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Drug company (FDA labeler)

Chartwell RX, LLC

NDC labeler code: 62135

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

212Prescription medicines
544Products (NDC)
297FDA 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
April 14, 2025ANDA211780 Sucralfate
SUCRALFATE		Chartwell Rx
August 28, 2024ANDA216368 Glycopyrrolate
GLYCOPYRROLATE		Chartwell Rx
May 15, 2024ANDA215154 Lacosamide
LACOSAMIDE		Chartwell Rx
January 31, 2024ANDA211407 Fenofibrate
FENOFIBRATE (MICRONIZED)		Chartwell
November 21, 2023ANDA205950 Trimethobenzamide hydrochloride
TRIMETHOBENZAMIDE HYDROCHLORIDE		Heritage Pharma Avet
May 12, 2023ANDA217337 Mesalamine
MESALAMINE		Sinotherapeutics Inc
October 25, 2022ANDA215595 Aripiprazole
ARIPIPRAZOLE		Chartwell Rx
August 11, 2022ANDA203003 Meclizine hydrochloride
MECLIZINE HYDROCHLORIDE		Chartwell Rx
June 8, 2022ANDA216399 Guanfacine
GUANFACINE HYDROCHLORIDE		Aiping Pharm Inc
May 18, 2022ANDA210163 Perphenazine
PERPHENAZINE		Somerset Theraps LLC
March 31, 2022ANDA215591 Carbamazepine
CARBAMAZEPINE		Zhejiang Jiuzhou
March 10, 2022ANDA209173 Colchicine
COLCHICINE		Strides Pharma
November 29, 2021ANDA212630 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Chartwell Rx
November 2, 2021ANDA211248 Paroxetine
PAROXETINE HYDROCHLORIDE		Pharmobedient
October 20, 2021ANDA215141 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Chartwell Rx
September 3, 2021ANDA214756 Chloroquine phosphate
CHLOROQUINE PHOSPHATE		Cohance Lifesciences
June 21, 2021ANDA212428 Oxcarbazepine
OXCARBAZEPINE		Chartwell Rx
March 4, 2021ANDA208920 Lisinopril
LISINOPRIL		Sciegen Pharms
February 10, 2021ANDA211222 Water
STERILE WATER FOR INJECTION		Nephron
February 3, 2021ANDA211963 Tavaborole
TAVABOROLE		Chartwell Rx
October 21, 2020ANDA207128 Diphenoxylate hydrochloride and atropine sulfate
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE		Chartwell Rx
October 20, 2020ANDA213530 Chlordiazepoxide hydrochloride and clidinium bromide
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE		Chartwell Rx
September 15, 2020ANDA205360 Doxercalciferol
DOXERCALCIFEROL		Avet
September 15, 2020ANDA212041 Lisinopril
LISINOPRIL		Sciegen Pharms
September 14, 2020ANDA212173 Acyclovir
ACYCLOVIR		Pharmobedient
September 4, 2020ANDA210268 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Chartwell Rx
August 17, 2020ANDA213555 Ursodiol
URSODIOL		Chartwell Rx
July 22, 2020ANDA213500 Mexiletine hydrochloride
MEXILETINE HYDROCHLORIDE		Crossmedika SA
April 24, 2020ANDA213110 Clobazam
CLOBAZAM		Chartwell Molecular
April 23, 2020ANDA212718 Acyclovir
ACYCLOVIR		Chartwell Rx
April 17, 2020ANDA213125 Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE		Chartwell Molecular
March 20, 2020ANDA212865 Pregabalin
PREGABALIN		Chartwell Rx
March 18, 2020ANDA209553 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE		Yiling
