Drug company (FDA labeler)

Advanced Rx of Tennessee, LLC

NDC labeler code: 80425

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

75Prescription medicines

257Products (NDC)

189FDA applications

0Recalls

Prescription medicines

GabapentinNeurontin, Gralise, Relgaabi · 12 products
MeloxicamZybic, Xifyrm, Qamzova · 12 products
DiclofenacZipsor, Lofena, Cambia · 12 products
Prednisone11 products
TizanidineZanaflex, Ontralfy · 9 products
Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 9 products
EszopicloneLunesta · 8 products
IbuprofenIbu, Caldolor · 8 products
PregabalinLyrica, Lyrica CR · 8 products
NaproxenNaprelan, Rugby All Day Relief · 8 products
BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 7 products
MethocarbamolRobaxin, Atmeksi, Tanlor · 6 products
Zolpidem tartrateAmbien, Ambien CR, Edluar · 6 products
Ondansetron6 products
LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 6 products
Venlafaxine hydrochlorideEffexor XR · 6 products
Amitriptyline hydrochloride5 products
DuloxetineDrizalma Sprinkle · 5 products
OmeprazolePrilosec · 4 products
Acetaminophen and codeine phosphate4 products
Tramadol hydrochlorideConzip · 4 products
CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
TopiramateTopamax, Qudexy XR, Trokendi XR · 4 products
AlprazolamXanax, Xanax XR · 4 products
AzithromycinZithromax, Azasite · 3 products
Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 3 products
BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 3 products
DiazepamValium, Valtoco · 3 products
Chlorzoxazone3 products
Ibuprofen and famotidine3 products
Metaxalone3 products
Rabeprazole sodiumAciphex · 3 products
Hydroxyzine3 products
Propranolol hydrochlorideInderal La, Inderal XL, Hemangeol · 3 products
CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 3 products
EsomeprazoleNexium · 3 products
Butalbital, acetaminophen and caffeineFioricet · 3 products
Metformin hydrochlorideGlumetza · 2 products
Trazodone hydrochlorideRaldesy Tm · 2 products
DesonideTridesilon Cream · 2 products
GlipizideGlucotrol XL · 2 products
LevetiracetamKeppra, Spritam, Keppra XR · 2 products
ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 2 products
SumatriptanImitrex, Tosymra, Zembrace Symtouch · 2 products
NabumetoneRelafen Ds · 2 products
Levofloxacin2 products
LubiprostoneAmitiza, Amitza · 2 products
SildenafilViagra, Vybrique, Revatio · 2 products
CitalopramCelexa · 2 products
ClonazepamKlonopin · 1 product
Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 1 product
Eletriptan hydrobromideRelpax · 1 product
TadalafilCialis, Tadliq, Adcirca · 1 product
Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 1 product
DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 1 product
FamotidinePepcid · 1 product
QuetiapineSeroquel, Seroquel XR · 1 product
Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
BuspironeBucapsol · 1 product
