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Drug company (FDA labeler)

Coupler LLC

NDC labeler code: 67046

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

150Prescription medicines
473Products (NDC)
306FDA applications
0Recalls

Prescription medicines

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.
ApprovedApplicationMedicineSponsor
February 5, 2025ANDA218830 Methimazole
METHIMAZOLE		Square Pharms PLC
January 14, 2025ANDA218939 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		Ascent Pharms Inc
August 8, 2024ANDA218988 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Granules
July 26, 2024ANDA214110 Metoprolol
METOPROLOL SUCCINATE		Zhejiang Jutai Pharm
July 23, 2024ANDA218173 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Alembic
May 28, 2024ANDA213682 Sacubitril and valsartan
SACUBITRIL AND VALSARTAN		Alembic
April 29, 2024ANDA217620 Colchicine
COLCHICINE		Annora Pharma
April 19, 2024ANDA218789 Haloperidol
HALOPERIDOL		Aurobindo Pharma Ltd
March 6, 2024ANDA218021 Hydroxyurea
HYDROXYUREA		Qilu
February 13, 2024ANDA217118 Atorvastatin
ATORVASTATIN CALCIUM		Aurobindo Pharma Ltd
January 5, 2024ANDA217081 Atorvastatin
ATORVASTATIN CALCIUM		Mankind Pharma
November 1, 2023ANDA217271 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE		Mankind Pharma
October 5, 2023ANDA217631 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Laurus
September 12, 2023ANDA214344 Atorvastatin
ATORVASTATIN CALCIUM		Hetero Labs Ltd V
September 6, 2023ANDA217334 Estradiol
ESTRADIOL		Novitium Pharma
September 5, 2023ANDA218122 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE		Aurobindo Pharma Ltd
August 30, 2023ANDA217531 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Prinston Inc
August 17, 2023ANDA217652 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Graviti Pharms
August 14, 2023ANDA217396 Losartan potassium
LOSARTAN POTASSIUM		Msn
July 11, 2023ANDA217357 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)		Mankind Pharma
May 31, 2023ANDA216800 Bupropion
BUPROPION HYDROCHLORIDE		Annora Pharma
May 18, 2023ANDA217390 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Granules
May 3, 2023ANDA215705 Sucralfate
SUCRALFATE		Zydus Lifesciences
April 27, 2023ANDA217293 Guanfacine
GUANFACINE HYDROCHLORIDE		Ajanta Pharma Ltd
March 31, 2023ANDA213052 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Aurobindo Pharma Ltd
March 29, 2023ANDA205321 Pregabalin
PREGABALIN		Aurobindo Pharma
March 10, 2023ANDA208045 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Aurobindo Pharma Ltd
March 10, 2023ANDA216957 Clindamycin
CLINDAMYCIN HYDROCHLORIDE		Glenmark Pharms Ltd
February 24, 2023ANDA210022 Olanzapine
OLANZAPINE		Cadila Pharms Ltd
December 30, 2022ANDA215697 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Mankind Pharma
December 21, 2022ANDA211417 Levothyroxine
LEVOTHYROXINE SODIUM		Macleods Pharms
November 28, 2022ANDA216537 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		Aurobindo Pharma Ltd
November 7, 2022ANDA216557 Isosorbide mononitrate
ISOSORBIDE MONONITRATE		Aurobindo Pharma
September 23, 2022ANDA216521 Diltiazem
DILTIAZEM HYDROCHLORIDE		Sciegen Pharms
September 21, 2022ANDA216505 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		Rubicon Research
August 15, 2022ANDA215478 Quetiapine
QUETIAPINE FUMARATE		Unichem
July 7, 2022ANDA213273 Enalapril maleate
ENALAPRIL MALEATE		Prinston Inc