March 6, 2020ANDA211412 Celecoxib
CELECOXIB		Pharmobedient
January 30, 2020ANDA210454 Methotrexate
METHOTREXATE SODIUM		Eugia Pharma
December 3, 2019ANDA210078 Diclofenac
DICLOFENAC POTASSIUM		Onesource
October 31, 2019ANDA209193 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Adaptis
August 21, 2019ANDA212411 Posaconazole
POSACONAZOLE		Sinotherapeutics Inc
July 10, 2019ANDA211355 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS		Sofgen Pharms
April 25, 2019ANDA210702 Linezolid
LINEZOLID		Chartwell Rx
February 26, 2019ANDA211063 Chlorthalidone
CHLORTHALIDONE		Chartwell Rx
February 22, 2019ANDA209097 Methylprednisolone
METHYLPREDNISOLONE		Chartwell Rx
February 22, 2019ANDA211049 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL		Sunshine
February 11, 2019ANDA209660 Fenofibrate
FENOFIBRATE		Chartwell Rx
January 17, 2019ANDA208429 Imatinib mesylate
IMATINIB MESYLATE		Chartwell Rx
December 28, 2018ANDA211496 Prednisone
PREDNISONE		Quagen
November 30, 2018ANDA209888 Etodolac
ETODOLAC		Adaptis
November 23, 2018ANDA209517 Lactulose
LACTULOSE		Chartwell Rx
November 14, 2018ANDA205869 Letrozole
LETROZOLE		Pharmobedient
November 9, 2018ANDA206037 Anastrozole
ANASTROZOLE		Pharmobedient
October 31, 2018ANDA209057 Vardenafil
VARDENAFIL HYDROCHLORIDE		Crossmedika SA
October 26, 2018ANDA210847 Felodipine
FELODIPINE		Pharmobedient
August 29, 2018ANDA210822 Isosorbide mononitrate
ISOSORBIDE MONONITRATE		Dexcel Ltd
August 16, 2018ANDA210616 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Chartwell Rx
July 31, 2018ANDA206481 Tenofovir disoproxil fumarate
TENOFOVIR DISOPROXIL FUMARATE		Chartwell
July 27, 2018ANDA201892 Rasagiline
RASAGILINE MESYLATE		Chartwell Rx
July 11, 2018ANDA090244 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE		Chartwell
July 9, 2018ANDA208987 Clarithromycin
CLARITHROMYCIN		Sunshine
July 6, 2018ANDA210543 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE		Chartwell Rx
March 7, 2018ANDA210401 Acyclovir
ACYCLOVIR		Pharmobedient
February 8, 2018ANDA209846 Clindamycin
CLINDAMYCIN PHOSPHATE		Chartwell Rx
September 28, 2017ANDA207797 Rivastigmine
RIVASTIGMINE TARTRATE		Chartwell Rx
August 21, 2017ANDA208652 Bupropion
BUPROPION HYDROCHLORIDE		Sinotherapeutics Inc
August 11, 2017ANDA207405 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE		Alkem Labs Ltd
July 21, 2017ANDA207905 Naltrexone hydrochloride
NALTREXONE HYDROCHLORIDE		Chartwell
July 13, 2017ANDA203191 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE		Chartwell Molecular
June 16, 2017ANDA203899 Niacin
NIACIN		Quagen
June 12, 2017ANDA209171 Amantadine
AMANTADINE HYDROCHLORIDE		Heritage Pharma
May 15, 2017ANDA204599 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE		Chartwell Molecular
May 5, 2017ANDA206958 Clindamycin palmitate hydrochloride
CLINDAMYCIN PALMITATE HYDROCHLORIDE		Chartwell Rx
April 28, 2017ANDA207833 Atovaquone
