Prescription medicine
Sodium ferric gluconate complex Brand names: Ferrlecit
Sodium ferric gluconate complex (Ferrlecit) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the sodium ferric gluconate complex FDA label on DailyMed (effective October 7, 2025, sanofi-aventis U.S. LLC); the NDA 20955 record on Drugs@FDA; every sodium ferric gluconate complex label on DailyMed.
Highlights of the record
FDA label of October 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFerrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
Forms and strengths
- 12.5 mg/ml
Injection.
On the market
- Earliest approval on file
- February 18, 1999 Ferrlecit, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first March 31, 2011; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2016 0 Class I among all firms' recalls; latest November 17, 2016
- FAERS reports
- 2,153 through July 30, 2026
What is sodium ferric gluconate complex used for?
From the label: indications and usageFerrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
Conditions named in the indications of sodium ferric gluconate complex's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Parenteral Iron Replacement and Phosphate Binder.
Source: FDA drug label (Ferrlecit), sanofi-aventis U.S. LLC, effective October 7, 2025 (SPL set b25b34ab-9cf1-4a2b-bdf2-5eaf66625999), via openFDA; the full label on DailyMed
Is there a generic for sodium ferric gluconate complex (Ferrlecit)?
The FDA approved the first generic sodium ferric gluconate complex on March 31, 2011. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium ferric gluconate complex from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has sodium ferric gluconate complex been recalled?
The FDA's Enforcement Report lists 1 recall naming sodium ferric gluconate complex since 2016: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 17, 2016 | Class III | West-Ward Pharmaceuticals Corp. | Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for sodium ferric gluconate complex?
The FDA Adverse Event Reporting System holds 2,153 reports that list sodium ferric gluconate complex among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 440 are coded as a death and 912 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sodium ferric gluconate complex?
8 other medicines are given the same way (intravenous) and in the same FDA class as sodium ferric gluconate complex or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Iron sucrose | Anemia | 3 labelers | n/a | A presentation being discontinued |
| Ferumoxytol | Anemia | 1 labeler | n/a | No current entry |
| Epoetin | Anemia | none listed | $32.27 per mL 2,000 units/mL vial | No current entry |
| Darbepoetin alfa | Anemia | none listed | $446.58 per mL 25 mcg/0.42 mL syring | No current entry |
| Methoxy polyethylene glycol-epoetin beta | Anemia | none listed | n/a | No current entry |
| Ferric derisomaltose | Anemia | none listed | n/a | No current entry |
| Imetelstat | Anemia | none listed | n/a | No current entry |
| Nipocalimab | Anemia | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as sodium ferric gluconate complex
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sodium ferric gluconate complex
- 8 medicines for the same use
- Other parenteral iron replacements
- the pharmacologic class, with prices and generics
- Sodium ferric gluconate complex side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other