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Drug company (FDA labeler)

Remedyrepack Inc.

Name in FDA records: REMEDYREPACK INC.

NDC labeler code: 70518

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

303Prescription medicines
1,518Products (NDC)
902FDA applications
1Recalls

Prescription medicines

Show the other 263 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.
  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
ApprovedApplicationMedicineSponsor
March 23, 2026ANDA217607 Cefixime
CEFIXIME		Aurobindo Pharma Ltd
September 8, 2025ANDA218734 Prochlorperazine
PROCHLORPERAZINE MALEATE		Aurobindo Pharma Ltd
July 25, 2025ANDA209199 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE		Hetero Labs Ltd V
June 24, 2025ANDA205336 Diphenhydramine
DIPHENHYDRAMINE HYDROCHLORIDE		Avet Lifesciences
May 13, 2025ANDA219168 Haloperidol decanoate
HALOPERIDOL DECANOATE		Caplin
February 21, 2025ANDA206942 Pregabalin
PREGABALIN		Torrent
December 31, 2024ANDA216750 Metronidazole
METRONIDAZOLE		Sciegen Pharms
December 27, 2024ANDA213942 Bumetanide
BUMETANIDE		Rubicon Research
November 20, 2024ANDA213708 Epinephrine
EPINEPHRINE		Fresenius Kabi USA
November 19, 2024ANDA219033 Guanfacine
GUANFACINE HYDROCHLORIDE		Unichem
October 18, 2024ANDA209694 Metformin hydrochloride
METFORMIN HYDROCHLORIDE		Aurobindo Pharma
October 1, 2024ANDA217397 Nebivolol
NEBIVOLOL HYDROCHLORIDE		Msn
September 17, 2024ANDA216727 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Msn
September 12, 2024ANDA218936 Cyclobenzaprine hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDE		Rising
August 27, 2024ANDA217740 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Graviti Pharms
August 21, 2024ANDA218174 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Annora Pharma
August 8, 2024ANDA218988 Trazodone hydrochloride
TRAZODONE HYDROCHLORIDE		Granules
August 6, 2024ANDA217400 Famotidine
FAMOTIDINE		Msn
August 5, 2024ANDA211572 Polymyxin b sulfate and trimethoprim sulfate
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE		Somerset Theraps LLC
July 11, 2024ANDA207037 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE		Alkem Labs Ltd
July 10, 2024ANDA212696 Glycopyrrolate
GLYCOPYRROLATE		Quagen
June 7, 2024ANDA218283 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Rising
May 21, 2024ANDA212447 Albuterol sulfate
ALBUTEROL SULFATE		Armstrong Pharms
May 9, 2024ANDA218515 Prochlorperazine
PROCHLORPERAZINE MALEATE		Ajanta Pharma Ltd
May 7, 2024ANDA217566 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Annora Pharma
Show the other 100 applications
ApprovedApplicationMedicineSponsor
May 6, 2024ANDA212545 Perphenazine
PERPHENAZINE		Macleods Pharms
April 25, 2024ANDA218450 Diazepam
DIAZEPAM		Alembic
April 11, 2024ANDA216918 Haloperidol
HALOPERIDOL		Mankind Pharma
March 21, 2024ANDA213095 Desmopressin acetate
DESMOPRESSIN ACETATE		Aurobindo Pharma
February 16, 2024ANDA218221 Carbamazepine
CARBAMAZEPINE		Bionpharma
February 7, 2024ANDA216282 Dexamethasone
DEXAMETHASONE		Zydus Lifesciences
January 18, 2024ANDA214287 Butalbital, acetaminophen and caffeine
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE		Quagen
January 8, 2024ANDA215237 Gentamicin sulfate
GENTAMICIN SULFATE		Eugia Pharma
January 5, 2024ANDA217081 Atorvastatin
ATORVASTATIN CALCIUM		Mankind Pharma
January 4, 2024ANDA205504 Eszopiclone
ESZOPICLONE		Hetero Labs Ltd V
December 8, 2023ANDA203632 Clopidogrel
CLOPIDOGREL BISULFATE		Alkem Labs Ltd
