Quick answers
- What is Elcys?
- Elcys is a brand name of Cysteine hydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Elcys products in 2 strengths and forms.
- Who makes Elcys?
- Exela Pharma holds the FDA application for Elcys (NDA210660, approved April 16, 2019).
- Is there a generic or store brand of Elcys?
- Other products of Cysteine hydrochloride are listed with the FDA, but none in exactly the same strength and form as a Elcys product.
- Has Elcys been recalled?
- FDA enforcement reports list 1 recall of Elcys products; the newest started October 18, 2023. A recall usually concerns specific lots, not every product.
What Elcys is
Each Elcys product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Cysteine hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| cysteine hydrochloride 10 mg/mL injection, solution (intravenous) | Elcys | None listed | DailyMed |
| cysteine hydrochloride 50 mg/mL injection, solution (intravenous) | Elcys | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Cysteine hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA210660 | Exela Pharma | April 16, 2019 | 2 |
Companies that list Elcys
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Elcys products.
- Exela Pharma Sciences, LLC2 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 18, 2023 · Class I · Ongoing · D-0118-2024
Presence of Particulate Matter: Silicone
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28 — Exela Pharma Sciences LLC
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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.