Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Drug company (FDA labeler)

Direct_Rx

NDC labeler codes: 61919, 72189

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

179Prescription medicines
550Products (NDC)
405FDA 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 20, 2025ANDA218684 Ibuprofen and famotidine
IBUPROFEN AND FAMOTIDINE		Zydus Lifesciences
February 7, 2024ANDA216282 Dexamethasone
DEXAMETHASONE		Zydus Lifesciences
January 5, 2024ANDA217081 Atorvastatin
ATORVASTATIN CALCIUM		Mankind Pharma
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 17, 2023ANDA217652 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Graviti Pharms
August 7, 2023ANDA217269 Guanfacine
GUANFACINE HYDROCHLORIDE		Alembic
August 3, 2023ANDA217748 Allopurinol
ALLOPURINOL		Hetero Labs Ltd V
June 12, 2023ANDA216916 Metoprolol
METOPROLOL SUCCINATE		Granules
May 19, 2023ANDA217411 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Rising
May 9, 2023ANDA217696 Dexamethasone
DEXAMETHASONE		Novitium Pharma
March 21, 2023ANDA217272 Nitrofurantoin
NITROFURANTOIN		Mankind Pharma
March 10, 2023ANDA208045 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Aurobindo Pharma Ltd
February 23, 2023ANDA216759 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Bionpharma
February 3, 2023ANDA213040 Diclofenac
DICLOFENAC SODIUM		Aurolife Pharma LLC
December 30, 2022ANDA215697 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Mankind Pharma
December 2, 2022ANDA206720 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL		Prinston Inc
November 23, 2022ANDA215886 Ofloxacin
OFLOXACIN		Mankind Pharma
September 21, 2022ANDA208021 Diclofenac
DICLOFENAC SODIUM		Lupin Pharms
August 8, 2022ANDA215604 Dexamethasone
DEXAMETHASONE		Novitium Pharma
July 27, 2022ANDA212351 Diclofenac
DICLOFENAC SODIUM		Alembic
July 14, 2022ANDA216130 Ofloxacin
OFLOXACIN		Mankind Pharma
June 24, 2022ANDA215113 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Msn
April 7, 2022ANDA212682 Nebivolol
NEBIVOLOL HYDROCHLORIDE		Prinston Inc
February 9, 2022ANDA215710 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Mankind Pharma
January 18, 2022ANDA209920 Lubiprostone
LUBIPROSTONE		Teva Pharms USA Inc
December 8, 2021ANDA213949 Lamotrigine
LAMOTRIGINE		Pharmobedient
December 3, 2021ANDA213320 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Harman Finochem
October 1, 2021ANDA214957 Gabapentin
GABAPENTIN		Ascent Pharms Inc
August 13, 2021ANDA208993 Colchicine
COLCHICINE		Hetero Labs Ltd V
August 3, 2021ANDA211890 Ibuprofen and famotidine
IBUPROFEN AND FAMOTIDINE		Alkem Labs Ltd
May 20, 2021ANDA212443 Ketoconazole
KETOCONAZOLE		Encube
May 19, 2021ANDA214548 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Unichem
April 21, 2021ANDA215076 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Alembic
April 20, 2021ANDA212695 Lidocaine
LIDOCAINE		Quagen
March 5, 2021ANDA214374 Baclofen
BACLOFEN		Rising
February 19, 2021ANDA210534 Cefdinir
CEFDINIR		Alkem Labs Ltd
February 19, 2021ANDA213999 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Mankind Pharma
February 11, 2021ANDA208412 Prednisone
PREDNISONE		Strides Pharma
November 27, 2020ANDA214129 Chlorthalidone
CHLORTHALIDONE		Ajanta Pharma Ltd
November 25, 2020ANDA213428 Guanfacine
GUANFACINE HYDROCHLORIDE		Yichang Humanwell
October 26, 2020ANDA213815 Ramelteon
RAMELTEON		Appco
October 21, 2020ANDA214452 Potassium chloride
POTASSIUM CHLORIDE		Granules
October 19, 2020ANDA212399 Levothyroxine
LEVOTHYROXINE SODIUM		Accord Hlthcare
August 28, 2020ANDA212982 Clobetasol propionate
CLOBETASOL PROPIONATE		Encube
August 24, 2020ANDA206463 Lidocaine
LIDOCAINE		Amneal
August 19, 2020ANDA213853 Atorvastatin
ATORVASTATIN CALCIUM		Umedica
August 17, 2020ANDA213603 Gabapentin
GABAPENTIN		Zhejiang Yongtai
July 1, 2020ANDA213063 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Taro