SucralfateCarafate · 1 product
ZonisamideZonegran, Zonisade · 1 product
Nortriptyline hydrochloridePamelor · 1 product
Diclofenac epolamineLicart, Flector, Diclox Patch 30ct · 1 product
LorazepamAtivan, Loreev XR · 1 product
LacosamideVimpat, Motpoly XR · 1 product
Etodolac1 product
Cefuroxime axetil1 product
Cefadroxil1 product
VancomycinTyzavan, Vancocin · 1 product
AllopurinolAloprim · 1 product
Tobramycin and dexamethasoneTobradex St, Tobradex · 1 product
Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 1 product
RamelteonRozerem · 1 product
Mefenamic acid1 product
Meclizine hydrochloride1 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
February 20, 2025	ANDA218684	Ibuprofen and famotidine IBUPROFEN AND FAMOTIDINE	Zydus Lifesciences
August 6, 2024	ANDA217400	Famotidine FAMOTIDINE	Msn
March 22, 2024	ANDA203658	Ibuprofen and famotidine IBUPROFEN AND FAMOTIDINE	Ph Health
January 18, 2024	ANDA214287	Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Quagen
December 14, 2023	ANDA217843	Diazepam DIAZEPAM	Aurobindo Pharma Ltd
October 18, 2023	ANDA217427	Esomeprazole ESOMEPRAZOLE MAGNESIUM	Granules
October 3, 2023	ANDA214874	Glipizide GLIPIZIDE	Rubicon Research
August 17, 2023	ANDA217652	Hydroxyzine HYDROXYZINE HYDROCHLORIDE	Graviti Pharms
August 3, 2023	ANDA217748	Allopurinol ALLOPURINOL	Hetero Labs Ltd V
May 19, 2023	ANDA217411	Amitriptyline hydrochloride AMITRIPTYLINE HYDROCHLORIDE	Rising
May 18, 2023	ANDA217390	Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE	Granules
April 19, 2023	ANDA217001	Dexamethasone DEXAMETHASONE	Bionpharma
March 15, 2023	ANDA215787	Diclofenac DICLOFENAC POTASSIUM	Pharmazone
February 9, 2023	ANDA215243	Ramelteon RAMELTEON	Micro Labs
September 23, 2022	ANDA216275	Diclofenac DICLOFENAC SODIUM	Ingenus Pharms LLC
September 21, 2022	ANDA208021	Diclofenac DICLOFENAC SODIUM	Lupin Pharms
August 25, 2022	ANDA216651	Ketorolac tromethamine KETOROLAC TROMETHAMINE	Hetero Labs Ltd III
May 6, 2022	ANDA207714	Diclofenac DICLOFENAC SODIUM	Apotex
April 5, 2022	ANDA213126	Chlorzoxazone CHLORZOXAZONE	Rising
March 31, 2022	ANDA214695	Lacosamide LACOSAMIDE	Alkem Labs Ltd
March 28, 2022	ANDA215672	Prednisone PREDNISONE	Aurobindo Pharma Ltd
August 13, 2021	ANDA214087	Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Pharmazone
August 6, 2021	ANDA214654	Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE	Yichang Humanwell
August 3, 2021	ANDA211890	Ibuprofen and famotidine IBUPROFEN AND FAMOTIDINE	Alkem Labs Ltd
July 13, 2021	ANDA214099	Baclofen BACLOFEN	Aurobindo Pharma Ltd
May 19, 2021	ANDA214548	Amitriptyline hydrochloride AMITRIPTYLINE HYDROCHLORIDE	Unichem
May 10, 2021	ANDA214956	Gabapentin GABAPENTIN	Ascent Pharms Inc
April 21, 2021	ANDA215076	Doxepin hydrochloride DOXEPIN HYDROCHLORIDE	Alembic
April 20, 2021	ANDA212695	Lidocaine LIDOCAINE	Quagen
March 5, 2021	ANDA214374	Baclofen BACLOFEN	Rising
