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Drug company (FDA labeler)

Glenmark Pharmaceuticals Inc., USA

NDC labeler code: 68462

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

312Products (NDC)

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
August 18, 2026ANDA219232 Fluticasone propionate
FLUTICASONE PROPIONATE
Glenmark Speclt
July 28, 2026ANDA214364 Sugammadex
SUGAMMADEX SODIUM
Gland
July 9, 2026ANDA212555 Nintedanib
NINTEDANIB ESYLATE
Glenmark Pharms Ltd
May 4, 2026ANDA218840 Calcium gluconate
CALCIUM GLUCONATE
Caplin
April 8, 2026ANDA216363 Progesterone
PROGESTERONE
Glenmark Pharms
March 12, 2026ANDA220373 Potassium phosphates
POTASSIUM PHOSPHATES
Caplin
March 5, 2026ANDA220323 Olanzapine
OLANZAPINE
Anthea Pharma
March 3, 2026ANDA219602 Fluticasone propionate
FLUTICASONE PROPIONATE
Glenmark Speclt
February 23, 2026ANDA220683 Sodium phosphates
SODIUM PHOSPHATES
Caplin
January 21, 2026ANDA220268 Lacosamide
LACOSAMIDE
Glenmark Pharms
January 5, 2026ANDA212141 Sucralfate
SUCRALFATE
Glenmark Pharms Ltd
December 23, 2025ANDA219550 Methylene blue
METHYLENE BLUE
Chengdu Shuode
November 12, 2025ANDA218200 Leucovorin calcium
LEUCOVORIN CALCIUM
Gland
August 5, 2025ANDA218142 Eribulin mesylate
ERIBULIN MESYLATE
Glenmark Pharms
June 26, 2025ANDA219701 Sodium bicarbonate
SODIUM BICARBONATE
Anthea Pharma
June 3, 2025ANDA218144 Epinephrine
EPINEPHRINE
Gland
April 3, 2025ANDA219273 Micafungin
MICAFUNGIN SODIUM
Qilu Pharm Hainan
March 21, 2025ANDA218140 Vancomycin
VANCOMYCIN HYDROCHLORIDE
Gland
March 21, 2025ANDA219883 Ropivacaine hydrochloride
ROPIVACAINE HYDROCHLORIDE
Anthea Pharma
February 6, 2025ANDA219239 Epinephrine
EPINEPHRINE
Gland
July 16, 2024ANDA217869 Topiramate
TOPIRAMATE
Glenmark Pharms Ltd
May 16, 2024ANDA214987 Brimonidine tartrate and timolol maleate
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Glenmark Pharms Ltd
December 26, 2023ANDA217553 Posaconazole
POSACONAZOLE
Gland
November 6, 2023ANDA216350 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE
Glenmark Pharms Ltd
October 13, 2023ANDA214926 Fosphenytoin sodium
FOSPHENYTOIN SODIUM
Gland
August 1, 2023ANDA214255 Varenicline tartrate
VARENICLINE TARTRATE
Mankind Pharma
July 31, 2023ANDA205994 Saxagliptin
SAXAGLIPTIN
Glenmark Pharms Ltd
June 22, 2023ANDA216839 Octreotide acetate
OCTREOTIDE ACETATE
Gland
May 10, 2023ANDA217789 Ketorolac tromethamine
KETOROLAC TROMETHAMINE
Caplin
March 17, 2023ANDA216595 Prochlorperazine
PROCHLORPERAZINE MALEATE
Glenmark Pharms Ltd
March 10, 2023ANDA216957 Clindamycin
CLINDAMYCIN HYDROCHLORIDE
Glenmark Pharms Ltd
December 16, 2022ANDA216357 Nicardipine
NICARDIPINE HYDROCHLORIDE
Glenmark Pharms Ltd
November 1, 2022ANDA216462 Sodium phenylbutyrate
SODIUM PHENYLBUTYRATE
Glenmark Pharms Ltd
July 5, 2022ANDA210754 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Cediprof Inc
May 26, 2022ANDA216434 Bumetanide
BUMETANIDE
Gland
March 17, 2022ANDA205006 Lacosamide
LACOSAMIDE
Glenmark Pharms Ltd
February 3, 2022ANDA213693 Acetylcysteine
ACETYLCYSTEINE
Glenmark Pharms
January 27, 2022ANDA215794 Metronidazole
METRONIDAZOLE
Glenmark Pharms Ltd