June 2, 2020ANDA211977 Esomeprazole
ESOMEPRAZOLE MAGNESIUM		Hetero Labs Ltd III
May 27, 2020ANDA213798 Tizanidine
TIZANIDINE HYDROCHLORIDE		Rubicon Research
May 8, 2020ANDA213794 Ibuprofen
IBUPROFEN		Aurobindo Pharma Ltd
April 15, 2020ANDA207798 Carbamazepine
CARBAMAZEPINE		Umedica
April 10, 2020ANDA212650 Ramelteon
RAMELTEON		Pharmazone
April 1, 2020ANDA207763 Lamotrigine
LAMOTRIGINE		Zydus Pharms
March 18, 2020ANDA209553 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE		Yiling
March 16, 2020ANDA211697 Lidocaine
LIDOCAINE		Macleods Pharms
March 2, 2020ANDA210129 Amantadine
AMANTADINE HYDROCHLORIDE		Rising
February 21, 2020ANDA212517 Naproxen
NAPROXEN		Sciegen Pharms
February 20, 2020ANDA213413 Diphenoxylate hydrochloride and atropine sulfate
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE		Leading
February 11, 2020ANDA213412 Chlorthalidone
CHLORTHALIDONE		Alkem Labs Ltd
January 27, 2020ANDA210986 Diclofenac
DICLOFENAC SODIUM		Encube
January 6, 2020ANDA212026 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Amta
November 15, 2019ANDA211575 Prednisone
PREDNISONE		Novitium Pharma
November 14, 2019ANDA210907 Buspirone
BUSPIRONE HYDROCHLORIDE		Unichem
October 30, 2019ANDA212199 Naproxen
NAPROXEN SODIUM		Sciegen Pharms
October 18, 2019ANDA209286 Divalproex sodium
DIVALPROEX SODIUM		Lupin
October 9, 2019ANDA211343 Doxycycline
DOXYCYCLINE HYCLATE		Changzhou Pharm
October 7, 2019ANDA209366 Acyclovir
ACYCLOVIR		Adaptis
September 13, 2019ANDA212624 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Ajanta Pharma Ltd
September 6, 2019ANDA209876 Colchicine
COLCHICINE		DR Reddys
August 6, 2019ANDA211627 Chlorthalidone
CHLORTHALIDONE		Unichem
July 22, 2019ANDA211567 Ramelteon
RAMELTEON		Zydus Pharms
July 19, 2019ANDA208677 Pregabalin
PREGABALIN		Sciegen Pharms
July 19, 2019ANDA209743 Pregabalin
PREGABALIN		Amneal Pharms Co
June 14, 2019ANDA208783 Diltiazem
DILTIAZEM HYDROCHLORIDE		Novast Labs
April 17, 2019ANDA208250 Azithromycin
AZITHROMYCIN		Cspc Ouyi
April 5, 2019ANDA203410 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Micro Labs Ltd India
March 26, 2019ANDA209654 Tadalafil
TADALAFIL		Ajanta Pharma Ltd
March 12, 2019ANDA205536 Valsartan
VALSARTAN		Alkem Labs Ltd
March 12, 2019ANDA210267 Tizanidine
TIZANIDINE HYDROCHLORIDE		Ingenus Pharms LLC
March 12, 2019ANDA211820 Allopurinol
ALLOPURINOL		Unichem
March 6, 2019ANDA204991 Atorvastatin
ATORVASTATIN CALCIUM		Lupin
February 26, 2019ANDA210000 Azithromycin
AZITHROMYCIN		Bionpharma
February 26, 2019ANDA210001 Azithromycin
AZITHROMYCIN		Bionpharma
February 22, 2019ANDA211518 Benzonatate
BENZONATATE		Ascent Pharms Inc
February 21, 2019ANDA207105 Aripiprazole
ARIPIPRAZOLE		Alkem Labs Ltd
February 8, 2019ANDA211933 Atorvastatin
ATORVASTATIN CALCIUM		Msn
January 18, 2019ANDA209713 Levothyroxine
LEVOTHYROXINE SODIUM		Lupin
January 15, 2019ANDA210708 Eletriptan hydrobromide
ELETRIPTAN HYDROBROMIDE		Aurobindo Pharma
December 19, 2018ANDA206948 Benzonatate
BENZONATATE		Puracap Pharm LLC
December 11, 2018ANDA210958 Lidocaine
LIDOCAINE		Strides Pharma
November 9, 2018ANDA206037 Anastrozole
ANASTROZOLE		Pharmobedient
November 7, 2018ANDA211487 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN		Ascent Pharms Inc
November 5, 2018ANDA207402 Clindamycin
CLINDAMYCIN HYDROCHLORIDE		Micro Labs
October 31, 2018ANDA209587 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE		Lgm Pharma
October 31, 2018ANDA210497 Bupropion
BUPROPION HYDROCHLORIDE		Accord Hlthcare
October 26, 2018ANDA211285 Progesterone
PROGESTERONE		Eugia Pharma
October 25, 2018ANDA208249 Azithromycin
AZITHROMYCIN		Cspc Ouyi
August 31, 2018ANDA210733 Potassium chloride
POTASSIUM CHLORIDE		Strides Pharma
August 27, 2018ANDA209882 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Laurus
July 25, 2018ANDA205430 Guanfacine
GUANFACINE HYDROCHLORIDE		Apotex
