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Drug company (FDA labeler)

Major Pharmaceuticals

NDC labeler code: 0904

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

209Prescription medicines
474Products (NDC)
267FDA applications
0Recalls

Prescription medicines

Show the other 169 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
September 16, 2024ANDA213764 Sacubitril and valsartan
SACUBITRIL AND VALSARTAN		Alkem Labs Ltd
April 11, 2024ANDA216918 Haloperidol
HALOPERIDOL		Mankind Pharma
February 20, 2024ANDA218138 Lidocaine
LIDOCAINE HYDROCHLORIDE VISCOUS		Pai Holdings Pharm
November 1, 2023ANDA217271 Midodrine hydrochloride
MIDODRINE HYDROCHLORIDE		Mankind Pharma
September 5, 2023ANDA218122 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE		Aurobindo Pharma Ltd
August 23, 2023ANDA214557 Varenicline tartrate
VARENICLINE TARTRATE		Alkem Labs Ltd
July 11, 2023ANDA217357 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)		Mankind Pharma
May 19, 2023ANDA217411 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Rising
December 13, 2022ANDA212244 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Alkem Labs Ltd
November 23, 2022ANDA215886 Ofloxacin
OFLOXACIN		Mankind Pharma
October 24, 2022ANDA215616 Metolazone
METOLAZONE		Renata
September 9, 2022ANDA208037 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Msn
September 8, 2022ANDA216295 Dexamethasone
DEXAMETHASONE		Amneal
September 7, 2022ANDA208256 Roflumilast
ROFLUMILAST		Msn
August 26, 2022ANDA216151 Lacosamide
LACOSAMIDE		Novitium Pharma
August 4, 2022ANDA215587 Chlorthalidone
CHLORTHALIDONE		Mankind Pharma
July 15, 2022ANDA214757 Levetiracetam
LEVETIRACETAM		Msn
June 13, 2022ANDA216202 Prochlorperazine
PROCHLORPERAZINE MALEATE		Novitium Pharma
May 31, 2022ANDA215279 Fludrocortisone acetate
FLUDROCORTISONE ACETATE		Novitium Pharma
May 24, 2022ANDA212772 Pirfenidone
PIRFENIDONE		Msn
April 7, 2022ANDA212682 Nebivolol
NEBIVOLOL HYDROCHLORIDE		Prinston Inc
March 31, 2022ANDA214695 Lacosamide
LACOSAMIDE		Alkem Labs Ltd
March 23, 2022ANDA215788 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Pharmazone
March 15, 2022ANDA211884 Sucralfate
SUCRALFATE		Vistapharm LLC
January 25, 2022ANDA215885 Baclofen
BACLOFEN		Mankind Pharma
Show the other 100 applications
ApprovedApplicationMedicineSponsor
November 15, 2021ANDA215458 OMEGA-3-ACID ethyl esters
OMEGA-3-ACID ETHYL ESTERS		Mankind Pharma
October 25, 2021ANDA214272 Atovaquone
ATOVAQUONE		Pai Holdings
October 14, 2021ANDA215106 Dexamethasone
DEXAMETHASONE		Amneal
September 23, 2021ANDA208315 Mycophenolic acid
MYCOPHENOLATE SODIUM		Alkem Labs Ltd
March 12, 2021ANDA214753 Sirolimus
SIROLIMUS		Alkem Labs Ltd
February 19, 2021ANDA210220 Cefdinir
CEFDINIR		Alkem Labs Ltd
February 18, 2021ANDA211741 Droxidopa
DROXIDOPA		Msn Pharms Inc
February 1, 2021ANDA213454 Posaconazole
POSACONAZOLE		Aet Pharma
November 30, 2020ANDA209953 Ranolazine
RANOLAZINE		Alkem Labs Ltd
July 30, 2020ANDA211132 Leucovorin calcium
LEUCOVORIN CALCIUM		Ingenus Pharms LLC
June 12, 2020ANDA213864 Fenofibrate
FENOFIBRATE		Mankind Pharma
May 8, 2020ANDA212861 Potassium chloride
POTASSIUM CHLORIDE		Amneal
March 11, 2020ANDA208040 Dabigatran etexilate
DABIGATRAN ETEXILATE MESYLATE		Alkem Labs Ltd