ATOVAQUONE		Chartwell Rx
April 27, 2017ANDA207029 Hydrocortisone
HYDROCORTISONE		Strides Pharma
February 13, 2017ANDA207285 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE		Chartwell Rx
January 3, 2017ANDA207201 Glycopyrrolate
GLYCOPYRROLATE		Appco
November 23, 2016ANDA202413 Ibuprofen
IBUPROFEN		Shandong Xinhua
October 27, 2016ANDA205530 Acetazolamide
ACETAZOLAMIDE		Heritage Pharma
August 30, 2016ANDA204945 Trospium chloride
TROSPIUM CHLORIDE		Heritage Pharms Inc
August 19, 2016ANDA206975 Bupropion
BUPROPION HYDROCHLORIDE		Heritage Pharma
July 19, 2016ANDA079168 Rosuvastatin
ROSUVASTATIN CALCIUM		Chartwell Rx
July 1, 2016NDA205525 Dronabinol
SYNDROS		Wellhouse Pharma
June 24, 2016ANDA206477 Diazepam
DIAZEPAM		Chartwell Molecular
June 10, 2016ANDA204435 Neomycin sulfate
NEOMYCIN SULFATE		Chartwell Molecular
June 10, 2016ANDA204744 Paroxetine
PAROXETINE HYDROCHLORIDE		Lannett Co Inc
May 10, 2016ANDA204074 Dapsone
DAPSONE		Chartwell Rx
May 5, 2016ANDA207433 Desipramine hydrochloride
DESIPRAMINE HYDROCHLORIDE		Heritage
April 26, 2016NDA208253 Doxycycline
ACTICLATE CAP		Chartwell Rx
February 18, 2016ANDA206815 Sodium polystyrene sulfonate
SODIUM POLYSTYRENE SULFONATE		Chartwell Rx
October 13, 2015ANDA204033 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE		Chartwell Molecular
September 23, 2015ANDA205245 Metronidazole
METRONIDAZOLE		Somerset Theraps LLC
May 15, 2015ANDA065488 Azithromycin
AZITHROMYCIN		Chartwell Rx
January 12, 2015ANDA202386 Risperidone
RISPERIDONE		Chartwell Molecular
December 12, 2014ANDA091356 Calcitriol
CALCITRIOL		Onesource Specialty
October 31, 2014ANDA203564 Lamivudine
LAMIVUDINE		Chartwell Molecular
August 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Heritage
July 25, 2014NDA205931 Doxycycline
ACTICLATE		Chartwell Rx
April 14, 2014ANDA204433 Diazepam
DIAZEPAM		Chartwell Molecular
January 8, 2014ANDA078710 Telmisartan
TELMISARTAN		Chartwell Rx
November 22, 2013ANDA078555 Repaglinide
REPAGLINIDE		Chartwell Rx
November 8, 2013ANDA090678 Rabeprazole sodium
RABEPRAZOLE SODIUM		Lannett Co Inc
August 21, 2013ANDA201674 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Lannett Co Inc
July 1, 2013ANDA078739 Rizatriptan benzoate
RIZATRIPTAN BENZOATE		Chartwell Rx
June 12, 2013ANDA090477 Escitalopram
ESCITALOPRAM OXALATE		Chartwell Molecular
June 3, 2013ANDA201507 Hydroxyzine
HYDROXYZINE PAMOATE		Heritage Pharma
April 25, 2013ANDA202644 Nifedipine
NIFEDIPINE		Heritage Pharma
February 5, 2013ANDA202420 Calcium acetate
CALCIUM ACETATE		Chartwell Molecular
December 31, 2012ANDA091563 Disulfiram
DISULFIRAM		Chartwell Molecules
November 14, 2012ANDA077205 Irbesartan
IRBESARTAN		Chartwell Molecular
November 6, 2012ANDA202598 Sildenafil
SILDENAFIL CITRATE		Chartwell Rx
October 26, 2012ANDA076798 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE		Chartwell Rx
September 25, 2012ANDA200892 Ethosuximide