June 16, 2022ANDA213730 Clorazepate dipotassium
CLORAZEPATE DIPOTASSIUM		Novitium Pharma
March 28, 2022ANDA215672 Prednisone
PREDNISONE		Aurobindo Pharma Ltd
March 17, 2022ANDA204787 Lacosamide
LACOSAMIDE		Hetero Labs Ltd V
March 7, 2022ANDA214443 Allopurinol
ALLOPURINOL		Harman Finochem
February 25, 2022ANDA214643 Divalproex sodium
DIVALPROEX SODIUM		Unichem
February 8, 2022ANDA214982 Digoxin
DIGOXIN		Aurobindo Pharma Ltd
February 2, 2022ANDA215568 Bupropion
BUPROPION HYDROCHLORIDE		Granules
January 27, 2022ANDA214827 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Msn
January 11, 2022ANDA215939 Oxcarbazepine
OXCARBAZEPINE		Annora Pharma
December 3, 2021ANDA213320 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Harman Finochem
October 1, 2021ANDA214957 Gabapentin
GABAPENTIN		Ascent Pharms Inc
July 14, 2021ANDA214659 Atorvastatin
ATORVASTATIN CALCIUM		DR Reddys
June 11, 2021ANDA215069 Levetiracetam
LEVETIRACETAM		Sciegen Pharms
May 19, 2021ANDA214548 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Unichem
May 13, 2021ANDA213248 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Alembic
May 7, 2021ANDA214092 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		Sciegen Pharms
February 19, 2021ANDA213999 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Mankind Pharma
February 12, 2021ANDA213854 Metoprolol
METOPROLOL SUCCINATE		Yichang Humanwell
February 11, 2021ANDA208412 Prednisone
PREDNISONE		Strides Pharma
December 17, 2020ANDA208165 Oxybutynin
OXYBUTYNIN CHLORIDE		Strides Pharma
October 15, 2020ANDA214284 Amantadine
AMANTADINE HYDROCHLORIDE		Alembic
July 9, 2020ANDA213647 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Amneal
May 8, 2020ANDA213794 Ibuprofen
IBUPROFEN		Aurobindo Pharma Ltd
April 15, 2020ANDA207798 Carbamazepine
CARBAMAZEPINE		Umedica
February 21, 2020ANDA212517 Naproxen
NAPROXEN		Sciegen Pharms
February 11, 2020ANDA213412 Chlorthalidone
CHLORTHALIDONE		Alkem Labs Ltd
January 24, 2020ANDA213343 Methotrexate
METHOTREXATE SODIUM		Accord Hlthcare
November 14, 2019ANDA210907 Buspirone
BUSPIRONE HYDROCHLORIDE		Unichem
November 7, 2019ANDA205945 Atorvastatin
ATORVASTATIN CALCIUM		Micro Labs Ltd India
September 23, 2019ANDA204707 Paliperidone
PALIPERIDONE		Amneal Pharms
September 13, 2019ANDA212624 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Ajanta Pharma Ltd
July 1, 2019ANDA207204 Chlorthalidone
CHLORTHALIDONE		Amneal Pharms Co
June 28, 2019ANDA208708 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE		Rubicon Research
May 23, 2019ANDA206993 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Cadila Pharms Ltd
May 8, 2019ANDA207165 Dapsone
DAPSONE		Rising
April 24, 2019ANDA206381 Rosuvastatin
ROSUVASTATIN CALCIUM		Sciegen Pharms
April 17, 2019ANDA208250 Azithromycin
AZITHROMYCIN		Cspc Ouyi
April 5, 2019ANDA211642 Thiothixene
THIOTHIXENE		Novitium Pharma
March 12, 2019ANDA210614 Nifedipine
NIFEDIPINE		Novast Labs
February 28, 2019ANDA211655 Oxybutynin
OXYBUTYNIN CHLORIDE		Ajanta Pharma Ltd
February 21, 2019ANDA207105 Aripiprazole
ARIPIPRAZOLE		Alkem Labs Ltd
February 20, 2019ANDA210189 Phytonadione
PHYTONADIONE		Zydus Lifesciences
January 18, 2019ANDA209713 Levothyroxine
LEVOTHYROXINE SODIUM		Lupin
December 19, 2018ANDA210921 Potassium chloride
POTASSIUM CHLORIDE		Aurobindo Pharma
November 23, 2018ANDA211659 Baclofen
BACLOFEN		Zydus Lifesciences
