NDC 64208-8235-5 Gammaplex
Human Immunoglobulin G Solution Intravenous

Package Information

What is NDC 64208-8235-5?

The NDC Code 64208-8235-5 is assigned to a package of 1 bottle, glass in 1 carton / 50 ml in 1 bottle, glass (64208-8235-1) of Gammaplex, a plasma derivative labeled by Bio Products Laboratory Limited. The product's dosage form is solution and is administered via intravenous form. The following table has all the important details about this NDC code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

Field Name Field Value
NDC Code 64208-8235-5
Package Description 1 BOTTLE, GLASS in 1 CARTON / 50 mL in 1 BOTTLE, GLASS (64208-8235-1)
Product Code 64208-8235
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Gammaplex
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		 Human Immunoglobulin G
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 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 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 64208823505
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk
  • RxCUI: 1809414 - immunoglobulin G, human 10 % in 50 ML Injection
  • RxCUI: 1809414 - 50 ML immunoglobulin G, human 100 MG/ML Injection
  • RxCUI: 1809414 - immunoglobulin G, human 5 GM per 50 ML Injection
  • RxCUI: 1809414 - immunoglobulin G, human 10 % per 50 ML Injection
  • RxCUI: 1809421 - immunoglobulin G, human 10 % in 100 ML Injection
    • Product Type What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.    		 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)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.    		 No
    Marketing Category What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.    		 BLA - A product marketed under an approved Biologic License Application.
    FDA Application Number What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.    		 BLA125329
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.    		 04-07-2017
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.    		 12-31-2023
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".     		N
    NDC 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.

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    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 64208-8235-5 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    64208823505J1557Gammaplex injection500 MG5011010

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    Other Product Packages

    The following packages are also available for Gammaplex with product NDC 64208-8235.

    NDC Package CodePackage Description
    64208-8235-61 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS (64208-8235-2)
    64208-8235-71 BOTTLE, GLASS in 1 CARTON / 200 mL in 1 BOTTLE, GLASS (64208-8235-3)

    * Please review the disclaimer below.