December 5, 2023ANDA217970 Nitroglycerin
NITROGLYCERIN		Mankind Pharma
November 20, 2023ANDA217020 Probenecid
PROBENECID		Rising
October 24, 2023ANDA217030 Probenecid and colchicine
PROBENECID AND COLCHICINE		Rising
October 23, 2023ANDA214571 Varenicline tartrate
VARENICLINE TARTRATE		Hetero Labs Ltd III
October 5, 2023ANDA216828 Guanfacine
GUANFACINE HYDROCHLORIDE		Pharmazone
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 14, 2023ANDA217396 Losartan potassium
LOSARTAN POTASSIUM		Msn
August 14, 2023ANDA218036 Lithium
LITHIUM CITRATE		Rubicon Research
August 3, 2023ANDA217748 Allopurinol
ALLOPURINOL		Hetero Labs Ltd V
July 18, 2023ANDA217350 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Alembic
July 11, 2023ANDA217357 Nitrofurantoin (monohydrate/macrocrystals)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)		Mankind Pharma
June 12, 2023ANDA216916 Metoprolol
METOPROLOL SUCCINATE		Granules
June 7, 2023ANDA215397 Medroxyprogesterone acetate
MEDROXYPROGESTERONE ACETATE		Amneal
June 1, 2023ANDA204801 Olmesartan medoxomil and hydrochlorothiazide
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE		Macleods Pharms
June 1, 2023ANDA216782 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Twi Pharms
May 31, 2023ANDA216800 Bupropion
BUPROPION HYDROCHLORIDE		Annora Pharma
May 23, 2023ANDA216730 Haloperidol decanoate
HALOPERIDOL DECANOATE		Mankind Pharma
May 19, 2023ANDA217411 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Rising
May 18, 2023ANDA217390 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Granules
May 10, 2023ANDA217789 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Caplin
April 27, 2023ANDA217293 Guanfacine
GUANFACINE HYDROCHLORIDE		Ajanta Pharma Ltd
April 4, 2023ANDA217478 Prochlorperazine
PROCHLORPERAZINE MALEATE		Bionpharma
April 3, 2023ANDA214823 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Msn
March 31, 2023ANDA213052 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Aurobindo Pharma Ltd
March 28, 2023ANDA216780 Lidocaine
LIDOCAINE HYDROCHLORIDE		Rubicon Research
March 28, 2023ANDA217116 Gabapentin
GABAPENTIN		Granules
March 21, 2023ANDA217272 Nitrofurantoin
NITROFURANTOIN		Mankind Pharma
March 10, 2023ANDA216957 Clindamycin
CLINDAMYCIN HYDROCHLORIDE		Glenmark Pharms Ltd
February 23, 2023ANDA216759 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Bionpharma
January 18, 2023ANDA216492 Gabapentin
GABAPENTIN		Rubicon Research
January 9, 2023ANDA205443 Febuxostat
FEBUXOSTAT		Zydus Lifesciences
January 5, 2023ANDA217410 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Ajanta Pharma Ltd
December 30, 2022ANDA215697 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Mankind Pharma
December 27, 2022ANDA217054 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Twi Pharms
December 21, 2022ANDA211417 Levothyroxine
LEVOTHYROXINE SODIUM		Macleods Pharms
December 13, 2022ANDA212244 Lurasidone hydrochloride
LURASIDONE HYDROCHLORIDE		Alkem Labs Ltd
November 28, 2022ANDA216044 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Unique
November 28, 2022ANDA216537 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		Aurobindo Pharma Ltd
November 23, 2022ANDA215886 Ofloxacin
OFLOXACIN		Mankind Pharma
October 21, 2022ANDA213406 Prazosin hydrochloride
PRAZOSIN HYDROCHLORIDE		Appco
October 21, 2022ANDA217038 Ketorolac tromethamine
KETOROLAC TROMETHAMINE		Zydus Lifesciences
October 17, 2022ANDA216629 Furosemide
FUROSEMIDE		Graviti Pharms
October 14, 2022ANDA213071 Calcium gluconate