ETHOSUXIMIDE		Heritage Pharms Inc
September 5, 2012ANDA090348 Ziprasidone
ZIPRASIDONE HYDROCHLORIDE		Chartwell Rx
August 3, 2012ANDA200405 Montelukast
MONTELUKAST SODIUM		Lannett Co Inc
July 30, 2012ANDA077388 Zolpidem tartrate
ZOLPIDEM TARTRATE		Chartwell Molecular
June 1, 2012ANDA091312 Calcium acetate
CALCIUM ACETATE		Chartwell Rx
May 11, 2012ANDA078876 Cetirizine
CETIRIZINE HYDROCHLORIDE		Chartwell Molecular
April 30, 2012ANDA202044 Tinidazole
TINIDAZOLE		Chartwell Rx
March 30, 2012ANDA076890 Levofloxacin
LEVOFLOXACIN		Chartwell Molecular
March 8, 2012ANDA202845 Diflunisal
DIFLUNISAL		Heritage Pharma
February 7, 2012ANDA202271 Acarbose
ACARBOSE		Avet Lifesciences
January 9, 2012ANDA078492 Fluticasone propionate
FLUTICASONE PROPIONATE		Chartwell Rx
December 20, 2011ANDA091605 Doxycycline
DOXYCYCLINE		Heritage
December 9, 2011ANDA201407 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE		Lannett Co Inc
October 24, 2011ANDA091680 Diethylpropion hydrochloride
DIETHYLPROPION HYDROCHLORIDE		Lannett Co Inc
September 26, 2011ANDA090695 Loxapine
LOXAPINE SUCCINATE		Lannett Co Inc
July 18, 2011ANDA200177 Diethylpropion hydrochloride
DIETHYLPROPION HYDROCHLORIDE		Lannett Co Inc
May 18, 2011ANDA077543 Risperidone
RISPERIDONE		Chartwell Molecular
May 11, 2011ANDA091188 Dexamethasone
DEXAMETHASONE		Chartwell Molecular
April 13, 2011ANDA091156 Theophylline
THEOPHYLLINE		Chartwell Molecular
February 28, 2011ANDA090937 Glyburide
GLYBURIDE		Heritage
January 27, 2011ANDA091342 Ondansetron
ONDANSETRON HYDROCHLORIDE		Chartwell Molecular
January 20, 2011ANDA078281 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Lannett Co Inc
December 20, 2010ANDA090836 Cephalexin
CEPHALEXIN		Alkem Labs Ltd
June 23, 2010ANDA078728 Glipizide and metformin hydrochloride
GLIPIZIDE AND METFORMIN HYDROCHLORIDE		Heritage
July 9, 2009ANDA079164 Flecainide acetate
FLECAINIDE ACETATE		Chartwell
June 9, 2009ANDA090035 Folic acid
FOLIC ACID		Chartwell Molecular
May 20, 2009ANDA040833 Ergocalciferol
ERGOCALCIFEROL		Chartwell Rx
April 28, 2009ANDA079244 Lorazepam
LORAZEPAM		Chartwell Molecular
April 3, 2009ANDA090263 Levetiracetam
LEVETIRACETAM		Chartwell Molecular
March 30, 2009ANDA078202 Budesonide
BUDESONIDE		Nephron
February 4, 2009ANDA078503 Oxybutynin
OXYBUTYNIN CHLORIDE		Osmotica Pharm Us
December 10, 2008ANDA040904 Acetazolamide
ACETAZOLAMIDE		Heritage Pharma
July 16, 2008ANDA065454 Doxycycline
DOXYCYCLINE		Chartwell
June 30, 2008ANDA040804 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Chartwell Rx
June 18, 2008ANDA078745 Ramipril
RAMIPRIL		Chartwell Molecular
March 28, 2008ANDA065390 Rifampin
RIFAMPIN		Chartwell Molecular
January 8, 2008ANDA077917 Pravastatin sodium
PRAVASTATIN SODIUM		Chartwell Rx
December 31, 2007ANDA076749 Ipratropium bromide and albuterol sulfate
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE; IPRATROPIUM BROMIDE		Nephron
