Slate Run Pharmaceuticals
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
- LevoleucovorinKhapzory · 2 products
- VoriconazoleVfend · 1 product
- Arformoterol tartrate1 product
- AzithromycinZithromax, Azasite · 1 product
- Dobutamine in dextroseDobutamine Hydrochloride in Dextrose · 1 product
- FluconazoleDiflucan · 1 product
- Amiodarone hydrochloridePacerone, Nexterone · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 11, 2024 | ANDA218253 | Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE | Zhejiang Poly Pharm |
| September 21, 2023 | ANDA215738 | Fluconazole FLUCONAZOLE | Zhejiang Poly Pharm |
| May 22, 2023 | ANDA217314 | Levoleucovorin LEVOLEUCOVORIN CALCIUM | Hainan Poly Pharm |
| December 21, 2022 | ANDA216131 | Dobutamine in dextrose DOBUTAMINE HYDROCHLORIDE | Hainan Poly |
| June 22, 2021 | ANDA213762 | Arformoterol tartrate ARFORMOTEROL TARTRATE | Adaptis |
| November 30, 2018 | ANDA211661 | Voriconazole VORICONAZOLE | Hainan Poly |
| October 9, 2018 | ANDA203412 | Azithromycin AZITHROMYCIN | Hainan Poly |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
-
February 12, 2026 · Class III · Ongoing · D-0343-2026 · Eptifibatide
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Are
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
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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