February 11, 2021	ANDA208412	Prednisone PREDNISONE	Strides Pharma
January 26, 2021	ANDA214492	Zonisamide ZONISAMIDE	Unichem
August 25, 2020	ANDA209302	Sildenafil SILDENAFIL CITRATE	Umedica
July 9, 2020	ANDA212067	Baclofen BACLOFEN	Unichem
June 2, 2020	ANDA211977	Esomeprazole ESOMEPRAZOLE MAGNESIUM	Hetero Labs Ltd III
May 27, 2020	ANDA213798	Tizanidine TIZANIDINE HYDROCHLORIDE	Rubicon Research
May 8, 2020	ANDA213794	Ibuprofen IBUPROFEN	Aurobindo Pharma Ltd
February 5, 2020	ANDA204852	Trazodone hydrochloride TRAZODONE HYDROCHLORIDE	Aurobindo Pharma
November 20, 2019	ANDA210198	Desonide DESONIDE	Cadila
November 15, 2019	ANDA211575	Prednisone PREDNISONE	Novitium Pharma
November 14, 2019	ANDA210907	Buspirone BUSPIRONE HYDROCHLORIDE	Unichem
October 30, 2019	ANDA212199	Naproxen NAPROXEN SODIUM	Sciegen Pharms
September 10, 2019	ANDA212418	Acetaminophen and codeine phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE	Elite Labs Inc
August 9, 2019	ANDA211825	Tramadol hydrochloride TRAMADOL HYDROCHLORIDE	Unichem
July 19, 2019	ANDA208677	Pregabalin PREGABALIN	Sciegen Pharms
July 19, 2019	ANDA209357	Pregabalin PREGABALIN	Msn
July 19, 2019	ANDA209743	Pregabalin PREGABALIN	Amneal Pharms Co
July 19, 2019	ANDA210432	Pregabalin PREGABALIN	Rising
July 8, 2019	ANDA212277	Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE	Annora Pharma
March 26, 2019	ANDA210420	Tadalafil TADALAFIL	Qilu Pharm Hainan
March 12, 2019	ANDA210267	Tizanidine TIZANIDINE HYDROCHLORIDE	Ingenus Pharms LLC
January 15, 2019	ANDA210708	Eletriptan hydrobromide ELETRIPTAN HYDROBROMIDE	Aurobindo Pharma
November 23, 2018	ANDA211469	Lidocaine LIDOCAINE	Alembic
November 5, 2018	ANDA207402	Clindamycin CLINDAMYCIN HYDROCHLORIDE	Micro Labs
October 31, 2018	ANDA209587	Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Lgm Pharma
October 31, 2018	ANDA210497	Bupropion BUPROPION HYDROCHLORIDE	Accord Hlthcare
October 25, 2018	ANDA208249	Azithromycin AZITHROMYCIN	Cspc Ouyi
October 12, 2018	ANDA206401	Sildenafil SILDENAFIL CITRATE	Ajanta Pharma Ltd
June 22, 2018	ANDA208921	Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE	Pharmobedient
May 14, 2018	ANDA206943	Gabapentin GABAPENTIN	Strides Pharma
May 7, 2018	ANDA209312	Methocarbamol METHOCARBAMOL	Granules
April 30, 2018	ANDA204776	Celecoxib CELECOXIB	Micro Labs
April 24, 2018	ANDA208644	Rabeprazole sodium RABEPRAZOLE SODIUM	Alkem Labs Ltd
March 9, 2018	ANDA208187	Tizanidine TIZANIDINE HYDROCHLORIDE	Cadila
December 22, 2017	ANDA203572	Lorazepam LORAZEPAM	Aurobindo Pharma
November 28, 2017	ANDA209102	Baclofen BACLOFEN	Rubicon Research
October 26, 2017	ANDA207057	Gabapentin GABAPENTIN	Cspc Ouyi
August 31, 2017	ANDA207466	Metaxalone METAXALONE	Sciegen Pharms
June 30, 2017	ANDA207224	Bupropion BUPROPION HYDROCHLORIDE	Anbison Lab
May 31, 2017	ANDA208170	Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE	Rubicon Research
April 12, 2017	ANDA207479	Bupropion BUPROPION HYDROCHLORIDE	Sciegen Pharms