December 26, 2007ANDA065436 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE		Chartwell Rx
October 26, 2007ANDA040728 Bethanechol chloride
BETHANECHOL CHLORIDE		Chartwell Rx
September 18, 2007ANDA078046 Ciclopirox
CICLOPIROX		Chartwell Rx
August 20, 2007ANDA065384 Clarithromycin
CLARITHROMYCIN		Chartwell
July 30, 2007ANDA040682 Benzonatate
BENZONATATE		Heritage Pharms Labs
July 25, 2007ANDA065336 Cephalexin
CEPHALEXIN		Yung Shin Pharm
July 2, 2007ANDA078199 Terbinafine hydrochloride
TERBINAFINE HYDROCHLORIDE		Chartwell
June 26, 2007ANDA077788 Albuterol sulfate
ALBUTEROL SULFATE		Chartwell Rx
June 25, 2007ANDA077303 Ondansetron
ONDANSETRON HYDROCHLORIDE		Chartwell Molecules
June 18, 2007ANDA065319 Amoxicillin
AMOXICILLIN		Chartwell Rx
February 27, 2007ANDA040708 Lidocaine
LIDOCAINE HYDROCHLORIDE VISCOUS		Chartwell Molecular
January 25, 2007ANDA078060 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM		Chartwell Molecules
January 24, 2007ANDA077785 Sulfamethoxazole and trimethoprim
SULFAMETHOXAZOLE AND TRIMETHOPRIM		Chartwell Molecular
December 26, 2006ANDA077406 Ondansetron
ONDANSETRON		Chartwell Molecules
November 30, 2006ANDA077536 Moexipril hydrochloride
MOEXIPRIL HYDROCHLORIDE		Chartwell Rx
July 19, 2006ANDA077920 Meloxicam
MELOXICAM		Aiping Pharm Inc
June 14, 2006ANDA077629 Citalopram
CITALOPRAM HYDROBROMIDE		Chartwell Molecular
February 23, 2006ANDA075900 Fluvoxamine maleate
FLUVOXAMINE MALEATE		Chartwell Rx
December 20, 2005ANDA077241 Baclofen
BACLOFEN		Lannett Co Inc
November 21, 2005ANDA077127 Nifedipine
NIFEDIPINE		Osmotica Pharm Us
November 16, 2005ANDA065253 Cephalexin
CEPHALEXIN		Aurobindo Pharma
November 10, 2005ANDA065277 Doxycycline
DOXYCYCLINE HYCLATE		Chartwell Molecular
November 8, 2005ANDA077310 Cilostazol
CILOSTAZOL		Chartwell Rx
September 28, 2005ANDA077246 Danazol
DANAZOL		Lannett Co Inc
September 13, 2005ANDA077086 Leflunomide
LEFLUNOMIDE		Heritage
September 8, 2005ANDA077353 Allopurinol
ALLOPURINOL		Chartwell
August 12, 2005ANDA065243 Clindamycin
CLINDAMYCIN HYDROCHLORIDE		Chartwell Molecular
May 31, 2005ANDA076894 Torsemide
TORSEMIDE		Heritage
April 18, 2005ANDA076683 Anagrelide
ANAGRELIDE HYDROCHLORIDE		Chartwell Rx
April 8, 2005ANDA077069 Amiodarone hydrochloride
AMIODARONE HYDROCHLORIDE		Chartwell Rx
March 25, 2005ANDA077152 Terbutaline sulfate
TERBUTALINE SULFATE		Lannett Co Inc
March 2, 2005ANDA065200 Griseofulvin
GRISEOFULVIN		Chartwell Rx
March 2, 2005ANDA076803 Quinapril
QUINAPRIL HYDROCHLORIDE		Chartwell Rx
February 9, 2005ANDA065205 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Chartwell Rx
November 23, 2004ANDA077021 Cilostazol
CILOSTAZOL		Chartwell Rx
November 4, 2004ANDA076896 Ciprofloxacin
CIPROFLOXACIN HYDROCHLORIDE		Chartwell
September 2, 2004ANDA075987 Oxaprozin
OXAPROZIN		Chartwell
July 29, 2004ANDA076665 Fluconazole
FLUCONAZOLE		Chartwell
June 28, 2004ANDA076355 Albuterol sulfate
