Drug company (FDA labeler)
Advagen Pharma Limited
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.
Prescription medicines
- BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 7 products
- MetoprololToprol XL, Lopressor, Kapspargo · 6 products
- LamotrigineLamictal, Lamictal XR, Subvenite · 4 products
- TizanidineZanaflex, Ontralfy · 4 products
- Tramadol hydrochlorideConzip · 4 products
- CarvedilolCoreg, Coreg CR · 4 products
- GlipizideGlucotrol XL · 4 products
- GuanfacineIntuniv · 4 products
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 3 products
- BumetanideBumex, Enbumyst · 3 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 3 products
- PrimidoneMysoline · 3 products
- Metolazone3 products
- OxcarbazepineTrileptal, Oxtellar XR · 3 products
- Amiodarone hydrochloridePacerone, Nexterone · 3 products
- Midodrine hydrochloride3 products
- OxybutyninOxytrol · 3 products
- Mycophenolic acidMyfortic · 2 products
- Mycophenolate mofetilCellcept, Myhibbin · 2 products
- Hydroxyzine1 product
- AcyclovirZovirax, Avaclyr · 1 product
- Rabeprazole sodiumAciphex · 1 product
- Levofloxacin1 product
- Tranexamic acidCyklokapron · 1 product
- AmantadineGocovri · 1 product
- CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 1 product
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.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 11, 2026 | ANDA219561 | Hydroxyzine HYDROXYZINE HYDROCHLORIDE | Rubicon Research |
| August 28, 2025 | NDA218698 | Metoprolol LOPRESSOR | Xtm Consulting |
| April 15, 2025 | ANDA219689 | Guanfacine GUANFACINE HYDROCHLORIDE | Rubicon Research |
| December 27, 2024 | ANDA213942 | Bumetanide BUMETANIDE | Rubicon Research |
| June 11, 2024 | ANDA218320 | Tranexamic acid TRANEXAMIC ACID | Rubicon Research |
| October 3, 2023 | ANDA214874 | Glipizide GLIPIZIDE | Rubicon Research |
| February 22, 2023 | ANDA217324 | Baclofen BACLOFEN | Rubicon Research |
| August 18, 2022 | ANDA215724 | Acyclovir ACYCLOVIR | Rubicon Research |
| June 28, 2022 | ANDA214896 | Primidone PRIMIDONE | Rubicon Research |
| March 24, 2022 | ANDA214108 | Potassium chloride POTASSIUM CHLORIDE | Rubicon Research |
| January 13, 2022 | ANDA214656 | Potassium chloride POTASSIUM CHLORIDE | Rubicon Research |
| August 20, 2021 | ANDA215184 | Metolazone METOLAZONE | Rubicon Research |
| October 27, 2020 | ANDA214415 | Oxybutynin OXYBUTYNIN CHLORIDE | Rubicon Research |
| July 31, 2020 | ANDA212087 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Concord Biotech Ltd |
| May 27, 2020 | ANDA213798 | Tizanidine TIZANIDINE HYDROCHLORIDE | Rubicon Research |
| May 21, 2020 | ANDA212044 | Amantadine AMANTADINE HYDROCHLORIDE | Rubicon Research |
| December 13, 2019 | ANDA211173 | Mycophenolic acid MYCOPHENOLATE SODIUM | Concord Biotech Ltd |
| August 19, 2019 | ANDA212543 | Midodrine hydrochloride MIDODRINE HYDROCHLORIDE | Rubicon Research |
| June 28, 2019 | ANDA208708 | Tramadol hydrochloride TRAMADOL HYDROCHLORIDE | Rubicon Research |
| January 8, 2019 | ANDA210181 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL | Concord Biotech Ltd |
| November 28, 2017 | ANDA209102 | Baclofen BACLOFEN | Rubicon Research |
| May 31, 2017 | ANDA208170 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Rubicon Research |
| November 18, 2015 | ANDA204237 | Rabeprazole sodium RABEPRAZOLE SODIUM | Rubicon Research |
| October 28, 2014 | ANDA200981 | Metoprolol METOPROLOL TARTRATE | Rubicon Research |
| December 20, 2010 | ANDA078282 | Levofloxacin LEVOFLOXACIN | Rubicon Research |
Show the other 5 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 22, 2009 | ANDA078786 | Carvedilol CARVEDILOL | Mlv |
| January 27, 2009 | ANDA078625 | Lamotrigine LAMOTRIGINE | Rubicon Research |
| November 6, 2008 | ANDA078578 | Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE | Rubicon Research |
| April 9, 2008 | ANDA077747 | Oxcarbazepine OXCARBAZEPINE | Rubicon Research |
| June 9, 2004 | ANDA075928 | Ciprofloxacin CIPROFLOXACIN HYDROCHLORIDE | Rubicon Research |
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.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026