NDC 0591-2508

Sodium Ferric Gluconate Complex in Sucrose

Sodium Ferric Gluconate Complex

Sodium Ferric Gluconate Complex in Sucrose 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: 0591-2508_7f8cad1c-04ec-4ca7-bf25-f0e2da50a03b
• NDC: 0591-2508
• Product Type: Human Prescription Drug
• Proprietary Name: Sodium Ferric Gluconate Complex in Sucrose
• Generic Name: Sodium Ferric Gluconate Complex
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-08-23
• 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 0591-2508-87

10 VIAL, SINGLE-DOSE in 1 CARTON (0591-2508-87) > 5 mL in 1 VIAL, SINGLE-DOSE (0591-2508-26)

• Marketing Start Date: 2012-08-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2508-87 [00591250887]

Sodium Ferric Gluconate Complex in Sucrose INJECTION

• Marketing Category: ANDA
• Application Number: ANDA078215
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-08-23
• Marketing End Date: 2019-06-30

NDC 0591-2508-26 [00591250826]

Sodium Ferric Gluconate Complex in Sucrose INJECTION

• Marketing Category: ANDA
• Application Number: ANDA078215
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-08-23
• 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: fc374c01-f3ed-4920-920b-b19f20fd20a9
• 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 in Sucrose" or generic name "Sodium Ferric Gluconate Complex"

NDC	Brand Name	Generic Name
0143-9298	Sodium Ferric Gluconate Complex in Sucrose	Sodium Ferric Gluconate Complex in Sucrose
0143-9570	Sodium Ferric Gluconate Complex in Sucrose	Sodium Ferric Gluconate Complex in Sucrose
0591-2508	Sodium Ferric Gluconate Complex in Sucrose	Sodium Ferric Gluconate Complex
0024-2792	Ferrlecit	sodium ferric gluconate complex
0024-2794	Ferrlecit	sodium ferric gluconate complex
0591-0149	Sodium Ferric Gluconate Complex	Sodium Ferric Gluconate Complex