July 5, 2018ANDA207370 Azithromycin
AZITHROMYCIN		Aurobindo Pharma Ltd
July 5, 2018ANDA207398 Azithromycin
AZITHROMYCIN		Aurobindo Pharma Ltd
June 29, 2018ANDA208130 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL		Sciegen Pharms
June 22, 2018ANDA208921 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE		Pharmobedient
June 14, 2018ANDA210015 Bupropion
BUPROPION HYDROCHLORIDE		Yichang Humanwell
June 11, 2018ANDA202659 Sildenafil
SILDENAFIL CITRATE		Hetero Labs Ltd V
May 24, 2018ANDA208516 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)		Sunny
May 18, 2018ANDA209535 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Macleods Pharms
May 14, 2018ANDA204072 Methylprednisolone
METHYLPREDNISOLONE		Tianjin Tianyao
May 14, 2018ANDA206943 Gabapentin
GABAPENTIN		Strides Pharma
May 7, 2018ANDA209312 Methocarbamol
METHOCARBAMOL		Granules
April 24, 2018ANDA208644 Rabeprazole sodium
RABEPRAZOLE SODIUM		Alkem Labs Ltd
March 23, 2018ANDA203894 Metoprolol
METOPROLOL SUCCINATE		Zydus Pharms
March 21, 2018ANDA207510 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN		Wes Pharma Inc
March 6, 2018ANDA206069 Armodafinil
ARMODAFINIL		Aurobindo Pharma Ltd
February 6, 2018ANDA204106 Metoprolol
METOPROLOL SUCCINATE		Novast Labs
January 26, 2018ANDA090513 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE		Aurobindo Pharma
January 26, 2018ANDA210347 Piroxicam
PIROXICAM		Strides Pharma
January 23, 2018ANDA210071 Celecoxib
CELECOXIB		Cspc Ouyi
December 26, 2017ANDA204963 Desipramine hydrochloride
DESIPRAMINE HYDROCHLORIDE		Ingenus Pharms LLC
November 29, 2017ANDA204253 Quetiapine
QUETIAPINE FUMARATE		Macleods Pharms
November 29, 2017ANDA209635 Quetiapine
QUETIAPINE FUMARATE		Sciegen Pharms
November 28, 2017ANDA209102 Baclofen
BACLOFEN		Rubicon Research
November 22, 2017ANDA208898 Rosuvastatin
ROSUVASTATIN CALCIUM		Msn
November 9, 2017ANDA202916 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE		Epic Pharma LLC
November 6, 2017ANDA204901 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE		Prinston Inc
October 30, 2017ANDA210211 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN		Wes Pharma Inc
October 20, 2017ANDA205229 Progesterone
PROGESTERONE		Xiromed
October 10, 2017ANDA205253 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Zydus Pharms
September 18, 2017ANDA208848 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Encube
August 30, 2017ANDA205868 Lansoprazole
LANSOPRAZOLE		Adaptis
August 29, 2017ANDA205186 Eletriptan hydrobromide
ELETRIPTAN HYDROBROMIDE		Chartwell Rx
June 15, 2017ANDA203695 Metaxalone
METAXALONE		Actavis Labs Fl Inc
June 12, 2017ANDA204021 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Novel Labs Inc
June 9, 2017ANDA209035 Amantadine
AMANTADINE HYDROCHLORIDE		Strides Pharma
June 7, 2017ANDA209047 Amantadine
AMANTADINE HYDROCHLORIDE		Strides Pharma
May 31, 2017ANDA208170 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Rubicon Research
April 24, 2017ANDA204798 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL		Aurobindo Pharma
April 24, 2017ANDA207662 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL		Accord Hlthcare
April 6, 2017ANDA090693 Bupropion
BUPROPION HYDROCHLORIDE		Lupin
March 24, 2017ANDA207099 Gabapentin
GABAPENTIN		Rising
March 22, 2017ANDA207152 Tramadol hydrochloride and acetaminophen
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN		Aurobindo Pharma
March 22, 2017ANDA207419 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN		Ascent Pharms Inc
March 10, 2017ANDA207810 Lidocaine
LIDOCAINE		Alkem Labs Ltd
February 28, 2017ANDA204022 Ropinirole
ROPINIROLE HYDROCHLORIDE		Accord Hlthcare
February 17, 2017ANDA205761 Rabeprazole sodium
RABEPRAZOLE SODIUM		Quagen
February 16, 2017ANDA208963 Fluconazole
FLUCONAZOLE		Zydus Pharms
January 6, 2017ANDA208706 Duloxetine
DULOXETINE HYDROCHLORIDE		Ajanta Pharma Ltd
