20, 1998	ANDA074726	Potassium chloride KLOR-CON M10, KLOR-CON M15, KLOR-CON M20	Upsher Smith Labs
April 30, 1998	ANDA075135	Amiodarone hydrochloride PACERONE	Upsher Smith Labs
August 19, 1996	ANDA074584	Baclofen BACLOFEN	Pharmobedient
July 31, 1996	ANDA074625	Oxybutynin OXYBUTYNIN CHLORIDE	Aiping Pharm Inc
February 22, 1996	ANDA073263	Cholestyramine PREVALITE	Aiping Pharm Inc
January 5, 1996	NDA020353	Naproxen NAPRELAN	Twi Pharms
October 29, 1991	ANDA073229	Valproic acid VALPROIC ACID	Catalent
May 19, 1988	NDA019777	Lisinopril ZESTRIL	Twi Pharms
January 7, 1987	ANDA070589	Amantadine AMANTADINE HYDROCHLORIDE	Upsher Smith Labs
April 17, 1986	NDA019123	Potassium chloride KLOR-CON	Upsher Smith Labs
August 30, 1985	NDA019071	Potassium citrate UROCIT-K	Mission Pharma
August 19, 1981	NDA018240	Atenolol TENORMIN	Twi Pharms
July 9, 1974	ANDA083386	Chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE	Upsher Smith Labs
July 9, 1974	ANDA084112	Chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE	Upsher Smith Labs
July 9, 1974	ANDA084113	Chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE	Upsher Smith Labs
July 9, 1974	ANDA084114	Chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE	Upsher Smith Labs
July 9, 1974	ANDA084115	Chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE	Upsher Smith Labs

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

No recall of these products (by NDC code) appears in the FDA enforcement reports.

Next steps

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Sources

NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

FDA Enforcement Report search → · Report an error →