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  5. NDC Package Code: 64208-8234-8 Gammaplex

NDC Package 64208-8234-8 Gammaplex

Human Immunoglobulin G Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
64208-8234-8
Package Description:
1 BOTTLE, GLASS in 1 CARTON / 400 mL in 1 BOTTLE, GLASS (64208-8234-4)
Product Code:
64208-8234
Proprietary Name:
Gammaplex
Non-Proprietary Name:
Human Immunoglobulin G
Substance Name:
Human Immunoglobulin G
Usage Information:
This medication is used to strengthen the body's natural defense system (immune system) to lower the risk of infection in persons with a weakened immune system. This medication is made from healthy human blood that has a high level of certain defensive substances (antibodies), which help fight infections. It is also used to increase the blood count (platelets) in persons with a certain blood disorder (idiopathic thrombocytopenia purpura-ITP). Platelets are needed to stop bleeding and form blood clots. Some immune globulin products may also be used to treat a certain type of muscle weakness problem (multifocal motor neuropathy) or a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). Some products may also be used to prevent certain blood vessel disorders in people with Kawasaki syndrome.
11-Digit NDC Billing Format:
64208823408
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1809456 - immunoglobulin G, human 5 % in 100 ML Injection
  • RxCUI: 1809456 - 100 ML immunoglobulin G, human 50 MG/ML Injection
  • RxCUI: 1809456 - immunoglobulin G, human 5 % per 100 ML Injection
  • RxCUI: 1809456 - immunoglobulin G, human 5 GM per 100 ML Injection
  • RxCUI: 1809463 - immunoglobulin G, human 5 % in 200 ML Injection
    • Product Type:
    Plasma Derivative
    Labeler Name:
    Bio Products Laboratory Limited
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • HUMAN IMMUNOGLOBULIN G 5 g/100mL
    • Pharmacologic Class(es):
  • Antigen Neutralization - [MoA] (Mechanism of Action)
  • Human Immunoglobulin G - [EPC] (Established Pharmacologic Class)
  • Immunoglobulins - [CS]
  • Passively Acquired Immunity - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    BLA125329
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    11-01-2010
    Listing Expiration Date:
    12-31-2024
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 64208-8234-8 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    64208823408J1557Gammaplex injection500 MG10014040

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    64208-8234-61 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS (64208-8234-2)
    64208-8234-71 BOTTLE, GLASS in 1 CARTON / 200 mL in 1 BOTTLE, GLASS (64208-8234-3)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 64208-8234-8?

    The NDC Packaged Code 64208-8234-8 is assigned to a package of 1 bottle, glass in 1 carton / 400 ml in 1 bottle, glass (64208-8234-4) of Gammaplex, a plasma derivative labeled by Bio Products Laboratory Limited. The product's dosage form is solution and is administered via intravenous form.

    Is NDC 64208-8234 included in the NDC Directory?

    Yes, Gammaplex with product code 64208-8234 is active and included in the NDC Directory. The product was first marketed by Bio Products Laboratory Limited on November 01, 2010 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 64208-8234-8?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 64208-8234-8?

    The 11-digit format is 64208823408. 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 5-4-1 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
    5-4-164208-8234-85-4-264208-8234-08