ALBUTEROL SULFATE		Nephron
May 25, 2004ANDA065089 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Chartwell Rx
May 25, 2004ANDA075988 Prednisolone
PREDNISOLONE SODIUM PHOSPHATE		Chartwell Rx
May 14, 2004ANDA076458 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Chartwell Molecular
April 23, 2004ANDA076483 Fosinopril sodium
FOSINOPRIL SODIUM		Chartwell Rx
March 31, 2004ANDA076374 Quinapril HCL and hydrochlorothiazide
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE		Chartwell Rx
March 12, 2004ANDA065162 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Chartwell Rx
March 3, 2004ANDA075006 Chlorhexidine gluconate
CHLORHEXIDINE GLUCONATE		Chartwell Rx
February 11, 2004ANDA076267 Benazepril hydrochloride
BENAZEPRIL HYDROCHLORIDE		Heritage Pharma
January 29, 2004ANDA076522 Metronidazole
METRONIDAZOLE		Chartwell Rx
December 22, 2003ANDA040506 Ethosuximide
ETHOSUXIMIDE		Chartwell Rx
January 28, 2003ANDA075757 Omeprazole
OMEPRAZOLE		Sandoz
December 4, 2002ANDA065119 Amoxicillin
AMOXICILLIN		Chartwell Rx
November 1, 2002ANDA075410 Omeprazole
OMEPRAZOLE		Lannett Co Inc
October 30, 2002ANDA065101 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Chartwell Rx
October 29, 2002ANDA065096 Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)
AMOXICILLIN AND CLAVULANATE POTASSIUM		Chartwell Rx
June 5, 2002ANDA075714 Carbamazepine
CARBAMAZEPINE		Chartwell Rx
February 25, 2002ANDA075280 Nabumetone
NABUMETONE		Chartwell Rx
February 20, 2002ANDA076175 Mefloquine hydrochloride
MEFLOQUINE HYDROCHLORIDE		Chartwell Rx
January 24, 2002ANDA075972 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Chartwell
September 27, 2001ANDA075562 Ipratropium bromide
IPRATROPIUM BROMIDE		Nephron
June 26, 2001ANDA075664 Albuterol sulfate
ALBUTEROL SULFATE		Nephron
April 16, 2001ANDA075786 Famotidine
FAMOTIDINE		Chartwell Rx
March 27, 2001ANDA040411 Methimazole
METHIMAZOLE		Chartwell Rx
January 30, 2001ANDA075614 Terazosin hydrochloride
TERAZOSIN HYDROCHLORIDE		Heritage Pharma Avet
December 22, 2000ANDA075782 Valproic acid
VALPROIC ACID		Chartwell Rx
October 18, 2000ANDA075646 Doxazosin
DOXAZOSIN MESYLATE		Chartwell Rx
September 18, 2000ANDA065056 Amoxicillin
AMOXICILLIN		Chartwell Rx
August 22, 2000ANDA075479 Enalapril maleate
ENALAPRIL MALEATE		Heritage Pharma
April 17, 2000ANDA075522 Isosorbide mononitrate
ISOSORBIDE MONONITRATE		Dexcel Ltd
December 3, 1999ANDA075172 Hydrocortisone
COLOCORT		Chartwell
September 27, 1999ANDA040251 Trihexyphenidyl hydrochloride
TRIHEXYPHENIDYL HYDROCHLORIDE		Chartwell Rx
May 13, 1999ANDA040323 Prednisolone
PREDNISOLONE		Chartwell Rx
February 26, 1999ANDA040230 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Lannett
January 29, 1999ANDA075039 Oxybutynin
OXYBUTYNIN CHLORIDE		Chartwell Rx
November 25, 1998NDA020943 Verapamil hydrochloride
VERELAN PM		Azurity
September 25, 1998ANDA040026 Promethazine hydrochloride