November 23, 2016	ANDA202413	Ibuprofen IBUPROFEN	Shandong Xinhua
September 15, 2016	ANDA208451	Eszopiclone ESZOPICLONE	Aurobindo Pharma
September 9, 2016	ANDA206498	Lidocaine LIDOCAINE	Glenmark Pharms Ltd
September 2, 2016	ANDA206116	Diclofenac DICLOFENAC SODIUM	Amneal Pharms
March 16, 2016	ANDA204590	Celecoxib CELECOXIB	Macleods Pharms
February 18, 2016	ANDA204989	Gabapentin RELGAABI	Sciegen Pharms
January 26, 2016	ANDA205119	Pantoprazole sodium PANTOPRAZOLE SODIUM	Amneal Pharms
December 23, 2015	ANDA206402	Gabapentin GABAPENTIN	Alkem Labs Ltd
November 18, 2015	ANDA204237	Rabeprazole sodium RABEPRAZOLE SODIUM	Rubicon Research
September 23, 2015	ANDA207446	Celecoxib CELECOXIB	Cipla
September 15, 2015	ANDA091625	Ibuprofen IBUPROFEN	Granules
August 26, 2015	ANDA203197	Duloxetine DULOXETINE HYDROCHLORIDE	Alkem Labs Ltd
August 20, 2015	ANDA204132	Diclofenac DICLOFENAC SODIUM	Lupin
July 31, 2015	ANDA203346	Alprazolam ALPRAZOLAM	Aurobindo Pharma
May 15, 2015	ANDA065398	Azithromycin AZITHROMYCIN	Lupin
May 15, 2015	ANDA065399	Azithromycin AZITHROMYCIN	Lupin
January 30, 2015	ANDA202929	Eszopiclone ESZOPICLONE	Macleods Pharms
January 8, 2015	ANDA202801	Levofloxacin LEVOFLOXACIN	Hetero Labs Ltd V
November 26, 2014	ANDA203818	Diclofenac DICLOFENAC SODIUM	Sun Pharma Canada
October 31, 2014	ANDA091672	Omeprazole OMEPRAZOLE	Glenmark Pharms Ltd
August 20, 2014	ANDA204279	Hydroxyzine HYDROXYZINE HYDROCHLORIDE	Heritage
April 15, 2014	ANDA091024	Eszopiclone ESZOPICLONE	DR Reddys
April 15, 2014	ANDA091166	Eszopiclone ESZOPICLONE	Glenmark Pharms Ltd
December 17, 2013	ANDA090776	Duloxetine DULOXETINE HYDROCHLORIDE	Actavis Elizabeth
December 11, 2013	ANDA090694	Duloxetine DULOXETINE HYDROCHLORIDE	Lupin
December 11, 2013	ANDA090778	Duloxetine DULOXETINE HYDROCHLORIDE	Aurobindo Pharma Ltd
November 27, 2013	ANDA202180	Trazodone hydrochloride TRAZODONE HYDROCHLORIDE	Torrent
July 1, 2013	ANDA203062	Rizatriptan benzoate RIZATRIPTAN BENZOATE	Aurobindo Pharma Ltd
June 21, 2013	ANDA203399	Metaxalone METAXALONE	Amneal Pharms
January 31, 2013	ANDA091281	Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE	Twi Pharms Inc
November 28, 2012	ANDA091283	Tizanidine TIZANIDINE HYDROCHLORIDE	Unichem Labs Ltd
September 28, 2012	ANDA202038	Pantoprazole sodium PANTOPRAZOLE SODIUM	Aurobindo Pharma Ltd
March 27, 2012	ANDA201109	Quetiapine QUETIAPINE FUMARATE	Lupin Ltd
November 8, 2011	ANDA200429	Naproxen NAPROXEN	Aurobindo Pharma
October 6, 2011	ANDA200651	Gabapentin GABAPENTIN	Aurobindo Pharma Ltd
September 13, 2011	ANDA091124	Eszopiclone ESZOPICLONE	Lupin Ltd
July 22, 2011	ANDA091322	Mefenamic acid MEFENAMIC ACID	Lupin Ltd
July 21, 2011	ANDA090007	Gabapentin GABAPENTIN	Pharmazone
June 20, 2011	ANDA201043	Levofloxacin LEVOFLOXACIN	Aurobindo Pharma Ltd
February 14, 2011	ANDA091416	Naproxen NAPROXEN	Pharmazone
January 19, 2011	ANDA077619	Pantoprazole sodium PANTOPRAZOLE SODIUM	DR Reddys Labs Ltd
