Drug company (FDA labeler)
Edenbridge Pharmaceuticals LLC.
NDC labeler codes: 42799, 82111
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
- Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 6 products
- PrednisoloneOrapred ODT · 4 products
- BumetanideBumex, Enbumyst · 3 products
- Bisoprolol fumarate and hydrochlorothiazide3 products
- Isosorbide mononitrate3 products
- NintedanibOfev · 2 products
- Etodolac2 products
- Venlafaxine hydrochlorideEffexor XR · 2 products
- TinidazoleTindazole, Tindamax · 2 products
- AtropineAtropen Auto-Injector, Isopto Atropine · 1 product
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 1 product
- MiglustatYargesa, Zavesca, Opfolda · 1 product
- DiclofenacZipsor, Lofena, Cambia · 1 product
- DexamethasoneTaperdex 6-Day, Hemady, Taperdex 12-Day · 1 product
- TofacitinibXeljanz, Xeljanz XR · 1 product
- AlbendazoleAlbenza · 1 product
- Ethacrynic acidEdecrin · 1 product
- Loperamide hydrochloride1 product
- CarbidopaLodosyn · 1 product
- VigabatrinSabril, Vigadrone, Vigafyde · 1 product
- Colestipol hydrochlorideColestid · 1 product
- IvermectinStromectol, Soolantra · 1 product
- Donepezil hydrochlorideAricept · 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 |
|---|---|---|---|
| April 15, 2026 | ANDA219013 | Atropine ATROPINE SULFATE | Edenbridge Pharms |
| April 2, 2026 | ANDA219819 | Nintedanib NINTEDANIB ESYLATE | Dexcel |
| December 16, 2024 | ANDA218668 | Tofacitinib TOFACITINIB CITRATE | Dexcel |
| August 16, 2024 | ANDA217667 | Colestipol hydrochloride COLESTIPOL HYDROCHLORIDE | Edenbridge Pharms |
| June 16, 2023 | ANDA216247 | Pantoprazole sodium PANTOPRAZOLE SODIUM | Dexcel |
| October 6, 2021 | ANDA215001 | Loperamide hydrochloride LOPERAMIDE HYDROCHLORIDE | Edenbridge Pharms |
| September 23, 2021 | ANDA215109 | Vigabatrin VIGABATRIN | Dexcel |
| August 6, 2020 | ANDA209821 | Miglustat YARGESA | Edenbridge Pharms |
| July 9, 2020 | ANDA212678 | Bisoprolol fumarate and hydrochlorothiazide BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | Edenbridge Pharms |
| October 31, 2019 | ANDA209193 | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | Adaptis |
| October 3, 2019 | NDA211379 | Dexamethasone HEMADY | Dexcel |
| May 14, 2019 | ANDA211117 | Albendazole ALBENDAZOLE | Edenbridge Pharms |
| November 30, 2018 | ANDA209888 | Etodolac ETODOLAC | Adaptis |
| August 29, 2018 | ANDA210822 | Isosorbide mononitrate ISOSORBIDE MONONITRATE | Dexcel Ltd |
| December 20, 2016 | ANDA203559 | Prednisolone PREDNISOLONE SODIUM PHOSPHATE | Edenbridge Pharms |
| June 30, 2016 | ANDA205609 | Ethacrynic acid ETHACRYNIC ACID | Adaptis |
| February 19, 2016 | ANDA203713 | Donepezil hydrochloride DONEPEZIL HYDROCHLORIDE | Dexcel |
| February 17, 2016 | ANDA205304 | Carbidopa CARBIDOPA | Edenbridge Pharms |
| August 4, 2015 | ANDA203808 | Tinidazole TINIDAZOLE | Edenbridge Pharms |
| October 24, 2014 | ANDA204154 | Ivermectin IVERMECTIN | Edenbridge Pharms |
| July 3, 2013 | NDA204242 | Buprenorphine and naloxone ZUBSOLV | Edenbridge Pharms |
| November 6, 2002 | ANDA076201 | Diclofenac DICLOFENAC SODIUM | Dexcel Ltd |
| April 17, 2000 | ANDA075522 | Isosorbide mononitrate ISOSORBIDE MONONITRATE | Dexcel Ltd |
| February 28, 1983 | NDA018225 | Bumetanide BUMEX | Validus Pharms |
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