Active ingredient
Cysteine
4 finished FDA listings contain Cysteine as their only active ingredient; 34 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CYSTEINE, CYSTEINE HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution, Liquid
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 10 mg/ml · 34.5 mg/ml · 4 [hp_x]/59ml · 50 mg/ml
- Brand names in FDA listings
- Elcys, L-Cysteine 7403
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3024
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 210660 | EXELA PHARMA | 2019-04-16 | 2 |
| NDA 212535 | BAXTER HLTHCARE CORP | 2019-12-13 | 1 |
Official labeling on DailyMed
- ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] · version 3 · 2026-04-10
- CYSTEINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION] · version 5 · 2026-02-19
- L-CYSTEINE 7403 (L-CYSTEINE) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS] · version 2 · 2026-01-12
- ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] · version 3 · 2024-02-02
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.