January 5, 2017ANDA204304 Finasteride
FINASTERIDE		Alkem Labs Ltd
December 30, 2016ANDA205707 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Micro Labs Ltd India
November 22, 2016ANDA204770 Metaxalone
METAXALONE		Lannett Co Inc
November 17, 2016ANDA207068 Pravastatin sodium
PRAVASTATIN SODIUM		Accord Hlthcare
November 1, 2016ANDA090681 Quetiapine
QUETIAPINE FUMARATE		Accord Hlthcare
November 1, 2016ANDA204216 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Gland
September 16, 2016ANDA202696 Valsartan
VALSARTAN		Macleods Pharms Ltd
September 13, 2016ANDA208301 Diclofenac
DICLOFENAC SODIUM		Glenmark Pharms Ltd
September 9, 2016ANDA206498 Lidocaine
LIDOCAINE		Glenmark Pharms Ltd
September 2, 2016ANDA206116 Diclofenac
DICLOFENAC SODIUM		Amneal Pharms
July 28, 2016ANDA204467 Allopurinol
ALLOPURINOL		Regcon Holdings
July 26, 2016ANDA203562 Potassium chloride
POTASSIUM CHLORIDE		Glenmark Pharms Ltd
July 15, 2016ANDA204228 Omeprazole and sodium bicarbonate
OMEPRAZOLE AND SODIUM BICARBONATE		Ajanta Pharma Ltd
May 20, 2016ANDA204041 Zolmitriptan
ZOLMITRIPTAN		Ajanta Pharma Ltd
April 29, 2016ANDA090295 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Pharmazone
April 28, 2016ANDA206298 Diclofenac
DICLOFENAC SODIUM		Sun Pharma Canada
March 16, 2016ANDA204590 Celecoxib
CELECOXIB		Macleods Pharms
February 29, 2016ANDA207138 Oxybutynin
OXYBUTYNIN CHLORIDE		Accord Hlthcare
February 18, 2016ANDA203269 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Alkem Labs Ltd
February 18, 2016ANDA204989 Gabapentin
RELGAABI		Sciegen Pharms
February 18, 2016ANDA205115 Doxycycline
DOXYCYCLINE		Zydus Pharms
February 4, 2016ANDA205101 Gabapentin
GABAPENTIN		Sciegen Pharms
January 29, 2016ANDA201760 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE		Sun Pharm
December 28, 2015ANDA203661 Cefazolin
CEFAZOLIN SODIUM		Qilu Antibiotics
December 23, 2015ANDA206402 Gabapentin
GABAPENTIN		Alkem Labs Ltd
November 30, 2015ANDA206528 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE		Ajanta Pharma Ltd
October 30, 2015ANDA202894 Clotrimazole and betamethasone dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE		Glenmark Speclt
September 15, 2015ANDA091625 Ibuprofen
IBUPROFEN		Granules
August 28, 2015ANDA078032 Escitalopram
ESCITALOPRAM OXALATE		Prinston Inc
August 20, 2015ANDA204132 Diclofenac
DICLOFENAC SODIUM		Lupin
August 12, 2015ANDA203835 Losartan potassium
LOSARTAN POTASSIUM		Hetero Labs Ltd V
August 7, 2015ANDA206297 Lidocaine
LIDOCAINE		Amneal Pharms
July 31, 2015ANDA203346 Alprazolam
ALPRAZOLAM		Aurobindo Pharma
July 28, 2015ANDA204418 Folic acid
FOLIC ACID		Nuvo Pharms Inc
June 29, 2015ANDA204003 Desvenlafaxine
DESVENLAFAXINE SUCCINATE		Alembic
June 29, 2015ANDA204028 Desvenlafaxine
DESVENLAFAXINE SUCCINATE		Rubicon Research
June 29, 2015ANDA204172 Desvenlafaxine
DESVENLAFAXINE SUCCINATE		Lupin
May 28, 2015ANDA204446 Doxycycline
DOXYCYCLINE		Cosette Pharms Nc
May 26, 2015ANDA202304 Bupropion
BUPROPION HYDROCHLORIDE		Prinston Inc
May 22, 2015ANDA204093 Montelukast
MONTELUKAST SODIUM		Hetero Labs Ltd V
May 21, 2015ANDA203468 Levetiracetam
LEVETIRACETAM		Prinston Inc
April 28, 2015ANDA201519 Aripiprazole
ARIPIPRAZOLE		Torrent
April 28, 2015ANDA205064 Aripiprazole
ARIPIPRAZOLE		Hetero Labs Ltd V
March 16, 2015ANDA204597 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Sciegen Pharms
January 30, 2015ANDA202929 Eszopiclone
ESZOPICLONE		Macleods Pharms
January 8, 2015ANDA202801 Levofloxacin
LEVOFLOXACIN		Hetero Labs Ltd V
December 30, 2014ANDA202557 Buspirone
BUSPIRONE HYDROCHLORIDE		Accord Hlthcare
December 5, 2014ANDA205019 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE		Nuvo Pharm
November 26, 2014ANDA203818 Diclofenac
DICLOFENAC SODIUM		Sun Pharma Canada
October 28, 2014ANDA200981 Metoprolol
METOPROLOL TARTRATE		Rubicon Research
September 19, 2014ANDA203146 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Macleods Pharms Ltd
