TruPharma, LLC
NDC labeler code: 52817
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
- ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 11 products
- MetoprololToprol XL, Lopressor, Kapspargo · 10 products
- BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 5 products
- SildenafilViagra, Vybrique, Revatio · 4 products
- Bisoprolol fumarate3 products
- Midodrine hydrochloride3 products
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 3 products
- Carbidopa and levodopaCrexont, Rytary, Sinemet · 3 products
- Tramadol hydrochlorideConzip · 3 products
- Oxazepam3 products
- NaproxenNaprelan, Rugby All Day Relief · 2 products
- Cyproheptadine2 products
- DapsoneAczone · 2 products
- Sertraline hydrochlorideZoloft · 2 products
- Metformin hydrochlorideGlumetza · 2 products
- Sapropterin dihydrochlorideKuvan, Javygtor, Zelvysia · 2 products
- TriamtereneDyrenium · 2 products
- Acetazolamide2 products
- OxybutyninOxytrol · 2 products
- Trazodone hydrochlorideRaldesy Tm · 2 products
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 1 product
- PrimidoneMysoline · 1 product
- ClonazepamKlonopin · 1 product
- Ethacrynic acidEdecrin · 1 product
- ClotrimazoleClotic (Clotrimazole) Otic Solution · 1 product
- Betamethasone dipropionateDiprolene, Sernivo · 1 product
- Acetic acid1 product
- ClozapineClozaril, Versacloz · 1 product
- Apomorphine hydrochlorideOnapgo, Apomorphine Hydrocloride, Apokyn · 1 product
- Aminocaproic acid1 product
- SucralfateCarafate · 1 product
- PrednisoloneOrapred ODT · 1 product
- GlipizideGlucotrol XL · 1 product
- LevocarnitineCarnitor, Carnitor Sf · 1 product
- RamelteonRozerem · 1 product
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 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 3, 2025 | ANDA216432 | Sapropterin dihydrochloride SAPROPTERIN DIHYDROCHLORIDE | Hopewell Pharma |
| June 23, 2025 | ANDA219509 | Prednisolone PREDNISOLONE | Tp Anda Holdings |
| November 29, 2024 | ANDA212222 | Nitroglycerin NITROGLYCERIN | Tp Anda Holdings |
| August 26, 2024 | ANDA213636 | Dapsone DAPSONE | Tp Anda Holdings |
| January 17, 2024 | ANDA213549 | Sucralfate SUCRALFATE | Pd Partners |
| October 3, 2023 | ANDA214874 | Glipizide GLIPIZIDE | Rubicon Research |
| June 6, 2023 | ANDA213907 | Dapsone DAPSONE | Tp Anda Holdings |
| May 31, 2023 | ANDA216908 | Naproxen NAPROXEN | Tp Anda Holdings |
| September 21, 2022 | ANDA216505 | Carbidopa and levodopa CARBIDOPA AND LEVODOPA | Rubicon Research |
| June 28, 2022 | ANDA214896 | Primidone PRIMIDONE | Rubicon Research |
| February 23, 2022 | ANDA212025 | Apomorphine hydrochloride APOMORPHINE HYDROCHLORIDE | Tp Anda Holdings |
| February 18, 2022 | ANDA215186 | Betamethasone dipropionate BETAMETHASONE DIPROPIONATE | Tp Anda Holdings |
| November 10, 2021 | ANDA212533 | Levocarnitine LEVOCARNITINE | Sciegen Pharms |
| February 22, 2021 | ANDA211372 | Acetazolamide ACETAZOLAMIDE | Somerset Theraps LLC |
| September 1, 2020 | NDA214044 | Tramadol hydrochloride QDOLO | Rosemont |
| August 11, 2020 | ANDA212494 | Aminocaproic acid AMINOCAPROIC ACID | Tp Anda Holdings |
| April 10, 2020 | ANDA212650 | Ramelteon RAMELTEON | Pharmazone |
| March 3, 2020 | ANDA211309 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Saptalis Pharms |
| September 18, 2019 | NDA208193 | Baclofen OZOBAX, OZOBAX DS | Rosemont |
| August 19, 2019 | ANDA211581 | Triamterene TRIAMTERENE | Tp Anda Holdings |
| August 19, 2019 | ANDA212543 | Midodrine hydrochloride MIDODRINE HYDROCHLORIDE | Rubicon Research |
| July 25, 2019 | ANDA212281 | Clotrimazole CLOTRIMAZOLE | Tp Anda Holdings |
| July 12, 2019 | ANDA211809 | Ethacrynic acid ETHACRYNIC ACID | Agnitio |
| June 28, 2019 | ANDA208708 | Tramadol hydrochloride TRAMADOL HYDROCHLORIDE | Rubicon Research |
| September 6, 2018 | ANDA210125 | Oxybutynin OXYBUTYNIN CHLORIDE | Tp Anda Holdings |
| June 11, 2018 | ANDA204882 | Sildenafil SILDENAFIL CITRATE | Rubicon Research |
| November 28, 2017 | ANDA209102 | Baclofen BACLOFEN | Rubicon Research |
| May 31, 2017 | ANDA208170 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Rubicon Research |
| November 29, 2016 | ANDA206553 | Cyproheptadine CYPROHEPTADINE HYDROCHLORIDE | Tp Anda Holdings |
| June 20, 2016 | ANDA204883 | Sildenafil SILDENAFIL CITRATE | Rubicon Research |
| October 28, 2014 | ANDA200981 | Metoprolol METOPROLOL TARTRATE | Rubicon Research |
| February 6, 2013 | NDA203479 | Clozapine VERSACLOZ | Douglas Pharms |
| December 3, 2009 | NDA022500 | Clonidine NEXICLON XR | Rosemont |
| February 6, 2007 | ANDA077713 | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE | Tp Anda Holdings |
| June 9, 2006 | ANDA040671 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Micro Labs |
| February 24, 2005 | ANDA040607 | Acetic acid ACETIC ACID | Sciegen Pharms |
| October 25, 2002 | ANDA075474 | Bisoprolol fumarate BISOPROLOL FUMARATE | Tp Anda Holdings |
| November 16, 2000 | ANDA075643 | Bisoprolol fumarate BISOPROLOL FUMARATE | Rubicon Research |
| October 6, 2000 | ANDA075468 | Clonazepam CLONAZEPAM | Rubicon Research |
| February 2, 1989 | ANDA072193 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Oxford Pharms |
| September 4, 1987 | ANDA070923 | Clonidine CLONIDINE HYDROCHLORIDE | Tp Anda Holdings |
| August 10, 1987 | ANDA071026 | Oxazepam OXAZEPAM | Tp Anda Holdings |
| October 10, 1984 | NDA018891 | Clonidine CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS-3 | Lavipharm |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
May 6, 2024 · Class II · Ongoing · D-0517-2024 · Metoprolol
Presence of Foreign Substance: metal in tablet
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
2021
-
December 31, 2021 · Class II · Terminated · D-0362-2022 · Metoprolol
Complaint received of foreign matter (metal) embedded in tablet.
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-
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
- 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