NDC 52584-931

Infed

Iron Dextran

Infed is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Iron Dextran.

• Product ID: 52584-931_3ffb428d-0e61-4057-8975-9e3175fc7373
• NDC: 52584-931
• Product Type: Human Prescription Drug
• Proprietary Name: Infed
• Generic Name: Iron Dextran
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2010-09-01
• Marketing Category: NDA / NDA
• Application Number: NDA017441
• Labeler Name: General Injectables & Vaccines, Inc
• Substance Name: IRON DEXTRAN
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 52584-931-07

1 VIAL, SINGLE-DOSE in 1 BAG (52584-931-07) > 2 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2010-09-01
• Marketing End Date: 2021-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-931-07 [52584093107]

Infed INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA017441
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-09-01
• Marketing End Date: 2021-08-31

Drug Details

Active Ingredients

Ingredient	Strength
IRON DEXTRAN	50 mg/mL

OpenFDA Data

• SPL SET ID: 06e33e48-0c96-4f34-bbfb-39d29ea97dde
• Manufacturer:
  • General Injectables & Vaccines, Inc
• UNII:
  • 95HR524N2M
• RxNorm Concept Unique ID - RxCUI:
  • 206216
  • 311144

Pharmacological Class

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

NDC Crossover Matching brand name "Infed" or generic name "Iron Dextran"

NDC	Brand Name	Generic Name
0023-6082	INFeD	Iron Dextran
0404-9879	INFED	iron dextran
52544-931	INFeD	Iron Dextran
52584-086	INFED	iron dextran
52584-931	Infed	Iron Dextran
51662-1441	IRON DEXTRAN	IRON DEXTRAN