December 21, 2010	ANDA090796	Ibuprofen IBUPROFEN	Pharmazone
December 17, 2010	ANDA090858	Gabapentin GABAPENTIN	Alkem
December 14, 2010	ANDA091491	Levetiracetam LEVETIRACETAM	Zhejiang Jingxin
December 1, 2010	ANDA090066	Diclofenac DICLOFENAC SODIUM	Unique
June 7, 2010	ANDA065496	Cefuroxime axetil CEFUROXIME AXETIL	Alkem Labs Ltd
April 22, 2010	ANDA090564	Metformin hydrochloride METFORMIN HYDROCHLORIDE	Granules India
April 12, 2010	ANDA090469	Ondansetron ONDANSETRON	Aurobindo Pharma
September 18, 2009	ANDA078401	Baclofen BACLOFEN	Northstar Hlthcare
August 10, 2009	ANDA078284	Sumatriptan SUMATRIPTAN SUCCINATE	Orbion Pharms
August 10, 2009	ANDA078327	Sumatriptan SUMATRIPTAN SUCCINATE	Aurobindo Pharma
April 17, 2009	ANDA078490	Omeprazole OMEPRAZOLE	DR Reddys Labs Ltd
March 27, 2009	ANDA078235	Topiramate TOPIRAMATE	Zydus Pharms USA Inc
March 27, 2009	ANDA090162	Topiramate TOPIRAMATE	Unichem Labs Ltd
February 5, 2009	ANDA078329	Ibuprofen IBUPROFEN	Strides Pharma
September 24, 2008	ANDA078420	Nabumetone NABUMETONE	Sciegen Pharms
June 30, 2008	ANDA077568	Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE	Fdc Ltd
June 2, 2008	ANDA078955	Propranolol hydrochloride PROPRANOLOL HYDROCHLORIDE	Ipca Labs Ltd
May 20, 2008	NDA022104	Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE	Osmotica Pharm Us
May 12, 2008	ANDA078722	Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE	Sun Pharm Inds Ltd
March 7, 2008	ANDA078671	Nabumetone NABUMETONE	Invagen Pharms
January 31, 2008	ANDA078787	Gabapentin GABAPENTIN	Aurobindo Pharma
October 22, 2007	ANDA075576	Omeprazole OMEPRAZOLE	DR Reddys Labs Ltd
August 17, 2007	ANDA077903	Zolpidem tartrate ZOLPIDEM TARTRATE	Torrent Pharms
July 31, 2007	ANDA078539	Ondansetron ONDANSETRON HYDROCHLORIDE	Aurobindo Pharma
June 27, 2007	ANDA078152	Ondansetron ONDANSETRON	Glenmark Pharms Ltd
June 18, 2007	ANDA078558	Ibuprofen IBUPROFEN	Amneal Pharms Ny
June 8, 2007	ANDA077863	Diclofenac DICLOFENAC SODIUM	Unique
May 29, 2007	ANDA065392	Cefadroxil CEFADROXIL	Lupin
May 4, 2007	ANDA078413	Zolpidem tartrate ZOLPIDEM TARTRATE	Aurobindo Pharma
April 27, 2007	ANDA078314	Naproxen NAPROXEN SODIUM	Glenmark Pharms Ltd
April 23, 2007	ANDA077214	Zolpidem tartrate ZOLPIDEM TARTRATE	Pharmazone
April 23, 2007	ANDA077322	Zolpidem tartrate ZOLPIDEM TARTRATE	Sandoz
March 28, 2007	ANDA078250	Naproxen NAPROXEN	Glenmark Pharms Ltd
March 27, 2007	ANDA078216	Citalopram CITALOPRAM HYDROBROMIDE	Torrent Pharms
February 28, 2007	ANDA077797	Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE	Prinston Inc
February 1, 2007	NDA021777	Cyclobenzaprine hydrochloride AMRIX	Teva Pharms Intl
January 31, 2007	NDA021234	Diclofenac epolamine FLECTOR	Ibsa
December 20, 2006	ANDA077927	Meloxicam MELOXICAM	Unichem
July 20, 2006	ANDA077882	Meloxicam MELOXICAM	Macleods Pharms
July 19, 2006	ANDA077921	Meloxicam MELOXICAM	Zydus Pharms USA
