NDC 0591-0149

Sodium Ferric Gluconate Complex

Sodium Ferric Gluconate Complex

Sodium Ferric Gluconate Complex is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Sodium Ferric Gluconate Complex.

• Product ID: 0591-0149_61d69a71-248d-482f-986b-2dae1bb035cd
• NDC: 0591-0149
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Ferric Gluconate Complex
• Generic Name: Sodium Ferric Gluconate Complex
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2011-03-31
• Marketing End Date: 2019-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078215
• Labeler Name: Actavis Pharma, Inc.
• 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

Packaging

NDC 0591-0149-87

10 VIAL in 1 CARTON (0591-0149-87) > 5 mL in 1 VIAL (0591-0149-26)

• Marketing Start Date: 2011-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-0149-87 [00591014987]

Sodium Ferric Gluconate Complex INJECTION

• Marketing Category: ANDA
• Application Number: ANDA078215
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-03-31
• Marketing End Date: 2019-06-30

NDC 0591-0149-26 [00591014926]

Sodium Ferric Gluconate Complex INJECTION

• Marketing Category: ANDA
• Application Number: ANDA078215
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-04-11
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM FERRIC GLUCONATE COMPLEX	12.5 mg/mL

OpenFDA Data

• SPL SET ID: 2b28ca1b-673e-491b-9421-678c999261b0
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • CC9149U2QX
• RxNorm Concept Unique ID - RxCUI:
  • 242761

Pharmacological Class

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

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

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