Drug company (FDA labeler)
Slate Run Pharmaceuticals, LLC
NDC labeler code: 70436
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
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 9 products
- GadobutrolGadavist, Pixxoscan · 8 products
- IopamidolIsovue-M, Isovue 370, Isovue 300 · 6 products
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 5 products
- Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideTribenzor · 5 products
- Leucovorin calciumVykoura · 5 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 4 products
- GuanfacineIntuniv · 4 products
- Memantine hydrochloride4 products
- Eptifibatide4 products
- Sodium nitroprussideNipride Rtu · 4 products
- AzithromycinZithromax, Azasite · 4 products
- VancomycinTyzavan, Vancocin · 4 products
- MetoprololToprol XL, Lopressor, Kapspargo · 4 products
- Galantamine3 products
- Cisatracurium besylate3 products
- CyclophosphamideFrindovyx · 3 products
- DesvenlafaxinePristiq Extended-Release · 3 products
- DroxidopaNorthera · 3 products
- LincomycinLincocin · 2 products
- TetrabenazineXenazine · 2 products
- Cilostazol2 products
- Mycophenolic acidMyfortic · 2 products
- Doxycycline hyclate2 products
- GanciclovirZirgan · 2 products
- Tolterodine tartrateDetrol · 2 products
- Gadoterate meglumineDotarem, Clariscan · 2 products
- EsomeprazoleNexium · 1 product
- AcyclovirZovirax, Avaclyr · 1 product
- MethocarbamolRobaxin, Atmeksi, Tanlor · 1 product
- VoriconazoleVfend · 1 product
- DaptomycinDapzura Rt · 1 product
- Dicyclomine hydrochloride1 product
- TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
- Bivalirudin1 product
- Trospium chloride1 product
- GadoteridolProhance · 1 product
- Oseltamivir phosphateTamiflu · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 14, 2025 | ANDA210718 | Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | Piramal |
| February 11, 2025 | ANDA218749 | Gadoteridol GADOTERIDOL | Hainan Poly |
| December 26, 2024 | ANDA218632 | Cyclophosphamide CYCLOPHOSPHAMIDE | Hainan Poly |
| August 27, 2024 | ANDA216539 | Cisatracurium besylate CISATRACURIUM BESYLATE PRESERVATIVE FREE | Hainan Poly |
| June 21, 2024 | ANDA217685 | Doxycycline hyclate DOXYCYCLINE HYCLATE | Hainan Poly |
| June 17, 2024 | ANDA218073 | Gadoterate meglumine GADOTERATE MEGLUMINE | Hainan Poly |
| March 8, 2024 | ANDA216538 | Cisatracurium besylate CISATRACURIUM BESYLATE | Hainan Poly |
| January 8, 2024 | ANDA218111 | Acyclovir ACYCLOVIR SODIUM | Hainan Poly |
| January 2, 2024 | ANDA216805 | Voriconazole VORICONAZOLE | Zhejiang Poly Pharm |
| November 24, 2023 | ANDA218009 | Oseltamivir phosphate OSELTAMIVIR PHOSPHATE | Zhejiang Poly Pharm |
| September 27, 2023 | ANDA217134 | Iopamidol IOPAMIDOL | Hainan Poly |
| July 27, 2023 | ANDA217036 | Azithromycin AZITHROMYCIN | Zhejiang Poly Pharm |
| July 10, 2023 | ANDA217021 | Leucovorin calcium LEUCOVORIN CALCIUM | Hainan Poly |
| March 15, 2023 | ANDA217480 | Gadobutrol GADOBUTROL | Hainan Poly Pharm |
| March 7, 2023 | ANDA216439 | Diltiazem DILTIAZEM HYDROCHLORIDE | Amta |
| February 27, 2023 | ANDA215382 | Iopamidol IOPAMIDOL | Hainan Poly |
| February 1, 2023 | ANDA217029 | Tobramycin TOBRAMYCIN SULFATE | Hainan Poly |
| December 21, 2022 | ANDA216662 | Lincomycin LINCOMYCIN HYDROCHLORIDE | Hainan Poly |
| August 26, 2022 | ANDA215846 | Sodium nitroprusside SODIUM NITROPRUSSIDE | Hainan Poly |
| August 18, 2022 | ANDA215890 | Daptomycin DAPTOMYCIN | Hainan Poly Pharm |
| August 8, 2022 | ANDA216304 | Diltiazem DILTIAZEM HYDROCHLORIDE | Utopic Pharms |
| February 10, 2022 | ANDA215732 | Esomeprazole ESOMEPRAZOLE SODIUM | Hainan Poly |
| November 18, 2021 | ANDA215821 | Vancomycin VANCOMYCIN HYDROCHLORIDE | Hainan Poly |
| November 1, 2021 | ANDA215265 | Droxidopa DROXIDOPA | Pharmazone |
| May 28, 2021 | ANDA213078 | Bivalirudin BIVALIRUDIN | Hainan Poly |
Show the other 20 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| April 30, 2021 | ANDA214760 | Trospium chloride TROSPIUM CHLORIDE | Utopic Pharms |
| April 2, 2021 | ANDA211100 | Memantine hydrochloride MEMANTINE HYDROCHLORIDE | Yichang Humanwell |
| February 12, 2021 | ANDA213854 | Metoprolol METOPROLOL SUCCINATE | Yichang Humanwell |
| February 10, 2021 | ANDA214376 | Mycophenolic acid MYCOPHENOLATE SODIUM | Yichang Humanwell |
| February 2, 2021 | ANDA213858 | Tolterodine tartrate TOLTERODINE TARTRATE | Utopic Pharms |
| November 25, 2020 | ANDA213428 | Guanfacine GUANFACINE HYDROCHLORIDE | Yichang Humanwell |
| August 25, 2020 | ANDA214199 | Sodium nitroprusside SODIUM NITROPRUSSIDE | Hainan Poly |
| January 22, 2020 | ANDA213316 | Tetrabenazine TETRABENAZINE | Piramal |
| September 30, 2019 | ANDA212561 | Potassium chloride POTASSIUM CHLORIDE | Yichang Humanwell |
| June 12, 2019 | ANDA212332 | Vancomycin VANCOMYCIN HYDROCHLORIDE | Hainan Poly |
| January 25, 2019 | ANDA209864 | Eptifibatide EPTIFIBATIDE | Hainan Poly |
| November 8, 2018 | ANDA204204 | Ganciclovir GANCICLOVIR SODIUM | Hainan Poly |
| November 2, 2018 | ANDA207076 | Dicyclomine hydrochloride DICYCLOMINE HYDROCHLORIDE | Slate Run Pharma |
| October 16, 2018 | ANDA211347 | Bupropion BUPROPION HYDROCHLORIDE | Yichang Humanwell |
| October 1, 2018 | ANDA210014 | Desvenlafaxine DESVENLAFAXINE SUCCINATE | Yichang Humanwell |
| June 22, 2018 | ANDA209314 | Potassium chloride POTASSIUM CHLORIDE | Yichang Humanwell |
| June 14, 2018 | ANDA210015 | Bupropion BUPROPION HYDROCHLORIDE | Yichang Humanwell |
| January 19, 2017 | ANDA208116 | Methocarbamol METHOCARBAMOL | Hainan Poly |
| February 6, 2009 | ANDA077604 | Galantamine GALANTAMINE HYDROBROMIDE | Yabao Pharm |
| March 29, 2006 | ANDA077208 | Cilostazol CILOSTAZOL | Slate Run Pharma |
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