January 26, 2022ANDA215995 Bisoprolol fumarate and hydrochlorothiazide
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Glenmark Pharms Ltd
January 13, 2022NDA211746 Olopatadine hydrochloride and mometasone furoate
RYALTRIS
Glenmark Speclt
September 20, 2021ANDA210778 Clindamycin
CLINDAMYCIN PHOSPHATE
Glenmark Pharms Ltd
June 3, 2021ANDA212184 Theophylline
THEOPHYLLINE
Glenmark Pharms Ltd
March 23, 2021ANDA212144 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE
Glenmark Pharms Ltd
March 22, 2021ANDA212317 Diltiazem
DILTIAZEM HYDROCHLORIDE
Glenmark Pharms Ltd
February 10, 2021ANDA214251 Clindamycin
CLINDAMYCIN PHOSPHATE
Glenmark Pharms Ltd
February 1, 2021ANDA210278 Topiramate
TOPIRAMATE
Glenmark Pharms Ltd
November 10, 2020ANDA206662 Tacrolimus
TACROLIMUS
Glenmark Pharms Ltd
October 16, 2020ANDA208691 Sirolimus
SIROLIMUS
Glenmark Pharms Ltd
October 6, 2020ANDA210309 Dimethyl fumarate
DIMETHYL FUMARATE
Glenmark Pharms Ltd
June 18, 2020ANDA207985 Fingolimod
FINGOLIMOD HYDROCHLORIDE
Glenmark Pharms Ltd
January 3, 2020ANDA209433 Deferasirox
DEFERASIROX
Glenmark Speclt
November 25, 2019ANDA212969 Metformin hydrochloride
METFORMIN HYDROCHLORIDE
Glenmark Pharms Ltd
November 8, 2019ANDA208108 Adapalene and benzoyl peroxide
ADAPALENE AND BENZOYL PEROXIDE
Glenmark Pharms Ltd
October 16, 2019ANDA209227 Abiraterone acetate
ABIRATERONE ACETATE
Glenmark Speclt
September 9, 2019ANDA211450 Clobetasol propionate
CLOBETASOL PROPIONATE
Glenmark Pharms Ltd
August 29, 2019ANDA211769 Pimecrolimus
PIMECROLIMUS
Glenmark Pharms Ltd
August 22, 2019ANDA207754 Fulvestrant
FULVESTRANT
Glenmark Pharms
July 5, 2019ANDA211082 Ranolazine
RANOLAZINE
Glenmark Pharms Ltd
June 27, 2019ANDA208699 Ezetimibe and simvastatin
EZETIMIBE AND SIMVASTATIN
Glenmark Pharms Ltd
May 24, 2019ANDA210318 Aspirin and extended-release dipyridamole
ASPIRIN AND DIPYRIDAMOLE
Glenmark Speclt
May 20, 2019ANDA209239 Solifenacin succinate
SOLIFENACIN SUCCINATE
Glenmark Speclt
March 14, 2019ANDA209252 Clindamycin phosphate and benzoyl peroxide
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Glenmark Speclt
March 4, 2019ANDA202544 Telmisartan and hydrochlorothiazide
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Glenmark Pharms Ltd
February 15, 2019ANDA210809 Clobetasol propionate
CLOBETASOL PROPIONATE
Glenmark Pharms Ltd
February 8, 2019ANDA204724 Sevelamer hydrochloride
SEVELAMER HYDROCHLORIDE
Glenmark Pharms Ltd
December 14, 2018ANDA211750 Hydrocortisone valerate
HYDROCORTISONE VALERATE
Glenmark Pharms Ltd
November 21, 2018ANDA209685 Atovaquone
ATOVAQUONE
Glenmark Speclt
November 19, 2018ANDA204637 Azelaic acid
AZELAIC ACID
Glenmark Speclt
November 15, 2018ANDA209663 Teriflunomide
TERIFLUNOMIDE
Glenmark Speclt
September 14, 2018ANDA210264 Estradiol
ESTRADIOL
Glenmark Pharms Ltd
July 16, 2018ANDA202190 Colesevelam hydrochloride
COLESEVELAM HYDROCHLORIDE
Glenmark Pharms Ltd
June 5, 2018ANDA209297 Norethindrone acetate and ethinyl estradiol
HAILEY 1.5/30
Glenmark Speclt
May 18, 2018ANDA203480 Colesevelam hydrochloride
COLESEVELAM HYDROCHLORIDE
Glenmark Pharms Ltd
April 16, 2018ANDA210393 Tacrolimus
TACROLIMUS
Glenmark Pharms Ltd
October 12, 2017ANDA207777 Aprepitant
