NDC 0024-2794

Ferrlecit

Sodium Ferric Gluconate Complex

Ferrlecit is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sanofi-aventis U.s. Llc. The primary component is Sodium Ferric Gluconate Complex.

• Product ID: 0024-2794_07ce6987-8136-40fd-8cab-84f8ac73a0d0
• NDC: 0024-2794
• Product Type: Human Prescription Drug
• Proprietary Name: Ferrlecit
• Generic Name: Sodium Ferric Gluconate Complex
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-07-07
• Marketing Category: NDA / NDA
• Application Number: NDA020955
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: SODIUM FERRIC GLUCONATE COMPLEX
• Active Ingredient Strength: 13 mg/mL
• Pharm Classes: Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0024-2794-10

10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) > 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01)

• Marketing Start Date: 2014-07-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0024-2794-10 [00024279410]

Ferrlecit INJECTION

• Marketing Category: NDA
• Application Number: NDA020955
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-07-07

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FERRIC GLUCONATE COMPLEX	12.5 mg/mL

OpenFDA Data

• SPL SET ID: b25b34ab-9cf1-4a2b-bdf2-5eaf66625999
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • CC9149U2QX
• RxNorm Concept Unique ID - RxCUI:
  • 261123
  • 242761

Pharmacological Class

• Iron [CS]
• Parenteral Iron Replacement [EPC]
• Phosphate Binder [EPC]
• Phosphate Chelating Activity [MoA]

NDC Crossover Matching brand name "Ferrlecit" or generic name "Sodium Ferric Gluconate Complex"

NDC	Brand Name	Generic Name
0024-2792	Ferrlecit	sodium ferric gluconate complex
0024-2794	Ferrlecit	sodium ferric gluconate complex
0591-0149	Sodium Ferric Gluconate Complex	Sodium Ferric Gluconate Complex
0591-2508	Sodium Ferric Gluconate Complex in Sucrose	Sodium Ferric Gluconate Complex