Drug company (FDA labeler)
Marlex Pharmaceuticals, Inc.
NDC labeler code: 10135
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
- Ropinirole7 products
- Haloperidol6 products
- Prednisone5 products
- LacosamideVimpat, Motpoly XR · 4 products
- Fluphenazine hydrochlorideFluphenazine Hydrochoride · 4 products
- Prazosin hydrochloride3 products
- Metolazone3 products
- Hydroxyzine3 products
- FurosemideLasix, Furoscix, Lasix Onyu · 3 products
- LabetalolLabetalol HCL in Dextrose · 3 products
- Venlafaxine hydrochlorideEffexor XR · 3 products
- Bisoprolol fumarate and hydrochlorothiazide3 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 3 products
- DesvenlafaxinePristiq Extended-Release · 2 products
- Acetazolamide2 products
- Alendronate sodiumBinosto, Fosamax · 2 products
- Pindolol2 products
- Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 2 products
- Isoniazid2 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- AmantadineGocovri · 2 products
- Atenolol and chlorthalidone2 products
- MethocarbamolRobaxin, Atmeksi, Tanlor · 2 products
- DigoxinLanoxin · 2 products
- Metformin hydrochlorideGlumetza · 2 products
- Ethambutol hydrochloride2 products
- BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 2 products
- Pyrazinamide1 product
- Probenecid1 product
- EzetimibeZetia · 1 product
- SelegilineEmsam, Zelapar · 1 product
- LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 1 product
- Rifabutin1 product
- RamelteonRozerem · 1 product
- OxcarbazepineTrileptal, Oxtellar XR · 1 product
- DiclofenacZipsor, Lofena, Cambia · 1 product
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 1 product
- Levocetirizine dihydrochlorideXyzal · 1 product
- RegadenosonLexiscan · 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 |
|---|---|---|---|
| August 22, 2024 | ANDA218054 | Regadenoson REGADENOSON | Indies Pharma |
| April 2, 2024 | ANDA218014 | Lacosamide LACOSAMIDE | Pharmazone |
| March 6, 2024 | ANDA217283 | Varenicline tartrate VARENICLINE TARTRATE | Ne Rx Pharma |
| February 14, 2024 | ANDA217782 | Oxcarbazepine OXCARBAZEPINE | Pharmazone |
| May 9, 2023 | ANDA217197 | Acetazolamide ACETAZOLAMIDE | Ne Rx Pharma |
| October 25, 2022 | ANDA216216 | Metolazone METOLAZONE | Ne Rx Pharma |
| September 13, 2022 | ANDA215693 | Ezetimibe EZETIMIBE | Orient Pharma |
| August 24, 2022 | ANDA215435 | Ramelteon RAMELTEON | Andas 5 Holding |
| March 23, 2022 | ANDA216250 | Lidocaine LIDOCAINE HYDROCHLORIDE | Novitium Pharma |
| December 17, 2021 | ANDA215041 | Rifabutin RIFABUTIN | Novitium Pharma |
| November 22, 2021 | ANDA215307 | Digoxin DIGOXIN | Novitium Pharma |
| November 4, 2021 | ANDA215562 | Bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | Novitium Pharma |
| October 25, 2021 | ANDA215560 | Atenolol and chlorthalidone ATENOLOL AND CHLORTHALIDONE | Novitium Pharma |
| April 30, 2021 | ANDA212623 | Methocarbamol METHOCARBAMOL | Pharmazone |
| March 1, 2021 | ANDA214674 | Fluphenazine hydrochloride FLUPHENAZINE HYDROCHLORIDE | Novitium Pharma |
| March 10, 2020 | ANDA210215 | Amantadine AMANTADINE HYDROCHLORIDE | Pharmobedient |
| March 2, 2020 | ANDA210129 | Amantadine AMANTADINE HYDROCHLORIDE | Rising |
| November 15, 2019 | ANDA211575 | Prednisone PREDNISONE | Novitium Pharma |
| May 7, 2019 | ANDA204805 | Desvenlafaxine DESVENLAFAXINE SUCCINATE | Platinum |
| May 6, 2019 | ANDA212183 | Potassium chloride POTASSIUM CHLORIDE | Ajenat Pharms |
| November 23, 2018 | ANDA201272 | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | Platinum |
| October 3, 2018 | ANDA210971 | Prazosin hydrochloride PRAZOSIN HYDROCHLORIDE | Novitium Pharma |
| March 29, 2017 | ANDA207121 | Hydroxyzine HYDROXYZINE HYDROCHLORIDE | Nuvo Pharms Inc |
| February 23, 2017 | ANDA202306 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Platinum |
| January 20, 2016 | ANDA202337 | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE | Rk Pharma |
Show the other 15 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 17, 2013 | ANDA202046 | Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE | Micro Labs Ltd India |
| February 7, 2012 | ANDA079165 | Ropinirole ROPINIROLE HYDROCHLORIDE | Mlv |
| September 24, 2009 | ANDA090258 | Alendronate sodium ALENDRONATE SODIUM | Hangzhou Binjiang |
| December 20, 2005 | ANDA077241 | Baclofen BACLOFEN | Lannett Co Inc |
| July 29, 1999 | ANDA075215 | Labetalol LABETALOL HYDROCHLORIDE | Innogenix |
| July 26, 1999 | ANDA075463 | Diclofenac DICLOFENAC POTASSIUM | Rising |
| November 30, 1998 | ANDA075352 | Selegiline SELEGILINE HYDROCHLORIDE | Novitium Pharma |
| June 26, 1997 | ANDA040090 | Isoniazid ISONIAZID | Omnivium Pharms |
| March 29, 1993 | ANDA073609 | Pindolol PINDOLOL | Ani Pharms |
| January 7, 1988 | ANDA071173 | Haloperidol HALOPERIDOL | Sciegen Pharms |
| October 19, 1981 | NDA018569 | Furosemide FUROSEMIDE | Epic Pharma LLC |
| September 21, 1976 | ANDA084754 | Dexamethasone DEXAMETHASONE | Pharmazone |
| July 29, 1976 | ANDA080966 | Probenecid PROBALAN | Lannett |
| June 3, 1971 | ANDA080157 | Pyrazinamide PYRAZINAMIDE | Novitium Pharma |
| November 6, 1967 | NDA016320 | Ethambutol hydrochloride MYAMBUTOL | Kanchan Hlthcare |
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