Active ingredient
Sodium Ferric Gluconate Complex
4 finished FDA listings contain Sodium Ferric Gluconate Complex as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SODIUM FERRIC GLUCONATE COMPLEX
- Dosage forms
- Injection
- Routes
- Intravenous
- Manufacturers / labelers
- 2
- Strengths listed
- 12.5 mg/ml
- Brand names in FDA listings
- Ferrlecit
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 261435
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 020955 | SANOFI AVENTIS US | 1999-02-18 | 2 |
| ANDA 078215 | HIKMA | 2011-03-31 | 2 |
Official labeling on DailyMed
- FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC] · version 16 · 2025-11-27
- FERRLECIT (SODIUM FERRIC GLUCONATE COMPLEX) INJECTION [SANOFI-AVENTIS U.S. LLC] · version 12 · 2025-11-27
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 7 · 2025-03-24
- SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION [HIKMA PHARMACEUTICALS USA INC.] · version 5 · 2023-06-09
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.