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Drug company (FDA labeler)

Quallent Pharmaceuticals Health LLC

NDC labeler code: 82009

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

51Prescription medicines
145Products (NDC)
62FDA applications
0Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
ApprovedApplicationMedicineSponsor
January 17, 2025ANDA206788 Eltrombopag
ELTROMBOPAG OLAMINE		Hetero Labs Ltd V
June 28, 2024BLA761373 Ustekinumab
PYZCHIVA		Samsung Bioepis Co Ltd
June 28, 2024BLA761425 Ustekinumab
PYZCHIVA		Samsung Bioepis Co Ltd
September 12, 2023ANDA214344 Atorvastatin
ATORVASTATIN CALCIUM		Hetero Labs Ltd V
March 19, 2021ANDA213486 Esomeprazole
ESOMEPRAZOLE MAGNESIUM		Graviti Pharms
December 4, 2020ANDA204345 Capecitabine
CAPECITABINE		DR Reddys
September 24, 2020ANDA210500 Dimethyl fumarate
DIMETHYL FUMARATE		Hetero Labs Ltd III
July 23, 2020ANDA212773 Imatinib mesylate
IMATINIB MESYLATE		Eugia Pharma
May 18, 2020ANDA203083 Lansoprazole
LANSOPRAZOLE		Hetero Labs Ltd III
December 4, 2019ANDA207979 Fingolimod
FINGOLIMOD HYDROCHLORIDE		Biocon Ltd
July 10, 2019ANDA210686 Abiraterone acetate
ABIRATERONE ACETATE		Msn
March 28, 2019ANDA210058 Ambrisentan
AMBRISENTAN		Zydus Pharms
March 26, 2019ANDA209654 Tadalafil
TADALAFIL		Ajanta Pharma Ltd
February 5, 2019ANDA210392 Tadalafil
TADALAFIL		Ajanta Pharma Ltd
October 22, 2018ANDA206145 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Alkem Labs Ltd
October 12, 2018ANDA206401 Sildenafil
SILDENAFIL CITRATE		Ajanta Pharma Ltd
May 4, 2018ANDA210394 Sildenafil
SILDENAFIL CITRATE		Ajanta Pharma Ltd
March 16, 2018ANDA209313 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Granules
January 26, 2018ANDA090513 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE		Aurobindo Pharma
November 22, 2017ANDA208898 Rosuvastatin
ROSUVASTATIN CALCIUM		Msn
June 12, 2017ANDA204331 Ezetimibe
EZETIMIBE		Zydus Pharms
April 24, 2017ANDA204798 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL		Aurobindo Pharma
April 6, 2017ANDA090693 Bupropion
BUPROPION HYDROCHLORIDE		Lupin
March 21, 2017ANDA206465 Rosuvastatin
ROSUVASTATIN CALCIUM		Alkem Labs Ltd
January 6, 2017ANDA208706 Duloxetine
DULOXETINE HYDROCHLORIDE		Ajanta Pharma Ltd
September 12, 2016ANDA206174 Aripiprazole
ARIPIPRAZOLE		Ajanta Pharma Ltd
May 5, 2016ANDA205118 Fenofibrate
FENOFIBRATE		Aurobindo Pharma
September 23, 2015ANDA207446 Celecoxib
CELECOXIB		Cipla
April 8, 2015ANDA203047 Valacyclovir
VALACYCLOVIR HYDROCHLORIDE		Hetero Labs Ltd V
January 30, 2015ANDA203034 Donepezil hydrochloride
DONEPEZIL HYDROCHLORIDE		Hetero Labs Ltd V
November 25, 2014ANDA200895 Simvastatin
SIMVASTATIN		Hetero Labs Ltd III
September 10, 2014ANDA202843 Montelukast
MONTELUKAST SODIUM		Hetero Labs Ltd V
September 10, 2014ANDA202882 Pantoprazole sodium
PANTOPRAZOLE SODIUM		Hetero Labs Ltd V
August 28, 2014ANDA203686 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Zydus Hlthcare
June 11, 2014ANDA203088 Duloxetine
DULOXETINE HYDROCHLORIDE		Breckenridge
February 13, 2013ANDA200268 Pioglitazone
PIOGLITAZONE HYDROCHLORIDE		Aurobindo Pharma Ltd
September 11, 2012ANDA090939 Escitalopram
ESCITALOPRAM OXALATE		Torrent Pharms Ltd
August 15, 2012ANDA078889 Metoprolol
METOPROLOL SUCCINATE		Reddys
August 1, 2012ANDA090617 Metoprolol
METOPROLOL SUCCINATE		DR Reddys Labs Ltd
May 17, 2012ANDA091023 Clopidogrel
CLOPIDOGREL BISULFATE		DR Reddys Labs Ltd
March 27, 2012ANDA201109 Quetiapine
QUETIAPINE FUMARATE		Lupin Ltd
October 6, 2011ANDA200651 Gabapentin
GABAPENTIN		Aurobindo Pharma Ltd
April 14, 2011ANDA200834 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Aurobindo Pharma Ltd
October 8, 2010ANDA090515 Levetiracetam
LEVETIRACETAM		Hetero Labs Ltd III
October 6, 2010ANDA078243 Losartan potassium
LOSARTAN POTASSIUM		Zydus Pharms USA Inc
May 12, 2010ANDA090509 Tacrolimus
TACROLIMUS		DR Reddys Labs Ltd
April 27, 2010ANDA078225 Tamsulosin hydrochloride
TAMSULOSIN HYDROCHLORIDE		Zydus Pharms USA Inc
April 22, 2010ANDA090564 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Granules India
April 17, 2009ANDA078490 Omeprazole
OMEPRAZOLE		DR Reddys Labs Ltd
March 27, 2009ANDA078235 Topiramate
TOPIRAMATE		Zydus Pharms USA Inc
January 27, 2009ANDA077633 Lamotrigine
LAMOTRIGINE		Zydus Pharms USA
January 31, 2008ANDA078619 Fluoxetine
FLUOXETINE HYDROCHLORIDE		Aurobindo Pharma
January 14, 2008ANDA076273 Clopidogrel
CLOPIDOGREL BISULFATE		DR Reddys
October 30, 2007ANDA078341 Finasteride
FINASTERIDE		Aurobindo Pharma
October 22, 2007ANDA075576 Omeprazole
OMEPRAZOLE		DR Reddys Labs Ltd
September 26, 2007ANDA077073 Amlodipine
AMLODIPINE BESYLATE		Cipla
September 21, 2007ANDA040657 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE		Zydus Pharms USA Inc
September 5, 2007ANDA077614 Carvedilol
CARVEDILOL		Zydus Pharms USA Inc
February 6, 2007ANDA077397 Sertraline hydrochloride
SERTRALINE HYDROCHLORIDE		Invagen Pharms
July 19, 2006ANDA077921 Meloxicam
MELOXICAM		Zydus Pharms USA
September 9, 2005ANDA077321 Lisinopril
LISINOPRIL		Lupin
October 28, 2004ANDA077031 Citalopram
CITALOPRAM HYDROBROMIDE		Aurobindo

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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