APREPITANT
Glenmark Speclt
September 19, 2017ANDA206391 Nitroglycerin
NITROGLYCERIN
Glenmark Speclt
September 8, 2017ANDA205268 Propafenone hydrochloride
PROPAFENONE HYDROCHLORIDE
Glenmark Pharms Ltd
August 22, 2017ANDA208320 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Glenmark Speclt
July 31, 2017ANDA205510 Acyclovir
ACYCLOVIR
Glenmark Speclt
June 22, 2017ANDA203501 Indomethacin
INDOMETHACIN
Glenmark Pharms Ltd
May 30, 2017ANDA079019 Atomoxetine
ATOMOXETINE HYDROCHLORIDE
Glenmark Pharms Ltd
May 25, 2017ANDA203281 Olmesartan medoxomil
OLMESARTAN MEDOXOMIL
Glenmark Pharms Ltd
May 25, 2017ANDA203821 Nebivolol
NEBIVOLOL HYDROCHLORIDE
Glenmark Pharms Ltd
April 7, 2017ANDA205566 Fenofibrate
FENOFIBRATE (MICRONIZED)
Glenmark Pharms Ltd
December 23, 2016ANDA208279 Tretinoin
TRETINOIN
Glenmark Pharms Ltd
October 24, 2016ANDA208136 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Glenmark Pharms Ltd
September 13, 2016ANDA208301 Diclofenac
DICLOFENAC SODIUM
Glenmark Pharms Ltd
September 9, 2016ANDA206498 Lidocaine
LIDOCAINE
Glenmark Pharms Ltd
August 5, 2016ANDA207117 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Glenmark Pharms Ltd
July 22, 2016ANDA206379 Triamcinolone acetonide
TRIAMCINOLONE ACETONIDE
Glenmark Pharms Ltd
June 23, 2016ANDA208300 Nystatin and triamcinolone acetonide
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Glenmark Pharms Ltd
May 16, 2016ANDA205075 Rufinamide
RUFINAMIDE
Glenmark Pharms Ltd
March 11, 2016ANDA204730 Frovatriptan succinate
FROVATRIPTAN SUCCINATE
Glenmark Pharms Ltd
January 21, 2016ANDA205694 Vancomycin
VANCOMYCIN HYDROCHLORIDE
Gland
January 20, 2016ANDA206969 Norethindrone acetate and ethinyl estradiol
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Glenmark Pharms Ltd
September 2, 2015ANDA203503 Voriconazole
VORICONAZOLE
Glenmark Pharms Ltd
June 26, 2015ANDA078560 Ezetimibe
EZETIMIBE
Glenmark Pharms Ltd
June 9, 2015ANDA205772 Calcipotriene
CALCIPOTRIENE
Glenmark Speclt
April 9, 2015ANDA202791 Levonorgestrel and ethinyl estradiol
LEVONORGESTREL AND ETHINYL ESTRADIOL
Glenmark Pharms Ltd
April 2, 2015ANDA203038 Norethindrone acetate and ethinyl estradiol
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Glenmark Pharms Ltd
October 31, 2014ANDA091672 Omeprazole
OMEPRAZOLE
Glenmark Pharms Ltd
July 7, 2014ANDA090032 Telmisartan
TELMISARTAN
Glenmark Pharms Ltd
April 15, 2014ANDA091166 Eszopiclone
ESZOPICLONE
Glenmark Pharms Ltd
July 16, 2013ANDA202229 Acamprosate calcium
ACAMPROSATE CALCIUM
Glenmark Pharms Ltd
July 1, 2013ANDA201914 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Glenmark Pharms Ltd
June 18, 2013ANDA091394 Riluzole
RILUZOLE
Glenmark Pharms Ltd
May 14, 2013ANDA201779 Zolmitriptan
ZOLMITRIPTAN
Glenmark Pharms Ltd
May 14, 2013ANDA202560 Zolmitriptan
ZOLMITRIPTAN
Glenmark Pharms Ltd
January 24, 2013ANDA201587 Mupirocin
MUPIROCIN
Glenmark Pharms
December 31, 2012ANDA201967 Rizatriptan benzoate
RIZATRIPTAN BENZOATE
Glenmark Pharms Ltd
March 6, 2012ANDA201994 Imiquimod
IMIQUIMOD
Glenmark Pharms
February 29, 2012ANDA091595 Ciclopirox
CICLOPIROX
Glenmark Pharms
August 3, 2011ANDA090700 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Glenmark Pharms Ltd