PROMETHAZINE HYDROCHLORIDE		Chartwell Rx
August 3, 1998ANDA074787 Labetalol
LABETALOL HYDROCHLORIDE		Heritage Pharma
June 8, 1998ANDA074415 Sucralfate
SUCRALFATE		Chartwell Rx
December 17, 1997ANDA074884 Clemastine fumarate
CLEMASTINE FUMARATE		Genus Lifesciences
September 30, 1997ANDA074925 Clonazepam
CLONAZEPAM		Chartwell Rx
September 17, 1997ANDA074880 Albuterol sulfate
ALBUTEROL SULFATE		Nephron
September 8, 1997ANDA040245 Carisoprodol
CARISOPRODOL		Chartwell Rx
July 21, 1997ANDA081118 Isoniazid
ISONIAZID		Chartwell Rx
October 31, 1996ANDA074603 Lactulose
GENERLAC		Chartwell Rx
August 15, 1996ANDA074561 Cholestyramine
LOCHOLEST		Chartwell Rx
August 15, 1996ANDA074562 Cholestyramine
LOCHOLEST LIGHT		Chartwell Rx
August 2, 1996ANDA074565 Selegiline
SELEGILINE HYDROCHLORIDE		Chartwell Molecules
July 26, 1996ANDA040166 Acetic acid
ACETIC ACID		Chartwell Rx
July 19, 1996ANDA040101 Prochlorperazine
PROCHLORPERAZINE MALEATE		Chartwell Rx
December 22, 1994ANDA074251 Cimetidine
CIMETIDINE HYDROCHLORIDE		Chartwell Molecular
May 17, 1994ANDA074329 Cimetidine
CIMETIDINE		Chartwell Molecules
September 27, 1993ANDA074270 Gemfibrozil
GEMFIBROZIL		Chartwell Molecules
June 28, 1993ANDA074028 Amantadine
AMANTADINE HYDROCHLORIDE		Chartwell Rx
December 22, 1992ANDA064013 Amoxicillin
AMOXICILLIN		Chartwell Rx
November 5, 1992ANDA074093 Diltiazem
DILTIAZEM HYDROCHLORIDE		Chartwell Molecules
October 27, 1992ANDA073680 Metoclopramide
METOCLOPRAMIDE HYDROCHLORIDE		Chartwell Molecular
July 31, 1992ANDA073588 Tolmetin sodium
TOLMETIN SODIUM		Chartwell Rx
January 23, 1992ANDA081265 Benztropine mesylate
BENZTROPINE MESYLATE		Chartwell Rx
June 28, 1991ANDA072879 Amoxapine
AMOXAPINE		Chartwell Rx
April 30, 1990ANDA089763 Theophylline
THEOPHYLLINE		Heritage Pharma Avet
December 29, 1989NDA050641 Doxycycline
MONODOX		Chartwell Rx
March 30, 1989ANDA072368 Flurazepam hydrochloride
FLURAZEPAM HYDROCHLORIDE		Chartwell Rx
March 30, 1989ANDA072369 Flurazepam hydrochloride
FLURAZEPAM HYDROCHLORIDE		Chartwell Rx
March 23, 1989ANDA072151 Albuterol sulfate
ALBUTEROL SULFATE		Chartwell Rx
August 12, 1988ANDA062752 Tetracycline hydrochloride
TETRACYCLINE HYDROCHLORIDE		Chartwell Tetra
June 13, 1988ANDA089776 Isoniazid
LANIAZID		Chartwell Molecular
April 5, 1988ANDA071881 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE		Heritage
October 13, 1987ANDA071591 Lorazepam
LORAZEPAM		Chartwell Rx
January 21, 1987ANDA089175 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE		Pharmobedient
March 5, 1986ANDA070651 Indomethacin
INDOMETHACIN		Chartwell Molecules
December 20, 1985ANDA070302 Diazepam
DIAZEPAM		Chartwell Rx
December 20, 1985ANDA070303 Diazepam
DIAZEPAM		Chartwell Rx
December 20, 1985ANDA070304 Diazepam
DIAZEPAM		Chartwell Rx
November 20, 1984ANDA088135 Thioridazine hydrochloride
THIORIDAZINE HYDROCHLORIDE		Chartwell Rx
September 11, 1984ANDA062500 Doxycycline