February 5, 2020ANDA210425 Colchicine
COLCHICINE		Granules
December 30, 2019ANDA210461 Febuxostat
FEBUXOSTAT		Msn
December 13, 2019ANDA212809 Captopril
CAPTOPRIL		Ajanta Pharma Ltd
November 26, 2019ANDA212492 Aminocaproic acid
AMINOCAPROIC ACID		Amneal
August 19, 2019ANDA204562 Tolterodine tartrate
TOLTERODINE TARTRATE		Inventia Hlthcare
July 26, 2019ANDA212114 Emtricitabine and tenofovir disoproxil fumarate
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE		Laurus
July 22, 2019ANDA211567 Ramelteon
RAMELTEON		Zydus Pharms
July 19, 2019ANDA210432 Pregabalin
PREGABALIN		Rising
March 29, 2019ANDA210766 Potassium chloride
POTASSIUM CHLORIDE		Pharm Assoc
March 12, 2019ANDA210614 Nifedipine
NIFEDIPINE		Novast Labs
February 8, 2019ANDA204724 Sevelamer hydrochloride
SEVELAMER HYDROCHLORIDE		Glenmark Pharms Ltd
January 18, 2019ANDA209713 Levothyroxine
LEVOTHYROXINE SODIUM		Lupin
December 19, 2018ANDA206948 Benzonatate
BENZONATATE		Puracap Pharm LLC
December 19, 2018ANDA210921 Potassium chloride
POTASSIUM CHLORIDE		Aurobindo Pharma
October 31, 2018ANDA208453 Abiraterone acetate
ABIRATERONE ACETATE		Apotex
October 3, 2018ANDA210971 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Novitium Pharma
August 30, 2018ANDA205231 Diltiazem
DILTIAZEM HYDROCHLORIDE		Twi Pharms
July 18, 2018ANDA205936 Spironolactone
SPIRONOLACTONE		Zydus Pharms
June 20, 2018ANDA209603 Labetalol
LABETALOL HYDROCHLORIDE		Appco
May 15, 2018ANDA210424 Methylergonovine maleate
METHYLERGONOVINE MALEATE		Granules
May 11, 2018ANDA209373 Phytonadione
PHYTONADIONE		Amneal Pharms Co
May 1, 2018ANDA210441 Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE		Appco
April 30, 2018ANDA209226 Cinacalcet
CINACALCET HYDROCHLORIDE		Strides Pharma
April 23, 2018ANDA206751 Methylprednisolone
METHYLPREDNISOLONE		Zydus Pharms
April 6, 2018ANDA205618 Paliperidone
PALIPERIDONE		Sun Pharm
March 21, 2018ANDA207510 Oxycodone and acetaminophen
OXYCODONE AND ACETAMINOPHEN		Wes Pharma Inc
February 23, 2018ANDA090609 Atomoxetine
ATOMOXETINE HYDROCHLORIDE		DR Reddys
January 26, 2018ANDA203232 Tenofovir disoproxil fumarate
TENOFOVIR DISOPROXIL FUMARATE		Macleods Pharms
December 21, 2017ANDA209234 Ezetimibe
EZETIMIBE		Alkem Labs Ltd
December 12, 2017ANDA205005 Nitrofurantoin
NITROFURANTOIN		Zydus Pharms
November 28, 2017ANDA209102 Baclofen
BACLOFEN		Rubicon Research
October 23, 2017ANDA209823 Oxybutynin
OXYBUTYNIN CHLORIDE		Novitium Pharma
October 18, 2017ANDA209724 Bumetanide
BUMETANIDE		Amneal Pharms Co
October 12, 2017ANDA210117 Allopurinol
ALLOPURINOL		Zydus Pharms
October 10, 2017ANDA205253 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Zydus Pharms
September 29, 2017ANDA206094 Sevelamer carbonate
SEVELAMER CARBONATE		DR Reddys
August 31, 2017ANDA207466 Metaxalone
METAXALONE		Sciegen Pharms
July 7, 2017ANDA204652 Flucytosine
FLUCYTOSINE		Novel Labs Inc
June 28, 2017ANDA207482 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Amneal Pharms Co
June 12, 2017ANDA209171 Amantadine
AMANTADINE HYDROCHLORIDE		Heritage Pharma
June 5, 2017ANDA091640 Mesalamine
MESALAMINE		Zydus Pharms
May 17, 2017ANDA204203 Quetiapine
QUETIAPINE FUMARATE		Lupin
May 4, 2017ANDA206134 Budesonide
BUDESONIDE		Zydus Pharms
April 6, 2017ANDA090693 Bupropion
BUPROPION HYDROCHLORIDE		Lupin
