NDC 76125-900-10 Gammaked
Immune Globulin (human) Injection Intravenous; Subcutaneous

Package Information

The NDC Code 76125-900-10 is assigned to a package of 1 vial, glass in 1 carton > 100 ml in 1 vial, glass (76125-900-11) of Gammaked, a plasma derivative labeled by Kedrion Biopharma, Inc.. The product's dosage form is injection and is administered via intravenous; subcutaneous form.This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package.

Field Name Field Value
NDC Code 76125-900-10
Package Description 1 VIAL, GLASS in 1 CARTON > 100 mL in 1 VIAL, GLASS (76125-900-11)
Product Code 76125-900
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.
Gammaked
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.
Immune Globulin (human)
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 in people with a certain type of weakened immune system (primary immune deficiency) to strengthen it and to lower the risk of infection. This medication is made from human blood that has a high level of antibodies which help fight infections. This product is also used to increase the number of certain blood cells (platelets) in people with a certain blood disorder (idiopathic thrombocytopenic purpura-ITP). Platelets are needed to stop bleeding and to form normal blood clots. In addition, this medication is used to treat a certain nerve disorder (chronic inflammatory demyelinating polyneuropathy-CIDP). This disorder causes weakness and numbness/tingling/pain in the arms and legs. This medication helps to improve these symptoms and prevents relapse.
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.
76125090010
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Estimated Billable Units per Package 100 ML
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 10 % per 50 ML Injection
  • RxCUI: 1809414 - immunoglobulin G, human 5 GM 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 Kedrion Biopharma, 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)
    • Intravenous - Administration within or into a vein or veins.
    • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    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.
    BLA125046
    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.
    10-13-2010
    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.
    12-31-2022
    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 76125-900-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    76125090010J1561Gamunex-c/gammaked500 MG10012020

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    Other Product Packages

    The following packages are also available for Gammaked with product NDC 76125-900.

    NDC Package CodePackage Description
    76125-900-011 VIAL, GLASS in 1 CARTON > 10 mL in 1 VIAL, GLASS (76125-900-02)
    76125-900-201 VIAL, GLASS in 1 CARTON > 200 mL in 1 VIAL, GLASS (76125-900-21)
    76125-900-251 VIAL, GLASS in 1 CARTON > 25 mL in 1 VIAL, GLASS (76125-900-26)
    76125-900-501 VIAL, GLASS in 1 CARTON > 50 mL in 1 VIAL, GLASS (76125-900-51)

    * Please review the disclaimer below.