November 2, 2018ANDA209674 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Novast Labs
October 26, 2018ANDA207465 Metoprolol
METOPROLOL SUCCINATE		Cipla
October 25, 2018ANDA208249 Azithromycin
AZITHROMYCIN		Cspc Ouyi
October 16, 2018ANDA211314 Gabapentin
GABAPENTIN		Strides Pharma
October 3, 2018ANDA210971 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Novitium Pharma
August 27, 2018ANDA209882 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Laurus
June 22, 2018ANDA208921 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE		Pharmobedient
May 7, 2018ANDA209312 Methocarbamol
METHOCARBAMOL		Granules
April 30, 2018ANDA209504 Fenofibrate
FENOFIBRATE (MICRONIZED)		Ani Pharms
April 19, 2018ANDA090457 Lamivudine
LAMIVUDINE		Strides Pharma
March 16, 2018ANDA209313 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Granules
March 9, 2018ANDA208187 Tizanidine
TIZANIDINE HYDROCHLORIDE		Cadila
February 6, 2018ANDA204106 Metoprolol
METOPROLOL SUCCINATE		Novast Labs
October 26, 2017ANDA207057 Gabapentin
GABAPENTIN		Cspc Ouyi
October 25, 2017ANDA090132 Carvedilol
CARVEDILOL PHOSPHATE		Sun Pharm Industries
October 6, 2017ANDA210086 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Zydus Pharms
July 10, 2017ANDA090961 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE		Zydus Lifesciences
June 9, 2017ANDA209035 Amantadine
AMANTADINE HYDROCHLORIDE		Strides Pharma
May 31, 2017ANDA208170 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Rubicon Research
May 26, 2017ANDA205236 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE		Sciegen Pharms
April 6, 2017ANDA090693 Bupropion
BUPROPION HYDROCHLORIDE		Lupin
March 24, 2017ANDA207099 Gabapentin
GABAPENTIN		Rising
January 6, 2017ANDA208706 Duloxetine
DULOXETINE HYDROCHLORIDE		Ajanta Pharma Ltd
December 30, 2016ANDA205707 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Micro Labs Ltd India
November 23, 2016ANDA202413 Ibuprofen
IBUPROFEN		Shandong Xinhua
September 12, 2016ANDA206174 Aripiprazole
ARIPIPRAZOLE		Ajanta Pharma Ltd
August 19, 2016ANDA206975 Bupropion
BUPROPION HYDROCHLORIDE		Heritage Pharma
July 28, 2016ANDA204467 Allopurinol
ALLOPURINOL		Regcon Holdings
July 11, 2016ANDA205096 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Cspc Ouyi
May 31, 2016ANDA208278 Amantadine
AMANTADINE HYDROCHLORIDE		Zydus Pharms
May 19, 2016ANDA205519 Atorvastatin
ATORVASTATIN CALCIUM		Sciegen Pharms
March 8, 2016ANDA202674 Quetiapine
QUETIAPINE FUMARATE		Unichem
February 18, 2016ANDA204989 Gabapentin
RELGAABI		Sciegen Pharms
February 18, 2016ANDA205115 Doxycycline
DOXYCYCLINE		Zydus Pharms
February 4, 2016ANDA205101 Gabapentin
GABAPENTIN		Sciegen Pharms
December 21, 2015ANDA204239 Linezolid
LINEZOLID		Hetero Labs Ltd V
August 28, 2015ANDA078032 Escitalopram
ESCITALOPRAM OXALATE		Prinston Inc
August 12, 2015ANDA203835 Losartan potassium
LOSARTAN POTASSIUM		Hetero Labs Ltd V
July 31, 2015ANDA203346 Alprazolam
ALPRAZOLAM		Aurobindo Pharma
July 28, 2015ANDA204418 Folic acid
FOLIC ACID		Nuvo Pharms Inc
June 29, 2015ANDA204003 Desvenlafaxine
DESVENLAFAXINE SUCCINATE		Alembic
May 15, 2015ANDA065398 Azithromycin
AZITHROMYCIN		Lupin
May 15, 2015ANDA065400 Azithromycin
AZITHROMYCIN		Lupin
April 28, 2015ANDA202101 Aripiprazole
ARIPIPRAZOLE		Alembic
April 8, 2015ANDA203047 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE		Hetero Labs Ltd V
March 16, 2015ANDA204597 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Sciegen Pharms