September 10, 2014ANDA202843 Montelukast
MONTELUKAST SODIUM		Hetero Labs Ltd V
September 10, 2014ANDA202882 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Hetero Labs Ltd V
September 4, 2014ANDA202867 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE		Lupin
August 28, 2014ANDA201278 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN		Rhodes Pharms
August 25, 2014ANDA202330 Buspirone
BUSPIRONE HYDROCHLORIDE		Strides Pharma
August 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Heritage
August 15, 2014ANDA202862 Olanzapine
OLANZAPINE		Macleods Pharms Ltd
August 6, 2014ANDA203068 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE		Aurobindo Pharma Ltd
June 11, 2014ANDA202824 Doxazosin
DOXAZOSIN MESYLATE		Accord Hlthcare
February 11, 2014ANDA203147 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Macleods Pharms
January 27, 2014ANDA203374 Carisoprodol
CARISOPRODOL		Sciegen Pharms
January 22, 2014ANDA203458 Metronidazole
METRONIDAZOLE		Unichem
December 11, 2013ANDA090694 Duloxetine
DULOXETINE HYDROCHLORIDE		Lupin
November 27, 2013ANDA202180 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Torrent
October 21, 2013ANDA203245 Amlodipine
AMLODIPINE BESYLATE		Unichem
September 11, 2013ANDA078970 Zolpidem tartrate
ZOLPIDEM TARTRATE		Lupin
September 11, 2013ANDA203769 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Sciegen Pharms
July 12, 2013ANDA203244 Gabapentin
GABAPENTIN		Strides Pharma
July 1, 2013ANDA203062 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Aurobindo Pharma Ltd
July 1, 2013ANDA204339 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Invagen Pharms
June 3, 2013ANDA201507 Hydroxyzine
HYDROXYZINE PAMOATE		Heritage Pharma
April 30, 2013ANDA202433 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE		Aurobindo Pharma Ltd
April 17, 2013ANDA202112 Glimepiride
GLIMEPIRIDE		Regcon Holdings
March 4, 2013ANDA202202 Warfarin sodium
WARFARIN SODIUM		Amneal Pharms
February 13, 2013ANDA200268 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE		Aurobindo Pharma Ltd
February 12, 2013ANDA201504 Quetiapine
QUETIAPINE FUMARATE		Alkem Labs Ltd
January 31, 2013ANDA091281 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Twi Pharms Inc
December 31, 2012ANDA202490 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Aurobindo Pharma Ltd
November 28, 2012ANDA079229 Ropinirole
ROPINIROLE HYDROCHLORIDE		Orbion Pharms
November 28, 2012ANDA091283 Tizanidine
TIZANIDINE HYDROCHLORIDE		Unichem Labs Ltd
September 27, 2012ANDA202910 Irbesartan
IRBESARTAN		Hetero Labs Ltd V
September 24, 2012ANDA202556 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE		Accord Hlthcare
September 18, 2012ANDA201845 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE		Jubilant Cadista
September 13, 2012ANDA200243 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE		Lannett Co Inc
September 11, 2012ANDA090939 Escitalopram
ESCITALOPRAM OXALATE		Torrent Pharms Ltd
September 5, 2012ANDA202239 Amlodipine besylate and benazepril hydrochloride
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE		Aurobindo Pharma Ltd
August 15, 2012ANDA078889 Metoprolol
METOPROLOL SUCCINATE		Reddys
July 25, 2012ANDA065489 Clarithromycin
CLARITHROMYCIN		Aurobindo
June 29, 2012ANDA202759 Glimepiride
GLIMEPIRIDE		Aurobindo Pharma Ltd
April 3, 2012ANDA201506 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE		Jubilant Generics
March 27, 2012ANDA091388 Quetiapine
QUETIAPINE FUMARATE		Aurobindo Pharma Ltd
December 20, 2011ANDA201090 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Aurobindo Pharma Ltd
December 7, 2011ANDA201384 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE		Sun Pharm
November 30, 2011ANDA076477 Atorvastatin
ATORVASTATIN CALCIUM		Sun Pharm Inds Ltd
October 6, 2011ANDA090170 Lamotrigine
LAMOTRIGINE		Unichem Labs Ltd