July 19, 2006	ANDA077929	Meloxicam MELOXICAM	Cipla
April 19, 2006	ANDA077563	Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE	Jubilant Cadista
January 31, 2006	NDA021908	Lubiprostone AMITIZA	Sucampo Pharma LLC
May 2, 2005	ANDA077147	Clonazepam CLONAZEPAM	Accord Hlthcare
March 16, 2004	ANDA076593	Ciprofloxacin CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE	Aiping Pharm Inc
September 29, 2003	ANDA076416	Tizanidine TIZANIDINE HYDROCHLORIDE	Sun Pharm Inds Inc
September 12, 2003	ANDA075350	Gabapentin GABAPENTIN	Actavis Elizabeth
January 29, 2003	ANDA040489	Methocarbamol METHOCARBAMOL	Oxford Pharms
June 25, 2002	ANDA075968	Tramadol hydrochloride TRAMADOL HYDROCHLORIDE	Graviti Pharms
June 20, 2002	ANDA076003	Tramadol hydrochloride TRAMADOL HYDROCHLORIDE	Amneal Pharms
January 25, 2002	ANDA075973	Metformin hydrochloride METFORMIN HYDROCHLORIDE	Mylan
December 18, 2001	ANDA075927	Naproxen NAPROXEN	Amneal Pharms Ny
August 29, 2001	ANDA040362	Prednisone PREDNISONE	Jubilant Cadista
April 19, 2001	NDA020983	Albuterol sulfate VENTOLIN HFA	Glaxosmithkline
February 2, 2001	ANDA065061	Clindamycin CLINDAMYCIN HYDROCHLORIDE	Sun Pharm Inds Ltd
November 13, 1998	ANDA075185	Diclofenac DICLOFENAC SODIUM	Carlsbad
March 11, 1998	ANDA075074	Etodolac ETODOLAC	Taro Pharm Inds
March 29, 1996	ANDA070848	Sucralfate SUCRALFATE	Teva
December 29, 1995	ANDA074112	Alprazolam ALPRAZOLAM	Sandoz
August 31, 1995	ANDA074497	Glipizide GLIPIZIDE	Ani Pharms
October 31, 1993	ANDA074342	Alprazolam ALPRAZOLAM	Actavis Elizabeth
September 28, 1992	ANDA074027	Desonide DESONIDE	Cosette Pharms Nc
March 30, 1992	ANDA073556	Nortriptyline hydrochloride NORTRIPTYLINE HYDROCHLORIDE	DR Reddys Labs SA
September 30, 1988	ANDA089805	Acetaminophen and codeine phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE	Strides Pharma Intl
September 30, 1988	ANDA089828	Acetaminophen and codeine phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE	Strides Pharma Intl
August 18, 1988	NDA050592	Tobramycin and dexamethasone TOBRADEX	Sandoz
July 21, 1988	ANDA072234	Baclofen BACLOFEN	Ivax Sub Teva Pharms
May 4, 1988	ANDA089853	Chlorzoxazone CHLORZOXAZONE	Aurobindo Pharma Ltd
April 6, 1988	ANDA071972	Propranolol hydrochloride PROPRANOLOL HYDROCHLORIDE	Impax Labs Inc
August 4, 1986	ANDA070322	Propranolol hydrochloride PROPRANOLOL HYDROCHLORIDE	Innogenix
April 15, 1986	NDA050606	Vancomycin VANCOCIN HYDROCHLORIDE	Ani Pharms
September 4, 1985	ANDA070325	Diazepam DIAZEPAM	Mylan
August 17, 1981	ANDA086724	Lidocaine LIDOCAINE	Sun Pharma Canada
November 12, 1976	ANDA085162	Prednisone PREDNISONE	Watson Labs
April 21, 1972	ANDA080352	Prednisone PREDNISONE	Hikma
February 14, 1957	NDA010721	Meclizine hydrochloride ANTIVERT	Casper Pharma LLC
—	ANDA084122	Prednisone	—

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.

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

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