January 5, 2015ANDA203311 Valsartan
VALSARTAN		Hetero Labs Ltd V
October 28, 2014ANDA200981 Metoprolol
METOPROLOL TARTRATE		Rubicon Research
September 26, 2014NDA204820 Colchicine
MITIGARE		Hikma
September 18, 2014ANDA203845 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE		Cadila Pharms Ltd
September 11, 2014ANDA203366 Montelukast
MONTELUKAST SODIUM		Macleods Pharms
August 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Heritage
August 19, 2014ANDA204314 Acyclovir
ACYCLOVIR		Zydus Pharms
August 15, 2014ANDA202862 Olanzapine
OLANZAPINE		Macleods Pharms Ltd
February 7, 2014ANDA078888 Buspirone
BUSPIRONE HYDROCHLORIDE		Zydus Pharms
January 27, 2014ANDA202437 Folic acid
FOLIC ACID		Cadila Pharms Ltd
January 22, 2014ANDA203458 Metronidazole
METRONIDAZOLE		Unichem
December 11, 2013ANDA090694 Duloxetine
DULOXETINE HYDROCHLORIDE		Lupin
September 13, 2013ANDA091560 Abacavir
ABACAVIR SULFATE		Hetero Labs Ltd III
June 13, 2013ANDA202297 Clonidine
CLONIDINE HYDROCHLORIDE		Yung Shin Pharm
June 3, 2013ANDA201507 Hydroxyzine
HYDROXYZINE PAMOATE		Heritage Pharma
May 28, 2013ANDA202871 Metoprolol
METOPROLOL TARTRATE		Alembic Pharms Ltd
May 3, 2013ANDA200770 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE		Strides Pharma
April 17, 2013ANDA202112 Glimepiride
GLIMEPIRIDE		Regcon Holdings
March 4, 2013ANDA202202 Warfarin sodium
WARFARIN SODIUM		Amneal Pharms
February 12, 2013ANDA201504 Quetiapine
QUETIAPINE FUMARATE		Alkem Labs Ltd
October 24, 2012ANDA040903 Imipramine
IMIPRAMINE HYDROCHLORIDE		Leading
September 28, 2012ANDA202038 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Aurobindo Pharma Ltd
September 18, 2012ANDA201170 Losartan potassium
LOSARTAN POTASSIUM		Jubilant Cadista
September 11, 2012ANDA078777 Escitalopram
ESCITALOPRAM OXALATE		Graviti Pharms
September 7, 2012ANDA077652 Levofloxacin
LEVOFLOXACIN		Zydus Lifesciences
May 30, 2012ANDA202230 Losartan potassium
LOSARTAN POTASSIUM		Macleods Pharms Ltd
April 23, 2012ANDA076255 Olanzapine
OLANZAPINE		DR Reddys Labs Ltd
March 27, 2012ANDA091388 Quetiapine
QUETIAPINE FUMARATE		Aurobindo Pharma Ltd
March 27, 2012ANDA201109 Quetiapine
QUETIAPINE FUMARATE		Lupin Ltd
March 27, 2012ANDA201190 Quetiapine
QUETIAPINE FUMARATE		Sun Pharm
March 15, 2012ANDA090161 Divalproex sodium
DIVALPROEX SODIUM		DR Reddys Labs Ltd
February 24, 2012ANDA090356 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE		Sun Pharm
January 20, 2012ANDA091568 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Aurobindo Pharma Ltd
December 6, 2011ANDA091368 Clonidine
CLONIDINE HYDROCHLORIDE		Alembic Pharms Ltd
November 29, 2011ANDA077493 Risperidone
RISPERIDONE		Prinston Inc
November 8, 2011ANDA200429 Naproxen
NAPROXEN		Aurobindo Pharma
October 24, 2011ANDA076133 Olanzapine
OLANZAPINE		DR Reddys Labs Ltd
October 24, 2011ANDA091265 Olanzapine
OLANZAPINE		Apotex Inc
October 6, 2011ANDA090170 Lamotrigine
LAMOTRIGINE		Unichem Labs Ltd
September 26, 2011ANDA090695 Loxapine
LOXAPINE SUCCINATE		Lannett Co Inc
August 29, 2011ANDA200503 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE		Lupin Ltd
August 24, 2011ANDA201003 Risperidone
RISPERIDONE		Ajanta Pharma Ltd
June 6, 2011ANDA091497 Losartan potassium
LOSARTAN POTASSIUM		Prinston Inc
May 31, 2011ANDA090056 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE		Aurobindo
May 20, 2011ANDA076697 Carbamazepine
CARBAMAZEPINE		Ani Pharms