CALCIUM GLUCONATE		Nivagen
September 29, 2022ANDA209488 Mirabegron
MIRABEGRON		Zydus Pharms
September 28, 2022ANDA209485 Mirabegron
MIRABEGRON		Lupin
September 27, 2022ANDA216798 Fenofibrate
FENOFIBRATE		Aurobindo Pharma
September 26, 2022ANDA203125 Methylprednisolone
METHYLPREDNISOLONE SODIUM SUCCINATE		Hikma
September 23, 2022ANDA216275 Diclofenac
DICLOFENAC SODIUM		Ingenus Pharms LLC
August 30, 2022ANDA215622 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Zydus Pharms
August 22, 2022ANDA213284 Carbamazepine
CARBAMAZEPINE		Unichem
August 18, 2022ANDA216594 Carbamazepine
CARBAMAZEPINE		Umedica
August 15, 2022ANDA215478 Quetiapine
QUETIAPINE FUMARATE		Unichem
August 15, 2022NDA211363 Epinephrine
EPINEPHRINE		Intl Medication Sys
August 11, 2022ANDA210608 Tadalafil
TADALAFIL		Prinston Inc
August 11, 2022ANDA210609 Tadalafil
TADALAFIL		Prinston Inc
August 8, 2022ANDA215604 Dexamethasone
DEXAMETHASONE		Novitium Pharma
August 8, 2022ANDA216495 Prochlorperazine
PROCHLORPERAZINE MALEATE		Zydus Lifesciences
August 4, 2022ANDA215587 Chlorthalidone
CHLORTHALIDONE		Mankind Pharma
July 27, 2022ANDA212351 Diclofenac
DICLOFENAC SODIUM		Alembic
July 14, 2022ANDA216130 Ofloxacin
OFLOXACIN		Mankind Pharma
July 8, 2022ANDA215723 Isosorbide dinitrate
ISOSORBIDE DINITRATE		Rubicon Research
July 7, 2022ANDA213273 Enalapril maleate
ENALAPRIL MALEATE		Prinston Inc
June 27, 2022ANDA213503 Tranylcypromine sulfate
TRANYLCYPROMINE SULFATE		Crossmedika SA
June 24, 2022ANDA215113 Doxepin hydrochloride
DOXEPIN HYDROCHLORIDE		Msn
June 16, 2022ANDA204316 Quetiapine
QUETIAPINE FUMARATE		Hetero Labs Ltd V
May 18, 2022ANDA210163 Perphenazine
PERPHENAZINE		Somerset Theraps LLC
May 18, 2022ANDA210568 Cefpodoxime proxetil
CEFPODOXIME PROXETIL		Alkem Labs Ltd
April 14, 2022ANDA215674 Fluphenazine hydrochloride
FLUPHENAZINE HYDROCHLORIDE		Taro
April 7, 2022ANDA212682 Nebivolol
NEBIVOLOL HYDROCHLORIDE		Prinston Inc
March 31, 2022ANDA214695 Lacosamide
LACOSAMIDE		Alkem Labs Ltd
March 28, 2022ANDA215672 Prednisone
PREDNISONE		Aurobindo Pharma Ltd
March 17, 2022ANDA204974 Lacosamide
LACOSAMIDE		Alembic
March 17, 2022ANDA205237 Lacosamide
LACOSAMIDE		Sciegen Pharms
February 25, 2022ANDA214643 Divalproex sodium
DIVALPROEX SODIUM		Unichem
February 25, 2022ANDA216146 Ephedrine sulfate
EPHEDRINE SULFATE		Gland
February 23, 2022ANDA216211 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE		Rubicon Research
February 9, 2022ANDA211320 Chlorthalidone
CHLORTHALIDONE		Adaptis
February 8, 2022ANDA214982 Digoxin
DIGOXIN		Aurobindo Pharma Ltd
February 2, 2022ANDA215568 Bupropion
BUPROPION HYDROCHLORIDE		Granules
January 27, 2022ANDA214827 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Msn
January 25, 2022ANDA215885 Baclofen
BACLOFEN		Mankind Pharma
January 19, 2022ANDA215038 Ofloxacin
OFLOXACIN		Fdc Ltd
January 11, 2022ANDA215939 Oxcarbazepine
OXCARBAZEPINE		Annora Pharma
January 7, 2022ANDA215630 Famotidine
FAMOTIDINE		Vkt Pharma
December 17, 2021ANDA215041 Rifabutin
RIFABUTIN		Novitium Pharma
December 8, 2021ANDA213949 Lamotrigine
LAMOTRIGINE		Pharmobedient

Showing the 125 newest of 902 applications. Full lists: Drugs@FDA →

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2022

  1. April 6, 2022 · Class II · Terminated · D-0788-2022 · Losartan potassium

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

    Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

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 →