DOXYCYCLINE HYCLATE		Chartwell
September 11, 1984ANDA062505 Doxycycline
DOXYCYCLINE HYCLATE		Chartwell
August 6, 1984NDA018829 Indomethacin
INDOMETHACIN		Chartwell Molecules
June 29, 1984NDA018934 Methyldopa
METHYLDOPA		Chartwell Rx
December 22, 1983ANDA062474 Nystatin
NYSTATIN		Heritage
November 30, 1983NDA018413 Furosemide
FUROSEMIDE		Chartwell Rx
August 30, 1983ANDA088131 Thioridazine hydrochloride
THIORIDAZINE HYDROCHLORIDE		Chartwell Rx
August 30, 1983ANDA088133 Thioridazine hydrochloride
THIORIDAZINE HYDROCHLORIDE		Chartwell Rx
August 30, 1983ANDA088134 Thioridazine hydrochloride
THIORIDAZINE HYDROCHLORIDE		Chartwell Rx
May 26, 1983ANDA088212 Cyproheptadine
CYPROHEPTADINE HYDROCHLORIDE		Chartwell Rx
December 1, 1982ANDA061931 Amoxicillin
AMOXICILLIN, AMOXICILLIN PEDIATRIC		Chartwell Rx
April 12, 1982ANDA087294 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Chartwell Rx
April 6, 1982ANDA061996 Griseofulvin
FULVICIN P/G, FULVICIN P/G 165, FULVICIN P/G 330		Chartwell Rx
December 28, 1981ANDA086996 Butalbital, aspirin, and caffeine
LANORINAL		Sandoz
December 8, 1978ANDA062059 Amoxicillin
AMOXICILLIN		Chartwell Rx
December 1, 1978ANDA084903 Primidone
PRIMIDONE		Lannett
October 23, 1978ANDA086242 Hydralazine hydrochloride
HYDRALAZINE HYDROCHLORIDE		Heritage
August 3, 1978ANDA062058 Amoxicillin
AMOXICILLIN		Chartwell
July 5, 1978ANDA080084 Sulfadiazine
SULFADIAZINE		Chartwell Molecular
January 20, 1978ANDA085182 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE		Heritage
July 1, 1976ANDA083923 Phentermine hydrochloride
PHENTERMINE HYDROCHLORIDE		Chartwell Rx
June 15, 1976ANDA084041 Chlordiazepoxide hydrochloride
CHLORDIAZEPOXIDE HYDROCHLORIDE		Chartwell Rx
June 15, 1976ANDA084678 Chlordiazepoxide hydrochloride
CHLORDIAZEPOXIDE HYDROCHLORIDE		Chartwell Rx
June 15, 1976ANDA084679 Chlordiazepoxide hydrochloride
CHLORDIAZEPOXIDE HYDROCHLORIDE		Chartwell Rx
May 7, 1976ANDA085070 Hydrocortisone
HYDROCORTISONE		Chartwell Molecular
February 9, 1976ANDA061926 Amoxicillin
AMOXICILLIN		Chartwell Rx
October 17, 1974ANDA080694 Cortisone acetate
CORTISONE ACETATE		Chartwell Molecular
September 30, 1974ANDA084285 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Lannett
June 27, 1974ANDA084275 Prednisone
PREDNISONE		Chartwell Molecular
May 31, 1974ANDA080531 Prednisolone
PREDNISOLONE		Chartwell Molecular
November 12, 1973ANDA080197 Sulfasalazine
SULFASALAZINE		Chartwell
September 9, 1971ANDA060569 Griseofulvin
FULVICIN-U/F		Chartwell Rx
April 14, 1971NDA050299 Nystatin
NILSTAT		Chartwell Molecules
July 24, 1970ANDA080016 Propylthiouracil
PROPYLTHIOURACIL		Chartwell Molecular
July 31, 1968ANDA060456 Penicillin v potassium
PENICILLIN-VK		Chartwell Rx
July 3, 1968ANDA060711 Penicillin v potassium
PENICILLIN-VK		Chartwell Rx
—ANDA211495 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

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