Drug company (FDA labeler)
DirectRx
NDC labeler codes: 61919, 72189
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
- Losartan potassium and hydrochlorothiazideHyzaar · 4 products
- Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 2 products
- CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 2 products
- AmoxicillinAmoxil · 2 products
- DiclofenacZipsor, Lofena, Cambia · 2 products
- Hydrocodone bitartrate and acetaminophenNorco · 2 products
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 2 products
- Phentermine hydrochlorideLomaira · 2 products
- Losartan potassiumLosortan Potassium, Cozaar, Arbli · 1 product
- CarisoprodolSoma · 1 product
- Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)Augmentin Es-600, Augmentin · 1 product
- Meclizine hydrochloride1 product
- OxcarbazepineTrileptal, Oxtellar XR · 1 product
- ArmodafinilNuvigil · 1 product
- Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 1 product
- AtorvastatinLipitor · 1 product
- AzithromycinZithromax, Azasite · 1 product
- Hydroxyzine1 product
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 1 product
- Nitrofurantoin (monohydrate/macrocrystals)Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono · 1 product
- Clarithromycin1 product
- Diethylpropion hydrochloride1 product
- LorazepamAtivan, Loreev XR · 1 product
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 1 product
- Emtricitabine and tenofovir disoproxil fumarateTruvada · 1 product
- Neomycin sulfate, polymyxin b sulfate and dexamethasoneNeomycin and Polymyxin B Sulfates and Dexamethasone, Neomycin Polymyxin B Sulfates and Dexamethasone, Maxitrol · 1 product
- Zolpidem tartrateAmbien, Ambien CR, Edluar · 1 product
- Levofloxacin1 product
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 1 product
- ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 1 product
- SildenafilViagra, Vybrique, Revatio · 1 product
- GabapentinNeurontin, Gralise, Relgaabi · 1 product
- MethocarbamolRobaxin, Atmeksi, Tanlor · 1 product
- Memantine hydrochloride1 product
- TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
- ErgocalciferolVitamin D · 1 product
- Donepezil hydrochlorideAricept · 1 product
- Cefdinir1 product
- Tramadol hydrochlorideConzip · 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 |
|---|---|---|---|
| June 4, 2021 | ANDA204131 | Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Chartwell Rx |
| February 19, 2021 | ANDA210220 | Cefdinir CEFDINIR | Alkem Labs Ltd |
| December 3, 2020 | ANDA205129 | Celecoxib CELECOXIB | Sciegen Pharms |
| August 19, 2020 | ANDA213853 | Atorvastatin ATORVASTATIN CALCIUM | Umedica |
| July 6, 2020 | ANDA213324 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Unichem |
| June 28, 2019 | ANDA208708 | Tramadol hydrochloride TRAMADOL HYDROCHLORIDE | Rubicon Research |
| November 7, 2018 | ANDA211487 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Ascent Pharms Inc |
| May 4, 2018 | ANDA210394 | Sildenafil SILDENAFIL CITRATE | Ajanta Pharma Ltd |
| April 9, 2018 | ANDA207531 | Azithromycin AZITHROMYCIN | Epic Pharma LLC |
| December 22, 2017 | ANDA203572 | Lorazepam LORAZEPAM | Aurobindo Pharma |
| July 10, 2017 | ANDA090961 | Memantine hydrochloride MEMANTINE HYDROCHLORIDE | Zydus Lifesciences |
| June 28, 2017 | ANDA207444 | Tobramycin TOBRAMYCIN | Somerset Theraps LLC |
| June 21, 2017 | ANDA209037 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Abhai LLC |
| May 31, 2017 | ANDA208170 | Cyclobenzaprine hydrochloride CYCLOBENZAPRINE HYDROCHLORIDE | Rubicon Research |
| March 1, 2016 | ANDA205794 | Bupropion BUPROPION HYDROCHLORIDE | Sciegen Pharms |
| February 4, 2016 | ANDA205101 | Gabapentin GABAPENTIN | Sciegen Pharms |
| August 12, 2015 | ANDA203835 | Losartan potassium LOSARTAN POTASSIUM | Hetero Labs Ltd V |
| January 8, 2015 | ANDA202801 | Levofloxacin LEVOFLOXACIN | Hetero Labs Ltd V |
| December 5, 2014 | ANDA205019 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Nuvo Pharm |
| November 26, 2014 | ANDA203818 | Diclofenac DICLOFENAC SODIUM | Sun Pharma Canada |
| August 9, 2012 | ANDA202289 | Losartan potassium and hydrochlorothiazide LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Macleods Pharms Ltd |
| December 6, 2011 | ANDA091368 | Clonidine CLONIDINE HYDROCHLORIDE | Alembic Pharms Ltd |
| October 24, 2011 | ANDA091680 | Diethylpropion hydrochloride DIETHYLPROPION HYDROCHLORIDE | Lannett Co Inc |
| May 31, 2011 | ANDA200292 | Donepezil hydrochloride DONEPEZIL HYDROCHLORIDE | Prinston Inc |
| April 5, 2011 | ANDA079163 | Divalproex sodium DIVALPROEX SODIUM | Unichem Labs Ltd |
| October 6, 2010 | ANDA091629 | Losartan potassium and hydrochlorothiazide LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma |
| March 31, 2008 | ANDA040876 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Kvk Tech |
| October 9, 2007 | ANDA077794 | Oxcarbazepine OXCARBAZEPINE | Sun Pharm Inds |
| August 17, 2007 | ANDA077903 | Zolpidem tartrate ZOLPIDEM TARTRATE | Torrent Pharms |
| June 15, 2007 | NDA021875 | Armodafinil NUVIGIL | Nuvo Pharms |
| December 28, 2006 | ANDA065334 | Amoxicillin AMOXICILLIN | Aurobindo |
| June 19, 2006 | ANDA065325 | Amoxicillin AMOXICILLIN | Hikma |
| August 25, 2005 | ANDA065136 | Clarithromycin CLARITHROMYCIN | Sandoz |
| April 5, 2005 | ANDA077066 | Nitrofurantoin (monohydrate/macrocrystals) NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Sandoz |
| June 9, 2004 | ANDA076558 | Ciprofloxacin CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE | Hikma |
| January 29, 2003 | ANDA040489 | Methocarbamol METHOCARBAMOL | Oxford Pharms |
| March 15, 2002 | ANDA065064 | Amoxicillin and clavulanate potassium (amoxicillin / clavulanate) AMOXICILLIN AND CLAVULANATE POTASSIUM | Sandoz |
| November 13, 1998 | ANDA075185 | Diclofenac DICLOFENAC SODIUM | Carlsbad |
| July 9, 1998 | ANDA074752 | Diltiazem CARTIA XT | Actavis Labs Fl Inc |
| March 7, 1997 | ANDA040188 | Carisoprodol CARISOPRODOL | Oxford Pharms |
| July 15, 1996 | ANDA040156 | Hydroxyzine HYDROXYZINE PAMOATE | Impax Labs Inc |
| September 13, 1995 | ANDA064135 | Neomycin sulfate, polymyxin b sulfate and dexamethasone DEXASPORIN | Bausch and Lomb Inc |
| November 5, 1981 | ANDA087385 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Padagis Us |
| October 16, 1978 | ANDA080704 | Ergocalciferol VITAMIN D | Bionpharma |
| March 9, 1978 | ANDA085692 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Fougera Pharms |
| February 14, 1957 | NDA010721 | Meclizine hydrochloride ANTIVERT | Casper Pharma LLC |
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.
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