April 14, 2011ANDA200834 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Aurobindo Pharma Ltd
April 5, 2011ANDA079163 Divalproex sodium
DIVALPROEX SODIUM		Unichem Labs Ltd
February 14, 2011ANDA091616 Lithium carbonate
LITHIUM CARBONATE		Glenmark Pharms Ltd
January 19, 2011ANDA077619 Pantoprazole sodium
PANTOPRAZOLE SODIUM		DR Reddys Labs Ltd
December 27, 2010ANDA091544 Lithium carbonate
LITHIUM CARBONATE		Glenmark Pharms
December 22, 2010ANDA091276 Indomethacin
INDOMETHACIN		Glenmark Pharms Ltd
December 14, 2010ANDA078932 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Alembic Pharms Ltd
December 14, 2010ANDA091491 Levetiracetam
LEVETIRACETAM		Zhejiang Jingxin
October 6, 2010ANDA091629 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE		Aurobindo Pharma
April 27, 2010ANDA078225 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE		Zydus Pharms USA Inc
April 22, 2010ANDA090564 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Granules India
April 7, 2010ANDA090555 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Aurobindo Pharma
March 24, 2010ANDA090429 Ropinirole
ROPINIROLE HYDROCHLORIDE		Alembic Ltd
February 26, 2010ANDA040858 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE		Heritage Pharms Inc
February 16, 2010ANDA090624 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM		Aurobindo Pharma
November 6, 2009ANDA090200 Methocarbamol
METHOCARBAMOL		Hetero Labs Ltd III
September 25, 2009ANDA090702 Lithium carbonate
LITHIUM CARBONATE		Hetero Labs Ltd III
May 4, 2009ANDA078925 Amlodipine
AMLODIPINE BESYLATE		Alkem
April 17, 2009ANDA078490 Omeprazole
OMEPRAZOLE		DR Reddys Labs Ltd
March 31, 2009ANDA078115 Carbamazepine
CARBAMAZEPINE		Taro
March 27, 2009ANDA076343 Topiramate
TOPIRAMATE		Cipla Ltd
March 27, 2009ANDA078235 Topiramate
TOPIRAMATE		Zydus Pharms USA Inc
March 27, 2009ANDA090162 Topiramate
TOPIRAMATE		Unichem Labs Ltd
February 3, 2009ANDA079139 Lithium carbonate
LITHIUM CARBONATE		Glenmark Pharms Ltd
January 27, 2009ANDA078956 Lamotrigine
LAMOTRIGINE		Aurobindo Pharma
January 15, 2009ANDA078993 Levetiracetam
LEVETIRACETAM		Aurobindo Pharma
November 25, 2008ANDA078853 Divalproex sodium
DIVALPROEX SODIUM		Orbion Pharms
August 15, 2008ANDA040907 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE		Unichem
July 29, 2008ANDA078597 Divalproex sodium
DIVALPROEX SODIUM		Sun Pharm Inds
June 2, 2008ANDA078955 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Ipca Labs Ltd
April 25, 2008ANDA090092 Zidovudine
ZIDOVUDINE		Hetero Labs Ltd III
January 31, 2008ANDA078619 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Aurobindo Pharma
January 11, 2008ANDA078069 Oxcarbazepine
OXCARBAZEPINE		Breckenridge Pharm
January 8, 2008ANDA078403 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Granules
December 11, 2007ANDA078005 Oxcarbazepine
OXCARBAZEPINE		Ani Pharms
November 29, 2007ANDA077580 Haloperidol
HALOPERIDOL		Zydus Pharms USA
October 31, 2007ANDA078512 Atenolol
ATENOLOL		Aurobindo Pharma
October 30, 2007ANDA078341 Finasteride
FINASTERIDE		Aurobindo Pharma
October 9, 2007ANDA077802 Oxcarbazepine
OXCARBAZEPINE		Glenmark Pharms Ltd
September 5, 2007ANDA077614 Carvedilol
CARVEDILOL		Zydus Pharms USA Inc
September 5, 2007ANDA078384 Carvedilol
CARVEDILOL		Regcon Holdings
August 27, 2007ANDA040715 Benztropine mesylate
BENZTROPINE MESYLATE		Ph Health
August 22, 2007ANDA077666 Mirtazapine
MIRTAZAPINE		Apotex
July 31, 2007ANDA078539 Ondansetron
