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Drug company (FDA labeler)

Advagen Pharma Ltd

NDC labeler code: 72888

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

48Prescription medicines
135Products (NDC)
58FDA applications
2Recalls

Prescription medicines

Show the other 8 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
October 7, 2026ANDA218248 Hydrochlorothiazide
HYDROCHLOROTHIAZIDE		Rubicon Research
September 10, 2026ANDA220884 Spironolactone and hydrochlorothiazide
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE		Rubicon Research
July 17, 2026ANDA216515 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Rubicon Research
June 23, 2026ANDA220869 Promethazine hydrochloride and dextromethorphan hydrobromide
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE		Rubicon Research
May 21, 2026ANDA216988 Clonazepam
CLONAZEPAM		Rubicon Research
March 20, 2026NDA220320 Atomoxetine
ATONCY		MAP77
February 25, 2026ANDA220335 Cetirizine
CETIRIZINE HYDROCHLORIDE		Rubicon Research
October 10, 2025ANDA216678 Chlorpromazine hydrochloride
CHLORPROMAZINE HYDROCHLORIDE		Rubicon Research
June 5, 2025ANDA216460 Valsartan
VALSARTAN		Rubicon Research
June 5, 2025ANDA218321 Fluticasone propionate
FLUTICASONE PROPIONATE		Rubicon Research
May 27, 2025ANDA216683 Topiramate
TOPIRAMATE		Rubicon Research
January 22, 2025ANDA215922 Ivermectin
IVERMECTIN		Rubicon Research
January 14, 2025ANDA219222 Ipratropium bromide
IPRATROPIUM BROMIDE		Rubicon Research
December 6, 2024ANDA214445 Baclofen
BACLOFEN		Rubicon Research
November 15, 2024ANDA219221 Ipratropium bromide
IPRATROPIUM BROMIDE		Rubicon Research
November 12, 2024ANDA216545 Clomiphene citrate
CLOMIPHENE CITRATE		Rubicon Research
September 17, 2024ANDA218372 Dexamethasone
DEXAMETHASONE		Solgen
June 4, 2024ANDA217482 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		Rubicon Research
March 5, 2024ANDA207717 Oxcarbazepine
OXCARBAZEPINE		Rubicon Research
January 31, 2024ANDA218371 Haloperidol
HALOPERIDOL		Rubicon Research
October 17, 2023ANDA216762 Guanfacine
GUANFACINE HYDROCHLORIDE		Rubicon Research
August 15, 2023ANDA217731 Nortriptyline hydrochloride
NORTRIPTYLINE HYDROCHLORIDE		Rubicon Research
August 14, 2023ANDA218036 Lithium
LITHIUM CITRATE		Rubicon Research
June 22, 2023ANDA216881 Dihydroergotamine mesylate
DIHYDROERGOTAMINE MESYLATE		Rubicon Research
June 16, 2023ANDA216321 Potassium chloride
POTASSIUM CHLORIDE		Rubicon Research
Show the other 33 applications
ApprovedApplicationMedicineSponsor
May 11, 2023ANDA216548 Diclofenac
DICLOFENAC SODIUM		Rubicon Research
May 1, 2023ANDA215376 Amitriptyline hydrochloride
AMITRIPTYLINE HYDROCHLORIDE		Rubicon Research
April 6, 2023ANDA216682 Cevimeline hydrochloride
CEVIMELINE HYDROCHLORIDE		Rubicon Research
March 28, 2023ANDA216780 Lidocaine
LIDOCAINE HYDROCHLORIDE		Rubicon Research
January 26, 2023ANDA216876 Loperamide hydrochloride
LOPERAMIDE HYDROCHLORIDE		Rubicon Research
January 18, 2023ANDA216492 Gabapentin
GABAPENTIN		Rubicon Research
December 14, 2022ANDA216736 Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE		Rubicon Research
October 27, 2022ANDA216351 Aripiprazole
ARIPIPRAZOLE		Rubicon Research
September 21, 2022ANDA216505 Carbidopa and levodopa
CARBIDOPA AND LEVODOPA		Rubicon Research
August 30, 2022ANDA215726 Oxcarbazepine
OXCARBAZEPINE		Rubicon Research
July 25, 2022ANDA215725 Potassium chloride
POTASSIUM CHLORIDE		Rubicon Research
July 8, 2022ANDA215723 Isosorbide dinitrate
ISOSORBIDE DINITRATE		Rubicon Research
March 22, 2022ANDA215249 Pregabalin
PREGABALIN		Rubicon Research
February 23, 2022ANDA216211 Triamterene and hydrochlorothiazide
TRIAMTERENE AND HYDROCHLOROTHIAZIDE		Rubicon Research
August 19, 2021ANDA215101 Acetazolamide
ACETAZOLAMIDE		Rubicon Research
August 18, 2021ANDA211953 Labetalol
LABETALOL HYDROCHLORIDE		Rubicon Research
May 3, 2021ANDA209779 Nitroglycerin
NITROGLYCERIN		Rubicon Research
March 12, 2020ANDA203332 Venlafaxine hydrochloride
VENLAFAXINE HYDROCHLORIDE		Adaptis
June 11, 2018ANDA204882 Sildenafil
SILDENAFIL CITRATE		Rubicon Research
June 20, 2016ANDA204883 Sildenafil
SILDENAFIL CITRATE		Rubicon Research
June 29, 2015ANDA204028 Desvenlafaxine
DESVENLAFAXINE SUCCINATE		Rubicon Research
June 10, 2015ANDA090279 Buprenorphine
BUPRENORPHINE HYDROCHLORIDE		Rubicon Research
October 28, 2014ANDA200981 Metoprolol
METOPROLOL TARTRATE		Rubicon Research
November 13, 2008ANDA077600 Diclofenac
DICLOFENAC SODIUM		Rubicon Research
October 28, 2008ANDA078395 Dorzolamide hydrochloride
DORZOLAMIDE HYDROCHLORIDE		Rubicon Research
September 5, 2007ANDA078165 Carvedilol
CARVEDILOL		Rubicon Research
September 13, 2006ANDA077661 Gabapentin
GABAPENTIN		Rubicon Research
April 5, 2002ANDA075521 Buspirone
BUSPIRONE HYDROCHLORIDE		Rubicon Research
November 16, 2000ANDA075643 Bisoprolol fumarate
BISOPROLOL FUMARATE		Rubicon Research
October 6, 2000ANDA075468 Clonazepam
CLONAZEPAM		Rubicon Research
November 20, 1998ANDA075229 Diclofenac
DICLOFENAC POTASSIUM		Rubicon Research
May 19, 1992NDA020033 Benazepril hydrochloride and hydrochlorothiazide
LOTENSIN HCT		Validus Pharms
August 30, 1984NDA018631 Pentoxifylline
TRENTAL		Validus Pharms

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

Recall timeline

2024

  1. August 24, 2024 · Class III · Ongoing · D-0659-2024 · Acetazolamide

    Discoloration

    AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01

  2. April 26, 2024 · Class II · Ongoing · D-0487-2024 · Tramadol hydrochloride

    Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

    traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited

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 →