Source: FDA, National Drug Code (US) Revision Year: 2016
Ferrlecit (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000-440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt.
The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22011)5]nā200ā¢
Ferrlecit is supplied as a clear, dark brown liquid in colorless glass vials. Each sterile, single-dose vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7-9.7.
Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.
| Dosage Forms and Strengths |
|---|
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Injection: 62.5 mg/5 mL (12.5 mg/mL) clear, dark brown liquid in single-dose vial. |
| How Supplied |
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Ferrlecit is a clear, dark brown liquid supplied in colorless glass vials. Each sterile, single-dose vial contains 62.5 mg of elemental iron in 5 mL for intravenous use. Discard unused portion. Carton containing 10 vials: NDC 0024-2792-10 |
| Drug | Countries | |
|---|---|---|
| FERRLECIT | Canada, Germany, Israel, United States |
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