ONDANSETRON HYDROCHLORIDE		Aurobindo Pharma
July 30, 2007ANDA078203 Lorazepam
LORAZEPAM		Leading
July 12, 2007ANDA078043 Amlodipine
AMLODIPINE BESYLATE		Lupin
June 14, 2007ANDA040766 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE		Ipca Labs Ltd
June 8, 2007ANDA077863 Diclofenac
DICLOFENAC SODIUM		Unique
May 11, 2007ANDA077987 Pravastatin sodium
PRAVASTATIN SODIUM		Glenmark Pharms Ltd
May 11, 2007ANDA078103 Simvastatin
SIMVASTATIN		Lupin
March 30, 2007ANDA040627 Benzonatate
BENZONATATE		Thepharmanetwork LLC
March 28, 2007ANDA078250 Naproxen
NAPROXEN		Glenmark Pharms Ltd
March 27, 2007ANDA078216 Citalopram
CITALOPRAM HYDROBROMIDE		Torrent Pharms
March 7, 2007ANDA077584 Paroxetine
PAROXETINE HYDROCHLORIDE		Zydus Pharms USA
February 6, 2007ANDA077206 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Aurobindo Pharma
February 6, 2007ANDA077397 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Invagen Pharms
February 6, 2007ANDA077670 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Lupin
December 20, 2006ANDA077927 Meloxicam
MELOXICAM		Unichem
October 23, 2006ANDA076341 Pravastatin sodium
PRAVASTATIN SODIUM		Apotex
September 27, 2006ANDA077912 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE		Lupin
September 18, 2006ANDA078010 Furosemide
FUROSEMIDE		Ipca Labs Ltd
September 5, 2006ANDA040684 Phenytoin
EXTENDED PHENYTOIN SODIUM		Taro
August 29, 2006ANDA040750 Spironolactone
SPIRONOLACTONE		Oxford Pharms
August 18, 2006ANDA077662 Gabapentin
GABAPENTIN		Glenmark Pharms Ltd
July 27, 2006ANDA077836 Gemfibrozil
GEMFIBROZIL		Invagen Pharms
July 19, 2006ANDA077921 Meloxicam
MELOXICAM		Zydus Pharms USA
June 28, 2006ANDA077856 Clonazepam
CLONAZEPAM		Prinston Inc
April 19, 2006ANDA077563 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Jubilant Cadista
March 29, 2006ANDA065308 Cefuroxime axetil
CEFUROXIME AXETIL		Aurobindo Pharma
January 25, 2006ANDA077253 Fluconazole
FLUCONAZOLE		Glenmark Pharms Ltd
January 17, 2006ANDA076143 Bupropion
BUPROPION HYDROCHLORIDE		Apotex
November 25, 2005ANDA065229 Cephalexin
CEPHALEXIN		Lupin
November 18, 2005ANDA040596 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE		Zydus Pharms USA
November 16, 2005ANDA065253 Cephalexin
CEPHALEXIN		Aurobindo Pharma
November 9, 2005ANDA065256 Amoxicillin
AMOXICILLIN		Aurobindo
November 9, 2005ANDA065271 Amoxicillin
AMOXICILLIN		Aurobindo
November 9, 2005ANDA077293 Furosemide
FUROSEMIDE		Leading
September 9, 2005ANDA077321 Lisinopril
LISINOPRIL		Lupin
August 25, 2005ANDA065136 Clarithromycin
CLARITHROMYCIN		Sandoz
December 21, 2004ANDA040581 Prednisone
PREDNISONE		Ph Health
December 20, 2004ANDA075317 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE		Jubilant Cadista
October 22, 2004ANDA076921 Mirtazapine
MIRTAZAPINE		Aurobindo
September 10, 2004ANDA076639 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE		Unique
March 16, 2004ANDA076593 Ciprofloxacin
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE		Aiping Pharm Inc
July 1, 2002ANDA076164 Lisinopril
LISINOPRIL		Prinston Inc
June 20, 2002ANDA076003 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE		Amneal Pharms
March 1, 2002NDA021342 Levothyroxine
LEVO-T		Cediprof Inc
July 5, 2001ANDA075712 Carbamazepine
CARBAMAZEPINE		Torrent Pharms
June 13, 2001ANDA075795 Glipizide
GLIPIZIDE		Apotex
October 6, 2000ANDA075468 Clonazepam
CLONAZEPAM		Rubicon Research
April 27, 2000ANDA075731 Clorazepate dipotassium