October 6, 2011ANDA200651 Gabapentin
GABAPENTIN		Aurobindo Pharma Ltd
September 13, 2011ANDA091124 Eszopiclone
ESZOPICLONE		Lupin Ltd
August 29, 2011ANDA200503 Tramadol hydrochloride
TRAMADOL HYDROCHLORIDE		Lupin Ltd
August 24, 2011ANDA201003 Risperidone
RISPERIDONE		Ajanta Pharma Ltd
July 21, 2011ANDA090007 Gabapentin
GABAPENTIN		Pharmazone
June 6, 2011ANDA091497 Losartan potassium
LOSARTAN POTASSIUM		Prinston Inc
May 31, 2011ANDA200292 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE		Prinston Inc
May 25, 2011ANDA090935 Warfarin sodium
WARFARIN SODIUM		Invagen Pharms
April 14, 2011ANDA200834 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Aurobindo Pharma Ltd
April 12, 2011ANDA091240 Indomethacin
INDOMETHACIN		Hetero Labs Ltd III
February 14, 2011ANDA091416 Naproxen
NAPROXEN		Pharmazone
December 22, 2010ANDA091276 Indomethacin
INDOMETHACIN		Glenmark Pharms Ltd
December 21, 2010ANDA090796 Ibuprofen
IBUPROFEN		Pharmazone
December 20, 2010ANDA090836 Cephalexin
CEPHALEXIN		Alkem Labs Ltd
December 14, 2010ANDA091491 Levetiracetam
LEVETIRACETAM		Zhejiang Jingxin
October 8, 2010ANDA090515 Levetiracetam
LEVETIRACETAM		Hetero Labs Ltd III
October 6, 2010ANDA078243 Losartan potassium
LOSARTAN POTASSIUM		Zydus Pharms USA Inc
October 6, 2010ANDA091629 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE		Aurobindo Pharma
September 7, 2010ANDA078837 Imiquimod
IMIQUIMOD		Padagis Israel
June 28, 2010ANDA090568 Anastrozole
ANASTROZOLE		Accord Hlthcare
May 21, 2010ANDA078245 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE		Lupin Ltd
April 12, 2010ANDA090469 Ondansetron
ONDANSETRON		Aurobindo Pharma
April 6, 2010ANDA077157 Losartan potassium and hydrochlorothiazide
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE		Teva Pharms
February 25, 2010ANDA090135 Ropinirole
ROPINIROLE HYDROCHLORIDE		Glenmark Pharms Ltd
February 16, 2010ANDA090624 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM		Aurobindo Pharma
December 9, 2009ANDA090485 Tramadol hydrochloride and acetaminophen
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN		Amneal Pharms
November 6, 2009ANDA090200 Methocarbamol
METHOCARBAMOL		Hetero Labs Ltd III
October 8, 2009ANDA078633 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE		Hikma
August 31, 2009ANDA091393 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Avanthi Inc
August 10, 2009ANDA065461 Tacrolimus
TACROLIMUS		Sandoz
August 10, 2009ANDA078284 Sumatriptan
SUMATRIPTAN SUCCINATE		Orbion Pharms
August 10, 2009ANDA078295 Sumatriptan
SUMATRIPTAN SUCCINATE		Sun Pharm Inds
August 6, 2009ANDA040792 Carisoprodol
CARISOPRODOL		Aurobindo Pharma
July 29, 2009NDA022352 Colchicine
COLCRYS		Takeda Pharms USA
May 22, 2009ANDA078916 Famotidine
FAMOTIDINE		Alembic Pharms Ltd
May 4, 2009ANDA078925 Amlodipine
AMLODIPINE BESYLATE		Alkem
February 5, 2009ANDA078329 Ibuprofen
IBUPROFEN		Strides Pharma
January 27, 2009ANDA079234 Torsemide
TORSEMIDE		Hetero Labs Ltd III
January 9, 2009ANDA078088 Alprazolam
ALPRAZOLAM		Ph Health
November 12, 2008ANDA040765 Phenytoin
EXTENDED PHENYTOIN SODIUM		Amneal Pharms Ny
October 7, 2008ANDA077731 Fluconazole
FLUCONAZOLE		Aurobindo Pharma
September 24, 2008ANDA078420 Nabumetone
NABUMETONE		Sciegen 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
May 12, 2008ANDA078722 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Sun Pharm Inds Ltd
April 17, 2008ANDA078321 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Cspc Ouyi
January 31, 2008ANDA078619 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Aurobindo Pharma
January 7, 2008ANDA065434 Cefdinir
CEFDINIR		Aurobindo Pharma
December 14, 2007ANDA065473 Cefdinir
CEFDINIR		Aurobindo Pharma
October 9, 2007ANDA077802 Oxcarbazepine
OXCARBAZEPINE		Glenmark Pharms Ltd
September 28, 2007ANDA076527 Ofloxacin
OFLOXACIN		Apotex Inc
September 12, 2007ANDA077538 Fluticasone propionate
