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  5. NDC Package Code: 52584-086-01 Infed

NDC Package 52584-086-01 Infed

Iron Dextran Injection Intramuscular; Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
52584-086-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 BAG / 2 mL in 1 VIAL, SINGLE-DOSE
Product Code:
52584-086
Proprietary Name:
Infed
Non-Proprietary Name:
Iron Dextran
Substance Name:
Iron Dextran
Usage Information:
This medication is used to treat "iron-poor" blood (anemia) in people who cannot take iron by mouth because of side effects or because their anemia has not been successfully treated by it. Low iron levels can occur when the body can't get enough iron from food (poor nutrition, poor absorption) or when there is a large or long-term blood loss (for example, due to hemophilia, stomach bleeding). It is also used by people who have anemia due to long-term kidney disease. Iron is an important part of your red blood cells and is needed to carry oxygen in the body.
11-Digit NDC Billing Format:
52584008601
NDC to RxNorm Crosswalk:
  • RxCUI: 206216 - INFeD 100 MG in 2 ML Injection
  • RxCUI: 206216 - 2 ML iron-dextran complex 50 MG/ML Injection [InFed]
  • RxCUI: 206216 - 2 ML InFed 50 MG/ML Injection
  • RxCUI: 206216 - INFeD 100 MG per 2 ML Injection
  • RxCUI: 311144 - iron dextran 100 MG in 2 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    General Injectables & Vaccines, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • IRON DEXTRAN 50 mg/mL
    • Pharmacologic Class(es):
  • Iron - [CS]
  • Parenteral Iron Replacement - [EPC] (Established Pharmacologic Class)
  • Phosphate Binder - [EPC] (Established Pharmacologic Class)
  • Phosphate Chelating Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA017441
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-21-2019
    End Marketing Date:
    01-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 52584-086-01?

    The NDC Packaged Code 52584-086-01 is assigned to a package of 1 vial, single-dose in 1 bag / 2 ml in 1 vial, single-dose of Infed, a human prescription drug labeled by General Injectables & Vaccines, Inc.. The product's dosage form is injection and is administered via intramuscular; intravenous form.

    Is NDC 52584-086 included in the NDC Directory?

    Yes, Infed with product code 52584-086 is active and included in the NDC Directory. The product was first marketed by General Injectables & Vaccines, Inc. on January 21, 2019.

    What is the 11-digit format for NDC 52584-086-01?

    The 11-digit format is 52584008601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-252584-086-015-4-252584-0086-01