CLORAZEPATE DIPOTASSIUM		Taro
April 17, 2000ANDA075491 Bupropion
BUPROPION HYDROCHLORIDE		Aurobindo Pharma USA
April 17, 2000ANDA075522 Isosorbide mononitrate
ISOSORBIDE MONONITRATE		Dexcel Ltd
September 7, 1999ANDA040317 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Aurobindo Pharma USA
September 7, 1999ANDA040319 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Aurobindo Pharma USA
May 26, 1999ANDA075274 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE		Elite Labs
December 28, 1998ANDA040298 Phenytoin
EXTENDED PHENYTOIN SODIUM, PHENYTEK		Mylan
November 27, 1998ANDA075147 Isosorbide mononitrate
ISOSORBIDE MONONITRATE		Ani Pharms
November 20, 1998ANDA075229 Diclofenac
DICLOFENAC POTASSIUM		Rubicon Research
August 3, 1998ANDA074787 Labetalol
LABETALOL HYDROCHLORIDE		Heritage Pharma
June 26, 1997ANDA040090 Isoniazid
ISONIAZID		Omnivium Pharms
May 28, 1997ANDA064150 Rifampin
RIFAMPIN		Epic Pharma LLC
May 2, 1997ANDA074910 Diltiazem
DILTIAZEM HYDROCHLORIDE		Mylan
December 12, 1996ANDA040103 Benztropine mesylate
BENZTROPINE MESYLATE		Aiping Pharm Inc
September 10, 1996ANDA074569 Clonazepam
CLONAZEPAM		Teva
August 9, 1996ANDA040159 Medroxyprogesterone acetate
MEDROXYPROGESTERONE ACETATE		Barr
August 29, 1995ANDA074388 Glyburide
GLYBURIDE		Teva
March 27, 1995ANDA074132 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE		Teva
September 30, 1994ANDA064076 Amoxicillin
AMOXICILLIN		Sandoz
June 30, 1993NDA020215 Isosorbide mononitrate
MONOKET		Omnivium Pharms
June 15, 1993ANDA072801 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE		Teva
March 24, 1993ANDA073137 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Sun Pharm Industries
January 29, 1993ANDA081297 Benzonatate
BENZONATATE		Bionpharma
March 30, 1992ANDA073556 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE		DR Reddys Labs SA
October 31, 1991ANDA072926 Lorazepam
LORAZEPAM		Watson Labs
October 31, 1991ANDA072927 Lorazepam
LORAZEPAM		Watson Labs
April 6, 1988ANDA071972 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Impax Labs Inc
April 6, 1988ANDA071976 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Impax Labs Inc
January 7, 1988ANDA071173 Haloperidol
HALOPERIDOL		Sciegen Pharms
December 16, 1986ANDA070975 Clonidine
CLONIDINE HYDROCHLORIDE		Actavis Elizabeth
December 10, 1986ANDA071321 Diazepam
DIAZEPAM		Ivax Sub Teva Pharms
December 10, 1986ANDA071322 Diazepam
DIAZEPAM		Ivax Sub Teva Pharms
October 24, 1986ANDA018659 Allopurinol
ALLOPURINOL		Mylan
June 10, 1986ANDA070278 Haloperidol
HALOPERIDOL		Mylan
July 29, 1985ANDA070184 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE		Teva
November 7, 1984ANDA062396 Doxycycline
DOXYCYCLINE HYCLATE		Hikma
December 14, 1981ANDA086183 Hydroxyzine
HYDROXYZINE PAMOATE		Sandoz
December 14, 1981ANDA087479 Hydroxyzine
HYDROXYZINE PAMOATE		Sandoz
June 10, 1976ANDA083116 Chlordiazepoxide hydrochloride
CHLORDIAZEPOXIDE HYDROCHLORIDE		Barr
August 24, 1972ANDA080937 Isoniazid
ISONIAZID		Genus Lifesciences
April 21, 1972ANDA080352 Prednisone
PREDNISONE		Hikma
August 19, 1966NDA016084 Allopurinol
ZYLOPRIM		Casper Pharma LLC
February 14, 1957NDA010721 Meclizine hydrochloride
ANTIVERT		Casper Pharma LLC

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

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. 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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