FLUTICASONE PROPIONATE		Apotex
September 5, 2007ANDA077614 Carvedilol
CARVEDILOL		Zydus Pharms USA Inc
September 5, 2007ANDA078227 Carvedilol
CARVEDILOL		Sandoz
September 5, 2007ANDA078384 Carvedilol
CARVEDILOL		Regcon Holdings
August 27, 2007ANDA040715 Benztropine mesylate
BENZTROPINE MESYLATE		Ph Health
August 22, 2007ANDA077666 Mirtazapine
MIRTAZAPINE		Apotex
August 17, 2007ANDA077903 Zolpidem tartrate
ZOLPIDEM TARTRATE		Torrent Pharms
July 31, 2007ANDA078539 Ondansetron
ONDANSETRON HYDROCHLORIDE		Aurobindo Pharma
July 30, 2007ANDA078203 Lorazepam
LORAZEPAM		Leading
July 2, 2007ANDA078297 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE		Aurobindo Pharma
June 15, 2007NDA021875 Armodafinil
NUVIGIL		Nuvo Pharms
June 8, 2007ANDA040597 Benzonatate
BENZONATATE		Zydus Pharms USA
May 29, 2007ANDA065392 Cefadroxil
CEFADROXIL		Lupin
May 11, 2007ANDA078103 Simvastatin
SIMVASTATIN		Lupin
April 26, 2007ANDA077859 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE		Aurobindo Pharma
March 7, 2007ANDA077584 Paroxetine
PAROXETINE HYDROCHLORIDE		Zydus Pharms USA
February 6, 2007ANDA077206 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Aurobindo Pharma
February 1, 2007NDA021777 Cyclobenzaprine hydrochloride
AMRIX		Teva Pharms Intl
January 31, 2007ANDA077712 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Strides Pharma Intl
January 25, 2007ANDA065352 Cefadroxil
CEFADROXIL		Aurobindo Pharma
December 28, 2006ANDA065334 Amoxicillin
AMOXICILLIN		Aurobindo
December 20, 2006ANDA077927 Meloxicam
MELOXICAM		Unichem
October 23, 2006ANDA076341 Pravastatin sodium
PRAVASTATIN SODIUM		Apotex
October 16, 2006ANDA077625 Zonisamide
ZONISAMIDE		Zydus Lifesciences
September 13, 2006ANDA077443 Atenolol
ATENOLOL		Unique
August 29, 2006ANDA040750 Spironolactone
SPIRONOLACTONE		Oxford Pharms
July 20, 2006ANDA077882 Meloxicam
MELOXICAM		Macleods Pharms
June 28, 2006ANDA077856 Clonazepam
CLONAZEPAM		Prinston Inc
May 31, 2006ANDA065259 Cefdinir
CEFDINIR		Lupin
April 19, 2006ANDA077563 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Jubilant Cadista
March 17, 2006ANDA077634 Zonisamide
ZONISAMIDE		Sun Pharm Inds (In)
January 31, 2006NDA021908 Lubiprostone
AMITIZA		Sucampo Pharma LLC
January 25, 2006ANDA077253 Fluconazole
FLUCONAZOLE		Glenmark Pharms Ltd
January 17, 2006ANDA076143 Bupropion
BUPROPION HYDROCHLORIDE		Apotex
November 18, 2005ANDA040596 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE		Zydus Pharms USA
November 9, 2005ANDA077293 Furosemide
FUROSEMIDE		Leading
July 13, 2005ANDA065228 Amoxicillin
AMOXICILLIN		Sandoz
February 24, 2005ANDA040586 Primidone
PRIMIDONE		Oxford Pharms
December 21, 2004ANDA040584 Prednisone
PREDNISONE		Ph Health
November 24, 2004ANDA077027 Cilostazol
CILOSTAZOL		Teva
October 22, 2004ANDA076921 Mirtazapine
MIRTAZAPINE		Aurobindo
July 29, 2004ANDA076658 Fluconazole
FLUCONAZOLE		DR Reddys Labs Inc
February 11, 2004ANDA076118 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE		Prinston Inc
November 7, 2003ANDA065085 Mupirocin
MUPIROCIN		Teva
October 23, 2003ANDA040526 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE		Sun Pharm Industries
September 29, 2003ANDA076416 Tizanidine
TIZANIDINE HYDROCHLORIDE		Sun Pharm Inds Inc
May 30, 2003ANDA076380 Norethindrone acetate and ethinyl estradiol
JUNEL 1/20		Barr Labs
January 29, 2003ANDA040489 Methocarbamol
METHOCARBAMOL		Oxford Pharms
October 24, 2002NDA021116 Levothyroxine
THYRO-TABS		Alvogen
August 2, 2002ANDA076002 Clotrimazole and betamethasone dipropionate
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE		Actavis Mid Atlantic
July 3, 2002ANDA076286 Tizanidine
TIZANIDINE HYDROCHLORIDE		DR Reddys Labs Inc
July 1, 2002ANDA076230 Lisinopril and hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE		Prinston Inc
January 10, 2002ANDA075912 Ketoconazole
KETOCONAZOLE		Pharmazone