July 12, 2011ANDA090801 Ursodiol
URSODIOL
Glenmark Pharms Ltd
June 8, 2011ANDA090480 Mupirocin
MUPIROCIN
Glenmark Pharms
February 24, 2011ANDA090385 Levocetirizine dihydrochloride
LEVOCETIRIZINE DIHYDROCHLORIDE
Glenmark Pharms Ltd
February 14, 2011ANDA091616 Lithium carbonate
LITHIUM CARBONATE
Glenmark Pharms Ltd
January 12, 2011ANDA091211 Atovaquone and proguanil hydrochloride
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Glenmark Pharms Ltd
December 27, 2010ANDA091544 Lithium carbonate
LITHIUM CARBONATE
Glenmark Pharms
December 22, 2010ANDA091276 Indomethacin
INDOMETHACIN
Glenmark Pharms Ltd
December 17, 2010ANDA090365 Felodipine
FELODIPINE
Glenmark Pharms Ltd
October 8, 2010ANDA090781 Pramipexole dihydrochloride
PRAMIPEXOLE DIHYDROCHLORIDE
Glenmark Pharms Ltd
August 13, 2010ANDA091575 Trospium chloride
TROSPIUM CHLORIDE
Glenmark Pharms Ltd
August 3, 2010ANDA090219 Clotrimazole
CLOTRIMAZOLE
Glenmark Pharms
July 22, 2010ANDA091209 Norethindrone
NORETHINDRONE
Glenmark Pharms Ltd
July 21, 2010ANDA091090 Norethindrone acetate
NORETHINDRONE ACETATE
Glenmark Pharms Ltd
July 13, 2010ANDA090355 Theophylline
THEOPHYLLINE
Glenmark Pharms Ltd
May 5, 2010ANDA079135 Trandolapril and verapamil hydrochloride
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
Glenmark Pharms Ltd
April 23, 2010ANDA090454 Norethindrone
HEATHER
Glenmark Pharms Ltd
March 30, 2010ANDA090416 Moexipril hydrochloride
MOEXIPRIL HYDROCHLORIDE
Glenmark Pharms Ltd
March 24, 2010ANDA090633 Calcipotriene
CALCIPOTRIENE
Glenmark Pharms
February 25, 2010ANDA090135 Ropinirole
ROPINIROLE HYDROCHLORIDE
Glenmark Pharms Ltd
November 10, 2009ANDA090273 Ciclopirox
CICLOPIROX
Glenmark Pharms
September 17, 2009ANDA078906 Verapamil hydrochloride
VERAPAMIL HYDROCHLORIDE
Glenmark Pharms Ltd
July 30, 2009ANDA079227 Alclometasone dipropionate
ALCLOMETASONE DIPROPIONATE
Glenmark Pharms Ltd
March 27, 2009ANDA077627 Topiramate
TOPIRAMATE
Glenmark Pharms Ltd
February 19, 2009ANDA079099 Lamotrigine
LAMOTRIGINE
Glenmark Pharms Ltd
February 3, 2009ANDA079139 Lithium carbonate
LITHIUM CARBONATE
Glenmark Pharms Ltd
January 14, 2009NDA022256 Milnacipran hydrochloride
SAVELLA
Abbvie
October 9, 2007ANDA077802 Oxcarbazepine
OXCARBAZEPINE
Glenmark Pharms Ltd
September 5, 2007ANDA078251 Carvedilol
CARVEDILOL
Glenmark Pharms Ltd
June 27, 2007ANDA078152 Ondansetron
ONDANSETRON
Glenmark Pharms Ltd
June 25, 2007ANDA077535 Ondansetron
ONDANSETRON HYDROCHLORIDE
Glenmark Pharms Ltd
May 11, 2007ANDA077987 Pravastatin sodium
PRAVASTATIN SODIUM
Glenmark Pharms Ltd
April 27, 2007ANDA078314 Naproxen
NAPROXEN SODIUM
Glenmark Pharms Ltd
March 28, 2007ANDA078250 Naproxen
NAPROXEN
Glenmark Pharms Ltd
August 18, 2006ANDA077662 Gabapentin
GABAPENTIN
Glenmark Pharms Ltd
January 30, 2006ANDA077651 Zonisamide
ZONISAMIDE
Glenmark Pharms
January 25, 2006ANDA077253 Fluconazole
FLUCONAZOLE
Glenmark Pharms Ltd
February 11, 2004ANDA076631 Benazepril hydrochloride and hydrochlorothiazide
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sandoz

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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