January 18, 2017ANDA207944 Aspirin and extended-release dipyridamole
ASPIRIN AND DIPYRIDAMOLE		Ph Health
January 13, 2017ANDA207812 Methotrexate
METHOTREXATE SODIUM		Zydus Pharms
January 3, 2017ANDA207201 Glycopyrrolate
GLYCOPYRROLATE		Appco
December 15, 2016ANDA208709 Fenofibrate
FENOFIBRATE		Cipla
November 29, 2016ANDA206433 Clozapine
CLOZAPINE		Aurobindo Pharma
November 23, 2016ANDA207511 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Adaptis
October 27, 2016ANDA205530 Acetazolamide
ACETAZOLAMIDE		Heritage Pharma
October 12, 2016ANDA206384 Raloxifene hydrochloride
RALOXIFENE HYDROCHLORIDE		Sciegen Pharms
September 28, 2016ANDA206028 Memantine hydrochloride
MEMANTINE HYDROCHLORIDE		Lupin
August 30, 2016ANDA204945 Trospium chloride
TROSPIUM CHLORIDE		Heritage Pharms Inc
August 19, 2016ANDA206975 Bupropion
BUPROPION HYDROCHLORIDE		Heritage Pharma
August 5, 2016ANDA079179 Imatinib mesylate
IMATINIB MESYLATE		Apotex
June 17, 2016ANDA204838 Aripiprazole
ARIPIPRAZOLE		Amneal Pharms
June 6, 2016ANDA207058 Dofetilide
DOFETILIDE		DR Reddys Labs SA
May 24, 2016ANDA206181 Voriconazole
VORICONAZOLE		Ajanta Pharma Ltd
May 24, 2016ANDA206747 Voriconazole
VORICONAZOLE		Cadila
March 25, 2016ANDA204572 Rivastigmine
RIVASTIGMINE TARTRATE		Aurobindo Pharma
March 18, 2016ANDA205166 Valganciclovir
VALGANCICLOVIR HYDROCHLORIDE		Hetero Labs Ltd V
January 7, 2016ANDA203621 Nystatin
NYSTATIN		Pharm Assoc
December 21, 2015ANDA205517 Linezolid
LINEZOLID		Alkem Labs Ltd
November 23, 2015ANDA204010 Oxybutynin
OXYBUTYNIN CHLORIDE		Amneal Pharms
September 25, 2015ANDA078279 Esomeprazole
ESOMEPRAZOLE MAGNESIUM		DR Reddys
September 23, 2015ANDA205245 Metronidazole
METRONIDAZOLE		Somerset Theraps LLC
September 18, 2015ANDA204582 Buspirone
BUSPIRONE HYDROCHLORIDE		Heritage Pharma
August 21, 2015ANDA204519 Celecoxib
CELECOXIB		Alembic
June 22, 2015ANDA205650 Pyridostigmine bromide
PYRIDOSTIGMINE BROMIDE		Zydus Pharms
June 19, 2015ANDA203437 Entacapone
ENTACAPONE		Aurobindo Pharma Ltd
June 4, 2015ANDA201157 Levetiracetam
LEVETIRACETAM		Pharm Assoc
May 29, 2015ANDA203730 Divalproex sodium
DIVALPROEX SODIUM		Amneal Pharms
May 26, 2015ANDA202304 Bupropion
BUPROPION HYDROCHLORIDE		Prinston Inc
May 15, 2015ANDA065398 Azithromycin
AZITHROMYCIN		Lupin
May 15, 2015ANDA065399 Azithromycin
AZITHROMYCIN		Lupin
April 28, 2015ANDA201519 Aripiprazole
ARIPIPRAZOLE		Torrent
September 26, 2014NDA204820 Colchicine
MITIGARE		Hikma
September 10, 2014ANDA202843 Montelukast
MONTELUKAST SODIUM		Hetero Labs Ltd V
August 20, 2014ANDA204279 Hydroxyzine
HYDROXYZINE HYDROCHLORIDE		Heritage
July 22, 2014ANDA090687 Tacrolimus
TACROLIMUS		Strides Pharma
June 27, 2014ANDA203326 Buprenorphine and naloxone
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE		Hikma
June 3, 2014ANDA203638 Oxycodone hydrochloride
OXYCODONE HYDROCHLORIDE		Amneal Pharms
April 17, 2014ANDA200565 Phenytoin
PHENYTOIN		Taro
April 3, 2014ANDA203126 Nifedipine
NIFEDIPINE		Twi Pharms
March 4, 2014ANDA202632 Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE		Aurobindo Pharma Ltd
February 7, 2014ANDA078888 Buspirone
BUSPIRONE HYDROCHLORIDE		Zydus Pharms

Showing the 125 newest of 267 applications. Full lists: Drugs@FDA →

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 →