May 31, 2001ANDA040419 Acetaminophen and codeine phosphate
ACETAMINOPHEN AND CODEINE PHOSPHATE		Specgx LLC
April 16, 2001ANDA075718 Famotidine
FAMOTIDINE		DR Reddys Labs Ltd
April 16, 2001ANDA075805 Famotidine
FAMOTIDINE		Carlsbad
January 31, 2001ANDA075855 Oxaprozin
OXAPROZIN		DR Reddys Labs Ltd
November 22, 2000ANDA065053 Doxycycline
DOXYCYCLINE		Sun Pharm Inds Ltd
October 20, 2000ANDA040409 Hydrocodone bitartrate and acetaminophen
ANEXSIA 5/325		Specgx LLC
September 8, 2000ANDA040405 Hydrocodone bitartrate and acetaminophen
ANEXSIA 7.5/325		Specgx LLC
July 26, 2000ANDA040400 Hydrocodone bitartrate and acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN		Specgx LLC
May 8, 2000ANDA075520 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE		Taro
June 15, 1999ANDA075319 Ketoconazole
KETOCONAZOLE		Taro
March 19, 1999NDA020612 Lidocaine
LIDODERM		Teikoku Pharma USA
December 29, 1998ANDA040275 Estradiol
ESTRADIOL		Epic Pharma LLC
June 8, 1998ANDA074415 Sucralfate
SUCRALFATE		Chartwell Rx
February 27, 1998ANDA040268 Prochlorperazine
PROCOMP		Jubilant Cadista
March 29, 1996ANDA070848 Sucralfate
SUCRALFATE		Teva
September 11, 1995NDA020401 Diltiazem
TIAZAC		Bausch
July 27, 1995ANDA074299 Indapamide
INDAPAMIDE		Ani Pharms
March 27, 1995ANDA074132 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE		Teva
July 29, 1994ANDA064067 Erythromycin
ERYTHROMYCIN		Bausch and Lomb Inc
July 25, 1994ANDA064063 Neomycin sulfate, polymyxin b sulfate and dexamethasone
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE		Bausch and Lomb Inc
May 11, 1994ANDA064048 Gentamicin sulfate
GENTAMICIN SULFATE		Bausch and Lomb Inc
January 29, 1993ANDA064022 Nystatin
NYSTATIN		Sun Pharma Canada
March 30, 1992ANDA073556 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE		DR Reddys Labs SA
January 24, 1992ANDA073457 Atenolol
ATENOLOL		Mylan
December 24, 1991NDA020064 Nitrofurantoin (monohydrate/macrocrystals)
MACROBID		Almatica
October 29, 1991ANDA073229 Valproic acid
VALPROIC ACID		Catalent
November 14, 1988ANDA071655 Oxybutynin
OXYBUTYNIN CHLORIDE		Teva Pharms USA
December 16, 1986ANDA089414 Hydrocortisone
HYDROCORTISONE		Fougera Pharms Inc
December 10, 1986ANDA071321 Diazepam
DIAZEPAM		Ivax Sub Teva Pharms
December 10, 1986ANDA071322 Diazepam
DIAZEPAM		Ivax Sub Teva Pharms
August 4, 1986ANDA070322 Propranolol hydrochloride
PROPRANOLOL HYDROCHLORIDE		Innogenix
July 10, 1986ANDA062676 Doxycycline
DOXYCYCLINE HYCLATE		Sun Pharm Industries
September 4, 1985ANDA070325 Diazepam
DIAZEPAM		Mylan
November 9, 1984ANDA088799 Hydrocortisone
HYDROCORTISONE		Taro
November 7, 1984ANDA062396 Doxycycline
DOXYCYCLINE HYCLATE		Hikma
October 10, 1984ANDA062452 Gentamicin sulfate
GENOPTIC		Allergan
September 11, 1984ANDA062505 Doxycycline
DOXYCYCLINE HYCLATE		Chartwell
March 19, 1984ANDA088042 Triamcinolone acetonide
TRIDERM		Crown Labs
May 3, 1983ANDA087795 Hydrocortisone
HYDROCORTISONE		Actavis Mid Atlantic
April 21, 1983ANDA085025 Hydrocortisone
HYDROCORTISONE		Padagis Us
February 25, 1982NDA018578 Silver sulfadiazine
SSD, SSD AF		DR Reddys
December 14, 1981ANDA086183 Hydroxyzine
HYDROXYZINE PAMOATE		Sandoz
December 14, 1981ANDA087479 Hydroxyzine
HYDROXYZINE PAMOATE		Sandoz
August 17, 1981ANDA086724 Lidocaine
LIDOCAINE		Sun Pharma Canada
April 9, 1981ANDA086413 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE		Padagis Us
December 11, 1979ANDA062225 Nystatin
NYSTATIN		Padagis Us
July 19, 1978ANDA084612 Dexamethasone
DEXAMETHASONE		Hikma
November 12, 1976ANDA085162 Prednisone
PREDNISONE		Watson Labs
February 14, 1957NDA010721 Meclizine hydrochloride
ANTIVERT		Casper Pharma LLC
—ANDA070217 Propranolol hydrochloride—
—ANDA084610 Dexamethasone—
—ANDA084613 Dexamethasone—
—ANDA209727 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

  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

FDA Enforcement Report search → · Report an error →